TEST REPORT EN 60601-1 Medical electrical equipment Part 1 ... · EN 60601-1 Medical electrical...

Report No.: EED33K00035001 of 132

中国认可

国际互认检测TESTING

CNAS L1910

TEST REPORT

EN 60601-1Medical electrical equipment

Part 1: General requirements for basic safety and essential performance

Report Reference No........................ : EED33K00035001

Compiled by (+ signature).................. : Rice Hong ...........................................................

Reviewed by (+ signature)................. : Koke Liu ...........................................................

Approved by (+ signature).................. : Shine yang ...........................................................

Lab Supervisor

Date of issue.........................................: Sept. 25, 2018

Testing Laboratory.............................: Centre Testing International Group Co., Ltd.

Address................................................. : Hongwei Industrial Zone, Bao’ an 70 District, Shenzhen,Guangdong, China

Testing location / address.................. : Same as above

Applicant’s name...............................: Wuhan Dimed Laser Technology Co., Ltd

Address................................................: Room 311, 313, 315, Building 1, Great Wall Innovative SciencePark, Tangxunhu North Road, East Lake Development Zone,Wuhan

Test specification:

Standard.............................................. : EN 60601-1: 2006+A1: 2013+ AC: 2014

Test procedure................................... : Test report only

Non-standard test method………..: N/A

Test Report Form No........................ : IEC60601_1K

Test Report Form Originator.......... : UL(US)

Master TRF.......................................... : 2015-11

Test item description.......................... : Medical diode laser system

Trade Mark............................................. : N/A

Manufacturer......................................... : Wuhan Dimed Laser Technology Co., Ltd

Address................................................. Room 311, 313, 315, Building 1, Great Wall Innovative SciencePark, Tangxunhu North Road, East Lake Development Zone,Wuhan

Model/Type reference......................... : BERYLAS-15FJ, BERYLAS-15FI, BERYLAS-15F, BERYLAS-15J,BERYLAS-15I, BERYLAS-10FJ, BERYLAS-10FI, BERYLAS-10F,BERYLAS-10J, BERYLAS-10I

Ratings....................................................: Input: 100-240V~, 50/60Hz, 160VA

Check No.: 3177404112


Summary of testing

Tests performed (name of test and test clause): Testing location:

All applicable test were performed and test result comply with thisstandard requirement.

Exceptions:

The following clause/ collaterals were not evaluated:

Clause 11.7 Biocompatibility, referencing ISO 10993

Clause 12.2 Usability & Clause 15.1 Arrangements of controls andindicators of ME EQUIPMENT, referencing EN 60601-1-6

Clause 12.3 Alarm system, referencing EN 60601-1-8

Clause 17 EMC, referencing EN 60601-1-2

US national differences clause 8.11b)

Centre Testing International GroupCo., Ltd.

Hongwei Industrial Zone, Bao’ an70 District, Shenzhen, Guangdong,China

Summary of compliance with National Differences

N/A

Copy of marking plate

Copy of marking plate:

The artwork below may be only a draft. The use of certification marks on a product must be authorized bythe respective NCBs that own these marks.

Figure 1. Product Label

The following are other markings:


Note1: The above markings are the minimum requirements required by the safety standard. For the finalproduction samples, the additional markings which do not give rise to misunderstanding may be added.


GENERAL INFORMATION

Test item particulars (see also Clause 6):

Classification of installation and use........................................... : Portable

Device type (component/sub-assembly/ equipment/ system): ME Equipment

Intended use (Including type of patient, application location).: See the general product information

Mode of operation..........................................................................: Continuous

Supply connection......................................................................... Adaptor

Accessories and detachable parts included.............................. : Foot switch, Laser safety goggles, Fiber

Other options include.................................................................... : None

Testing

Date of receipt of test item(s).......................................................: Aug. 03, 2018

Dates tests performed...................................................................: Aug. 14, 2018 to Sept. 20, 2018

Possible test case verdicts:

- test case does not apply to the test object .............................: N/A (N)

- test object does meet the requirement.................................... : Pass (P)

- test object was not evaluated for the requirement................... : N/E (collateral standards only)

- test object does not meet the requirement..............................: Fail (F)

Abbreviations used in the report:

- normal condition..................................................... : N.C. - single fault condition.................. : S.F.C.

- means of Operator protection ............................. : MOOP - means of Patient protection ..... : MOPP

- switching mode power supply............................: SMPS

Name and address of factory (ies)..............................................:

Wuhan Dimed Laser Technology Co., Ltd

Room 311, 313, 315, Building 1, GreatWall Innovative Science Park, TangxunhuNorth Road, East Lake DevelopmentZone, Wuhan

General remarks:"(See Attachment #)" refers to additional information appended to the report."(See appended table)" refers to a table appended to the report.The tests results presented in this report relate only to the object tested.This report shall not be reproduced except in full without the written approval of the testing laboratory.List of test equipment must be kept on file and available for review.Additional test data and/or information provided in the attachments to this report.


General product information:

1. The Number of the Risk Management File is DM-RMF-001, Version: A0.2. The working environment specified by the manufacturer is 5℃-30℃, 10-90% RH, 800-1060hPa.3. The BERYLAS diode laser is a surgical and therapeutic device at the cutting edge of technology, designedfor a wide variety of dental and surgical procedures, as well as for use in providing temporary relief of minorpain.4. The adaptor (Model: GSM160A12) are evaluated and tested by CB Testing Laboratory: TUV Rheinland, tocomply with the requirements of standard EN 60601-1 and Certificate No.: TA 50345678 01.5. Models BERYLAS-15FJ and other models are almost the same (including main PCB, enclosure material,circuit schematic diagram, components, PCB layout, construction) except parameters. Model BERYLAS-15FJwas selected for full test to represent the series.6. “*” indicates the item(s)/method(s) is (are) not in CNAS accreditation scope.


INSULATION DIAGRAM

TABLE: To insulation diagram P

Pollution degree.............................................: 2 --

Overvoltage category.................................... : II --

Altitude............................................................ : ≤2000m --

Additional details on parts considered asapplied parts...................................................:

None Areas_ ______(See Clause 4.6 for details)

N

Area

Number andtype of Meansof Protection:

MOOP,MOPP

CTI Working voltage Requiredcreepage(mm)

Requiredclearance (mm)

Measuredcreepage(mm)

Measuredclearance(mm)

Remarks

Vrms Vpk

A 1 MOOP IIIb 240 339

See supplementary information, Note 2）

Betweenparts of theoppositepolarity

B 1 MOPP IIIb 240 339

Betweenmains parts(L and N)

andprotectiveearthingparts

C 2 MOPP IIIb 240 339

Betweeninput andoutput ofisolation

transformer

D 2 MOPP IIIb 240 339

Betweenmains andaccessiblepart ofadapter


E 2 MOPP IIIb 240 339 8.0 5.0 >10.41) >10.01)Betweenmains andapplied part

F 2 MOOP IIIb 240 339 5.0 4.0 >6.51) >5.21)Betweenmains andfoot switch

G 2 MOOP IIIb 240 339 5.0 4.0 >10.41) >10.01)

Betweenmains andPlastic

enclosure

H 1 MOPP IIIb 240 339 4.0 2.5 -3) -3)

BetweenMetal

accessibleparts and

Applied part

Supplementary information:

1) The values given by more than [minimum required value + 30%] are acceptable according to OD-2020:2015 (sub-clause 4.6.1)

2) The adaptor (Model: GSM160A12) are evaluated and tested by CB Testing Laboratory: TUV Rheinland, tocomply with the requirements of standard EN 60601-1 and Certificate No.TA 50345678 01

3) The applied part connects to device with the optical fiber that there is no conductive connection, refer toClauses 8.7 and 8.8.3 to evaluate safety.


INSULATION DIAGRAM CONVENTIONS and GUIDANCE:

A measured value must be provided in the value columns for the device under evaluation. The symbol >(greater than sign) must not be used. Switch-mode power supplies must be re-evaluated in the device underevaluation therefore N/A must not be used with a generic statement that the component is certified.

Insulation diagram is a graphical representation of equipment insulation barriers, protective impedance andprotective earthing. If feasible, use the following conventions to generate the diagram:

- All isolation barriers are identified by letters between separate parts of diagram, for example separatetransformerwindings, optocouplers, wire insulation, creepage and clearance distances.- Parts connected to earth with large dots are protectively earthed. Other connections to earth are functional- Applied parts are extended beyond the equipment enclosure and terminated with an arrow.- Parts accessible to the operator only are extended outside of the enclosure, but are not terminated with anarrow.


EN 60601-1

Clause Requirement + Test Result - Remark Verdict

4 GENERAL REQUIREMENTS P

4.1 Requirements of this standard applied inNORMAL USE and reasonably foreseeable misuse

Normal use and reasonablyforeseeable misuse wereconsidered.

P

4.2 RISK MANAGEMENT PROCESS FOR ME EQUIPMENT OR ME SYSTEMS P

4.2.2 General requirement for RISK MANAGEMENT -PROCESS complies with ISO14971 (2007)........... :

See Appended RM ResultsTable 4.2.2.

Risk management fileschecked according to ISO14971: 2007

Risk management files (filesNo.: DM-RMF-001, Version:A0) was reviewed.

P

4.2.3 Evaluating RISK P

4.2.3.1 a) Compliance with the standard reducesresidual risk to an acceptable level

P

b) Manufacturer has defined risk acceptabilitycriteria in the RISK MANAGEMENT PLAN.................. :

Refer to the RM File No.: DM-RMF-001 (Version: A0), Table(1-3)

P

c) When no specific technical requirementsprovided manufacturer has determined HAZARDS

or HAZARDOUS SITUATIONS exists.

Refer to the RM File No.: DM-RMF-001 (Version: A0), RiskAnalysis

P

- HAZARDS or HAZARDOUS SITUATIONS have beenevaluated using the RISK MANAGEMENT PROCESS.

P

4.2.3.2 MANUFACTURER has addressed HAZARDS orHAZARDOUS SITUATIONS not specificallyaddressed in the IEC 60601-1 series.

N

4.3 Performance of clinical functions necessary toachieve iNTENDED USE or that could affect thesafety of the ME EQUIPMENT or ME SYSTEM wereidentified during RISK ANALYSIS.

See Appended Table 4.3 P

- Performance limits were identified in bothNORMAL CONDITION and SINGLE FAULT CONDITION.

P

- Loss or degradation of performance beyondthe limits specified by the MANUFACTURER wereevaluated

P

- Functions with unacceptable risks areidentified as ESSENTIAL PERFORMANCE................. :

Refer to the RM File No.: DM-RMF-001 (Version: A0)

P

- RISK CONTROL measures implemented P

- Methods used to verify the effectiveness ofRISK CONTROL measures implemented

P

4.4 EXPECTED SERVICE LIFE stated in RISK

MANAGEMENT FILE..................................................... :Refer to the RM File No.: DM-RMF-001 (Version: A0):

P


EN 60601-1


4.5 Alternative RISK CONTROL methods utilized: No alternative methods utilized N

RESIDUAL RISK resulting from the alternativeRISK CONTROL measures or tests is acceptableand comparable to RESIDUAL RISK resultingfrom application of this standard.........................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

Alternative means based scientific data orclinical opinion or comparative studies............ :

N

4.6 RISK MANAGEMENT PROCESS identifies parts thatcan come into contact with PATIENT but notdefined as APPLIED PARTS, subjected to therequirements for APPLIED PARTS, except forClause 7.2.10............................................................:

N

MANUFACTURER assesses the risk of accessibleparts coming into contact with the patient..... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

Assessment identified the APPLIED PART TYPE

requirements............................................................:N

4.7 ME EQUIPMENT remained SINGLE FAULT SAFE, orthe RISK remained acceptable as determined byClause 4.2................................................................. :

See below P

MANUFACTURER RISK ANALYSIS was used todetermine failures to be tested...........................:

(ISO 14971 Cl. 4.2-4.4)

Refer to the RM File No.: DM-RMF-001 (Version: A0), RiskAnalysis

(ISO 14971 Cl. 4.2-4.4)

P

Failure of any one component at a time thatcould result in a HAZARDOUS SITUATION, includingthose in 13.1, simulated physically ortheoretically ............................................................ :

See appended Table 13.2 forsimulated physical test

P

4.8 All components and wiring whose failure couldresult in a HAZARDOUS SITUATION used accordingto their applicable ratings, unless specified.... :

All critical components andwiring are used within theirspecified ratings

P

Components and wiring exception in thestandard or by RISK MANAGEMENT PROCESS

N

RISK MANAGEMENT PROCESS assessescomponents to identify components where thefailure results in a HAZARDOUS SITUATION forcomponents used outside their ratings...........:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

MANUFACTURER identified components wherethe failure results in a HAZARDOUS SITUATION... :

Refer to the RM File No.: DM-RMF-001 (Version: A0)

P

Components determined to be acceptablewhere used as a MEANS OF PROTECTION............. :

See appended Table 8.10 P


EN 60601-1


Reliability of components used as MEANS OF

PROTECTION assessed for conditions of use inME EQUIPMENT, and they complied with one ofthe following

P

a) Applicable safety requirements of a relevantIEC or ISO standard

P

b) Requirements of this standard applied in theabsence of a relevant IEC or ISO standard

P

4.9 A COMPONENT WITH HIGH-INTEGRITY

CHARACTERISTICS provided and selectedappropriately............................................................:

No HIGH-INTEGRITY componentused

N

RISK MANAGEMENT FILE includes an assessmentto determine if the failure of componentsresults in unacceptable RISK............................... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

Components identified and required to beCOMPONENTS WITH HIGH INTEGRITY

CHARACTERISTIC:

N

4.10 Power supply P

4.10.1 ME EQUIPMENT is suitable for connection toindicated power source (select applicable)........ :

Suitable for connection to aSUPPLY MAINS

P

4.10.2 Maximum rated voltage for ME EQUIPMENT

intended to be connected to SUPPLY MAINS:P

- 250 V for HAND-HELD ME EQUIPMENT (V)...............: Portable ME equipment N

– 250 V d.c. or single-phase a.c., or 500 V poly-phase a.c. for ME EQUIPMENT and ME SYSTEMS witha RATED input ≤ 4 kVA (V)....................................... :

Rated power: 160VA

Rated Maximum Voltage: 100-240V~

P

– 500 V for all other ME EQUIPMENT and ME

SYSTEMS

N

4.11 Power input P

Steady-state measured input of ME EQUIPMENT orME SYSTEM at RATED voltage or voltage range andat operating settings indicated in instructionsfor use didn’t exceed marked rating by morethan 10%.................................................................... :


5 GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT P

5.1 Test not performed when analysis indicatedcondition being tested was adequatelyevaluated by other tests or methods................. :

All relevant tests wereperformed

N


EN 60601-1


RISK MANAGEMENT FILE identifies combinations ofsimultaneous independent faults that couldresult in a HAZARDOUS SITUATION.

(ISO 14971 Cl. 4.2-4.4)

N

5.3 Tests conducted within the environmentalconditions specified in technical description

Environment conditionspecified in “FacilityRequirements” of operationmanual

P

Temperature (ºC), Relative Humidity (%) ..........: Temperature: 5~30℃Relative Humidity: 10-90%RH

—

Atmospheric Pressure (kPa)................................ : 800hPa-1060hPa —

5.5 a) Supply voltage during tests was the leastfavourable of the voltages specified in 4.10.2 orvoltages marked on ME EQUIPMENT (V) ...............:

Rating: 100-240Va.c.

Test considered: 90V &100V &240V & 264Va.c.

P

b) ME EQUIPMENT marked with a RATED frequencyrange tested at the least favourable frequencywithin the range (Hz)...............................................:

50/60Hz P

c) ME EQUIPMENT with more than one RATED

voltage, both a.c./ d.c. or both external powerand INTERNAL ELECTRICAL POWER SOURCE tested inconditions (see 5.4) related to the leastfavourable voltage, nature of supply, and typeof current................................................................... :

Not such equipment N

d) ME EQUIPMENT intended for only d.c. supplyconnection tested with d.c. and influence ofpolarity considered................................................. :

Not intended to be connectedto d.c. supply

N

e)ME EQUIPMENT tested with alternativeACCESSORIES and components specified inACCOMPANYING DOCUMENTS to result in the leastfavourable conditions.............................................:

No such alternativeaccessories and components

N

f) ME EQUIPMENT connected to a separate powersupply as specified in instructions for use

The adapter is regarded as aseparate power supply

P

5.7 ME EQUIPMENT or parts thereof affected byclimatic conditions were set up completely, orpartially, with covers detached and subjected toa humidity preconditioning prior to tests ofClauses 8.7.4 and 8.8.3.............................................:

Humidity preconditioning wasperformed prior to tests ofClauses 8.7.4 and 8.8.3

P

ME EQUIPMENT heated to a temperature betweenT and T + 4°C for at least 4 h and placed in ahumidity chamber with a relative humidity of93%±3% and ambient within 2 °C of T in rangeof +20°C to +32°C for indicated time

Testing performed as below:

Main device: 25°C, 93%R.H.,48h (IPX0)

foot switch: 25°C, 93%R.H.,168h (IP68)

—

5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS P


EN 60601-1


5.9.1 APPLIED PARTS identified by inspection andreference to ACCOMPANYING DOCUMENTS.............. :

By inspection and reference touser manual

P

5.9.2 ACCESSIBLE PARTS P

5.9.2.1 Accessibility determined using standard testfinger of Fig. 6

See Appended Table 5.9.2 P

5.9.2.2 Test hook of Fig. 7 inserted in all openings ofME EQUIPMENT and pulled with a force of 20 N for10 s


5.9.2.3 Conductive parts of actuating mechanisms ofelectrical controls accessible after removal ofhandles, knobs, levers and the like regarded asACCESSIBLE PARTS................................................... :

No such conductive part N

Conductive parts of actuating mechanisms notconsidered ACCESSIBLE PARTS when removal ofhandles, knobs, required use of a TOOL..........:

N

6 CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS P

6.2 CLASS I ME EQUIPMENT, externally powered CLASS I ME EQUIPMENT P

CLASS II ME EQUIPMENT, externally powered N

INTERNALLY POWERED ME EQUIPMENT N

EQUIPMENT with means of connection to a SUPPLY

MAINS complied with CLASS I or CLASS II ME

EQUIPMENT requirements when so connected,and when not connected to SUPPLY MAINS withINTERNALLY POWERED ME EQUIPMENT requirements

N

TYPE B APPLIED PART P

TYPE BF APPLIED PART N

TYPE CF APPLIED PART N

DEFIBRILLATION-PROOF APPLIED PARTS N

6.3 ENCLOSURES classified according to degree ofprotection against ingress of water andparticulate matter as per IEC 60529.................... :

The equipment is classified asIPX0(ordinary equipment).

Foot switch is IP68

P

6.4 ME EQUIPMENT or its parts intended to besterilized classified according to method(s) ofsterilization in instructions for use..................... :

Not intended to be sterilized N

6.5 ME EQUIPMENT and ME SYSTEMS intended for usein an OXYGEN RICH ENVIRONMENT classified forsuch use and complied with 11.2.2

Not intended for use in anOXYGEN RICH ENVIRONMENT

N

6.6 CONTINUOUS or Non-CONTINUOUS OPERATION........: CONTINUOUS OPERATION P


EN 60601-1


7 ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS P

7.1.2 Legibility of Markings Test for Markingsspecified in Clause 7.2-7.6...................................... :


7.1.3 Required markings can be removed only with aTOOL or by appreciable force, are durable andremain CLEARLY LEGIBLE during EXPECTED

SERVICE LIFE of ME EQUIPMENT in NORMAL USE

See appended Tables 7.1.3 P

7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts P

7.2.1 At least markings in 7.2.2, 7.2.5, 7.2.6, 7.2.10,and 7.2.13 were applied when size ofEQUIPMENT, its part, an ACCESSORY, orENCLOSURE did not permit application of allrequired markings .................................................. :

See attached copy of MarkingPlate

P

Remaining markings fully recorded inACCOMPANYING DOCUMENTS..................................... :

Described in “Labeling” in usermanual

P

Markings applied to individual packaging whenimpractical to apply to ME EQUIPMENT

N

Single use item marked........................................... : No single use item N

7.2.2 ME EQUIPMENT marked with: Marked on the product label P

– the name or trademark and contactinformation of the MANUFACTURER

The name and contractinformation of themanufacturer are marked onthe product label.

P

– a MODEL OR TYPE REFERENCE A model is marked P

– a serial number or lot or batch identifier; and A serial number is marked P

– the date of manufacture or use by date The date of manufacture ismarked

P

Detachable components of the ME EQUIPMENT

not marked; misidentification does not presentan unacceptable risk, or

Misidentification does notpresent an unacceptable risk

P

RISK MANAGEMENT FILE includes an assessmentof the RISKS relating to misidentification of alldetachable parts.......................................................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.4)

N

Detachable components of the ME EQUIPMENT

are marked with the name or trademark of theMANUFACTURER, and

N

– a MODEL OR TYPE REFERENCE N

Software forming part of a PEMS identified witha unique identifier.................................................... :

P

7.2.3 Symbol 11 on Table D.1 used, optionally,advice to OPERATOR to consult ACCOMPANYING

DOCUMENTS

N


EN 60601-1


Safety sign 10 on Table D.2) used, advisingOPERATOR that ACCOMPANYING DOCUMENTS mustbe consulted

Symbol marked on thelabel.

P

7.2.4 ACCESSORIES marked with name or trademarkand contact information of their MANUFACTURER,and................................................................................:

Accessories inspected:

Foot switch

P

- with a MODEL or TYPE REFERENCE P

– a serial number or lot or batch identifier P

– the date of manufacture or use by date N

Markings applied to individual packaging whennot practical to apply to ACCESSORIES

N

7.2.5 ME EQUIPMENT and ME SYSTEM intended toreceive power from other equipment, providedwith one of the following

Not such equipment N

- the name or trademark of the manufacturer ofthe other electrical equipment and typereference marked adjacent to the relevantconnection point; or

N

– Table D.2, safety sign No. 10 adjacent to therelevant connection point and listing of therequired details in the instructions for use; or

N

– Special connector style used that is notcommonly available on the market and listing ofthe required details in the instructions for use.

N

7.2.6 Connection to the Supply Mains P

Marking appearing on the outside of partcontaining SUPPLY MAINS connection and,adjacent to connection point

P

For PERMANENTLY INSTALLED ME EQUIPMENT,NOMINAL supply voltage or range marked insideor outside of ME EQUIPMENT

Not PERMANENTLY INSTALLED

ME EQUIPMENT

N

– RATED supply voltage(s) or RATED voltagerange(s) with a hyphen (-) between minimumand maximum voltages (V, V-V)............................ :

Adapter input: 100-240V~ P

Multiple RATED supply voltages or multipleRATED supply voltage ranges are separated by(V/V)..............................................................................:

N

– Nature of supply and type of current...............: Single-phase, AC P

Symbols 1-5, Table D.1 (used for sameparameters................................................................. :

P

– RATED supply frequency or RATED frequencyrange in hertz............................................................. :

50/60Hz P

– Symbol 9 of Table D.1 used for CLASS II ME

EQUIPMENT.................................................................... :Class I ME EQUIPMENT N


EN 60601-1


7.2.7 RATED input in amps or volt-amps, (A, VA)........ : VA P

RATED input in amps or volt-amps, or in wattswhen power factor exceeds 0.9 (A, VA, W)........ :


RATED input for one or more RATED voltageranges provided for upper and lower limits ofthe range or ranges when the range(s) is/aregreater than ± 10 % of the mean value ofspecified range (A, VA,W)....................................... :

N

Input at mean value of range marked whenrange limits do not differ by more than 10 %from mean value (A, VA, W)................................... :

N

Marking includes long-time and most relevantmomentary volt-ampere ratings when provided,each plainly identified and indicated inACCOMPANYING DOCUMENTS (VA).............................. :

No such marking N

Marked input of ME EQUIPMENT provided withmeans for connection of supply conductors ofother electrical equipment includes RATED andmarked output of such means (A, VA, W)...........:

No such means for connection N

7.2.8 Output connectors N

7.2.8.2 Output connectors are marked, except forMULTIPLE SOCKET-OUTLETS or connectorsintended for specified ACCESSORIES orequipment

Without output connectors N

Rated Voltage (V), Rated Current (A).................. : —

Rated Power (W), Output Frequency (Hz)......... : —

7.2.9 ME EQUIPMENT or its parts marked with the IPenvironmental Code per IEC 60529 according toclassification in 6.3 (Table D.3, Code 2), markingoptional for ME EQUIPMENT or parts rated IPX0....:

The equipment is classified asIPX0(ordinary equipment).

Foot switch is IP68

P

7.2.10 Degrees of protection against electric shock asclassified in 6.2 for all APPLIED PARTS markedwith relevant symbols .............................................:

See below P

TYPE B APPLIED PARTS with symbol 19 of TableD.1

P

TYPE BF APPLIED PARTS with symbol 20 of TableD.1.................................................................................:

N

TYPE CF APPLIED PARTS with symbol 21 of TableD.1.................................................................................:

N

DEFIBRILLATION-PROOF APPLIED PARTS marked withsymbols 25-27 of Table D.1.................................... :

No DEFIBRILLATION-PROOFAPPLIED PARTS

N

Proper symbol marked adjacent to or onconnector for APPLIED PART..................................... :

Marked adjacent to APPLIED

PART

P

Safety sign 2 of Table D.2 placed near relevantoutlet............................................................................ :

No such part N


EN 60601-1


An explanation indicating protection of ME

EQUIPMENT against effects of discharge of acardiac defibrillator depends on use of propercables included in instructions for use............... :

N

7.2.11 ME EQUIPMENT suitable for CONTINUOUS OPERATION CONTINUOUS OPERATION P

DUTY CYCLE for ME EQUIPMENT intended for non-CONTINUOUS OPERATION appropriately marked toprovide maximum “on” and “off” time................ :

N

7.2.12 Type and full rating of a fuse marked adjacentto ACCESSIBLE fuse-holder

No ACCESSIBLE fuse-holder N

Fuse type.................................................................... : —

Voltage (V) and Current (A) rating....................... : —

Operating speed (s) and Breaking capacity..... : —

7.2.13 Physiological effects – safety sign and warningstatements ................................................................:

Marked on the equipment P

Nature of HAZARD and precautions for avoidingor minimizing the associated RISK described ininstructions for use.................................................. :

(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

Refer to RM File No.: DM-RMF-001 (Version: A0)

(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

P

7.2.14 HIGH VOLTAGE TERMINAL DEVICES on the outside ofME EQUIPMENT accessible without the use of aTOOL marked with symbol 24 of Table D.1

No such high voltage terminal N

7.2.15 Requirements for cooling provisions marked... : No such cooling provisions N

7.2.17 Packaging marked with special handlinginstructions for transport and/or storage........... :

Refer to the packaging P

Permissible environmental conditions markedon outside of packaging.........................................:

Refer to the packaging P

Packaging marked with a suitable safety signindicating premature unpacking of ME EQUIPMENT

could result in an unacceptable RISK....................:

N

RISK MANAGEMENT FILE includes the assessmentto determine premature unpacking of ME

EQUIPMENT or its parts could result in anunacceptable RISK.................................................... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.3-6.4)

N

Packaging of sterile ME EQUIPMENT orACCESSORIES marked sterile and indicates themethods of sterilization

N

7.2.18 RATED maximum supply pressure from anexternal source marked on ME EQUIPMENT

adjacent to each input connector, and .............. :

No such external sourcepressure

N

- the RATED flow rate also marked N

7.2.19 Symbol 7 of Table D.1 marked on FUNCTIONAL

EARTH TERMINAL...........................................................:No FUNCTIONAL EARTH

TERMINAL

N


EN 60601-1


7.2.20 Removable protective means marked toindicate the necessity for replacement when thefunction is no longer needed.................................. :

No such part N

7.2.21 MOBILE ME EQUIPMENT marked with its massincluding its SAFE WORKING LOAD in kilograms.... :

Not Mobile ME equipment N

7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts P

7.3.1 Maximum power loading of heating elements orlamp-holders designed for use with heatinglamps marked near or in the heater (W).............. :

N

A marking referring to ACCOMPANYING DOCUMENTS

provided for heating elements or lamp-holdersdesigned for heating lamps that can bechanged only by SERVICE PERSONNEL using aTOOL

N

7.3.2 Symbol 24 of Table D.1, or safety sign No.3 ofTable D.2 used to mark presence of HIGH

VOLTAGE parts.............................................................:

No high voltage parts insidethe equipment

N

7.3.3 Type of battery and mode of insertion marked: No battery used N

An identifying marking provided referring toinstructions in ACCOMPANYING DOCUMENTS forbatteries intended to be changed only bySERVICE PERSONNEL using a TOOL............................:

N

A warning provided indicating replacement oflithium batteries or fuel cells when incorrectreplacement would result in an unacceptableRISK.............................................................................. :

N

RISK MANAGEMENT FILE includes an assessmentto determine the replacement of lithiumbatteries or fuel cells leads to an unacceptableRISK if replaced incorrectly.................................... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

N

ACCOMPANYING DOCUMENTS contain a warningindicating the replacement of lithium batteriesor fuel cells by inadequately trained personnelcould result in a HAZARD......................................... :

N

7.3.4 Fuses, replaceable THERMAL CUT-OUTS and OVER-CURRENT RELEASES, accessible by use of a TOOL

Identified .................................................................... :

Fuses used in approvedadapter

N

Voltage (V) and Current (A) rating....................... : —

Operating speed(s), size & breaking capacity. : —

7.3.5 PROTECTIVE EARTH TERMINAL marked with symbol6 of Table D.1

Protective earth terminalmarked on the plug

N

Markings on or adjacent to PROTECTIVE EARTH

TERMINALS not applied to parts requiring removalto make the connection, and remained visibleafter connection made

N


EN 60601-1


7.3.6 Symbol 7 of Table D.1 marked on FUNCTIONAL

EARTH TERMINALS

No FUNCTIONAL EARTH

TERMINALS

N

7.3.7 Terminals for supply conductors markedadjacent to terminals................................................ :

N

Terminals for supply connections are notmarked, the RISK MANAGEMENT FILE includes anassessment of the RISKS resulting frommisconnections......................................................... :(ISO 14971 Cl. 4.3)

N

Terminal markings included in ACCOMPANYING

DOCUMENTS when ME EQUIPMENT too small toaccommodate markings

N

Terminals exclusively for neutral supplyconductor in PERMANENTLY INSTALLED ME

EQUIPMENT marked with Code 1 of Table D.3


ME EQUIPMENT

N

Marking for connection to a 3-phase supply,complies with IEC 60445

N

Markings on or adjacent to electrical connectionpoints not applied to parts requiring removal tomake connection, and remained visible afterconnection made

N

7.3.8 “For supply connections, use wiring materialssuitable for at least X °C” or equivalent, markedat the point of supply connections

N

Statement not applied to parts requiringremoval to make the connection, and CLEARLY

LEGIBLE after connections made

N

7.4 Marking of controls and instruments P

7.4.1 The “on” & “off” positions of switch to controlpower to ME EQUIPMENT or its parts, includingmains switch, marked with symbols 12 and 13 ofTable D.1 or

N

– indicated by an adjacent indicator light, or N

– indicated by other unambiguous means P

The “on/off” positions of push button switchwith bi-stable positions marked with symbol 14of Table D.1, and

No such button switch N

– status indicated by adjacent indicator light N

– status indicated by other unambiguousmeans

N

The “on/off” positions of push button switchwith momentary on position marked withsymbol 15 of Table D.1 or

N

– status indicated by adjacent indicator light N


EN 60601-1


– status indicated by other unambiguousmeans

N

7.4.2 Different positions of control devices/switchesindicated by figures, letters, or other visualmeans

All of control options aredisplayed on the touch screenthrough the obvious way.

P

RISK MANAGEMENT FILE identifies controls wherea change in setting during NORMAL USE results

in an unacceptable RISK..........................................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2, 6.3)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2,6.3)

P

Controls provided with an associatedindicating device when change of setting of acontrol could result in an unacceptable RISK toPATIENT in NORMAL USE............................................. :

N

– or an indication of direction in whichmagnitude of the function changes

N

Control device or switch that brings the ME

EQUIPMENT into the "stand-by" condition markedwith symbol IEC 60417-5009

N

7.4.3 Numeric indications of parameters on ME

EQUIPMENT expressed in SI units according toISO 80000-1 except the base quantities listed inTable 1 expressed in the indicated units

SI units used P

ISO 80000-1 applied for application of SI units,their multiples, and certain other units

N

All Markings in Sub-clause 7.4 complied withtests and criteria of 7.1.2 and 7.1.3..................... :

See Appended Tables 7.1.2and 7.1.3.

P

7.5 Safety signs P

Safety sign with established meaning used P

RISK MANAGEMENT PROCESS identifies markingsused to convey a warning, prohibition ormandatory action that mitigate a RISK notobvious to the OPERATOR........................................ :

(ISO 14971 Cl. 4.2-4.4, 5, 6.3)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2,6.3)

P

Affirmative statement together with safety signplaced in instructions for use if insufficientspace on ME EQUIPMENT

N

Specified colours in ISO 3864-1 used for safetysigns............................................................................ :

Specified colours used P

Safety notices include appropriate precautionsor instructions on how to reduce RISK(S)

P

Safety signs including any supplementary textor symbols described in instructions for use

Described in “Labeling” ofoperation manual.

P


EN 60601-1


- and in a language acceptable to the intendedOPERATOR

English version wasevaluated. Version in otherlanguages shall be evaluatedduring relevant nationalapprovals

P

7.6 Symbols P

7.6.1 Meanings of symbols used for markingdescribed in instructions for use.........................:

Described in “Labeling” ofoperation manual.

P

7.6.3 Symbols used for controls and performanceconform to the IEC or ISO publication wheresymbols are defined, as applicable

P

7.7 Colours of the insulation of conductors P

7.7.1 PROTECTIVE EARTH CONDUCTOR identified bygreen and yellow insulation

Green and yellow insulation isused

P

7.7.2 Insulation on conductors inside ME EQUIPMENT

forming PROTECTIVE EARTH CONNECTIONS

identified by green and yellow at least atterminations

P

7.7.3 Green and yellow insulation identify onlyfollowing conductors:

P

– PROTECTIVE EARTH CONDUCTORS P

– conductors specified in 7.7.2 P

– POTENTIAL EQUALIZATION CONDUCTORS N

– FUNCTIONAL EARTH CONDUCTORS No such functional earthinginsulation conductor

N

7.7.4 Neutral conductors of POWER SUPPLY CORDS are“light blue”

light blue, Approved powersupply cords used

P

7.7.5 Colours of conductors in POWER SUPPLY CORDS

in accordance with IEC 60227-1 or IEC 60245-1Approved power supply cordsused

P

7.8 Indicator lights and controls P

7.8.1 Red indicator lights used only for Warning N

Yellow indicator lights used only for Caution N

Green indicator lights used only for Ready foruse

P

Other colours: Meaning other than red, yellow,or green (colour, meaning).................................... :

No other colours used N

7.8.2 Red used only for emergency control Red used only for emergencycontrol device

P

7.9 ACCOMPANYING DOCUMENTS P

7.9.1 ME EQUIPMENT accompanied by documentscontaining instructions for use, and a technicaldescription

Technical descriptioncontained in user manual

P


EN 60601-1


ACCOMPANYING DOCUMENTS identify ME EQUIPMENT

by the following, as applicable:P

– Name or trade-name of MANUFACTURER andcontact information for the RESPONSIBLE

ORGANIZATION can be referred to............................:

Refer to the manual P

– MODEL or TYPE REFERENCE.....................................: Refer to the manual P

When ACCOMPANYING DOCUMENTS providedelectronically, USABILITY ENGINEERING PROCESS

includes instructions as to what is required inhard copy or as markings on ME EQUIPMENT

Only in paper form N

ACCOMPANYING DOCUMENTS specify special skills,training, and knowledge required of OPERATOR orRESPONSIBLE ORGANIZATION and environmentalrestrictions on locations of use

Described in “Warnings andPrecautions” of operationmanual

P

ACCOMPANYING DOCUMENTS written at a levelconsistent with education, training, and otherneeds of individuals for whom they are intended

P

7.9.2 Instructions for use include the required information P

7.9.2.1 – use of ME EQUIPMENT as intended by theMANUFACTURER:

Described in “Introduction” ofoperation manual

P

– frequently used functions, P

– known contraindication(s) to use of MEEQUIPMENT

Described in“Contraindications” ofoperation manual

P

- parts of the ME EQUIPMENT that are notserviced or maintained while in use with thepatient

Described in “DailyMaintenance” of operationmanual

P

– name or trademark and address of theMANUFACTURER

Refer to the manual P

– MODEL OR TYPE REFERENCE P

Instruction for use included the followingwhen the PATIENT is an intended OPERATOR:

The patient is not an intendedoperator

N

– the PATIENT is an intended OPERATOR N

– warning against servicing and maintenancewhile the ME EQUIPMENT is in use

N

- functions the PATIENT can safely use and,where applicable, which functions the PATIENT

cannot safely use; and

N

–maintenance the PATIENT can perform N

Classifications as in Clause 6, all markings perClause 7.2, and explanation of safety signsand symbols marked on ME EQUIPMENT

Described in “APPENDIX A” ofoperation manual

P


EN 60601-1


Instructions for use are in a languageacceptable to the intended operator

English version was evaluated.Version in other languagesshall be evaluated duringrelevant national approvals

P

7.9.2.2 Instructions for use include all warning andsafety notices

Described in “Warnings andPrecautions” of operationmanual

P

Warning statement for CLASS I ME EQUIPMENT

includedN

Warnings regarding significant RISKS ofreciprocal interference posed by ME EQUIPMENT

during specific investigations or treatments

N

Information on potential electromagnetic orother interference and advice on how to avoidor minimize such interference

Described in “Warnings andPrecautions” of operationmanual.

P

Warning statement for ME EQUIPMENT suppliedwith an integral MULTIPLE SOCKET-OUTLET

provided

No multiple socket-outletprovided

N

The RESPONSIBLE ORGANIZATION is referred tothis standard for the requirements applicableto ME SYSTEMS

Not ME system N

7.9.2.3 Statement on ME EQUIPMENT for connection to aseparate power supply provided ininstructions

Described in “Specifications”of operation manual.

P

7.9.2.4 Warning statement for mains- operated ME

EQUIPMENT with additional power source notautomatically maintained in a fully usablecondition indicating the necessity for periodicchecking or replacement of power source

No additional power source N

RISK MANAGEMENT FILE assesses the RISK

resulting from leakage of batteries.....................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

N

Where the RISK is unacceptable, the IFU

includes a warning to remove the battery if theME EQUIPMENT is not likely to be used for sometime..............................................................................:

N

Specifications of replaceable INTERNAL

ELECTRICAL POWER SOURCE when provided........ :N

Warning indicating ME EQUIPMENT must beconnected to an appropriate power sourcewhen loss of power source would result in anunacceptable RISK................................................... :

N


EN 60601-1


7.9.2.5 Instructions for use include a description of ME

EQUIPMENT, its functions, significant physicaland performance characteristics together withthe expected positions of OPERATOR, PATIENT, orother persons near ME EQUIPMENT in NORMAL

USE

Described in “OperationInstructions” of operationmanual

P

Information provided on materials andingredients PATIENT or OPERATOR is exposed to

No materials and ingredientscan constitute an unacceptableRISK

N

Restrictions specified on other equipment orNETWORK/DATA COUPLINGS, other than thoseforming part of an ME SYSTEM, to which a SIGNAL

INPUT/OUTPUT PART may be connected

Not with other equipment ornetwork/data couplings

N

APPLIED PARTS specified P

7.9.2.6 Information provided indicating where theinstallation instructions may be found orinformation on qualified personnel who canperform the installation


P

7.9.2.7 Instructions provided indicating not to positionME EQUIPMENT to make it difficult to operate thedisconnection device

Mains plug is not the onlydisconnect device

N

7.9.2.8 Necessary information provided for OPERATOR

to bring ME EQUIPMENT into operationDescribed in “OperationInstructions” of operationmanual

P

7.9.2.9 Information provided to operate ME EQUIPMENT Described in “OperationInstructions” of operationmanual

P

Meanings of figures, symbols, warningstatements, abbreviations and indicator lightsdescribed in instructions for use


P

7.9.2.10 A list of all system messages, error messages,and fault messages provided with anexplanation of messages including importantcauses and possible action(s) to be taken toresolve the problem indicated by the message

Described in “Error” and“Troubleshooting” of operationmanual

P

7.9.2.11 Information provided for the OPERATOR tosafely terminate operation of ME EQUIPMENT

Described in “Turn the LaserConsole Off” of operationmanual

P

7.9.2.12 Information provided on cleaning, disinfection,and sterilization methods, and applicableparameters that can be tolerated by ME

EQUIPMENT parts or ACCESSORIES specified

Described in “DailyMaintenance” of operationmanual

P

Components, ACCESSORIES or ME EQUIPMENT

marked for single use, except when requiredby MANUFACTURER to be cleaned, disinfected, orsterilized prior to use

No single use part N


EN 60601-1


7.9.2.13 Instructions provided on preventiveinspection, calibration, maintenance and itsfrequency

Described in “Calibration” ofoperation manual

P

Information provided for safe performance ofroutine maintenance necessary to ensurecontinued safe use of ME EQUIPMENT

P

Parts requiring preventive inspection andmaintenance to be performed by SERVICE

PERSONNEL identified including periods ofapplication

P

Instructions provided to ensure adequatemaintenance of ME EQUIPMENT containingrechargeable batteries to be maintained byanyone other than SERVICE PERSONNEL

No rechargeable battery N

7.9.2.14 A list of ACCESSORIES, detachable parts, andmaterials for use with ME EQUIPMENT provided

Described in “APPENDIX B” ofoperation manual

P

Other equipment providing power to ME SYSTEM

sufficiently describedNo such device N

7.9.2.15 Disposal of waste products, residues, etc., andof ME EQUIPMENT and ACCESSORIES at the end oftheir EXPECTED SERVICE LIFE are identified in theinstruction for use................................................... :

P

7.9.2.16 Instructions for use include informationspecified in 7.9.3 or identify where it can befound (e.g. in a service manual)

N

7.9.2.17 Instruction for use for ME EQUIPMENT emittingradiation for medical purposes, indicate thenature, type, intensity and distribution of thisradiation

Not intended to emit radiation N

7.9.2.18 The instructions for use for ME EQUIPMENT orACCESSORIES supplied sterile indicate that theyhave been sterilized and the method ofsterilization

Described in “TransmissionSystem” of operation manual

P

The instructions for use indicate the necessaryinstructions in the event of damage to thesterile packaging, and where appropriate,details of the appropriate methods of re-sterilization

N

7.9.2.19 The instructions for use contain a uniqueversion identifier...................................................... :

A0 P

7.9.3 Technical description P

7.9.3.1 All essential data provided for safe operation,transport, storage, and measures orconditions necessary for installing ME

EQUIPMENT, and preparing it for use

Described in “Specifications”and “Facility Requirements” ofoperation manual

P

Technical description separable from instructions for use contains requiredinformation, as follows

N


EN 60601-1


– all applicable classifications in Clause 6,warning and safety notices, and explanation ofsafety signs marked on ME EQUIPMENT

The technical description is apart of operation manual

N

– a brief description of the ME EQUIPMENT, howthe ME EQUIPMENT functions and its significantphysical and performance characteristics; and

N

a unique version identifier......................................: N

MANUFACTURER’S optional requirements forminimum qualifications of SERVICE PERSONNEL

documented in technical description

N

7.9.3.2 The technical description contains the following required information P

–type and full rating of fuses used in SUPPLY

MAINS external to PERMANENTLY INSTALLED ME

EQUIPMENT...................................................................:


ME EQUIPMENT

N

– a statement for ME EQUIPMENT with a non-DETACHABLE POWER SUPPLY CORD if POWER

SUPPLY CORD is replaceable by SERVICE

PERSONNEL, and

Detachable power supply cord N

– instructions for correct replacement ofinterchangeable or detachable parts specifiedby MANUFACTURER as replaceable by SERVICE

PERSONNEL, and


P

RISK MANAGEMENT FILE includes an assessmentto determine if replacement of componentsresults in any unacceptable RISKS.......................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2,6.3)

P

– warnings identifying nature of HAZARD whenreplacement of a component could result in anunacceptable RISK, and when replaceable bySERVICE PERSONNEL all information necessary tosafely replace the component

N

7.9.3.3 Technical description indicates, MANUFACTURER

will provide circuit diagrams, component partlists, descriptions, calibration instructions toassist to SERVICE PERSONNEL in parts repair

Described in “Introduction” and“Specifications” of operationmanual

P

7.9.3.4 Means used to comply with requirements of8.11.1 clearly identified in technical description

P

8 PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT P

8.1 Limits specified in Clause 8.4 not exceeded forACCESSIBLE PARTS and APPLIED PARTS in NORMAL

or SINGLE FAULT CONDITIONS

The limits are not exceeded.

Refer to clause 8.4 for details

P

RISK MANAGEMENT FILE identifies conductorsand connectors where breaking free results ina HAZARDOUS SITUATION............................................:(ISO 14971 Cl. 4.3)

Refer to RM File No.: DM-RMF-001 (Version: A0), RiskAnalysis

(ISO 14971 Cl. 4.3)

P


EN 60601-1


8.2 Requirements related to power sources P

8.2.1 Connection to a separate power source P

When ME EQUIPMENT specified for connection toa separate power source other than SUPPLY

MAINS, separate power source considered aspart of ME EQUIPMENT or combinationconsidered as an ME SYSTEM

Adapter considered as a partof device

P

Tests performed with ME EQUIPMENT connectedto separate power supply when one specified

P

When a generic separate power supplyspecified, specification in ACCOMPANYING

DOCUMENTS examined

N

8.2.2 Connection to an external d.c. power source N

No HAZARDOUS SITUATION as described in 13.1developed when a connection with wrongpolarity made for ME EQUIPMENT from anexternal d.c. source

Not intended to be connect toan external d.c. power source

N

ME EQUIPMENT connected with correct polaritymaintained BASIC SAFETY and ESSENTIAL

PERFORMANCE

N

Protective devices that can be reset by anyonewithout a TOOL returns to NORMAL CONDITION onreset

N

8.3 Classification of APPLIED PARTS P

a) APPLIED PART specified in ACCOMPANYING

DOCUMENTS as suitable for DIRECT CARDIAC

APPLICATION is TYPE CF

N

b) An APPLIED PART provided with a PATIENT

CONNECTION intended to deliver electricalenergy or an electrophysiological signal to orfrom PATIENT is TYPE BF or CF APPLIED PART

N

c) An APPLIED PART not covered by a) or b) is aTYPE B, BF, or CF

Type B applied part P

8.4 Limitation of voltage, current or energy P

8.4.2 ACCESSIBLE PARTS and APPLIED PARTS P

a) Currents from, to, or between PATIENT

CONNECTIONS did not exceed limits for PATIENT

LEAKAGE CURRENT & PATIENT AUXILIARY CURRENT:


b) LEAKAGE CURRENTS from, to, or betweenACCESSIBLE PARTS did not exceed limits forTOUCH CURRENT..........................................................:



EN 60601-1


c) Limits specified in b) not applied to partswhen probability of a connection to a PATIENT,directly or through body of OPERATOR, isnegligible in NORMAL USE, and the OPERATOR isappropriately instructed

No such parts N

Voltage to earth or to other ACCESSIBLE PARTS

did not exceed 42.4 V peak a.c. or 60 V d.c. forabove parts in NORMAL or single fault condition(V a.c. or d.c.)............................................................:

N

Energy did not exceed 240 VA for longer than60 s or stored energy available did not exceed20 J at a potential of 2 V or more (VA or J).......:

N

d) Voltage and energy limits specified in c)above also applied to the following:

See below P

– internal parts touchable by test pin in Fig 8inserted through an opening in an ENCLOSURE;and

No internal parts can betouched by test pin except theconnector of foot switch

See appended Table 8.4.2

P

– internal parts touchable by a metal test rodwith a diameter of 4 mm and a length 100 mm,inserted through any opening on top ofENCLOSURE or through any opening providedfor adjustment of pre-set controls byRESPONSIBLE ORGANIZATION in NORMAL USE usinga TOOL

No opening on top ofenclosure, and no pre-setcontrols parts

N

Test pin or the test rod inserted throughrelevant openings with minimal force of nomore than 1 N

1 N force considered P

Test rod inserted in every possible positionthrough openings provided for adjustment ofpre-set controls that can be adjusted inNORMAL USE, with a force of 10 N

No such openings provided foradjustment of pre-set controls

N

Test repeated with a TOOL specified ininstructions for use

No such tool specified ininstructions for use

N

Test rod freely and vertically suspendedthrough openings on top of ENCLOSURE

N

e) Devices used to de-energize parts when anACCESS COVER opened without a TOOL givesaccess to parts at voltages above levelspermitted by this Clause comply with 8.11.1 formains isolating switches and remain effectivein SINGLE FAULT CONDITION

No such devices used N

A TOOL is required when it is possible toprevent the devices from operating

N

8.4.3 Worst case voltage between pins of plug andbetween either supply pin and ENCLOSURE didnot exceed 60 V one sec after disconnectingthe plug of ME EQUIPMENT or its parts (V)........... :

Approved adapter is used, seeappended Table 8.10

N


EN 60601-1


When voltage exceeded 60 V, calculated ormeasured stored charge didn’t exceed 45 μC........................................................................................:

N

8.4.4 Residual voltage of conductive parts ofcapacitive circuits, having become accessibleafter ME EQUIPMENT was de-energized afterremoval of ACCESS COVERS, didn’t exceed 60Vor calculated stored charge didn’t exceed45μA...................................................................... :

No such parts N

A device manually discharging capacitorsused when automatic discharging was notpossible and ACCESS COVERS could be removedonly with aid of a TOOL

N

Capacitor(s) and connected circuitry markedwith symbol 24 of Table D.1, and manualdischarging device specified in technicaldescription................................................................ :

N

8.5 Separation of parts P

8.5.1 MEANS OF PROTECTION (MOP) P

8.5.1.1 Two MEANS of PROTECTION provided for ME

EQUIPMENT to prevent APPLIED and otherACCESSIBLE PARTS from exceeding limits in 8.4

Two means of protectionprovided

P

Varnishing, enamelling, oxidation, and similarprotective finishes and coatings with sealingcompounds re-plasticizing at temperaturesexpected during operation and sterilizationdisregarded as MEANS OF PROTECTION

N

Components and wiring forming a MEANS OF

PROTECTION comply with 8.10See Appended Table 8.10 P

8.5.1.2 MEANS OF PATIENT PROTECTION (MOPP) P

Solid insulation forming a MEANS OF PATIENT

PROTECTION complied with dielectric strengthtest...............................................................................:

See appended Table 8.8.3 P

CREEPAGE and CLEARANCES forming a MEANS OF

PATIENT PROTECTION complied with Table 12Refer to Insulation Diagramand Table

P

PROTECTIVE EARTH CONNECTIONS forming aMEANS OF PATIENT PROTECTION complied with Cl.8.6

N

Y1 or Y2 capacitor complying with standardIEC 60384-14 considered one MEANS OF PATIENT

PROTECTION ................................................................:

Evaluated in approval adaptortest reports, see their IEC testreports for details

N

Single Y1 capacitor used for two MEANS OF

PATIENT PROTECTION when the working voltageis less than 42,4 V peak a.c. or 60 V d.c............ :

See above N


EN 60601-1


Two capacitors used in series, each RATED fortotal WORKING VOLTAGE across the pair andhave the same NOMINAL capacitance

See above N

Voltage Total Working (V) and C Nominal (F)...............: —

8.5.1.3 MEANS OF OPERATOR PROTECTION (MOOP) P

Solid insulation forming a MEANS OF OPERATOR

PROTECTION complied with:P

– dielectric strength test .......................................: See appended Table 8.8.3 P

– requirements of IEC 60950-1 for INSULATION

CO-ORDINATION

N

CREEPAGE and CLEARANCES forming a MEANS OF

OPERATOR PROTECTION complied with:See appended InsulationDiagram and Table

P

– limits of Tables 13 to 16 (inclusive); or P

– requirements of IEC 60950-1 for INSULATION

CO-ORDINATION

N

PROTECTIVE EARTH CONNECTIONS forming aMEANS OF OPERATOR PROTECTION complied withCl. 8.6

N

– or with requirements and tests of IEC 60950-1 for protective earthing......................................... :

N

A Y2 (IEC 60384-14) capacitor is consideredone MEANS OF OPERATOR PROTECTION.................... :

N

A Y1 (IEC 60384-14 ) capacitor is consideredtwo MEANS OF OPERATOR PROTECTION.................... :

N

Two capacitors used in series each RATED fortotal WORKING VOLTAGE across the pair andhave the same NOMINAL capacitance

N

Voltage Total Working (V) and C Nominal (F)...............: —

Points and applied parts at which impedancesof components, CREEPAGE, CLEARANCES,PROTECTIVE EARTH CONNECTIONS or insulation,prevent ACCESSIBLE PARTS from exceedinglimits in 8.4 were examined whether a failure atany of these points is to be regarded as aNORMAL or SINGLE FAULT CONDITION

Checked P

A MEANS OF PROTECTION protecting APPLIED

PARTS, or parts identified by 4.6 as partssubject to the same requirements, consideredMEANS OF PATIENT PROTECTION................................ :

Refer to insulation diagram P

A MEANS OF PROTECTION protecting other partsconsidered MEANS OF OPERATOR PROTECTION..... :

Refer to insulation diagram P

8.5.2 Separation of PATIENT CONNECTIONS P


EN 60601-1


8.5.2.1 PATIENT CONNECTIONS of F-TYPE APPLIED PART

separated from all other parts by equivalent toone MEANS OF PATIENT PROTECTION for a WORKING

VOLTAGE equal to the MAX. MAINS VOLTAGE..........:

No F-type applied part N

Separation requirement not applied betweenmultiple functions of a single F-TYPE APPLIED

PART

N

PATIENT CONNECTIONS treated as one APPLIED

PART in the absence of electrical separationbetween PATIENT CONNECTIONS of same oranother function

N

MANUFACTURER has defined if multiplefunctions are to be considered as all withinone APPLIED PART or as multiple APPLIED PARTS

........................................................................................:

N

Classification as TYPE BF, CF, or DEFIBRILLATION-PROOF applied to one entire APPLIED PART

N

LEAKAGE CURRENT tests conducted per 8.7.4.....: N

Dielectric strength test conducted per 8.8.3.....: N

CREEPAGE and CLEARANCES measured ................: N

A protective device connected betweenPATIENT CONNECTIONS of an F-TYPE APPLIED PART

and ENCLOSURE to protect against excessivevoltages did not operate below 500 V r.m.s

N

8.5.2.2 PATIENT CONNECTIONS of a TYPE B APPLIED PART

not PROTECTIVELY EARTHED are separated byone MEANS OF PATIENT PROTECTION from metalACCESSIBLE PARTS not PROTECTIVELY EARTHED.....:

Type B applied part P

– except when metal ACCESSIBLE PART isphysically close to APPLIED PART and can beregarded as a part of APPLIED PART; and

N

– RISK that metal ACCESSIBLE PART will makecontact with a source of voltage or LEAKAGE

CURRENT above permitted limits is acceptablylow

N

LEAKAGE CURRENT tests conducted per 8.7.4.....: See appended Table 8.7.4 P

Dielectric strength test conducted per 8.8.3.....: See appended Table 8.8.3 P

Relevant CREEPAGE and CLEARANCES measured P

RISK MANAGEMENT FILE includes an assessmentof the RISK of metal ACCESSIBLE PARTS

contacting a source of voltage or LEAKAGE

CURRENT above the limits........................................ :(ISO 14971 Cl. 4.2-4.4, 5)

Tested to meet the aboverequirements

N


EN 60601-1


8.5.2.3 A connector on a PATIENT lead or PATIENT cable located at the end of the leador cable remote from PATIENT, with conductive part not separated from allPATIENT CONNECTIONS by one MEANS OF PATIENT PROTECTION for a WORKING

VOLTAGE equal to MAXIMUM MAINS VOLTAGE

N

- cannot be connected to earth or hazardousvoltage while the PATIENT CONNECTIONS are incontact with PATIENT.................................................:

No PATIENT lead or PATIENTcable

N

– conductive part of connector not separatedfrom all PATIENT CONNECTIONS did not come intocontact with a flat conductive plate of not lessthan 100 mm diameter

N

– CLEARANCE between connector pins and a flatsurface is at least 0.5 mm

N

– conductive part pluggable into a mainssocket protected from making contact withparts at MAINS VOLTAGE by insulation with aCREEPAGE DISTANCE of at least 1.0 mm, a 1500 Vdielectric strength and complying with 8.8.4.1

N

– required test finger did not make electricalcontact with conductive part when appliedagainst access openings with a force of 10 N,

N

Test finger test (10 N)..........................................: N

Except when RISK MANAGEMENT PROCESS

includes an assessment of RISKS resultingfrom contact with objects other than mainssockets or flat surfaces.......................................:

(ISO 14971 Cl. 4.2-4.4, 5)

N

8.5.4 WORKING VOLTAGE P

– Input supply voltage to ME EQUIPMENT wasRATED voltage or voltage within RATED rangeresulting in highest measured value (V)........... :

Rated voltage: 100-240V~ P

– WORKING VOLTAGE for d.c. voltages withsuperimposed ripple was average value whenpeak-to-peak ripple less than 10% of averagevalue or peak voltage when peak-to-peakripple exceeding 10% of average value (V)...... :

Less than 10% P

– WORKING VOLTAGE for each MEANS OF

PROTECTION forming DOUBLE INSULATION wasvoltage DOUBLE INSULATION, as a whole,subjected to (V)........................................................ :

Considered P

– Intentional or accidental earthing of PATIENT

regarded as a NORMAL CONDITION for WORKING

VOLTAGE involving a PATIENT CONNECTION notconnected to earth

Considered P


EN 60601-1


– WORKING VOLTAGE between PATIENT

CONNECTIONS of an F-TYPE APPLIED PART andENCLOSURE was highest voltage appearingacross insulation in NORMAL USE includingearthing of any part of APPLIED PART (V)............ :

No F-type applied parts N

– WORKING VOLTAGE for DEFIBRILLATION-PROOF

APPLIED PARTS determined disregardingpossible presence of defibrillation voltages


N

– WORKING VOLTAGE was equal to resonancevoltage in case of motors provided withcapacitors between the point where a windingand a capacitor are connected together and aterminal for external conductors (V).................. :

No such parts N

8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS No DEFIBRILLATION-PROOFapplied part

N

8.5.5.1 Classification “DEFIBRILLATION-PROOF APPLIED

PART” applied to one APPLIED PART in itsentirety

N

Isolation of PATIENT CONNECTIONS of aDEFIBRILLATION-PROOF APPLIED PART from otherparts of ME EQUIPMENT accomplished asfollows:

N

a) No hazardous electrical energies appearduring a discharge of cardiac defibrillator .......:

N

b) ME EQUIPMENT complied with relevantrequirements of this standard, providing BASIC

SAFETY and ESSENTIAL PERFORMANCE followingexposure to defibrillation voltage, andrecovery time stated in ACCOMPANYING

DOCUMENTS.................................................................. :

N

8.5.5.2 Means provided to limit energy delivered to a100 Ω load.................................................................. :

N

8.6 Protective and functional earthing and potential equalization of ME EQUIPMENT P

8.6.1 Requirements of 8.6.2 to 8.6.8 applied P

Parts complying with IEC 60950-1 forprotective earthing and serving as MEANS OF

OPERATOR PROTECTION but not PATIENT

PROTECTION exempted from requirements of8.6.2 to 8.6.8

N

8.6.2 PROTECTIVE EARTH TERMINAL is suitable forconnection to an external protective earthingsystem by a PROTECTIVE EARTH CONDUCTOR in aPOWER SUPPLY CORD and a suitable plug or by aFIXED PROTECTIVE EARTH CONDUCTOR..................... :

By a PROTECTIVE EARTH

CONDUCTOR in a POWER SUPPLY

CORD and a suitable plug

P


EN 60601-1


Clamping means of PROTECTIVE EARTH TERMINAL

of ME EQUIPMENT for FIXED supply conductors orPOWER SUPPLY CORDS comply with 8.11.4.3, andcannot be loosened without TOOL

N

Screws for internal PROTECTIVE EARTH

CONNECTIONS completely covered or protectedagainst accidental loosening from outside...... :

N

Earth pin of APPLIANCE INLET forming supplyconnection to ME EQUIPMENT regarded asPROTECTIVE EARTH TERMINAL

Earth pin of appliance inlet isregarded as protective earthterminal.

P

PROTECTIVE EARTH TERMINAL not used formechanical connection between different partsof ME EQUIPMENT or securing components notrelated to protective or functional earthing

Protective earth terminal is notused for such mechanicalconnection or securingcomponents

P

8.6.3 PROTECTIVE EARTH CONNECTION not used for amoving part,

No such part N

except when MANUFACTURER demonstrated inRISK MANAGEMENT FILE connection will remainreliable during EXPECTED SERVICE LIFE .................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

8.6.4 a) PROTECTIVE EARTH CONNECTIONS carried faultcurrents reliably and without excessivevoltage drop................................................................:

Evaluated in approval adaptortest reports

N

b) Allowable TOUCH CURRENT and PATIENT

LEAKAGE CURRENT in SINGLE FAULT CONDITION

were not exceeded, when impedance ofPROTECTIVE EARTH CONNECTIONS exceededvalues in 8.6.4 a) and Table 8.6.4, due tolimited current capability of relevant circuits...:

N

8.6.5 Surface coatings N

Poorly conducting surface coatings onconductive elements removed at the point ofcontact

N

Coating not removed when requirements forimpedance and current-carrying capacity met

N

8.6.6 Plugs and sockets P

PROTECTIVE EARTH CONNECTION whereconnection between SUPPLY MAINS and ME

EQUIPMENT or between separate parts of ME

EQUIPMENT made via a plug and socket wasmade before and interrupted after supplyconnections

PROTECTIVE EARTH CONNECTION

was made before andinterrupted after supplyconnections

P

- applied also where interchangeable parts arePROTECTIVELY EARTHED

Not such interchangeable parts N

8.6.7 Terminal for connection of a POTENTIAL EQUALIZATION CONDUCTOR N


EN 60601-1


– Terminal is accessible to OPERATOR with ME

EQUIPMENT in any position of NORMAL USE

No potential equalizationconductor used

N

–accidental disconnection avoided in NORMAL

USE

N

– Terminal allows conductor to be detachedwithout a TOOL

N

– Terminal not used for a PROTECTIVE EARTH

CONNECTION

N

– Terminal marked with symbol 8 of Table D.1 N

– Instructions for use contain information onfunction and use of POTENTIAL EQUALIZATION

CONDUCTOR together with a reference torequirements of this standard

N

POWER SUPPLY CORD does not incorporate aPOTENTIAL EQUALIZATION CONDUCTOR

N

8.6.8 FUNCTIONAL EARTH TERMINAL not used to providea PROTECTIVE EARTH CONNECTION

No functional earth terminalused

N

8.6.9 Class II ME EQUIPMENT N

Third conductor of POWER SUPPLY CORD

connected to protective earth contact of MAINS

PLUG provided with CLASS II ME EQUIPMENT withisolated internal screens used as functionalearth connection to the screen’s FUNCTIONAL

EARTH TERMINAL, coloured green and yellow

Class I ME EQUIPMENT N

ACCOMPANYING DOCUMENTS include a statementthat the third conductor in the POWER SUPPLY

CORD is only a functional earth.

N

Two MEANS OF PROTECTION provided betweeninsulation of internal screens and all internalwiring connected to them and ACCESSIBLE

PARTS

N

8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS P

8.7.1 a) Electrical isolation providing protectionagainst electric shock limits currents to valuesin 8.7.3......................................................................... :

See appended Tables 8.7 P

b) Specified values of EARTH LEAKAGE, TOUCH,PATIENT LEAKAGE, and PATIENT AUXILIARY

CURRENTS applied in combination of conditionsin appended Table 8.7............................................. :

See appended Tables 8.7 P

8.7.2 Allowable values specified in 8.7.3 appliedunder SINGLE FAULT CONDITIONS of 8.1 b), except

P

– where insulation used in conjunction with aPROTECTIVE EARTH CONNECTION, insulation shortcircuited only under conditions in 8.6.4 b)

Conditions in clause 8.6.4b) isnot applied.

N


EN 60601-1


– the only SINGLE FAULT CONDITION for EARTH

LEAKAGE CURRENT was interruption of onesupply conductor at a time

Interruption of one supply wasconsidered

P

– LEAKAGE CURRENTS and PATIENT AUXILIARY

CURRENT not measured in SINGLE FAULT

CONDITION of short circuiting of one constituentpart of DOUBLE INSULATION

P

SINGLE FAULT CONDITIONS not applied at sametime as special test conditions of MAXIMUM

MAINS VOLTAGE on APPLIED PARTS and non-PROTECTIVELY EARTHED parts of ENCLOSURE

P

8.7.3 Allowable Values P

a) Allowable values in 8.7.3 b), c), and d)measured based on, and are relative tocurrents in Fig 12 a), or by a device measuringfrequency contents of currents as in Fig 12 b. :


b) Allowable values of PATIENT LEAKAGE andAUXILIARY CURRENTS are according to Tables 3& 4, and values of a.c. are relative to currentshaving a frequency not less than 0.1Hz............. :


c) TOUCH CURRENT did not exceed 100 μA inNORMAL CONDITION and 500 μA in SINGLE FAULT

CONDITION (ITNC, ITSFC).................................................:


d) EARTH LEAKAGE CURRENT did not exceed 5mA in NORMAL CONDITION and 10 mA in SINGLE

FAULT CONDITION (IENC, IESFC).....................................:


Higher values of EARTH LEAKAGE CURRENT

permitted for PERMANENTLY INSTALLED ME

EQUIPMENT connected to a supply circuitsupplying only this ME EQUIPMENT according tolocal regulations or IEC 60364-7-710.................. :

Not PERMANENTLY INSTALLED ME

EQUIPMENT

N

e) LEAKAGE CURRENTS, regardless of waveformand frequency, did not exceed 10 mA r.m.s. inNORMAL or in SINGLE FAULT CONDITION (measuredwith a non-frequency-weighted device.............. :


f) LEAKAGE CURRENTS flowing in a FUNCTIONAL

EARTH CONDUCTOR in a non-PERMANENTLY

INSTALLED ME EQUIPMENT are 5 mA in NORMAL

CONDITION, 10 mA in SINGLE FAULT CONDITION...... :

N

8.7.4 LEAKAGE and PATIENT AUXILIARY CURRENTS

measurements...........................................................:See appended Table 8.7 P

8.8 Insulation P

8.8.1 Insulation relied on as MEANS OF PROTECTION,including REINFORCED INSULATION subjected totesting

Refer to insulation diagram. P


EN 60601-1


Insulation exempted from test (complies withclause 4.8)

Insulation of appliance inletwas exempted from dielectrictest.

P

Insulation forming MEANS OF OPERATOR

PROTECTION and complying with IEC 60950-1for INSULATION CO-ORDINATION not tested as in8.8

N

8.8.2 Distance through solid insulation or use of thin sheet material N

Solid insulation forming SUPPLEMENTARY orREINFORCED INSULATION for a PEAK WORKING

VOLTAGE greater than 71 V provided with:

Evaluated in approval adaptortest reports, see their IEC testreports for details

N

a) 0.4 mm, min, distance through insulation, or N

b) does not form part of an ENCLOSURE and notsubject to handling or abrasion during NORMAL

USE, and comprised of:

N

– at least two layers of material, each passedthe appropriate dielectric strength test............:

N

– or three layers of material, for which allcombinations of two layers together passedthe appropriate dielectric strength test........................................................................................:

N

Dielectric strength test for one or two layerswas same as for one MEANS OF PROTECTION forSUPPLEMENTARY INSULATION

N

Dielectric strength test for one or two layerswas same as for two MEANS OF PROTECTION forREINFORCED INSULATION

N

BASIC, SUPPLEMENTARY, and REINFORCED

INSULATION required between windings ofwound components separated by interleavedinsulation complying with a) or b), or both,except when

N

c) Wire with solid insulation, other thansolvent based enamel, complying with a)

No such wire with solidinsulation

N

d) Wire with multi-layer extruded or spirallywrapped insulation complying with b) andcomplying with Annex L

No such wire N

e) Finished wire with spirally wrapped or multi-layer extruded insulation, complying withAnnex L

No such wire N

– BASIC INSULATION: minimum two wrappedlayers or one extruded layer

N

– SUPPLEMENTARY INSULATION: minimum twolayers, wrapped or extruded

N


EN 60601-1


– REINFORCED INSULATION: minimum threelayers, wrapped or extruded

N

In d) and e), for spirally wrapped insulationwith CREEPAGE DISTANCES between layers lessthan in Table 12 or 16 (Pollution Degree 1)depending on type of insulation, path betweenlayers sealed as a cemented joint in 8.9.3.3and test voltages of TYPE TESTS in L.3 equal 1.6times of normal values

N

Protection against mechanical stress providedwhere two insulated wires or one bare and oneinsulated wire are in contact inside woundcomponent, crossing at an angle between 45°and 90° and subject to winding tension............:

N

Finished component complied with routinedielectric strength tests of 8.8.3......................... :

N

Tests of Annex L not repeated since materialdata sheets confirm compliance.........................:

N

8.8.3 Dielectric Strength P

Solid insulating materials with a safetyfunction withstood dielectric strength testvoltages ..................................................................... :


8.8.4 Insulation other than wire insulation P

8.8.4.1 Resistance to heat retained by all insulationand insulating partition walls during EXPECTED

SERVICE LIFE of ME EQUIPMENT

Resistance to heat retainedaccordingly

P

ME EQUIPMENT and design documentationexamined.................................................................... :

Considered P

RISK MANAGEMENT FILE examined in conjunctionwith resistance to moisture, dielectricstrength, and mechanical strength tests........... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

Satisfactory evidence of compliance providedby manufacturer for resistance to heat.............. :

Ball pressure test carried out. N

Tests conducted in absence of satisfactoryevidence for resistance to heat............................ :

See below P

a) ENCLOSURE and other external parts ofinsulating material, except insulation offlexible cords and parts of ceramic material,subjected to ball-pressure test using Fig 21apparatus....................................................................:

Non-metallic enclosuresubjected to ball-pressure testSee appended table 8.8.4.1

P


EN 60601-1


b) Parts of insulating material supportinguninsulated parts of MAINS PART subjected toball-pressure test in a), except at 125 °C ± 2 ° Cor ambient indicated in technical description±2°C plus temperature rise determined duringtest of 11.1 of relevant part, if higher (°C)..........:

N

Test not performed on parts of ceramicmaterial, insulating parts of commutators,brush-caps, and similar, and on coil formersnot used as REINFORCED INSULATION

No such material used N

8.8.4.2 Resistance to environmental stress P

Insulating characteristics and mechanicalstrength of all MEANS OF PROTECTION not likelyto be impaired by environmental stressesincluding deposition of dirt resulting fromwear of parts within EQUIPMENT, potentiallyreducing CREEPAGE and CLEARANCES below 8.9

P

Ceramic and similar materials not tightlysintered, and beads alone not used asSUPPLEMENTARY or REINFORCED INSULATION

No such materials N

Insulating material with embedded heatingconductors considered as one MEANS OF

PROTECTION but not two MEANS OF PROTECTION

No such materials N

Parts of natural latex rubber aged bysuspending samples freely in an oxygencylinder containing commercial oxygen to apressure of 2.1 MPa ± 70 kPa, with an effectivecapacity of at least 10 times volume ofsamples

No natural latex rubber used N

There were no cracks visible to naked eyesafter samples kept in cylinder at 70 °C ± 2 °Cfor 96h, and afterwards, left at roomtemperature for at least 16h

N

8.9 CREEPAGE DISTANCES and AIR CLEARANCES P

8.9.1.1 CREEPAGE DISTANCES and AIR CLEARANCES areequal to or greater than values in Tables 12 to16 (inclusive).............................................................:

Refer to Insulation Diagramand Table

P

8.9.1.15 CREEPAGE DISTANCES and AIR CLEARANCES forDEFIBRILLATION-PROOF APPLIED PARTS are 4 mmor more to meet 8.5.5.1


N

8.9.2 a) Short circuiting of each single one ofCREEPAGE DISTANCES and CLEARANCES in turn didnot result in a HAZARDOUS SITUATION , minCREEPAGE and CLEARANCES not applied...............:

N

8.9.3 Spaces filled by insulating compound N


EN 60601-1


8.9.3.1 Only solid insulation requirements appliedwhere distances between conductive partsfilled with insulating compound

No such construction N

Thermal cycling, humidity preconditioning,and dielectric strength tests

N

8.9.3.2 For insulating compound forming solidinsulation between conductive parts, a singlesample subjected to thermal cyclingPROCEDURE of 8.9.3.4 followed by humiditypreconditioning per 5.7 (for 48 hours), followedby dielectric strength test (cl. 8.8.3 at 1,6 x testvoltage)....................................................................... :

N

Cracks or voids in insulating compoundaffecting homogeneity of material didn’t occur

N

8.9.3.3 Where insulating compound forms a cementedjoint with other insulating parts, three samplestested for reliability of joint

N

A winding of solvent-based enamelled wirereplaced for the test by a metal foil or by a fewturns of bare wire placed close to cementedjoint, and three samples tested as follows:

N

– One sample subjected to thermal cyclingPROCEDURE of 8.9.3.4, and immediately after thelast period at highest temperature duringthermal cycling followed by dielectric strengthtest of cl. 8.8.3 at 1.6 x the test voltage ............. :

N

– The other two samples subjected to humiditypreconditioning of 5.7, except for 48 hoursonly followed by a dielectric strength test of cl.8.8.3 at 1.6 times the test voltage

N

8.9.4 Minimum spacing of grooves transvers to thecreepage distances considered a means ofoprerator protection adjusted based onpollution degree

Pollution degree: 2 P

Force was applied between bare conductorsand outside metal enclosure when measuringcreepage distance and air clearances

P

8.10 Components and wiring P

8.10.1 Components of ME EQUIPMENT likely to result inan unacceptable RISK by their movementsmounted securely.....................................................:

Mounted securely P

RISK MANAGEMENT FILE includes an assessmentof RISKS related to unwanted movement ofcomponents.............................................................. :

(ISO 14791 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14791 Cl. 4.2-4.4, 5, 6.2-6.5)

P


EN 60601-1


8.10.2 Conductors and connectors of ME EQUIPMENT

adequately secured or insulated to preventaccidental detachment............................................:

Adequately secured P

Stranded conductors are not solder-coatedwhen secured by clamping means to preventHAZARDOUS SITUATIONS

N

8.10.3 Interconnecting flexible cords detachablewithout a TOOL used provided with means forconnection to comply with requirements formetal ACCESSIBLE PARTS when a connection isloosened or broken ................................................. :

No such interconnectingflexible cords

N

8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated controldevices

P

8.10.4.1 Control devices of ME EQUIPMENT and theirconnection cords contain only conductors andcomponents operating at 42.4 V peak a.c.,max, or 60 V d.c. in circuits isolated from MAINS

PART by two MEANS OF PROTECTION

Isolated from mains part by2MOPP through approvedAdaptor

Working voltage: 25VAC

P

8.10.4.2 Connection and anchorage of a flexible cord toa HAND-HELD or foot-operated control device ofME EQUIPMENT, at both ends of the cable to thecontrol device, complies with the requirementsfor POWER SUPPLY CORDS in Cl. 8.11.3

See appended Table 8.11.3.5and 8.11.3.6

P

Other HAND-HELD parts, if disturbance orbreaking of one or more of the connectionscould result in a HAZARDOUS SITUATION, alsocomply with tests of Cl. 8.11.3

No hand-held parts N

8.10.5 Mechanical protection of wiring P

a) Internal cables and wiring adequatelyprotected against contact with a moving partor from friction at sharp corners and edges.....:

Adequately protected thatcannot result in hazardoussituation.

P

b) Wiring, cord forms, or components are notlikely to be damaged during assembly orduring opening or closing of ACCESS COVERS

No access covers N

8.10.6 Guiding rollers prevent bending of movableinsulated conductors around a radius of lessthan five times the outer diameter of the lead

No guiding rollers used N

8.10.7 a) Insulating sleeve adequately secured...........: Adequately secured P

b) Sheath of a flexible cord not used as aMEANS OF PROTECTION inside ME EQUIPMENT whenit is subject to mechanical or thermal stressesbeyond its RATED characteristics

Flexible cord inside MEequipment are not subject tomechanical or terminalstresses.

P

c) Insulated conductors of ME EQUIPMENT

subject to temperatures exceeding 70 °C..........:No such insulated conductorsused

N

8.11 MAINS PARTS, components and layout P


EN 60601-1


8.11.1 a) ME EQUIPMENT provided with means ofelectrically isolating its circuits from SUPPLY

MAINS simultaneously on all poles....................... :

Appliance inlet used P

PERMANENTLY INSTALLED ME EQUIPMENT

connected to a poly-phase SUPPLY MAINS

equipped with a device not interrupting neutralconductor, provided local installationconditions prevent voltage on neutralconductor from exceeding limits in 8.4.2 c)


ME EQUIPMENT

N

PERMANENTLY INSTALLED ME EQUIPMENT providedwith means to isolate its circuits electricallyfrom the SUPPLY MAINS are capable of beinglocked in the off position

N

- the isolation device specified in theACCOMPANYING DOCUMENTS

N

b) Means of isolation incorporated in ME

EQUIPMENT, or if external, described intechnical description ..............................................:

Incorporated in ME EQUIPMENt P

c) A SUPPLY MAINS switch used to comply with8.11.1 a) complies with CREEPAGE / CLEARANCES

for a MAINS TRANSIENT VOLTAGE of 4 kV.................:

No such switch used N

d) A SUPPLY MAINS switch not incorporated in aPOWER SUPPLY CORD or external flexible lead

N

e) Actuator of a SUPPLY MAINS switch used tocomply with 8.11.1 a) complies with IEC 60447

N

f) A suitable plug device used in non-PERMANENTLY INSTALLED ME EQUIPMENT with noSUPPLY MAINS SWITCH.................................................:

N

g) A fuse or a semiconductor device not usedas an isolating means

Not used as isolating means P

h) ME EQUIPMENT not provided with a devicecausing disconnection of ME EQUIPMENT fromSUPPLY MAINS by producing a short circuitresulting in operation of an overcurrentprotection device

ME EQUIPMENT not providedsuch disconnection.

P

i) Parts within ENCLOSURE of ME EQUIPMENT witha circuit > 42.4 V peak a.c. or 60 V d.c. thatcannot be disconnected from its supply by anexternal switch or a plug device accessible atall times is protected against touch even afteropening ENCLOSURE by an additional covering

No such parts N

A clear warning notice is marked on outside ofME EQUIPMENT to indicate it exceeds allowabletouch voltage

N


EN 60601-1


For a part that could not be disconnected fromsupply by an external switch or a plug deviceaccessible at all times, the required cover orwarning notice complied with this clause

N

Standard test finger applied N

8.11.2 MULTIPLE SOCKET-OUTLETS integral with ME

EQUIPMENT complied with 16.2 d), second dash;and 16.9.2

No MULTIPLE SOCKET-OUTLETS N

8.11.3 POWER SUPPLY CORDS P

8.11.3.1 MAINS PLUG not fitted with more than one POWER

SUPPLY CORD

Only one power supply cord P

8.11.3.2 POWER SUPPLY CORDS are no less robust thanordinary tough rubber sheathed flexible cord(IEC 60245-1:2003, Annex A, designation 53) orordinary polyvinyl chloride sheathed flexiblecord (IEC 60227-1:1993, Annex A, design 53)..:

H05VV-F P

Only polyvinyl chloride insulated POWER SUPPLY

CORD with appropriate temperature rating usedfor ME EQUIPMENT having external metal partswith a temperature > 75 °C touchable by thecord in NORMAL USE ...............:

N

8.11.3.3 NOMINAL cross-sectional area of conductors ofPOWER SUPPLY CORDS of ME EQUIPMENT is not lessthan in Table 17........................................................:

0.75 mm2 P

8.11.3.4 APPLIANCE COUPLERS complying with IEC 60320-1 are considered to comply with 8.11.3.5 and8.11.3.6..........................................................:

Approved appliance couplerused.

See appended Table 8.10

P

8.11.3.5 Cord anchorage P

a) Conductors of POWER SUPPLY CORD providedwith strain relief and insulation protected fromabrasion at point of entry to ME EQUIPMENT or aMAINS CONNECTOR by a cord anchorage

foot switch is consideredaccording to clause 8.10.4.2

Cable gland is used for strainrelief and insulation protected

P

b) Cord anchorage of POWER SUPPLY CORD is aninsulating material, or

N

– metal, insulated from conductive ACCESSIBLE

PARTS non-PROTECTIVELY EARTHED by a MEANS OF

PROTECTION, or

N

– metal provided with an insulating liningaffixed to cord anchorage

N

c) Cord anchorage prevents cord from beingclamped by a screw bearing directly on cordinsulation

P

d) Screws to be operated when replacingPOWER SUPPLY CORD do not serve to secure anycomponents

No other used P


EN 60601-1


e) Conductors of POWER SUPPLY CORD arrangedto prevent PROTECTIVE EARTH CONDUCTOR

against strain as long as phase conductors arein contact with their terminals

N

f) Cord anchorage prevents POWER SUPPLY

CORD from being pushed into ME EQUIPMENT orMAINS CONNECTOR

Can no be pushed into footswitch

P

Conductors of POWER SUPPLY CORD supplied byMANUFACTURER disconnected from terminals orfrom MAINS CONNECTOR and cord subjected 25times to a pull applied with no jerks, each timefor 1 s, on sheath of the value in Table 18.........:

See appended Table 8.11.3.5 P

Cord subjected to a torque in Table 18 for oneminute immediately after pull tests

P

Cord anchorage did not allow cord sheath tobe longitudinally displaced by more than 2 mmor conductor ends to move over a distance ofmore than 1 mm from their connected position

Displacement: less than 2mm P

CREEPAGE and CLEARANCES not reduced belowlimits in 8.9

N

It was not possible to push the cord into ME

EQUIPMENT or MAINS CONNECTOR to an extent thecord or internal parts would be damaged

Can not be push into the footswitch

N

8.11.3.6 POWER SUPPLY CORDS protected againstexcessive bending at inlet opening ofequipment

For foot switch P

Cord guard complied with test of IEC 60335-1:2001, Clause 25.14, or

N

ME EQUIPMENT placed such that axis of cordguard projected at an angle of 45° with cordfree from stress, and a mass equal 10 x D2

gram attached to the free end of cord (g)........:

P

Cord guard of temperature-sensitive materialtested at 23 °C ± 2 °C, and flat cords bent inthe plane of least resistance

N

Curvature of the cord radius, immediately aftermass attached, was not less than 1.5 x D....... :


8.11.4 MAINS TERMINAL DEVICES N

8.11.4.1 PERMANENTLY INSTALLED and ME EQUIPMENT withnon-DETACHABLE POWER SUPPLY CORD providedwith MAINS TERMINAL DEVICES ensuring reliableconnection

Not PERMANENTLY INSTALLED orME EQUIPMENT with non-DETACHABLE POWER SUPPLY

CORD

N

Terminals alone are not used to keepconductors in position

N


EN 60601-1


Terminals of components other than terminalblocks complying with requirements of thisClause and marked accordingly used asterminals intended for external conductors

N

Screws and nuts clamping externalconductors do not serve to secure any othercomponent

N

8.11.4.2 Arrangement of MAINS TERMINAL DEVICES N

a) Terminals provided for connection ofexternal cords or POWER SUPPLY CORDS togetherwith PROTECTIVE EARTH TERMINAL grouped toprovide convenient means of connection

. N

d) MAINS TERMINAL DEVICES not accessiblewithout use of a TOOL

N

e) A MEANS OF PROTECTION are not shortcircuited when one end of a flexible conductorwith NOMINAL cross-sectional area is stripped 8mm and a single free wire is bent in eachpossible direction

N

8.11.4.3 Internal wiring not subjected to stress andCREEPAGE and CLEARANCES not reduced afterfastening and loosening a conductor of largestcross-sectional area 10 times

N

8.11.4.4 Terminals with clamping means for arewireable flexible cord did not require specialpreparation of conductors and conductorswere not damaged and did not slip out whenclamping means tightened

N

8.11.4.5 Adequate space provided inside ME EQUIPMENT

designed for FIXED wiring or a rewireablePOWER SUPPLY CORD to allow for connection ofconductors

N

Correct connection and positioning ofconductors before ACCESS COVER verified by aninstallation test

N

8.11.5 Mains fuses and OVER-CURRENT RELEASES N

A fuse or OVER-CURRENT RELEASE provided ineach supply lead for CLASS I and CLASS II ME

EQUIPMENT with a functional earth connection..:

A fuse is used in the approvedadapter, see appended Table8.10

N

- in at least one supply lead for other single-phase CLASS II ME EQUIPMENT.................................. :

N

– neutral conductor not fused for PERMANENTLY

INSTALLED ME EQUIPMENT


ME EQUIPMENT

N

– fuses or OVER-CURRENT RELEASES omitted dueto provision of two MEANS OF PROTECTION

between all parts within MAINS PART

N


EN 60601-1


Protective devices have adequate breakingcapacity to interrupt the max. fault current.......:

N

A fuse or OVER-CURRENT RELEASE not providedin a PROTECTIVE EARTH CONDUCTOR

N

Justification for omission of fuses or OVER-CURRENT RELEASES documented........................... :

N

8.11.6 Internal wiring of the MAINS PART N

a) Cross-sectional area of internal wiring in aMAINS PART between MAINS TERMINAL DEVICE orAPPLIANCE INLET and protective devices suitable...................................................................................... :

Evaluated in approval adapter,comply with this requirement

N

b) Cross-sectional area of other wiring in MAINS

PART and sizes of tracks on printed wiringcircuits are sufficient...............................................:

N

9 PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT ANDME SYSTEMS

P

9.2 HAZARDS associated with moving parts N

9.2.1 When ME EQUIPMENT with moving partsPROPERLY INSTALLED, used per ACCOMPANYING

DOCUMENTS or under foreseeable misuse, RISKS

associated with moving parts reduced to anacceptable level........................................................ :

No such moving N

RISK from contact with moving parts reducedto an acceptable level using protectivemeasures, (access, function, shape of parts,energy, speed of motion, and benefits toPATIENT considered)

N

RESIDUAL RISK associated with moving partsconsidered acceptable when exposure wasneeded for ME EQUIPMENT to perform itsintended function, and

N

RISK CONTROLS implemented.................................. : N

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with moving parts.............. :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

All RISKS associated with moving parts havebeen reduced to an acceptable level

N

9.2.2 TRAPPING ZONE N

9.2.2.1 ME EQUIPMENT with a TRAPPING ZONE compliedwith one or more of the following as feasible:

N

– Gaps in Clause 9.2.2.2, or N

– Safe distances in Clause 9.2.2.3, or N


EN 60601-1


– GUARDS and other RISK CONTROL measures in9.2.2.4, or

N

– Continuous activation in Clause 9.2.2.5 N

Control of relevant motion complied with9.2.2.6 when implementation of aboveprotective measures were inconsistent withINTENDED USE of ME EQUIPMENT or ME SYSTEM

N

9.2.2.2 A TRAPPING ZONE considered not to present aMECHANICAL HAZARD when gaps of TRAPPING

ZONE complied with dimensions per Table 20.. :

N

9.2.2.3 A TRAPPING ZONE considered not to present aMECHANICAL HAZARD when distances separatingOPERATOR, PATIENT, and others from TRAPPING

ZONES exceeded values in ISO 13857:2008 ...... :

N

9.2.2.4 GUARDS and other RISK CONTROL measures N

9.2.2.4.1 A TRAPPING ZONE do not to present aMECHANICAL HAZARD when GUARDS or other RISK

CONTROL measures are of robust construction,not easy to bypass or render non-operational,and did not introduce additional unacceptableRISK............................................................................... :

N

9.2.2.4.2 FIXED GUARDS held in place by systems thatcan only be dismantled with a TOOL

N

9.2.2.4.3 Movable GUARDS that can be opened without aTOOL remained attached when GUARD wasopen

N

– they are associated with an interlockpreventing relevant moving parts fromstarting to move while TRAPPING ZONE isaccessible, and stops movement when theGUARD is opened,

N

– absence or failure of one of theircomponents prevents starting, and stopsmoving parts

N

Movable GUARDS complied with any applicabletests

N

9.2.2.4.4 Other RISK CONTROL designed andincorporated into to the control system stopsmovement and

N

– SINGLE FAULT CONDITIONS have a second RISK

CONTROL, orN

ME EQUIPMENT is SINGLE FAULT SAFE N

9.2.2.5 Continuous activation N

Continuous activation used as a RISK CONTROL,complies with the following

N


EN 60601-1


a) movement was in OPERATOR'S field of view N

b) movement of ME EQUIPMENT or its parts waspossible only by continuous activation ofcontrol by OPERATOR

N

c) a second RISK CONTROL provided for SINGLE

FAULT CONDITION of continuous activationsystem, or

N

- the continuous activation system is SINGLE

FAULT SAFE

N

9.2.2.6 Speed of movement(s) positioning parts of ME

EQUIPMENT or PATIENT limited to allow OPERATOR

control of the movement

N

Over travel of such movement occurring afteroperation of a control to stop movement, didnot result in an unacceptable RISK

N

9.2.3 Other MECHANICAL HAZARDS associated with moving parts N

9.2.3.1 Controls positioned, recessed, or protected byother means so that they cannot beaccidentally actuated

N

- unless for the intended PATIENT, the USABILITY

ENGINEERING PROCESS concludes otherwise(e.g. PATIENT with special needs), or

N

- activation does not result in an unacceptableRISK

N

9.2.3.2 Over travel past range limits of the ME

EQUIPMENT prevented................................................:N

Over travel means provided with mechanicalstrength to withstand loading in NORMAL

CONDITION & reasonably foreseeable misuse.... :

N

9.2.4 Emergency stopping devices P

Where necessary to have one or moreemergency stopping device(s), emergencystopping device complied with all thefollowing, except for actuating switch capableof interrupting all power......................................... :

A Emergency stopping devicesprovided

P

a) Emergency stopping device reduced RISK toan acceptable level

P

RISK MANAGEMENT FILE indicates the use of anemergency stopping device reduces the RISK

to an acceptable level.............................................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.6)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.6)

P

b) Proximity and response of OPERATOR toactuate emergency stopping device could berelied upon to prevent HARM

P


EN 60601-1


c) Emergency stopping device actuator wasreadily accessible to OPERATOR

Readily accessible to operator P

d) Emergency stopping device(s) are not partof normal operation of ME EQUIPMENT

Use for emergency situations P

e) Emergency switching operation or stoppingmeans neither introduced further HAZARD norinterfered with operation necessary to removeoriginal MECHANICAL HAZARD

P

f) Emergency stopping device was able tobreak full load of relevant circuit, includingpossible stalled motor currents and the like

P

g) Means for stopping of movements operateas a result of one single action

P

h) Emergency stopping device provided withan actuator in red and easily distinguishableand identifiable from other controls

P

i) An actuator interrupting/opening mechanicalmovements marked on or immediatelyadjacent to face of actuator with symbol 18 ofTable D.1 or “STOP”

“STOP” marked closed to theemergency stopping device

P

j) Emergency stopping device, once actuated,maintained ME EQUIPMENT in disabled conditionuntil a deliberate action, different from thatused to actuate it, was performed

P

k) Emergency stopping device is suitable forits application

P

9.2.5 Means provided to permit quick and saferelease of PATIENT in event of breakdown of ME

EQUIPMENT or failure of power supply,activation of a RISK CONTROL measure, oremergency stopping............................................... :

N

– and uncontrolled or unintended movementof ME EQUIPMENT that could result in anunacceptable RISK prevented

N

– Situations where PATIENT is subjected tounacceptable RISKS due to proximity of movingparts, removal of normal exit routes, or otherHAZARDS prevented

N

– Measures provided to reduce RISK to anacceptable level when after removal ofcounterbalanced parts, other parts of ME

EQUIPMENT can move in a hazardous way

N

RISK MANAGEMENT FILE includes an assessmentof RISKS to the PATIENT related to breakdown ofthe ME EQUIPMENT...................................................... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N


EN 60601-1


9.3 Rough surfaces, sharp corners and edges ofME EQUIPMENT that could result in injury ordamage avoided or covered.................................. :

Smooth surface designed P

9.4 Instability HAZARDS P

9.4.1 ME EQUIPMENT and its parts, other than FIXED,for placement on a surface did notoverbalance (tip over) or move unexpectedlyin NORMAL USE

Tested to meet theserequirements

P

9.4.2 Instability – overbalance P

9.4.2.1 ME EQUIPMENT or its parts did not overbalancewhen prepared per ACCOMPANYING DOCUMENTS,or when tested...........................................................:


9.4.2.2 Instability excluding transport P

ME EQUIPMENT or its did not overbalance whenplaced in different positions of NORMAL USE,....:


A warning provided when overbalanceoccurred during 10° inclined plane test

ME equipment did notoverbalance at the angle of10°

N

9.4.2.3 Instability from horizontal and vertical forces N

a) ME EQUIPMENT or its parts with a mass of25kg or more, intended to be used on thefloor, didn’t overbalance due to pushing,leaning against it

<25kg N

Surfaces of ME EQUIPMENT or its parts where aRISK of overbalancing exists from pushing,etc., permanently marked with a warning ofthe RISK

N

ME EQUIPMENT did not overbalance when testedaccording to Cl. 9.4.2.3 a)

N

b) ME EQUIPMENT, for use on the floor or on atable, did not overbalance due to sitting orstepping

N

ME EQUIPMENT or its parts, for use on the flooror on a table, where RISK of overbalancingexists, permanently marked with the RISK

warning.......................................................................:

N

ME EQUIPMENT did not overbalance when testedaccording to Cl. 9.4.2.3b)....................................... :

N

9.4.2.4 Castors and wheels N

9.4.2.4.1 Means used for transportation of MOBILE ME

EQUIPMENT did not result in an unacceptableRISK when MOBILE ME EQUIPMENT moved orparked in NORMAL USE

N

9.4.2.4.2 Force required to move MOBILE ME EQUIPMENT

did not exceed 200 N............................................... :N


EN 60601-1


9.4.2.4.3 MOBILE ME EQUIPMENT exceeding 45 kg able topass over threshold ................................................:

N

9.4.3 Instability from unwanted lateral movement (including sliding) N

9.4.3.1 a) Brakes of power-driven MOBILE ME EQUIPMENT

normally activated and could only be releasedby continuous actuation of a control

N

b) MOBILE ME EQUIPMENT provided with lockingmeans to prevent unwanted movements

N

c) No unwanted lateral movement resultedwhen MOBILE ME EQUIPMENT placed in itstransport position when test per 9.4.3.1

N

9.4.3.2 Instability excluding transport N

a) MOBILE ME EQUIPMENT provided with wheellocks or braking system compliant with 5 tilttest ..............................................................................:

N

b) MOBILE ME EQUIPMENT provided with wheellocks or braking system compliant with lateralstability test

N

9.4.4 Grips and other handling devices N

a) ME EQUIPMENT with a mass of over 20 kgrequiring lifting in NORMAL USE or transportprovided with suitable handling means, orACCOMPANYING DOCUMENTS specify safe liftingmethod

Not intended to be lifted innormal use or transport

N

Handles, suitably placed to enable ME

EQUIPMENT or its part to be carried by two ormore persons and by examination ofEQUIPMENT, its part, or ACCOMPANYING

DOCUMENTS

N

b) PORTABLE ME EQUIPMENT with a mass > 20 kgprovided with one or more carrying-handlessuitably placed to enable carrying by two ormore persons as confirmed by actual carrying

N

c) Carrying handles and grips and their meansof attachment withstood loading test................ :

N

9.5 Expelled parts HAZARD N

9.5.1 Suitability of means of protecting againstexpelled parts determined by assessment andexamination of RISK MANAGEMENT FILE................ :

(ISO 14971 Cl. 4.3, 4.4, 5, 6.2-6.5)

No expelled parts N

All identified RISKS associated with expelledparts mitigated to an acceptable level

N

9.5.2 Cathode Ray tube(s) complied with IEC60065:2001, Clause 18, or IEC 61965................. :

N

9.6* Acoustic energy (including infra- and ultrasound) and vibration P


EN 60601-1


9.6.1* Human exposure to acoustic energy andvibration from ME EQUIPMENT doesn’t result inunacceptable RISK and

Compliance verificationthrough testing, see below

P

If necessary, confirmed in RISK MANAGEMENT

FILE including audibility of auditory alarmsignals, PATIENT sensitivity, and

(ISO 14971 Cl. 4.2-44, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

All identified RISKS mitigated to an acceptablelevel

P

9.6.2* Acoustic energy P

9.6.2.1* PATIENT, OPERATOR, and other persons are notexposed to acoustic energy from ME EQUIPMENT

in NORMAL USE

P

– 80 dBA for a cumulative exposure of 24 hover a 24 h period (dBA)........................................:

58dB(A) —

- 83 dBA (when halving the cumulativeexposure time) (dBA)............................................. :

—

– 140 dBC (peak) sound pressure level forimpulsive or impact acoustic energy (dB)........:

—

9.6.2.2 RISK MANAGEMENT FILE examined..........................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

9.6.3 Hand-transmitted vibration N

Means provided to protect PATIENT andOPERATOR when hand-transmitted frequency-weighted r.m.s. acceleration generated inNORMAL USE exceeds specified values

N

– 2.5 m/s2 for a cumulative time of 8 h during a24 h period (m/s2).................................................... :

N

– Accelerations for different times, inverselyproportional to square root of time (m/s2)........ :

N

9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure N

9.7.2 Pneumatic and hydraulic parts of ME

EQUIPMENT or ACCESSORIES met requirementsbased on examination of RISK MANAGEMENT FILE

......................................................................................:

(ISO 14971 Cl. 4.3-4.4, 5, 6.2-6.5)

No pressure vessels used N

– No unacceptable RISK resulted from loss ofpressure or loss of vacuum

N

– No unacceptable RISK resulted from a fluidjet caused by leakage or a component failure

No fluid jet N

– Elements of ME EQUIPMENT or an ACCESSORY,especially pipes and hoses leading to anunacceptable RISK protected against harmfulexternal effects

N


EN 60601-1


– Reservoirs and similar vessels leading to anunacceptable RISK are automaticallydepressurized when ME EQUIPMENT is isolatedfrom its power supply

Automatic release pressure N

Means provided for isolation, or localdepressurizing reservoirs and similar vessels,and pressure indication when above notpossible

N

– All elements remaining under pressure afterisolation of ME EQUIPMENT or an ACCESSORY

from its power supply resulting in anunacceptable RISK provided with clearlyidentified exhaust devices, and a warning todepressurize these elements before setting ormaintenance activity

No such parts N

9.7.3 Maximum pressure a part of ME EQUIPMENT canbe subjected to in NORMAL and SINGLE FAULT

CONDITIONS considered to be highest offollowing:

N

a) RATED maximum supply pressure from anexternal source

No external source N

b) Pressure setting of a pressure-relief deviceprovided as part of assembly

N

c) Max pressure that can develop by a sourceof pressure that is part of assembly, unlesspressure limited by a pressure-relief device

N

9.7.4 Max pressure in NORMAL and SINGLE FAULT

CONDITIONS did not exceed MAXIMUM PERMISSIBLE

WORKING PRESSURE for EQUIPMENT part, exceptas allowed in 9.7.7, confirmed by inspection ofTHE MANUFACTURER'S data for the component,ME EQUIPMENT, and by functional tests............... :

N

9.7.5 A pressure vessel withstood a HYDRAULIC TEST

PRESSURE when pressure was more than 50kPa, and product of pressure and volume wasmore than 200 kPaI................................................. :

No such parts N

9.7.6 Pressure-control device regulating pressure inME EQUIPMENT with pressure-relief devicecompleted 100,000 cycles of operation underRATED load and prevented pressure fromexceeding 90 % of setting of pressure-reliefdevice in different conditions of NORMAL USE . :

No Pressure-control device N

9.7.7 Pressure-relief device(s) used where MAXIMUM

PERMISSIBLE WORKING PRESSURE could otherwisebe exceeded met the following, as confirmedby MANUFACTURER’S data, ME EQUIPMENT, RISK

MANAGEMENT FILE, and functional tests.............. :

N

a) Connected as close as possible to pressurevessel or parts of system it is to protect

N


EN 60601-1


b) Installed to be readily accessible forinspection, maintenance, and repair

N

c) Could be adjusted or rendered inoperativewithout a TOOL

N

d) With discharge opening located anddirected as to not to release material towardsany person

N

e) With discharge opening located anddirected as to not to deposit material on partsthat could result in an unacceptable RISK

N

f) Adequate discharge capacity provided toensure that pressure will not exceed MAXIMUM

PERMISSIBLE WORKING PRESSURE of system it isconnected to by more than 10 % when failureoccurs in control of supply pressure

N

g) No shut-off valve provided between apressure-relief device and parts it is to protect

N

h) Min number of cycles of operation 100 000,except for one-time use devices (burstingdisks)

N

RISK MANAGEMENT FILE includes an assessmentof the risks associated with the dischargeopening of the pressure relief device................ :

(ISO 14971 Cl. 4.3, 4.4, 5, 6.2-6.5)

N

9.8 HAZARDS associated with support systems N

9.8.1 ME EQUIPMENT parts designed to support loadsor provide actuating forces when amechanical fault could constitute anunacceptable RISK .................................................. :

No support system N

– Construction of support, suspension, oractuation system complied with Table 21 andTOTAL LOAD

N

– Means of attachment of ACCESSORIES preventpossibility of incorrect attachment that couldresult in an unacceptable RISK

N

– RISK ANALYSIS of support systems includedMECHANICAL HAZARDS from static, dynamic,vibration, foundation and other movements,impact and pressure loading, temperature,environmental, manufacture and serviceconditions..................................................................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N


EN 60601-1


– RISK ANALYSIS included effects of failuressuch as excessive deflection, plasticdeformation, ductile/brittle fracture, fatiguefracture, instability (buckling), stress-assistedcorrosion cracking, wear, material creep anddeterioration, and residual stresses frommanufacturing PROCESSES

N

– Instructions on attachment of structures to afloor, wall, ceiling, included in ACCOMPANYING

DOCUMENTS making adequate allowances forquality of materials used to make theconnection and list the required materials

N

Additional instructions provided on checkingadequacy of surface of structure parts will beattached to

N

9.8.2 Support systems maintain structural integrityduring EXPECTED SERVICE LIFE, and TENSILE

SAFETY FACTORS are not less than in Table 21,except when an alternative method used todemonstrate structural integrity throughoutEXPECTED SERVICE LIFE, or for a foot rest

N

Compliance with 9.8.1 and 9.8.2 confirmed byexamination of ME EQUIPMENT, RISK MANAGEMENT

FILE, specifications and material processing... :

N

RISK MANAGEMENT FILE includes an assessmentof the structural integrity of support system...:

(ISO 14971 Cl. 4.3-4.4, 5, 6.2-6.5)

N

All identified RISKS are mitigated to anacceptable level

N

When test were conducted, testing consistedof application of a test load to supportassembly equal to TOTAL LOAD times requiredTENSILE SAFETY FACTOR while support assemblyunder test was in equilibrium after 1 min, ornot resulted in an unacceptable RISK................. :

N

Where the equipment is not at equilibriumafter 1 min, the RISK MANAGEMENT FILE includesan assessment of the test results.......................:

(ISO 14971 Cl. 4.3-4.4, 5, 6.2-6.5)

N

9.8.3 Strength of PATIENT or OPERATOR support or suspension systems N

9.8.3.1 ME EQUIPMENT parts supporting orimmobilizing PATIENTS presents nounacceptable RISK of physical injuries andaccidental loosening of secured joints............. :

N

RISK MANAGEMENT FILE includes assessment ofthe RISKS associated with physical injuries andaccidental loosening of fixings........................... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N


EN 60601-1


SAFE WORKING LOAD of ME EQUIPMENT or its partssupporting or suspending PATIENTS orOPERATORS is sum of mass of PATIENTS or massof OPERATORS plus mass of ACCESSORIES

supported by ME EQUIPMENT or its parts

N

Supporting and suspending parts for adulthuman PATIENTS or OPERATORS designed for aPATIENT or OPERATOR with a min mass of 135 kgand ACCESSORIES with a min mass of 15 kg,unless stated by MANUFACTURER

N

Maximum mass of PATIENT included in SAFE

WORKING LOAD of ME EQUIPMENT or its partssupporting or suspending PATIENTS adaptedwhen MANUFACTURER specified applications

N

Max allowable PATIENT mass < 135 kg markedon ME EQUIPMENT and stated in ACCOMPANYING

DOCUMENTS

N

Max allowable PATIENT mass over 135 kg statedin ACCOMPANYING DOCUMENTS

N

Examination of markings, ACCOMPANYING

DOCUMENTS, and RISK MANAGEMENT FILE

confirmed compliance .......................................... :

N

9.8.3.2 a) Entire mass of PATIENT or OPERATOR

distributed over an area of 0.1 m2 on a footrest temporarily supporting a standing PATIENT

or OPERATOR.............................................................. :

N

Compliance confirmed by examination of ME

EQUIPMENT specifications of materials and theirprocessing, and tests.............................................:

N

b) Deflection of a support surface from PATIENT

or OPERATOR loading on an area of support/suspension where a PATIENT or OPERATOR cansit did not result in an unacceptable RISK

N


EQUIPMENT, specifications of materials andtheir processing, and by a test............................:

N

9.8.3.3 Dynamic forces that can be exerted onequipment parts supporting or suspending aPATIENT or OPERATOR in NORMAL USE maintainedBASIC SAFETY and ESSENTIAL PERFORMANCE

confirmed test

N

9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES N

9.8.4.1 a) A MECHANICAL PROTECTIVE DEVICE providedfor the support system

N

b) MECHANICAL PROTECTIVE complies with therequirements as follows:

N

– Designed based on TOTAL LOAD N


EN 60601-1


– Has TENSILE SAFETY FACTORS for all parts notless than Table 21, row 7

N

– Activated before travel produced anunacceptable RISK

N

– Takes into account Clauses 9.2.5 and 9.8.4.3 N


EQUIPMENT over travel calculations andevaluation plus functional tests .........................:

N

9.8.4.2 Activation of MECHANICAL PROTECTIVE DEVICE ismade obvious to OPERATOR when ME EQUIPMENT

can still be used after failure of suspension oractuation means and activation of aMECHANICAL PROTECTIVE DEVICE

N

MECHANICAL PROTECTIVE DEVICE requires use ofa TOOL to be reset or replaced

N

9.8.4.3 MECHANICAL PROTECTIVE DEVICE intended to function once N

–use of ME EQUIPMENT not possible untilreplacement of MECHANICAL PROTECTIVE DEVICE

......................................................................................:

N

– ACCOMPANYING DOCUMENTS provided withrequired information on replacement byservice personal

N

– ME EQUIPMENT permanently marked withsafety sign 2 of Table D.

N

– Marking is adjacent to MECHANICAL

PROTECTIVE DEVICE

N

– Compliance confirmed by examination andfollowing test............................................................ :

N

A chain, cable, band, spring, belt, jack screwnut, pneumatic or hydraulic hose, structuralpart or the like, employed to support a load,defeated by a convenient means causingmaximum normal load to fall from mostadverse position permitted by construction ofME EQUIPMENT

N

Load included SAFE WORKING LOAD in 9.8.3.1when system was capable of supporting aPATIENT or OPERATOR

N

No evidence of damage to MECHANICAL

PROTECTIVE DEVICE affecting its ability toperform its intended function

N

9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES N

Support Systems does not require MECHANICAL

PROTECTIVE DEVICES.................................................. :N


EN 60601-1


RISK MANAGEMENT FILE includes an assessmentof RISKS associated with wear on the supportsystem........................................................................ :

(ISO 14971 Cl. 4.3,4.4,5,6.2-6.5)

N

10 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATIONHAZARDS

P

10.1 X-Radiation N

10.1.1 The air kerma did not exceed 5 µGy/hat 5 cmfrom surface of ME EQUIPMENT...............................:

No such source of radiationpart of equipment

N

Annual exposure reduced taking into accountthe irradiated body part, national regulations,and/or international recommendations for ME

EQUIPMENT that has permanent proximity to aPATIENT as part of the INTENDED USE

N

10.1.2 RISK from unintended X-radiation from ME

EQUIPMENT producing X-radiation fordiagnostic and therapeutic purposesaddressed application of applicable particularand collateral standards, or................................. :

No X-radiation N

RISK MANAGEMENT PROCESS as indicated in RISK

MANAGEMENT

FILE...................................................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

10.2 RISK associated with alpha, beta, gamma,neutron, and other particle radiation,addressed in RISK MANAGEMENT PROCESS asshown in RISK MANAGEMENT FILE........................... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

No alpha, beta, gamma,neutron, or other particleradiation

N

10.3 The power density of unintended microwaveradiation at frequencies between 1 GHz and100 GHz does not exceed 10 W/m2

No microwave radiationproduced by such MEequipment.

N

Microwave radiation is propagatedintentionally

N

10.4 Relevant requirements of IEC 60825-1:2007applied to lasers, laser light barriers or similarwith a wavelength range of 180nm to 1 mm.

Refer to the IEC 60825-1:2007test report No.: EED31K002467

P

10.5 RISK associated with visible electromagneticradiation other than emitted by lasers andLEDS, when applicable, addressed in RISK

MANAGEMENT PROCESS as indicated in RISK

MANAGEMENT FILE...................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

No any visible electromagneticradiation other than emitted bylasers produced by such MEequipment

N

10.6 RISK associated with infrared radiation otherthan emitted by lasers and LEDS addressed inRISK MANAGEMENT PROCESS as indicated in RISK


No infrared radiation producedby such ME equipment

N


EN 60601-1


10.7 RISK associated with ultraviolet radiationother than emitted by lasers and LEDS

addressed in RISK MANAGEMENT PROCESS asindicated in RISK MANAGEMENT FILE...................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

No ultraviolet radiationproduced by such MEequipment.

N

11 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHERHAZARDS

P

11.1 Excessive temperatures in ME EQUIPMENT P

11.1.1 Temperatures on ME EQUIPMENT parts did notexceed values in Tables 22 and.......................... :


Surfaces of test corner did not exceed 90 °C P

THERMAL CUT-OUTS did not operate in NORMAL

CONDITION

No such part N

RISK MANAGEMENT FILE includes an assessmentof the duration of contact for all APPLIED PARTS

and ACCESSIBLE PARTS............................................. :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

11.1.2 Temperature of APPLIED PARTS P

11.1.2.1 APPLIED PARTS (hot or cold intended to supplyheat to a PATIENT comply....................................... :

N

Clinical effects determined and documented inthe RISK MANAGEMENT FILE

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

Temperature (hot or cold) of APPLIED PARTS

intended to supply heat to a PATIENT disclosedin the instructions for use

N

11.1.2.2 APPLIED PARTS not intended to supply heat to aPATIENT complies with the limits of Table 24 inNORMAL CONDITION and SINGLE FAULT CONDITION.:

P

APPLIED PARTS surface temperature exceeds41°C disclosed in the user manual:

No exceed 41℃ N

Maximum Temperature.......................................... : —

Conditions for safe contact, e.g. duration orcondition of the PATIENT......................................... :

—

Clinical effects with respect to characteristicstaken or surface pressure documented in theRISK MANAGEMENT FILE

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

APPLIED PARTS surface temperature of equal toor less than 41°C

Less than 41℃ P


EN 60601-1


Analysis documented in the RISK MANAGEMENT

FILE show that APPLIED PART temperatures arenot affected by operation of the ME EQUIPMENT

including SINGLE FAULT CONDITIONS.Measurement of APPLIED PART temperatureaccording to 11.1.3 is not conducted................ :

N

Surfaces of APPLIED PARTS that are cooledbelow ambient temperatures evaluated in theRISK MANAGEMENT PROCESS..................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

11.1.3 Measurements not made when engineeringjudgment and rationale by MANUFACTURER

indicated temperature limits could not exceed,as documented in RISK MANAGEMENT FILE.......... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

Temperature measurementtest carried out.

N

Test corner not used where engineeringjudgment and rationale by MANUFACTURER

indicated test corner will not impactmeasurements, as documented in RISK


Test corner used N

Probability of occurrence and duration ofcontact for parts likely to be touched and forAPPLIED PARTS documented in RISK MANAGEMENT

FILE............................................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

e) Where thermal regulatory devices make thismethod inappropriate, alternative methods formeasurement are justified in the RISK

MANAGEMENT FILE.......................................................:

N

11.1.4 GUARDS preventing contact with hot or coldaccessible surfaces removable only with aTOOL

No such surface N

11.2 Fire prevention P

11.2.1 ENCLOSURE has strength and rigidity necessaryto prevent a fire and met mechanical strengthtests for ENCLOSURES in 15.3

See Clause 15.3 P

11.2.2 Me equipment and me systems used in conjunction with OXYGEN RICH

ENVIRONMENTS

N

11.2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENT

reduced by means limiting spread of................. :The equipment is not intendedto be used in oxygen richenvironments.

N

a) No sources of ignition discovered in anOXYGEN RICH ENVIRONMENT under any of thefollowing conditions

N

1) when temperature of material raised to itsignition temperature

N


EN 60601-1


2) when temperatures affected solder or solderjoints causing loosening, short circuiting, orother failures causing sparking or increasingmaterial temperature to its ignitiontemperature

N

3) when parts affecting safety cracked orchanged outer shape exposing temperatureshigher than 300°C or sparks due tooverheating

N

4) when temperatures of parts or componentsexceeded 300°C, atmosphere was 100 %oxygen, contact material solder, and fuelcotton

N

5) when sparks provided adequate energy forignition by exceeding limits of Figs 35 to 37(inclusive), atmosphere was 100 % oxygen,contact material solder, and fuel cotton

N

Deviations from worst case limits in 4) and 5)above based on lower oxygen concentrationsor less flammable fuels justified anddocumented in RISK MANAGEMENT FILE................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

Alternative test in this clause did not identifyexistence of ignition sources at highestvoltage or current, respectively........................... :

N

A safe upper limit determined by dividingupper limit of voltage or current, respectively,with safety margin factor of three.......................:

N

b) RESIDUAL RISK of fire in an OXYGEN RICH

ENVIRONMENT as determined by application ofRISK MANAGEMENT PROCESS is based onfollowing configurations, or in combination ... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

1) Electrical components in an OXYGEN RICH

ENVIRONMENT provided with power supplieshaving limited energy levels lower than thoseconsidered sufficient for ignition in 11.2.2.1 a)as determined by examination, measurementor calculation of power, energy, andtemperatures in NORMAL and SINGLE FAULT

CONDITIONS identified in 11.2.3............................... :

N

2) Max oxygen concentration measured until itdid not exceed 25 % in ventilatedcompartments with parts that can be a sourceof ignition only in SINGLE FAULT CONDITION andcan be penetrated by oxygen due to anundetected leak (%)................................................ :

N


EN 60601-1


3) A compartment with parts or componentsthat can be a source of ignition only underSINGLE FAULT CONDITION separated from anothercompartment containing an OXYGEN RICH

ENVIRONMENT by sealing all joints and holes forcables, shafts, or other purposes

N

Effect of possible leaks and failures underSINGLE FAULT CONDITION that could causeignition evaluated using a RISK ASSESSMENT todetermine maintenance intervals byexamination of documentation and RISK

MANAGEMENT FILE....................................................... :

N

4) Fire initiated in ENCLOSURE of electricalcomponents in a compartment with OXYGEN

RICH ENVIRONMENT that can become a source ofignition only under SINGLE FAULT CONDITIONS

self-extinguished rapidly and no hazardousamount of toxic gases reached PATIENT asdetermined by analysis of gases ........................ :

N

11.2.2.2 RISK of ignition did not occur and oxygenconcentration did not exceed 25% inimmediate surroundings due to location ofexternal exhaust outlets of an OXYGEN RICH

ENVIRONMENT

N

11.2.2.3 Electrical connections within a compartmentcontaining an OXYGEN RICH ENVIRONMENT underNORMAL USE did not produce sparks

N

– Screw-attachments protected againstloosening during use by varnishing, use ofspring washers, or adequate torques

N

– Soldered, crimped, and pin-and-socketconnections of cables exiting ENCLOSURE

include additional mechanical securing means

N

11.2.3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS ME EQUIPMENT

and ME SYSTEMS consideredN

– Failure of a ventilation system constructedin accordance with 11.2.2.1 b) 2)..........................:

N

– Failure of a barrier constructed inaccordance with 11.2.2.1 b) 3).............................. :

N

– Failure of a component creating a source ofignition (as defined in 11.2.2.1 a)......................... :

N

– Failure of solid insulation or creepage andclearances providing equivalent of at least oneMEANS OF PATIENT PROTECTION but less than twoMEANS OF PATIENT PROTECTION that could createa source of ignition defined in 11.2.2.1 a)..........:

N

– Failure of a pneumatic component resultingin leakage of oxygen-enriched gas..................... :

N


EN 60601-1


11.3 Constructional requirements for fire ENCLOSURES of ME EQUIPMENT P

ME EQUIPMENT met this clause for alternatemeans of compliance with selected HAZARDOUS

SITUATIONS and fault conditions in 13.1.2........... :

Clause 13.1.2 applied P

Constructional requirements were met, or See below P

- constructional requirements specificallyanalysed in RISK MANAGEMENT FILE .......................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

Justification, when requirement not met........... : N

a) Flammability classification of insulated wirewithin fire ENCLOSURE is FV-1, or better, basedon IEC 60695 series as determined byexamination of data on materials.........................:


Flammability classification of connectors,printed circuit boards, and insulating materialon which components are mounted is FV-2, orbetter, based on IEC 60695-11-10 as decidedby examination of materials data.........................:


If no FV Certification, FV tests based on IEC60695-11-10 conducted on 3 samples ofcomplete parts (or sections of it), includingarea with min. thickness, ventilation openings

N

b) Fire ENCLOSURE met following: P

1) No openings at bottom or, as specified inFig 39, constructed with baffles as in Fig 38, ormade of perforated metal as in Table 25, or ametal screen with a mesh 2 × 2 mm centre tocentre and wire diameter of at least 0.45 mm

No opening at bottom P

2) No openings on the sides within the areaincluded within the inclined line C in Fig 39

P

3) ENCLOSURE, baffles, and flame barriers haveadequate rigidity and are made of appropriatemetal or of non-metallic materials....................... :

Non-metallic materials: V-0

See appended Table 8.10

P

11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics N

ME EQUIPMENT, ME SYSTEMS and parts describedin ACCOMPANYING DOCUMENTS for use withflammable with Annex G

Equipment is not intended foruse with flammableanaesthetics

Described in “SafetyInstructions” of operationmanual.

N

11.5 ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammableagents

N


EN 60601-1


MANUFACTURER’S RISK MANAGEMENT PROCESS

addresses possibility of fire and associatedmitigations as confirmed by examination ofRISK MANAGEMENT FILE...............................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

Equipment is not intended foruse in conjunction withflammable agents

N

11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,disinfection, sterilization and compatibility with substances used with the ME

EQUIPMENT

P

11.6.1 Sufficient degree of protection providedagainst overflow, spillage, leakage, ingress ofwater or particulate matter, cleaning,disinfection and sterilization, and compatibilitywith substances used with ME EQUIPMENT.........:


11.6.2 Overflow in ME EQUIPMENT N

ME EQUIPMENT incorporates a reservoir or liquidstorage that did not wet any MEANS OF

PROTECTION, nor result in the loss of BASIC

SAFETY or ESSENTIAL PERFORMANCE........................:

N

Maximum fill level is indicated by marking onthe ME EQUIPMENT and a warning or safetynotice is given, no HAZARDOUS SITUATION (asspecified in 13.1) or unacceptable RISK due tooverflow developed when the reservoir orliquid storage chamber is filled to itsmaximum capacity and the TRANSPORTABLE ME

EQUIPMENT is tilted through an angle of 10°, orfor MOBILE ME EQUIPMENT exceeding 45 kg, ismoved over a threshold as described in9.4.2.4.3.

N

No warning or safety notice providedregarding the maximum fill level, noHAZARDOUS SITUATION (as specified in 13.1) orunacceptable RISK due to overflow developedwhen the reservoir or liquid storage chamberwas filled to 15 % above the maximumcapacity and the TRANSPORTABLE ME EQUIPMENT

was tilted through an angle of 10°, or in MOBILE

ME EQUIPMENT exceeding 45 kg, was movedover a threshold as described in 9.4.2.4.3.

N

11.6.3 Spillage on ME EQUIPMENT and ME SYSTEM N

ME EQUIPMENT and ME SYSTEMS handling liquidsconstructed that spillage does not wet partsas determined by review of the RISK

MANAGEMENT FILE and test ...................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

RISK ANALYSIS identifies the type of liquid,volume, duration and location of the spill.........:

N

11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS P


EN 60601-1


ME EQUIPMENT with IP Code placed in leastfavourable position of NORMAL USE andsubjected to tests of IEC 60529 (IP Code)........ :

See Appended Table 11.6.1

Main device: IPX0 (ordinaryequipment)

Foot switch is IP68

P

ME EQUIPMENT met dielectric strength andLEAKAGE CURRENT tests and there were nobridging of insulation or electricalcomponents that could result in the loss ofBASIC SAFETY or ESSENTIAL PERFORMANCE inNORMAL CONDITION or in combination with aSINGLE FAULT CONDITION............................................ :

See appended Tables 8.78.8.3

P

11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS P

ME EQUIPMENT/ME SYSTEM and their parts andACCESSORIES cleaned or disinfected usingmethods specified in instructions for use.......................................................................................:

See Appended Tables 11.6.1,8.7, and 8.8.3

P

Effects of multiple cleanings/disinfectionsduring EXPECTED SERVICE LIFE of EQUIPMENT

evaluated by MANUFACTURER.............................:

Described in “Maintenance” ofoperation manual.

P

11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS N

ME EQUIPMENT, ME SYSTEMS and their parts orACCESSORIES intended to be sterilizedassessed and documented and compliantwith tests.......................................................................................:

No sterilization needed N

RISK MANAGEMENT FILE includes an assessmentof the RISKS associated with any deteriorationfollowing sterilization.......................................................................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

11.6.8 RISKS associated with compatibility ofsubstances used with ME EQUIPMENT

addressed in RISK MANAGEMENT PROCESS

.......................................................................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

11.7 ME EQUIPMENT, ME SYSTEM, and ACCESSORIES

coming into direct or indirect contact withbiological tissues, cells, or body fluidsassessed and documented

N/E


EN 60601-1


11.8 Interruption and restoration of power supplydid not result in a loss of BASIC SAFETY orESSENTIAL PERFORMANCE

Interruption of power supplyresults in interruption ofintended function only.

Restoration of power supplymake the EUT go back to thenormal operating.

No unacceptable risk. No safetyhazard.

P

12 ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTIONAGAINST HAZARDOUS OUTPUTS

P

12.1 RISKS associated with accuracy of controls andinstruments stated.................................................. :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

12.2 RISK of poor USABILITY, including identification,marking, and documents addressed in aUSABILITY ENGINEERING............................................. :

N/E

12.3 MANUFACTURER implemented an ALARM SYSTEM

compliant with IEC 60601-1-8. ............................ :N/E

12.4 Protection against hazardous output P

12.4.1 RISKS associated with hazardous output arisingfrom intentional exceeding of safety limitsaddressed in RISK MANAGEMENT PROCESS............:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

No specified the safety limitsin accompanying documents.The relevant tests of thisstandard is performed underthe worst output.

N

12.4.2 - need for indication associated withhazardous output addressed in RISK

MANAGEMENT PROCESS

........................................................................................:

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

Laser output with yellowindicator.


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

12.4.3 RISKS associated with accidental selection ofexcessive output values for ME EQUIPMENT witha multi-purpose unit addressed in RISK

MANAGEMENT PROCESS..............................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

12.4.4 RISKS associated with incorrect outputaddressed in RISK MANAGEMENT PROCESS........... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

12.4.5 Diagnostic or therapeutic radiation N

12.4.5.1 Adequate provisions to protect OPERATORS,PATIENTS, other persons and sensitive devicesin vicinity of unwanted or excessive radiation

No radiation N


EN 60601-1


Radiation safety ensured by compliance withrequirements of appropriate standards

N

12.4.5.2 ME EQUIPMENT and ME SYSTEMS designed toproduce X-radiation for diagnostic imagingpurposes complied with IEC 60601-1-3.............:

Not X-rays diagnosticequipment

N

12.4.5.3 RISKS associated with radiotherapy addressedin RISK MANAGEMENT PROCESS as...........................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

12.4.5.4 RISKS associated with ME EQUIPMENT producingdiagnostic or therapeutic radiation other thandiagnostic X-rays and radiotherapy addressedin RISK MANAGEMENT PROCESS as...........................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

12.4.6 RISKS associated with diagnostic or therapeuticacoustic pressure addressed in RISK

MANAGEMENT.............................................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

13 HAZARDOUS SITUATIONS AND FAULT CONDITIONS P

13.1 Specific HAZARDOUS SITUATIONS P

13.1.2 Emissions, deformation of ENCLOSURE or exceeding maximum temperature P

– Emission of flames, molten metal, poisonousor ignitable substance in hazardous quantitiesdid not occur

No such hazardous situationsresult after tests

P

– Deformation of ENCLOSURE impairingcompliance with 15.3.1 did not occur

P

– Temperatures of APPLIED PARTS did notexceed allowable values in Table 24...................:


– Temperatures of ME EQUIPMENT parts that arenot APPLIED PARTS likely to be touched did notexceed values in Table 23...................................... :


–Allowable values for “other components andmaterials” in Table 22 times 1.5 minus 12.5 °Cwere not exceeded

P

Limits for windings in Tables 26, 27, and 31 notexceeded

P

Table 22 not exceeded in all other cases P

After tests of this Clause, settings of THERMAL

CUT-OUTS and OVER-CURRENT RELEASES did notchange sufficiently to affect their safetyfunction

P

13.1.3 – limits for LEAKAGE CURRENT in SINGLE FAULT

CONDITION did not exceed........................................:See appended Table 8.7 P

– voltage limits for ACCESSIBLE PARTS includingAPPLIED PARTS did not exceed...............................:

No voltage limits were exceed P

13.2 SINGLE FAULT CONDITIONS P


EN 60601-1


13.2.1 During the application of the SINGLE FAULT

CONDITIONS listed in 13.2.2 to 13.2.13(inclusive), the NORMAL CONDITIONS identified in8.1 a) also applied in the least favourablecombination

P

ME EQUIPMENT complied with 13.2.2 -13.2.12...... : See appended Table 13.2 P

RISK MANAGEMENT FILE includes and assessmentof RISKS associated with leakage of liquid in aSINGLE FAULT CONDITION.......................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

RISK MANAGEMENT FILE defines the appropriatetest conditions....................................................:

N

13.2.13 ME EQUIPMENT remained safe after tests of13.2.13.2 to 13.2.13.4, and cooling down towithin 3 C of test environment temperature

N

ME EQUIPMENT examined for compliance orappropriate tests such as dielectric strength ofmotor insulation according to 8.8.3 conducted

N

For insulation of thermoplastic materials reliedupon as a MEANS OF PROTECTION, the ball-pressure test specified in 8.8.4.1 a) performed ata temperature 25 °C higher than temperature ofinsulation measured during tests of 13.2.13.2 to13.2.13.4 (inclusive).

N

13.2.13.2 ME EQUIPMENT with heating elements N

a 1) thermostatically controlled ME EQUIPMENT

with heating elements for building-in, r forunattended operation, or with a capacitor notprotected by a fuse connected in parallel withTHERMOSTAT contacts met tests

No heating elements N

a 2) ME EQUIPMENT with heating elements RATED

for non-CONTINUOUS OPERATION met testsN

a 3) other ME EQUIPMENT with heating elementsmet test

N

When more than one test was applicable tosame ME EQUIPMENT, tests performedconsecutively

N

Heating period stopped when a heatingelement or an intentionally weak part of a non-SELF-RESETTING THERMAL CUT-OUT ruptured, orcurrent interrupted before THERMAL STABILITY

without possibility of automatic restoration

N

Test repeated on a second sample wheninterruption was due to rupture of a heatingelement or an intentionally weak part

N


EN 60601-1


Both samples met 13.1.2, and open circuitingof a heating element or an intentionally weakpart in second sample not considered a failureby itself

N

b) ME EQUIPMENT with heating elements withoutadequate heat discharge, and supply voltageset at 90 or 110 % of RATED supply voltage,least favourable of the two (V)............................. :

N

Operating period stopped when a non-SELF-RESETTING THERMAL CUT-OUT operated, orcurrent interrupted without possibility ofautomatic restoration before THERMAL STABILITY

N

ME EQUIPMENT switched off as soon as THERMAL

STABILITY established and allowed to cool toroom temperature when current notinterrupted

N

Test duration was equal to RATED operatingtime for non-CONTINUOUS OPERATION

N

c) Heating parts of ME EQUIPMENT tested with ME

EQUIPMENT operated in NORMAL CONDITION at 110% of RATED supply voltage and as in 11.1, and

N

1) Controls limiting temperature in NORMAL

CONDITION disabled, except THERMAL CUT-OUTS

N

2) When more than one control provided, theywere disabled in turn

N

3) ME EQUIPMENT operated at RATED DUTY CYCLE

until THERMAL STABILITY achieved, regardless ofRATED operating time

N

13.2.13.3 ME EQUIPMENT with motors N

a 1) For the motor part of the ME EQUIPMENT,compliance checked by tests of 13.2.8- 13.2.10,13.2.13.3 b), 13.2.13.3 c), and 13.2.13.4, asapplicable

N

To determine compliance with 13.2.9 and13.2.10 motors in circuits running at 42.4 Vpeak a.c./ 60 V d.c. or less are covered with asingle layer of cheesecloth which did not igniteduring the test

N

a 2) Tests on ME EQUIPMENT containing heatingparts conducted at prescribed voltage withmotor & heating parts operated simultaneouslyto produce the least favourable condition

No such heating parts N

a 3) Tests performed consecutively when moretests were applicable to the same ME EQUIPMENT

N

b) Motor met running overload protection testof this clause when:

No such intended use N


EN 60601-1


1) it is intended to be remotely or automaticallycontrolled by a single control device with noredundant protection, or

N

2) it is likely to be subjected to CONTINUOUS

OPERATION while unattendedN

Motor winding temperature determined duringeach steady period and maximum value didnot exceed Table 27 (Insulation Class,Maximum temperature measured C)................ :

N

Motor removed from ME EQUIPMENT and testedseparately when load could not be changed inappropriate steps

N

Running overload test for motors operating at42.4 V peak a.c./60 V d.c. or less performedonly when examination and review of designindicated possibility of an overload

N

Test not conducted where electronic drivecircuits maintained a substantially constantdrive current

N

Test not conducted based on otherjustifications (justification)................................... :

N

c) ME EQUIPMENT with 3-phase motors operatedwith normal load, connected to a 3-phaseSUPPLY MAINS with one phase disconnected,and periods of operation per 13.2.10

N

13.2.13.4 ME EQUIPMENT RATED for NON-CONTINUOUS OPERATION N

ME EQUIPMENT (other than HAND-HELD) operatedunder normal load and at RATED voltage or atupper limit of RATED voltage range untilincrease in temperature was 5 °C in onehour, or a protective device operated

Intended for CONTINUOUSOPERATION

N

When a load-reducing device operated inNORMAL USE, test continued with ME EQUIPMENT

running idle

N

Motor winding temperatures did not exceedvalues in 13.2.10...................................................... :

N

Insulation Class....................................................... : —

Maximum temperature measured (C)............... : —

14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) P

14.1 Requirements in 14.2 to 14,12 not applied toPEMS when it provides no functionalitynecessary for BASIC SAFETY or ESSENTIAL

PERFORMANCE, or

N


EN 60601-1


- when application of RISK MANAGEMENT showedthat failure of PESS does not lead tounacceptable RISK....................................................:

See Appended RM ResultsTable 4.2.2

P

RISK MANAGEMENT FILE contains an assessmentof RISKS associated with the failure of the PESS:(ISO 14971 Cl. 4.2-4.4, 5)

RMF Reference to specificRISKS:

DM-RMF-001

(ISO 14971 Cl. 4.2-4.4, 5)

P

Requirements of 14.13 not applied to PEMS

intended to be incorporated into an IT NETWORK

No such parts N

When the requirements of 14.2 to 14.13 apply,the requirements of IEC 6204:2006 clause 4.3,5, 7, 8 and 9 apply for the development ormodification of software of each PESS

P

Software development process for SoftwareClassification applied in accordance withClause 4.3 of IEC 62304......................................... :

Software Class: C P

Software development process appliedaccording to Clause 5 of IEC 62304................... :

Document No.: DM-QR-734-03(Version: A0) for SoftwareArchitecture

P

Software development process for Softwarerisk management applied according to Clause7 of IEC 62304...........................................................:

Document No.: DM/CXCE-07(Version: A0) for BERYLASSoftware Risk Management

P

Software development process ConfigurationManagement applied according to Clause 8 ofIEC 62304................................................................... :

Document No.: DM-QR-721-02(Version: A0) for SoftwareRequirements Specification

P

Software development process for SoftwareProblem Resolution applied according toClause 9 of IEC 62304.............................................:

Document No.: DM-QP736-02(Version: A0) for SoftwareArchitecture

P

14.2 Documents required by Clause 14 reviewed,approved, issued and revised according to aformal document control process...................... :

P

14.3 RISK MANAGEMENT plan required by 4.2.2includes reference to PEMS VALIDATION plan

Risk management files (filesNo.: DM-RMF-001, Version:A0)

P

14.4 A PEMS DEVELOPMENT LIFE-CYCLE including a setof defined milestones has been documented

Document No.: DM-QP732-02(Version: A0) for SoftwareDevelopment Life Cycle

P

At each milestone, activities to be completed,and VERIFICATION methods to be applied toactivities have been defined

P

Each activity including its inputs and outputsdefined, and each milestone identifies RISK

MANAGEMENT activities that must be completedbefore that milestone

P


EN 60601-1


PEMS DEVELOPMENT LIFE-CYCLE tailored for aspecific development by making plansdetailing activities, milestones, and schedules

P

PEMS DEVELOPMENT LIFE-CYCLE includesdocumentation requirements

P

14.5 A documented system for problem resolutionwithin and between all phases and activities ofPEMS DEVELOPMENT LIFE-CYCLE has beendeveloped and maintained

P

14.6 RISK MANAGEMENT PROCESS P

14.6.1 MANUFACTURER considered HAZARDS associatedwith software and hardware aspects of PEMS

including those associated with theincorporating PEMS into an IT-NETWORK,components of third-party origin, legacysubsystems when compiling list of known orforeseeable HAZARDS................................................ :

No such parts. N

RISK MANAGEMENT FILE includes known orforeseeable HAZARDS associated with software,hardware, incorporation of the PEMS into an IT-NETWORK, components of 3rd party origin andlegacy subsystems.................................................. :(ISO 14971 Cl. 4.3)

RMF Reference to specificHAZARDS: DM-RMF-001, RiskAnalysis

(ISO 14971 Cl. 4.3)

P

14.6.2 Suitably validated tools and PROCEDURES

assuring each RISK CONTROL measure reducesidentified RISK(S) satisfactorily provided inaddition to PEMS requirements in Clause 4.2.2. :

P

RISK MANAGEMENT FILE documents the suitabilityof tools and procedures to validate each RISK

CONTROL measure......................................................:(ISO 14971 Cl. 6.1)

RMF Reference to specificHAZARDS: DM-RMF-001, RiskAnalysis

(ISO 14971 Cl. 6.1)

P

14.7 A documented requirement specification forPEMS and each of its subsystems (e.g. for aPESS) which includes ESSENTIAL PERFORMANCE

and RISK CONTROL measures implemented bythat system or subsystem......................................:(ISO 14971 Cl. 6.3)

RMF Reference to specificRISK CONTROLS:

DM-RMF-001, Risk Analysis(ISO 14971 Cl.6.3)

P

14.8 An architecture satisfying the requirement isspecified for PEMS and each of subsystems......:(ISO 14971 Cl. 6.3)

P

14.9 Design is broken up into sub systems anddescriptive data on design environmentdocumented............................................................... :

P


EN 60601-1


14.10 A VERIFICATION plan containing the specifiedinformation used to verify and documentfunctions implementing BASIC SAFETY,ESSENTIAL PERFORMANCE, or RISK CONTROL

measures.................................................................... :(ISO 14971 Cl. 6.3)

P

– milestone(s) when VERIFICATION is to beperformed for each function

Document No.: DM-QP736-02(Version: A0) for SoftwareVerification and ValidationPlan

P

– selection and documentation of VERIFICATION

strategies, activities, techniques, andappropriate level of independence of thepersonnel performing the VERIFICATION

P

– selection and utilization of VERIFICATION tools P

– coverage criteria for VERIFICATION P

The VERIFICATION performed according to theVERIFICATION plan and results of theVERIFICATION activities documented

P

14.11 A PEMS VALIDATION plan containing validation ofBASIC SAFETY & ESSENTIAL PERFORMANCE ............. :

Document No.: DM-WI737-02(Version: A0) for SoftwareVerification and ValidationReport

P

The PEMS VALIDATION performed according tothe PEMS VALIDATION plan with results of PEMS

VALIDATION activities and methods used forPEMS VALIDATION documented

P

The person with overall responsibility for PEMS

VALIDATION is independentP

All professional relationships of members ofPEMS VALIDATION team with members of designteam documented in RISK MANAGEMENT FILE

(ISO 14971 Cl. 6.3)

P

14.12 Continued validity of previous designdocumentation assessed under a documentedmodification/change PROCEDURE

P

Software Classification for Software changesapplied in accordance with Clause 4.3 of IEC62304............................................................................:

P

Software Process for Software changesapplied according to Clause 5 of IEC 62304..... :

P

RISK MANAGEMENT for Software changes appliedaccording to Clause 7 of IEC 62304.................... :

P

Configuration management of softwarechanges applied per Clause 8 of IEC 62304......:

P


EN 60601-1


Problem resolution for Software changesapplied according to Clause 9 of IEC 62304..... :

P

14.13 For PEMS incorporated into an IT-NETWORK notVALIDATED by the PEMS MANUFACTURER,instructions made available for implementingthe connection include the following................. :

N

a) Purpose of the PEMS connection to an IT-NETWORK

N

b) required characteristics of the IT-NETWORK N

c) required configuration of the IT-NETWORK N

d) technical specifications of the networkconnection, including security specifications

N

e) intended information flow between the PEMS,the IT-NETWORK and other devices on the IT-NETWORK, and the intended routing through theIT-NETWORK

N

f) a list of HAZARDOUS SITUATIONS resulting fromfailure of the IT-NETWORK to provide therequired characteristics(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.3)

N

ACCOMPANYING DOCUMENTS for the RESPONSIBLE

ORGANIZATION include the following:N

– statement that connection to IT-NETWORKS

including other equipment could result inpreviously unidentified RISKS TO PATIENTS,OPERATORS or third parties

N

– Notification that the RESPONSIBLE

ORGANIZATION should identify, analyse, evaluateand control these RISKS

N

– Notification that changes to the IT-NETWORK

could introduce new RISKS that requireadditional analysis

N

- Changes to the IT-NETWORK include:- changes in network configuration- connection of additional items- disconnection of items- update of equipment- upgrade of equipment

N

15 CONSTRUCTION OF ME EQUIPMENT P

15.1 RISKS associated with arrangement of controlsand indicators of ME EQUIPMENT addressedthrough the application of a USABILITY

ENGINEERING PROCESS................................................:

N/E


EN 60601-1


15.2 Parts of ME EQUIPMENT subject to mechanicalwear, electrical, environmental degradation orageing resulting in unacceptable RISK whenunchecked for a long period, are accessiblefor inspection, replacement, and maintenance

P

Inspection, servicing, replacement, andadjustment of parts of ME EQUIPMENT can easilybe done without damage to or interferencewith adjacent parts or wiring

P

15.3 Mechanical strength P

15.3.1 Mould stress relief, push, impact, drop, andrough handling tests did not result in loss ofBASIC SAFETY or ESSENTIAL PERFORMANCE

After all of these test, nocracking, no damaged, and nosafety hazards.

P

15.3.2 Push test conducted............................................... : See Appended Table 15.3 P

No damage resulting in an unacceptable RISK

sustainedP

15.3.3 Impact test conducted............................................ : See Appended Table 15.3 P


sustainedP

15.3.4 Drop test P

15.3.4.1 Sample of HAND-HELD ME EQUIPMENT,ACCESSORIES and HAND-HELD part with SAFE

WORKING LOAD tested................................................ :

N

No unacceptable RISK resulted N

15.3.4.2 Sample of PORTABLE ME EQUIPMENT, ACCESSORIES

and PORTABLE part with SAFE WORKING LOAD

withstood stress as demonstrated by test....... :

See Appended Table 15.3 P


sustainedP

15.3.5 MOBILE ME EQUIPMENT and MOBILE part with SAFE

WORKING LOAD and in most adverse conditionin NORMAL USE passed Rough Handling tests... :

N


sustainedN

15.3.6 Examination of ENCLOSURE made from mouldedor formed thermoplastic material indicatedthat material distortion due to release ofinternal stresses by moulding or formingoperations will not result in an unacceptableRISK

P

Mould-stress relief test conducted by placingone sample of complete ME EQUIPMENT,ENCLOSURE or a portion of larger ENCLOSURE, for7 hours in a circulating air oven at 10°C overthe max temperature measured on ENCLOSURE

in 11.1.3, but no less than 70 °C........................:

70°C, for 7h P


EN 60601-1


No damage resulting in an unacceptable RISK P

15.3.7 INTENDED USE, EXPECTED SERVICE LIFE, andconditions for transport and storage weretaken into consideration for selection andtreatment of materials used in construction ofME EQUIPMENT

P

Based on review of EQUIPMENT, ACCOMPANYING

DOCUMENTS, specifications and processing ofmaterials, and MANUFACTURER’S relevant testsor calculations, corrosion, ageing, mechanicalwear, degradation of biological materials dueto bacteria, plants, animals and the like, willnot result in an unacceptable RISK

P

15.4 ME EQUIPMENT components and general assembly P

15.4.1 Incorrect connection of accessibleconnectors, removable without a TOOL,prevented where an unacceptable RISK exists, :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

P

a) Plugs for connection of PATIENT leads orPATIENT cables cannot be connected to outletson same ME EQUIPMENT intended for otherfunctions,....................................................................:

No such plugs for connectionof patient leads or patientcables

N

b) Medical gas connections on ME EQUIPMENT

for different gases to be operated in NORMAL

USE are not interchangeable inspection............. :

No medical gas connection N

15.4.2 Temperature and overload control devices N

15.4.2.1 a) THERMAL CUT-OUTS and OVER-CURRENT

RELEASES with automatic resetting not used inME EQUIPMENT when their use could lead to aHAZARDOUS SITUATION................................................ :(ISO 14971 Cl. 4.2-4.4, 5)

No such parts N

b) THERMAL CUT-OUTS with a safety functionwith reset by a soldering not fitted in ME

EQUIPMENT

N

c) An additional independent non-SELF-RESETTING THERMAL CUT-OUT is provided..............:(ISO 14971 Cl. 4.2-4.4)

N

d) Operation of THERMAL CUT-OUT or OVER

CURRENT RELEASE doesn’t result in a HAZARDOUS

SITUATION or loss of ESSENTIAL PERFORMANCE .... :(ISO 14971 Cl. 4.2-4.4)

N

e) Capacitors or other spark-suppressiondevices not connected between contacts ofTHERMAL CUT-OUTS

N

f) Use of THERMAL CUT-OUTS or OVER-CURRENT

RELEASES do not affect safety as verified byfollowing tests

N


EN 60601-1


- Positive temperature coefficient devices)complied with IEC 60730-1: 2010, Clauses 15,17, J.15, and J.17

No such parts N

- ME EQUIPMENT containing THERMAL CUT-OUTS

and OVER-CURRENT RELEASES operated underthe conditions of Clause 13...................................:

N

- SELF-RESETTING THERMAL CUT-OUTS and OVER-CURRENT RELEASES including circuitsperforming equivalent functions Certifiedaccording to appropriate standards.....................

N

- In the absence of Certification in accordancewith IEC standards, SELF-RESETTING THERMAL

CUT-OUTS and OVER-CURRENT RELEASES includingcircuits performing equivalent functionsoperated 200 times

N

Manual reset THERMAL CUT-OUTS and OVER-CURRENT RELEASES Certified in accordance withappropriate IEC standards

N

manual reset THERMAL CUT-OUTS and OVER-CURRENT RELEASES operated 10 times

N

Thermal protective devices tested separatelyfrom ME EQUIPMENT when engineering judgmentindicated test results would not be impacted

N

g) Protective device incorporating a fluid filledcontainer with heating means, operated whenheater switched on with container empty andprevented an unacceptable RISK due tooverheating

No such heating means N

h) ME EQUIPMENT with tubular heating elementsprovided with protection against overheating. :(ISO 14971 Cl. 4.2-4.4)

No such parts N

15.4.2.2 Temperature settings clearly indicated whenmeans provided to vary setting of THERMOSTATS

N

15.4.3 Batteries N

15.4.3.1 Battery housings provided with ventilation.....:

(ISO 14971 Cl. 4.2-4.4)

No battery used N

Battery compartments designed to preventaccidental short circuiting

N

15.4.3.2 Means provided to prevent incorrectconnection of polarity............................................ :

N

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with incorrect connectionor replacement of batteries...................................:(ISO 14971 Cl. 4.2-4.4)

N

15.4.3.3 Overcharging of battery prevented by virtue ofdesign......................................................................... :

N


EN 60601-1


RISK MANAGEMENT FILE includes an assessmentof RISKS associated with overcharging ofbatteries..................................................................... :(ISO 14971 Cl. 4.2-4.4)

N

15.4.3.4 Primary lithium batteries comply with IEC80086-4

N

Secondary lithium batteries comply with IEC62133

N

15.4.3.5 A properly RATED protective device providedwithin INTERNAL ELECTRICAL POWER SOURCE toprotect against fire..................................................:

N

Protective device has adequate breakingcapacity

N

Justification for OVER-CURRENT RELEASES orFUSE exclusion is documented

N

Short circuit test between the positive andnegative poles of an INTERNAL ELECTRICAL

POWER SOURCE between the output andprotective device(s) omitted where 2 MOOPsprovided, or

N

Short circuit between the positive andnegative poles of an INTERNAL ELECTRICAL

POWER SOURCE between the output andprotective device(s) does not result in anyHAZARDOUS SITUATION

N

15.4.4 Indicator lights provided to indicate ME

EQUIPMENT is ready for............................................ :N

An additional indicator light provided on ME

EQUIPMENT with a stand-by state or a warm-upstate exceeding 15 s,

N

Indicator lights provided on ME EQUIPMENT

incorporating non-luminous heaters toindicate heaters are operational

No non-luminous heaters N

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with the use of indicatorlights for EQUIPMENT incorporating non-luminous heaters.....................................................:(ISO 14971 Cl. 4.2-4.4)

N

Requirement not applied to heated stylus-pensfor recording purposes

N

Indicator lights provided on ME EQUIPMENT toindicate an output exists

Laser output indicator used P

Colours of indicator lights complied with 7.8.1 Laser output indicator: Yellow P

Charging mode visibly indicated No internal powered used N


EN 60601-1


15.4.5 RISKS associated with pre-set controlsaddressed in RISK MANAGEMENT PROCESS........... :

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

No pre-set controls used N

15.4.6 Actuating parts of controls of ME EQUIPMENT P

15.4.6.1 a) Actuating parts cannot be pulled off orloosened during NORMAL USE

P

b) Controls secured so that the indication ofany scale always corresponds to the positionof the control

N

c) Incorrect connection prevented by adequateconstruction when it could be separatedwithout use of a TOOL

N

When torque values per Table 30 appliedknobs did not rotate .............................................. :

N

Tests conducted with no unacceptable RISK .. : N

15.4.6.2 Stops on rotating/ movable parts of controlsare of adequate mechanical strength ............... :

N

Torque values in Table 30 applied......................: N

No unexpected change of the controlledparameter when tested.......................................... :

N

15.4.7 Cord-connected HAND-HELD and foot-operated control devices P

15.4.7.1 a) HAND-HELD control devices of ME EQUIPMENT

complied with 15.3.4.1No hand-held control devicesused

N

b) Foot-operated control device supported anactuating force of 1350 N in its position ofNORMAL USE with no damage..................................:

No damage after test P

15.4.7.2 Control device of HAND-HELD and foot-operatedcontrol devices turned in all possible abnormalpositions and placed on a flat surface .............. :

No actuation was observedwhen foot switch is turned inall possible abnormalpositions.

P

No unacceptable RISK caused by changingcontrol setting when accidentally placed in anabnormal position

P

15.4.7.3 a) Foot-operated control device is at leastrated IPX1.....................................................................:

P

b) ENCLOSURE of foot operated control devicescontaining electrical circuits is at least IPX6...:

N

15.4.8 Aluminium wires less than 16 mm2 in cross-sectional area are not used

N

15.4.9 a) Oil container in PORTABLE ME EQUIPMENT

allows for expansion of oil and is adequatelysealed

No oil container used N

b) Oil containers in MOBILE ME EQUIPMENT sealedto prevent loss of oil during transport

N


EN 60601-1


A pressure-release device operating duringNORMAL USE is provided

N

c) Partially sealed oil-filled ME EQUIPMENT andits parts provided with means for checking theoil level to detect leakage

N

ME EQUIPMENT and technical descriptionexamined, and manual tests conducted toconfirm compliance with above requirements

N

15.5 MAINS SUPPLY TRANSFORMERS OF ME EQUIPMENT and transformers providingseparation in accordance with 8.5

N

15.5.1 Overheating N

15.5.1.1 Transformers of ME EQUIPMENT are protectedagainst overheating................................................. :

N

During tests, windings did not open, noHAZARDOUS SITUATION occurred, and maximumtemperatures of windings did not exceedvalues in Table 31

N

Dielectric strength test conducted after shortcircuit and overload tests ..................................... :

N

15.5.1.2 Transformer output winding short circuited,and test continued until protective deviceoperated or THERMAL STABILITY achieved ........... :

N

Short circuit applied directly across outputwindings

N

15.5.1.3 Multiple overload tests conducted on windings.......................................................................................:

N

15.5.2 Transformers operating at a frequency above1kHz tested according to clause 8.8.3................ :

N

Transformer windings provided with adequateinsulation

N

Dielectric strength tests were conducted ....... : N

15.5.3 Transformers forming MEANS OF PROTECTION asrequired by 8.5 comply with.................................. :

N

- Means provided to prevent displacement ofend turns

N

- protective earth screens with a single turnhave insulated overlap

N

- Exit of wires form internal windings of toroidtransformers protected with double sleeving

N

- insulation between primary and secondarywindings complies with 8.8.2

N

- CREEPAGE DISTANCES and AIR CLEARANCE

comply with 8.9.4N


EN 60601-1


16 ME SYSTEMS N

16.1 After installation or subsequent modification,ME SYSTEM didn’t result in an unacceptable RISK

No ME systems N

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with installation andmodification of an ME SYSTEM................................:(ISO 14971 Cl. 4.2-4.4, 5)

N

Only HAZARDS arising from combining variousequipment to form a ME SYSTEM considered

N

– ME SYSTEM provides the level of safety withinthe PATIENT ENVIRONMENT equivalent to ME

EQUIPMENT complying with this standard

N

– ME SYSTEM provides the level of safety outsidePATIENT ENVIRONMENT equivalent to equipmentcomplying with their respective IEC or ISOsafety standards

N

– tests performed in NORMAL CONDITION, exceptas specified

N

– tests performed under operating conditionsspecified by MANUFACTURER of ME SYSTEM

N

Safety tests previously conducted on individualequipment of ME SYSTEM according to relevantstandards not repeated

N

RISK MANAGEMENT methods used byMANUFACTURER of an ME SYSTEM reconfigurableby RESPONSIBLE ORGANIZATION or OPERATOR

N

Non-ME EQUIPMENT used in ME SYSTEM compliedwith applicable IEC or ISO safety standards

N

Equipment relying only on BASIC INSULATION forprotection against electric shock not used inME SYSTEM

N

16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM N

Documents containing all data necessary forME SYSTEM to be used as intended byMANUFACTURER including a contact addressaccompany ME SYSTEM or modified ME SYSTEM

N

ACCOMPANYING DOCUMENTS regarded as a part ofME SYSTEM

N

a) ACCOMPANYING DOCUMENTS provided for eachitem of ME EQUIPMENT supplied byMANUFACTURER

N

b) ACCOMPANYING DOCUMENTS provided for eachitem of non-ME EQUIPMENT supplied byMANUFACTURER

N


EN 60601-1


c) the required information is provided: N

– specifications, instructions for use asintended by MANUFACTURER, and a list of allitems forming the ME SYSTEM

N

– instructions for installation, assembly, andmodification of ME SYSTEM to ensure continuedcompliance with this standard

N

– instructions for cleaning and, whenapplicable, disinfecting and sterilizing eachitem of equipment or equipment part formingpart of the ME SYSTEM

N

– additional safety measures to be appliedduring installation of ME SYSTEM

N

– identification of parts of ME SYSTEM suitablefor use within the PATIENT ENVIRONMENT

N

– additional measures to be applied duringpreventive maintenance

N

– a warning forbidding placement of MULTIPLE

SOCKET-OUTLET, when provided and it is aseparate item, on the floor

N

– a warning indicating an additional MULTIPLE

SOCKET-OUTLET or extension cord not to beconnected to ME SYSTEM

N

– a warning to connect only items that havebeen specified as part of ME SYSTEM or specifiedas being compatible with ME SYSTEM

N

– maximum permissible load for any MULTIPLE

SOCKET-OUTLET(S) used with ME SYSTEM

N

– instructions indicating MULTIPLE SOCKET-OUTLETS provided with the ME SYSTEM to be usedonly for supplying power to equipmentintended to form part of ME SYSTEM

N

– an explanation indicating RISKS of connectingnon-ME EQUIPMENT supplied as a part of ME

SYSTEM directly to wall outlet when non-ME

EQUIPMENT is intended to be supplied via aMULTIPLE SOCKET-OUTLET with a separatingtransformer

N

– an explanation indicating RISKS of connectingany equipment supplied as a part of ME SYSTEM

to MULTIPLE SOCKET-OUTLET

N

– permissible environmental conditions of usefor ME SYSTEM including conditions fortransport and storage

N


EN 60601-1


– instructions to OPERATOR not to,simultaneously, touch parts referred to in 16.4and PATIENT

N

d) the following instructions provided for useby RESPONSIBLE ORGANIZATION:

N

– adjustment, cleaning, sterilization, anddisinfection PROCEDURES

N

– assembly of ME SYSTEMS and modificationsduring actual service life shall be evaluatedbased on the requirements of this standard

N

16.3 Instructions for use of ME EQUIPMENT intendedto receive its power from other equipment in anME SYSTEM, describe the other equipment toensure compliance with these requirements

N

Transient currents restricted to allowable levelsfor the specified IPS or UPS................................. :

N

Technical description and installationinstructions specify the actual transientcurrents where an IPS or UPS is not specified

N

16.4 Parts of non-ME EQUIPMENT in PATIENT

ENVIRONMENT subject to contact by OPERATOR

during maintenance, calibration, after removalof covers, connectors operated at a voltage voltage in 8.4.2 c)

N

16.5 Safety measures incorporating a SEPARATION

DEVICE applied when FUNCTIONAL CONNECTION

between ME EQUIPMENT and other items of an ME

SYSTEM or other systems can cause allowablevalues of LEAKAGE CURRENT to exceed

N

SEPARATION DEVICE has dielectric strength,CREEPAGE and CLEARANCES required for oneMEANS OF OPERATOR PROTECTION

N

WORKING VOLTAGE was highest voltage acrossSEPARATION DEVICE during a fault condition, butnot less than MAXIMUM MAINS VOLTAGE (V).......... :

N

16.6 LEAKAGE CURRENTS N

16.6.1 TOUCH CURRENT in NORMAL CONDITION did notexceed 100 μA...........................................................:

N

TOUCH CURRENT did not exceed 500 μA in eventof interruption of any non-PERMANENTLY

INSTALLED PROTECTIVE EARTH CONDUCTOR............. :

N

16.6.2 Current in PROTECTIVE EARTH CONDUCTOR ofMULTIPLE SOCKET-OUTLET didn’t exceed 5 mA.... :

N

16.6.3 PATIENT LEAKAGE CURRENT and total PATIENT

LEAKAGE CURRENT of ME SYSTEM in NORMAL

CONDITION did not exceed values..........................:

N


EN 60601-1


16.7 ME SYSTEM complied with applicablerequirements of Clause 9.......................................:

N

16.8 Interruption and restoration power to the ME

SYSTEM or any part of the ME SYSTEM did notresult in a loss of BASIC SAFETY or ESSENTIAL

PERFORMANCE

N

16.9 ME SYSTEM connections and wiring N

16.9.1 Incorrect connection of accessible connectors,removable without a TOOL, prevented whereunacceptable RISK can result...............................:

N

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with plugs for connectionof PATIENT leads or cables likely to be located inthe PATIENT ENVIRONMENT......................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N

– Plugs for connection of PATIENT leads orPATIENT cables could not be connected to otheroutlets of the same ME SYSTEM likely to belocated in PATIENT ENVIRONMENT, except whenexamination of connectors and interchangingthem proved no unacceptable RISK results

N

Medical gas connections on the ME SYSTEM fordifferent gasses operated in NORMAL USE are notinterchangeable

N

16.9.2 MAINS PARTS, components and layout N

16.9.2.1 a) – MULTIPLE SOCKET-OUTLET only allowsconnection using a TOOL, or

N

– MULTIPLE SOCKET-OUTLET is of a type thatcannot accept MAINS PLUGS of any of the kindsspecified in IEC/TR 60083, or

N

– MULTIPLE SOCKET-OUTLET is supplied via aseparating transformer

N

b) – MULTIPLE SOCKET-OUTLET marked with safetysign 2 of Table D.2 visible in NORMAL USE, and

N

– marked either individually or in combinations,with the maximum allowed continuous outputin amperes or volt-amperes, or

N

– marked to indicate the equipment orequipment parts it may safely be attached to

N

– MULTIPLE SOCKET-OUTLET is a separate item oran integral part of ME EQUIPMENT or non-ME

EQUIPMENT

N

c) MULTIPLE SOCKET-OUTLET complied with IEC60884-1 and the following requirements:

N

– CREEPAGE and CLEARANCES complied with 8.9 N


EN 60601-1


– It is CLASS I, and PROTECTIVE EARTH CONDUCTOR

is connected to earthing contacts in socket-outlets

N

– PROTECTIVE EARTH TERMINALS and PROTECTIVE

EARTH CONNECTIONS comply with 8.6:N

– ENCLOSURE complied with 8.4.2 d) N

– MAINS TERMINAL DEVICES and wiring compliedwith 8.11.4, when applicable

N

– RATINGS of components are not in conflictwith conditions of use ........................................... :

N

– Electrical terminals and connectors ofMULTIPLE SOCKET-OUTLETS prevent incorrectconnection of accessible connectorsremovable without a TOOL

N

– POWER SUPPLY CORD complied with 8.11.3 N

d) Additional requirements applied whenMULTIPLE SOCKET-OUTLET combined with aseparating transformer:

N

– Separating transformer complied with thisstandard or IEC 61558-2-1,.................................... :

N

– Separating transformer is CLASS I N

– Degree of protection against ingress of waterspecified as in IEC 60529

N

– Separating transformer assembly markedaccording to 7.2 and 7.3

N

– MULTIPLE SOCKET-OUTLET permanentlyconnected to separating transformer, orsocket-outlet of separating transformerassembly cannot accept MAINS PLUGS asidentified in IEC/TR 60083

N

16.9.2.2 The impedance between the protective earthpin in the MAINS PLUG and any part that isPROTECTIVELY EARTHED did not exceed 200 m

N

Removal of any single item of equipment in ME

SYSTEM will not interrupt the protective earthingof any other part without simultaneousdisconnection of electrical supply to that part

N

Additional PROTECTIVE EARTH CONDUCTORS canbe detachable only by use of a TOOL

N

16.9.2.3 Conductors connecting different items withinan ME SYSTEM protected against mechanicaldamage

N

17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND MESYSTEMS

N/E


EN 60601-1


RISKS associated confirmed by review............... : See EN 60601-1-2 Report N/E

– electromagnetic phenomena at locationswhere ME EQUIPMENT or ME SYSTEM is to be usedas stated in ACCOMPANYING DOCUMENTS............... :

N/E

RISK MANAGEMENT FILE includes an assessmentof risks associated with the introduction ofelectromagnetic phenomena into theenvironment by the EQUIPMENT or SYSTEM.......... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

N/E

– introduction of electromagnetic phenomenainto environment by ME EQUIPMENT or ME

SYSTEM that might degrade performance ofother devices, electrical equipment, andsystems

N/E

ANNEX G PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLEANESTHETIC MIXTURES

N

G.2 Locations and basic requirements N

G.2.1 Parts of CATEGORY APG ME EQUIPMENT in which aFLAMMABLE ANAESTHETIC MIXTURE WITH AIR

occurs are CATEGORY AP or APG ME EQUIPMENT

and complied with G.3, G.4, and G.5

N

G.2.2 FLAMMABLE AESTHETIC MIXTURE WITH N

G.2.3 A FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN orNITROUS OXIDE

N

G.2.4 ME EQUIPMENT specified for use withFLAMMABLE AESTHETIC MIXTURE WITH AIR

complied with G.4 and G.5

N

G.2.5 ME EQUIPMENT or parts thereof for use withFLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR

NITROUS OXIDE comply with G.4 and G.6

N

ME EQUIPMENT in G.2.4 to G.2.5 met appropriatetests of G.3-G.5 conducted after tests of 11.6.6and 11.6.7

N

G.3 Marking, ACCOMPANYING DOCUMENTS N

G.3.1 CATEGORY APG ME EQUIPMENT prominentlymarked “APG” (symbol 23 in Table D.1)..............:

N

Length of green-coloured band is 4 cm, andsize of marking is as large as possible forparticular case

N

When above marking not possible, relevantinformation included in instructions for use.... :

N

Marking complied with tests and criteria of7.1.2 and 7.1.3

N


EN 60601-1


G.3.2 CATEGORY AP ME EQUIPMENT prominentlymarked, with a green-coloured circle “AP”(symbol 22 in Table D.1)......................................... :

N

Marking is as large as possible for theparticular case

N

When above marking not possible, therelevant information included in instructionsfor use......................................................................... :

N

Marking complied with tests and criteria of7.1.2 and 7.1.3

N

G.3.3 The marking placed on major part of ME

EQUIPMENT for CATEGORY AP or APG partsN

G.3.4 ACCOMPANYING DOCUMENTS contain anindication enabling the RESPONSIBLE

ORGANIZATION to distinguish between CATEGORY

AP and APG parts

N

G.3.5 Marking clearly indicates which parts areCATEGORY AP or APG when only certain ME

EQUIPMENT parts are CATEGORY AP or APG

N

G.4 Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT N

G.4.1 a) CREEPAGE and CLEARANCES are according toTable 12 for one MEANS OF PATIENT PROTECTION

N

b) Connections protected against accidentaldisconnection

N

c) CATEGORY AP and APG not provided with aDETACHABLE POWER SUPPLY CORD,

N

G.4.2 Construction details N

a) Opening of an ENCLOSURE protecting againstpenetration of gases or vapours into ME

EQUIPMENT or its parts possible only with aTOOL

N

b) ENCLOSURE complies with..................................: N

– no openings on top covers of ENCLOSURE, N

– openings in side-covers preventedpenetration of a solid cylindrical test rod

N

– openings in base plates preventedpenetration of a solid cylindrical test

N

c) Short circuiting conductor(s) to aconductive part (when no explosive gasses)did not result in loss of integrity of the part, anunacceptable temperature, or any HAZARDOUS

SITUATION

N

G.4.3 a) Electrostatic charges prevented onCATEGORY AP and APG ME EQUIPMENT by acombination of appropriate measures

N


EN 60601-1


– Use of antistatic materials with a limitedelectrical resistance.................................................:

N

– Provision of electrically conductive pathsfrom ME EQUIPMENT or its parts to a conductivefloor, protective earth or potential equalizationsystem, or via wheels to an antistatic floor

N

b) Electrical resistance limits of aesthetictubing, mattresses/ pads, castor tires & otherantistatic material comply with ISO 2882...........:

N

G.4.4 Corona cannot be produced by componentsor parts of ME EQUIPMENT operating at morethan 2000 V a.c. or 2400 V d.c. and notincluded in ENCLOSURES complying with G.5.4or G.5.5

N

G.5 Requirements and tests for CATEGORY AP ME EQUIPMENT, parts andcomponents

N

G.5.1 ME EQUIPMENT, its parts or components do notignite FLAMMABLE AESTHETIC MIXTURES WITH AIR

under NORMAL USE and CONDITIONS based oncompliance with G.5.2 to G.5.5

N

Alternatively, ME EQUIPMENT, its parts, andcomponents complied with requirements ofIEC 60079-0 for pressurized ENCLOSURES (IEC60079-2); for sand-filled ENCLOSURES, IEC60079-5; or for oil immersed equipment, IEC60079-6; and with this standard excludingG.5.2 to G.5.5............................................................. :

N

G.5.2 Temperature limits................................................... : N

G.5.3 ME EQUIPMENT, its parts, and componentsproducing sparks in NORMAL USE and CONDITION

complied with temperature requirements ofG.5.2, and Umax and Imax occurring in theircircuits, and complied as follows:

N

Measured Umax ≤ UzR with IzR as in Fig. G.1....... : N

Measured Umax ≤ Uc with Cmax as in Fig. G.2 .....: N

Measured Imax ≤ IzR with UzR as in Fig G.1 ......... : N

Measured Imax ≤ IzL with Lmax and a Umax ≤ 24 Vas in Fig G.3.............................................................. :

N

– Combinations of currents andcorresponding voltages within the limitationsIzR.UzR ≤ 50 W extrapolated from Fig G.1

N

No extrapolation made for voltages above 42V

N

– Combinations of capacitances andcorresponding voltages within limitations ofC/2U2 1.2 mJ extrapolated from Fig G.2

N


EN 60601-1


No extrapolation made for voltages above242V

N

Umax determined using actual resistance R N

– Combinations of currents andcorresponding inductances within limitationsL/2I2 0.3 mJ extrapolated from Fig G.3

N

No extrapolation made for inductances largerthan 900 mH

N

– Umax was the highest supply voltageoccurring in circuit under investigation withsparking contact open

N

– Imax was the highest current flowing in circuitunder investigation with sparking contactclosed

N

– Cmax and Lmax taken as values occurring atthe component under investigation producingsparks

N

– Peak value considered when a.c. supplied N

– An equivalent circuit calculated to determineequivalent max capacitance, inductance, andequivalent Umax and Imax, either as d.c. or a.c.peak values in case of a complicated circuit....:

N

Temperature measurements made accordingto 11.1, and Umax, Imax, R, Lmax , and Cmax

determined with application of Figs G.1-G.3... :

N

Alternatively, compliance was verified byexamination of design data...................................:

N

G.5.4 External ventilation with internal overpressure N

ME EQUIPMENT, its parts, and componentsenclosed in an ENCLOSURE with externalventilation by means of internal overpressurecomplied with the following requirements:

N

a) FLAMMABLE AESTHETIC MIXTURES WITH AIR tremoved by ventilation before EQUIPMENT

energized,

N

b) Overpressure inside ENCLOSURE was 75 Pa,min., in NORMAL CONDITION (Pa)............................. :

N

Overpressure maintained at the site ofpotential ignition

N

ME EQUIPMENT could be energized only afterthe required minimum overpressure waspresent long enough to ventilate theENCLOSURE

N

ME EQUIPMENT energized at will or repeatedlywhen overpressure was continuously present

N


EN 60601-1


c) Ignition sources de-energized automaticallywhen during operation overpressure droppedbelow 50 Pa (Pa)...................................................... :

N

d) External surface of ENCLOSURE did notexceed 150 °C in 25 °C........................................... :

N

G.5.5 ENCLOSURES with restricted breathing N

ME EQUIPMENT, its parts, and componentsenclosed in an ENCLOSURE with restrictedbreathing complied with the following:

N

a) A FLAMMABLE AESTHETIC MIXTURE WITH AIR didnot form inside ENCLOSURE with restrictedbreathing

N

b) Gasket or sealing material used to maintaintightness complied with aging test B-b of IEC60068-2-2, Clause 15, at 70 °C ± 2 °C and 96 h. :

N

c) Gas-tightness of ENCLOSURE containinginlets for flexible cords maintained

N

Cords are fitted with adequate anchorages tolimit stresses as determined by test

N

Overpressure not reduced below 200 Pa N

Tests waived when examination of ENCLOSURE

indicated it is completely sealed or gas-tightwithout a doubt (100 % degree of certainty)

N

Operating temperature of external surface ofENCLOSURE was 150 °C in 25 °C (°C)................ :

N

Steady state operating temperature ofENCLOSURE also measured (°C)............................ :

N

G.6 CATEGORY APG ME EQUIPMENT, parts and components thereof N

G.6.1 ME EQUIPMENT, its parts, and components didnot ignite FLAMMABLE AESTHETIC MIXTURE WITH

OXYGEN OR NITROUS OXIDE under NORMAL USE

and SINGLE FAULT CONDITION

N

ME EQUIPMENT, its parts, and components notcomplying with G.6.3 subjected to aCONTINUOUS OPERATION test

N

G.6.2 Parts and components of CATEGORY APG ME

EQUIPMENT operating in a FLAMMABLE AESTHETIC

MIXTURE WITH OXYGEN OR NITROUS OXIDE

supplied from a source isolated from earth byinsulation equal to one MEANS OF PATIENT

PROTECTION and from electrical parts byinsulation twice the MEANS OF PATIENT

PROTECTION

.......................................................................................:

N


EN 60601-1


G.6.3 Test of G.6.1 waived when the followingrequirements were met in NORMAL USE andunder NORMAL and SINGLE FAULT CONDITIONS

.......................................................................................:

N

a) no sparks produced and temperatures didnot exceed 90 °C, or

N

b) a temperature limit of 90 °C not exceeded,sparks produced in NORMAL USE, and SINGLE

FAULT CONDITIONS, except Umax and Imax

occurring in their circuits complied withrequirements, taking Cmax and Lmax intoconsideration:

N

Measured Umax ≤ UzR with IzR as in Fig. G.4 ...... : N

Measured Umax ≤ UzC with Cmax as in Fig. G.5.... : N

Measured Imax ≤ IzR with UzR as in Fig G.4 ......... : N

Measured Imax ≤ IzL with Lmax and a Umax ≤ 24 Vas in Fig G.6 ............................................................. :

N

– Extrapolation from Figs G.4, G.5, and G.6was limited to areas indicated

N

– Umax was the highest no-load voltageoccurring in the circuit under investigation,taking into consideration mains voltagevariations as in 4.10

N

– Imax was the highest current flowing in thecircuit under investigation, taking intoaccount MAINS VOLTAGE variations as in 4.10

N

– Cmax and Lmax are values occurring inrelevant circuit

N

– Umax additionally determined with actualresistance R when equivalent resistance R inFig G.5 was less than 8000

N

– Peak value considered when a.c. supplied N

– An equivalent circuit calculated todetermine max capacitance, inductance, andUmax and Imax, either as d.c. or a.c. peak valuesin case of a complicated circuit.......................................................................................:

N

– When energy produced in an inductance orcapacitance in a circuit is limited by voltageor current-limiting devices, two independentcomponents applied, to obtain the requiredlimitation even when a first fault (short oropen circuit) in one of these components

N


EN 60601-1


- requirement not applied to transformerscomplying with this standard

N

- requirement not applied to wire-woundcurrent-limiting resistors provided with aprotection against unwinding of the wire incase of rupture

N

Compliance verified by examination ofCATEGORY APG ME EQUIPMENT, parts, andcomponents , or

N

Temperature measurements made inaccordance with 11.1..............................................:

N

- or Umax, Imax, R, Lmax and Cmax determinedtogether with application of Figs G.4-G.6......... :

N

Alternatively, compliance verified bycomparison with design data............................... :

N

G.6.4 ME EQUIPMENT, its parts, and componentsheating a FLAMMABLE AESTHETIC MIXTURE WITH

OXYGEN OR NITROUS OXIDE provided with a non-SELF-RESETTING THERMAL CUT-OUT and compliedwith 15.4.2.1................................................................ :

N

Current-carrying part of heating element is notin direct contact with FLAMMABLE AESTHETIC

MIXTURE WITH OXYGEN OR NITROUS OXIDE

N

G.7 Test apparatus for flammable mixturesaccording to this Clause and Fig G.7

N

ANNEX L INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVEDINSULATION

N

L.1 BASIC, SUPPLEMENTARY, DOUBLE, and REINFORCED

INSULATION in wound components withoutinterleaved insulation complied with thisAnnex

Evaluated in approved SMPS. N

L.2 Wire construction N

Overlap of layers when wire is insulated withtwo or more spirally wrapped layers of tape isadequate to ensure continued overlap duringmanufacture of wound component

N

Layers of spirally wrapped wire insulation aresufficiently secured to maintain the overlap

N

L.3 Type Test N

The wire subjected to tests of L.3.1 to L.3.4 ata temperature and a relative humidity specified

N

Temperature (°C)..................................................... : —

Humidity (%)............................................................. : —


EN 60601-1


L.3.1 Dielectric strength N

Dielectric strength test of Clause 8.8.3 for theappropriate type and number of MOP(s)conducted with no breakdown:

N

– 3000 V for BASIC and SUPPLEMENTARY

INSULATION (V)............................................................ :N

– 6000 V for REINFORCED INSULATION (V).............. : N

L.3.2 Flexibility and adherence N

Sample subjected to flexibility and adherence N

Sample examined per IEC 60851-3: 1997, cl.5.1.1.4, followed by dielectric test of cl. 8.8.3,with no breakdown

N

Test voltage was at least the voltage in Tables6 and 7 but not less than the following:

N


INSULATION (V)............................................................ :N


Tension applied to wire during winding onmandrel calculated from the wire diameterequivalent to 118 MPa ± 11.8 MPa ..................... :

N

L.3.3 Heat Shock N

Sample subjected to heat shock test 9 of IEC60851-6:1996, followed by dielectric strengthtest of clause 8.8.3

N

Test voltage was at least the voltage in Tables6 and 7, but not less than the following:

N


INSULATION (V)............................................................ :N


Oven temperature based on Table L.2 (C)...... : —

Mandrel diameter and tension applied as inclause L.3.2, (MPa; N/mm2)................................... :

N

Dielectric strength test conducted at roomtemperature after removal from the oven

N

L.3.4 Retention of electric strength after bending N

Five samples prepared as in L.3.2 subjected todielectric strength and bending tests

N

Test voltage was at least the voltage in Tables6 and 7, but not less than the following:

N


INSULATION (V)............................................................ :N



EN 60601-1


Test voltage applied between the shot andconductor

N

Mandrel diameter and tension applied as inL.3.2, (MPa; N/mm2).................................................:

N

L.4 Tests during manufacture N

L.4.1 Production line dielectric strength tests doneby the manufacture per L.4.2 and L.4.3............. :

N

L.4.2 Test voltage for routine testing (100 % testing)is at least the voltage in Tables 6 and 7 but notless than the following:

N

– 1500 V r.m.s. or 2100 V peak for BASIC andSUPPLEMENTARY INSULATION (V)...............................:

N

– 3000 V r.m.s. or 4200 V peak for REINFORCED

INSULATION (V)............................................................ :N

L.4.3 Sampling tests conducted using twisted pairsamples (IEC 60851-5:1996, clause 4.4.1)......... :

N

Minimum breakdown test voltage at least twicethe voltage in Tables 6 and 7 but not less than:

N

– 3000 V r.m.s. or 4200 V peak for BASIC andSUPPLEMENTARY INSULATION......................................:

N

– 6000 V r.m.s. or 8400 V peak for REINFORCED

INSULATION....................................................................:N


EN 60601-1


4.2.2 RM RESULTS TABLE: General requirements for RISK MANAGEMENT1) P

Clauseof ISO14971

Document Ref. in RMF (Document No.paragraph/clause, version) Result - Remarks Verdict

General process Particular MedicalDevice

3.1 Refer to riskmanagement file,No.: DM-RMF-001(Version: A0)

—

Risk Management Process(excluding production and post-production)

P

3.2 Refer to riskmanagement file,No.: DM-RMF-001(Version: A0)

—

Adequate Resources P

3.2 Refer to riskmanagement file,No.: DM-RMF-001,Team of riskmanagement(Version: A0)

—

Assignment of qualified personnel P

3.2 Refer to riskmanagement file,No.: DM-RMF-001,Table 1 to Table 3(Version: A0)

—

Policy for determining criteria for riskacceptability

P

3.3 — Refer to riskmanagement file, No.:DM-RMF-001, Teamof risk management(Version: A0)

Qualification of personnel P

3.4a — Refer to riskmanagement file, No.:DM-RMF-001,qualitative andquantitative analysisof the characteristics(Version: A0)

The scope of the risk managementactivities of the plan

P

3.4b — Refer to riskmanagement file, No.:DM-RMF-001, Teamof risk management(Version: A0)

Assignment of responsibilities andauthorities

P

3.4c — Refer to riskmanagement file, No.:DM-RMF-001(Version: A0)

Requirements for review of riskmanagement activities

P

3.4d — Refer to riskmanagement file, No.:DM-RMF-001, Table 1to Table 3 (Version:A0)

Criteria for risk acceptability P


EN 60601-1



Clauseof ISO14971



3.4e — Refer to riskmanagement file, No.:DM-RMF-001, RiskAnalysis (Version: A0)

Verification activities P

3.5 — Refer to riskmanagement file, No.:DM-RMF-001(Version: A0)

Risk management file P

4.1 — Refer to riskmanagement file, No.:DM-RMF-001, RiskAnalysis (Version: A0)

Risk analysis process P

4.2 — Refer to riskmanagement file, No.:DM-RMF-001,qualitative andquantitative analysisof the characteristics(Version: A0)

Safety characteristic questionspotential hazard

P


Identification of hazards P


Estimation of the risk(s) for eachhazardous situation

P

5 — Refer to riskmanagement file, No.:DM-RMF-001, RiskAnalysis (Version: A0)

Risk evaluation recorded P

6.2 — Refer to riskmanagement file, No.:DM-RMF-001, Annex2 (Version: A0)

Risk control option analysis recorded P


a, Risk control measures recorded

b, Effectiveness of the risk controlmeasures verified and recorded

c, Implementation of the risk controlmeasures verified and recorded

P


Residual risk evaluation P


EN 60601-1



Clauseof ISO14971



6.5 — Refer to riskmanagement file, No.:DM-RMF-001(Version: A0)

All residual risks are acceptable N

6.6a —No risks arising from risk controlmeasures

N

6.6b — N


Completeness of risk control P

7 — Refer to riskmanagement file, No.:DM-RMF-001,Conclusion (Version:A0)

Evaluation of overall residual riskacceptability

P

8 — Refer to riskmanagement file, No.:DM-RMF-001(Version: A0)

Risk management report P

Supplementary Information:

1) Document Ref should be with regards to the policy/procedure documents and documents containingdevice specific output.

4.3 TABLE: ESSENTIAL PERFORMANCE P

List of ESSENTIAL PERFORMANCE

functions

MANUFACTURER’S document numberreference or reference from this standardor collateral or particular standard(s)

Remarks

Excessive energy output Risk management file, No.: DM-RMF-001(Version: A0) /


ESSENTIAL PERFORMANCE is performance, the absence or degradation of which, would result in an unacceptablerisk.


EN 60601-1


4.11 TABLE: Power Input P

Operating Conditions / RatingsVoltage

(V)Frequency

(Hz)Current

(A)Power( VA)

Power factor(cos φ)

Rated input: 100-240V~, 50/60Hz, 160VA

90 50 0.830 74.7 0.87

100 50 0.740 74.0 0.89

240 50 0.324 77.8 0.81

264 50 0.300 79.2 0.79

90 60 0.832 74.9 0.90

100 60 0.754 75.4 0.89

240 60 0.333 79.9 0.81

264 60 0.320 84.4 0.78


5.9.2 TABLE: Determination of ACCESSIBLE parts P

Location Determination method (NOTE1) Comments

The outer surface of device(LCD screen, switch, key, non-metallic enclosure and footswitch, etc.)

Visual Can be touch

Internal parts inside theopenings

Visual, rigid test finger, jointed testfinger, test hook

Can no be touched


NOTE 1 - The determination methods are: visual; rigid test finger; jointed test finger; test hook.

7.1.2 TABLE: Legibility of Marking P

Markings tested Ambient Illuminance(lx)

Remarks

Outside Markings (Clause 7.2).................. : 100-1500 lx Clearly legible

Inside Markings (Clause 7.3)......................: 100-1500 lx Clearly legible

Controls & Instruments (Clause 7.4)....... : 100-1500 lx Clearly legible

Safety Signs (Clause 7.5)............................ : 100-1500 lx Clearly legible

Symbols (Clause 7.6)................................... : 100-1500 lx Clearly legible


EN 60601-1


7.1.2 TABLE: Legibility of Marking P


Observer, with a visual acuity of 0 on the log Minimum Angle of Resolution (log MAR) scale or 6/6 (20/20) and is able to readN6 of the Jaeger test card in normal room lighting condition (~500lx), reads marking at ambient illuminance least favourablelevel in the range of 100 lx to 1,500 lx. The ME EQUIPMENT or its part was positioned so that the viewpoint was the intendedposition of the OPERATOR or if not defined at any point within the base of a cone subtended by an angle of 30° to the axisnormal to the centre of the plane of the marking and at a distance of 1 m.

7.1.3 TABLE: Durability of marking test P

Characteristics of the Marking Label tested: Remarks

Material of Marking Label .......................................... : PET /

Ink/other printing material or process.....................: Ink /

Material (composition) of Warning Label .............. : PET /

Ink/other printing material or process.....................: Ink /

Other................................................................................: None /

Marking Label Tested: Remarks

Product label P

Warning markings P

Indicating markings P

Supplementary information:Marking rubbed by hand, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a cloth ragsoaked with ethanol 96%, and then for 15 s with a cloth rag soaked with isopropyl alcohol.

8.4.2 TABLE: TABLE: Working Voltage / Power Measurement N

Test supply voltage/frequency (V/Hz)1).................................................................... :

LocationFrom/To

Measured valuesRemarks

VrmsVpk orVdc

Peak-to-peak ripple2)

PowerW/VA

Energy(J)

Supplementary Information:1)The input supply voltage to the ME EQUIPMENT was the RATED voltage or the voltage within the RATED voltage range whichresults in the highest measured value. See clause 8.5.4.2). If the d.c peak-to-peak ripple >10%, waveform considered as a.c. See clause 8.4.2.2

8.4.3 TABLE: ME EQUIPMENT for connection to a power source by a plug- measurement of voltage or calculation of stored charge 1 s afterdisconnection of plug from mains supply

N

Maximum allowable voltage (V).................................................................................................. : 60

Voltage measured (V)


EN 60601-1


Voltage Measured Between: 1 2 3 4 5 6 7 8 9 10

Plug pins 1 and 2 - - - - - - - - - -

Plug pin 1 and plug earth pin - - - - - - - - - -


Plug pin 1 and enclosure - - - - - - - - - -


Maximum allowable stored charge when measured voltage exceeded 60 v (c)........: 45

Calculated stored charge (c)

Voltage Measured Between: 1 2 3 4 5 6 7 8 9 10

Plug pins 1 and 2 - - - - - - - - - -






8.4.4 TABLE: Internal capacitive circuits – measurement of residual voltage orcalculation of the stored charge in capacitive circuits (i.e., accessiblecapacitors or circuit parts) after de-energizing ME EQUIPMENT

N

Maximum allowable residual voltage (V)..................................................................: 60 V

Maximum allowable stored charge when residual voltage exceeded 60 V......: 45 C

Description of the capacitive circuit(i.e., accessible capacitor or circuit

parts)

Measured residualvoltage (V)

Calculated storedcharge (C) Remarks


8.5.5.1a TABLE: defibrillation-proof applied parts – measurement of hazardouselectrical energies

N

TestCondition:Figs. 9 & 10

Measurementmade on

accessible part

Applied part withtest voltage

Test voltagepolarity

Measuredvoltage betweenY1 and Y2 (mV)

Remarks



EN 60601-1


8.5.5.1b TABLE: defibrillation-proof applied parts – verification of recovery time N

Applied part with testvoltage

Test voltagepolarity

Recovery time fromdocuments (s)

Measuredrecovery time (s) Remarks


8.5.5.2 TABLE: DEFIBRILLATION-PROOF APPLIED PARTS or PATIENT CONNECTIONS ofDEFIBRILLATION-PROOF APPLIED PARTS - Energy reduction test –measurement ofEnergy delivered to a 100 load

N

Test Voltage applied toMeasured Energy

E1 (mJ)Measured Energy

E2 (mJ)Energy E1

as % of E2 (%)

PATIENT CONNECTION 1 or APPLIED PART withPATIENT CONNECTIONS 2, 3, and 4 of the sameAPPLIED PART connected to earth




Supplementary information: For compliance: E1 must at least 90% of E2E1= Measured energy delivered to 100 with ME Equipment connected;E2= Measured energy delivered to 100 without ME equipment connected.


EN 60601-1


8.6.4 TABLE: Impedance and current-carrying capability of PROTECTIVE EARTH

CONNECTIONS

N

Type of ME EQUIPMENT & impedance measuredbetween parts

Test current(A)

/Duration (s)

Voltage dropmeasuredbetweenparts (V)

Maximumcalculatedimpedance

(m)

Maximumallowable

impedance(m)

PERMANENTLY INSTALLED ME EQUIPMENT, impedancebetween protective earth terminal and aprotectively earthed part

/ / / /

Me equipment with an appliance inlet, impedancebetween earth pin in the appliance inlet and aprotectively earthed part

/ / / /

Me equipment with an appliance inlet, impedancebetween earth pin in the protective earth pin on theDETACHABLE POWER SUPPLY CORD and aprotectively earthed part

/ / / /

Me equipment with a non-detachable powersupply cord, impedance between the protectiveearth pin in the mains plug and a protectivelyearthed part

/ / / /


PERMANENTLY INSTALLED ME EQUIPMENT, impedance between PROTECTIVE EARTH TERMINAL and a PROTECTIVELY EARTHED part - Limit 100 m

ME EQUIPMENT with an APPLIANCE INLET, impedance between earth pin in the APPLIANCE INLET and a PROTECTIVELY EARTHED part - Limit100 mME EQUIPMENT with an APPLIANCE INLET, impedance between earth pin in the protective earth pin on the DETACHABLE POWERSUPPLY CORD and a PROTECTIVELY EARTHED part - Limit 200 mME EQUIPMENT with a non-DETACHABLE POWER SUPPLY CORD, impedance between the protective earth pin in the MAINS PLUG and aPROTECTIVELY EARTHED part - Limit 200 m


EN 60601-1


8.7 TABLE: leakage current P

Type of leakage current and testcondition (including single faults)

Supplyvoltage

(V)

Supplyfrequency

(Hz)

Measuredmax. value

(µA)Remarks

Fig. 13 - Earth Leakage (ER) (V) (Hz)Before/AfterHumidity (µA)

Maximum allowed values:5 mA NC; 10 mA SFC

ER, NC, S1 = 1, S5 = N 264 60 96.8/97.5

Measured with frequencyweighted device

ER, NC, S1 = 1, S5 = R 264 60 86.9/88.7

ER, SFC (Neutral Open), S1 = 0, S5 = N 264 60 171.4/172.5

ER, SFC (Neutral Open), S1 = 0, S5 = R 264 60 171.5/172.4

ER, NC, S1 = 1, S5 = N 264 60 646.1/646.7

Not exceed 10mA r.m.s.

Measured with non-frequencyweighted device

ER, NC, S1 = 1, S5 = R 264 60 635.2/636.5

ER, SFC (Neutral Open), S1 = 0, S5 = N 264 60 733.2/736.1

ER, SFC (Neutral Open), S1 = 0, S5 = R 264 60 733.4/735.6

Fig. 14 - Touch Current (TC) (V) (Hz)Before/AfterHumidity (µA)

Maximum allowed values:

100 uA NC; 500 uA SFC

TC, NC, S1 = 1, S5 = N, S7 = 1 264 60 <1/<1

MD between enclosure

Measured With frequency-weighted device

TC, NC, S1 = 1, S5 = R, S7 = 1 264 60 <1/<1

TC, SFC (Neutral Open), S1 = 0, S5 = N,S7 = 1

264 60 <1/<1

TC, SFC (Neutral Open), S1 = 0, S5 = R,S7 = 1

264 60 <1/<1

TC, SFC (Ground Open), S1 = 1, S5 = N,S7 = 0

264 60 <1/<1

TC, SFC (Ground Open), S1 = 1, S5 = R,S7 = 0

264 60 <1/<1

TC, NC, S1 = 1, S5 = N, S7 = 1 264 60 20.5/21.5


MD between enclosure

Measured With non-frequency-weighted device

TC, NC, S1 = 1, S5 = R, S7 = 1 264 60 20.6/21.4


264 60 14.9/15.4


264 60 15.0/15.6


264 60 68.6/68.9


264 60 68.4/68.5

TC, NC, S1 = 1, S5 = N, S7 = 1 264 60 1.9/2.1Measured with frequencyweighted device

MD between enclosure and

TC, NC, S1 = 1, S5 = R, S7 = 1 264 60 2.1/2.1

TC, SFC (Neutral Open), S1 = 0, S5 = N, 264 60 2.4/2.3


EN 60601-1


earthS7 = 1


264 60 2.4/2.5


264 60 4.3/4.4


264 60 4.3/4.4

TC, NC, S1 = 1, S5 = N, S7 = 1 264 60 54.1/55.2


MD between enclosure andearth

Measured With non-frequency-weighted device

TC, NC, S1 = 1, S5 = R, S7 = 1 264 60 54.3/55.1


264 60 49.7/50.2


264 60 49.8/49.9


264 60 162.4/163.5


264 60 156.0/156.8

Fig. 15 - Patient Leakage Current (P) (V) (Hz)Before/AfterHumidity (µA)

With frequency-weighteddeviceMaximum allowed values:Type B or BF AP: 10 µA NC; 50µA SFC (d.c. current);100 µA NC; 500 µA SFC (a.c.)Type CF AP: 10 µA NC; 50 µASFC (d.c. or a.c. current)

With non-frequency-weighteddevice

Maximum allowedvalues:10mA

P, NC, S1 = 1, S5 = N, S7 = 1 264 60AC:1.7/1.8

Measured with frequencyweighted device

MD between applied part andprotective earth

DC:0.0/0.0

P, NC, S1 = 1, S5 = R, S7 = 1 264 60AC:2.0/2.1

DC:0.0/0.0

P, SFC (Neutral Open), S1 = 0, S5 = N S7= 1

264 60AC:2.2/2.2

DC:0.0/0.0

P, SFC (Neutral Open), S1 = 0, S5 = R, S7= 1

264 60AC:2.2/2.2

DC:0.0/0.0

P, SFC (Ground Open), S1 = 1, S5 = N, S7= 0

264 60AC:2.5/2.8

DC:0.0/0.0

P, SFC (Ground Open), S1 = 1, S5 = R, S7= 0

264 60AC:2.7/2.8

DC:0.0/0.0


EN 60601-1


P, NC, S1 = 1, S5 = N, S7 = 1 264 60 62.9/62.7


Measured with non-frequencyweighted device

MD between applied part andprotective earth

P, NC, S1 = 1, S5 = R, S7 = 1 264 60 63.0/63.1

P, SFC (Neutral Open), S1 = 0, S5 = N S7= 1

264 60 56.6/56.5

P, SFC (Neutral Open), S1 = 0, S5 = R, S7= 1

264 60 56.2/56.3

P, SFC (Ground Open), S1 = 1, S5 = N, S7= 0

264 60 92.5/92.6

P, SFC (Ground Open), S1 = 1, S5 = R, S7= 0

264 60 92.4/92.4

Fig. 16 - Patient leakage current with mainson the F-type applied parts (PM)

— — —

With frequency-weighteddevice

Maximum allowed values:Type B: N/AType BF AP: 5000 µAType CF AP: 50 µA


Maximum allowedvalues:10mA

N/A (Type B applied part)

Fig. 17 - Patient leakage current withexternal voltage on Signal Input/Outputpart (SIP/SOP)

— — —

Maximum allowed values:Type B or BF AP: 10 µA NC; 50µA SFC(d.c. current);100 µA NC; 500 µA SFC (a.c.) ;Type CF AP: 10 µA NC; 50 µASFC (d.c. or a.c. current)

N/A

Fig. 18 - Patient leakage current withexternal voltage on metal Accessible Partthat is not Protectively Earthed

— — —Maximum allowed values:Type B or BF AP: 500 µAType CF: N/A

P, SFC, S1=0, S5=N, S7=0, S9=N 264 60 2.0/2.2 MD Between non-protectivemetal accessible part andtype B applied part

With frequency-weighteddevice

P, SFC, S1=0, S5=R, S7=0, S9=N 264 60 <1/<1

P, SFC, S1=0, S5=N, S7=0, S9=R 264 60 2.3/2.6

P, SFC, S1=0, S5=R, S7=0, S9=R 264 60 <1/<1

P, SFC, S1=0, S5=N, S7=0, S9=N 264 60 55.7/56.5 MD Between non-protectivemetal accessible part andtype B applied part


P, SFC, S1=0, S5=R, S7=0, S9=N 264 60 58.2/58.8

P, SFC, S1=0, S5=N, S7=0, S9=R 264 60 56.6/57.8

P, SFC, S1=0, S5=R, S7=0, S9=R 264 60 59.1/59.6


EN 60601-1


Fig. 19 – Patient Auxiliary Current — — —

Maximum allowed values:Type B or BF AP: 10 µA NC; 50µA SFC (d.c. current);100 µA NC; 500 µA SFC (a.c.) ;Type CF AP: 10 µA NC;50 µASFC (d.c. or a.c. current)

N/A

Fig. 15 and 20 – Total Patient LeakageCurrent with all AP of same type connectedtogether

— — —

Maximum allowed values:Type B or BF AP: 50 µA NC;100µA SFC (d.c. current);500 µA NC; 1000 µA SFC (a.c.);Type CF AP: 50 µA NC; 100 µASFC (d.c. or a.c. current)

N/A

Fig. 17 and 20 – Total Patient LeakageCurrent with all AP of same type connectedtogether with external voltage on SIP/SOP

— — —

Maximum allowed values:Type B or BF AP: 50 µA NC;100µA SFC (d.c. current);500 µA NC;1000 µA SFC (a.c.);Type CF AP: 50 µA NC; 100 µASFC (d.c. or a.c. current)

N/A

Fig. 16 and 20 – Total Patient LeakageCurrent with all AP of same type connectedtogether with external voltage on F-type AP

— — —

Maximum allowed values:Type B: NAType BF: 5000 µAType CF: 100 µA

N/A

Fig. 18 and 20 – Total Patient Leakage Currentwith all AP of same type connected togetherwith external voltage on metal Accessible Partnot Protectively Earthed

— — —Maximum allowed values:Type B & BF: 1000 µAType CF: N/A

N/A

Function Earth Conductor Leakage Current(FECLC)

— — —Maximum allowed values:5 mA NC; 10 mA SFC

N/A


Note 1: For EARTH LEAKAGE CURRENT see 8.7.3 d) and 8.7.4.5;Note 2: For TOUCH CURRENT see 8.7.3 c) and 8.7.4.6;

Note 3: For PATIENT LEAKAGE CURRENT SEE 8.7.3.b) and 8.7.4.7Note 4: Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS of the same type.See 8.7.4.7 h). The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values.

Note 5: In addition to conditions indicated in the Table, tests conducted at operating temperature and after humiditypreconditioning of 5.7, EQUIPMENT energized in stand-by condition and fully operating, max rated supply frequency, at 110 % ofthe max RATED MAINS VOLTAGE, and after relevant tests of Clause 11.6 (i.e., overflow, spillage, leakage, ingress of water andparticulate matter, cleaning & disinfection, & sterilization).

ER - Earth leakage currentTC – Touch currentP - Patient leakage currentPA – Patient auxiliary currentTP – Total Patient currentPM - Patient leakage current with mains on the applied partsMD - Measuring device

A - After humidity conditioningB - Before humidity conditioning1 - Switch closed or set to normal polarity0 - Switch open or set to reversed polarityNC - Normal conditionSFC - Single fault condition


EN 60601-1


8.8.3 TABLE: Dielectric strength test of solid insulating materials with safetyfunction – MEANS OF OPERATOR PROTECTION (MOOP) / MEANS OF PATIENT

PROTECTION (MOPP)

P

Insulation under test(area from insulation

diagram)

Insulation Type(1 or 2

MOOP/MOPP)

Reference Voltage

A.C. testvoltages in V

r.m.s1)

Dielectricbreakdown

after 1minute

Yes/No2)

PEAK WORKING

VOLTAGE (U)V peak

PEAK

WORKING

VOLTAGE (U)V d.c.

A 1MOOP 339 - 1500 -3

B 1MOPP 339 - 1500 -3

C 2MOPP 339 - 4000 -3

D 2MOPP 339 - 4000 -3

E 2MOPP 339 - 4000 No

F 2MOOP 339 - 3000 No

G 2MOOP 339 - 3000 No

H 1MOPP 339 - 1500 No

Supplementary information:1 Alternatively, per the Table (i.e., __dc), a d.c. test voltage equal to the peak value of the a.c. test voltage used.2 A) Immediately after humidity treatment of 5.7, ME EQUIPMENT de-energized, B) after required sterilization PROCEDURE, MEEQUIPMENT de-energized, C) after reaching steady state operating temperature as during heating test of 11.1.1, and D) afterrelevant tests of 11.6 (i.e., overflow, spillage, leakage, ingress of water, cleaning, disinfection, and sterilization).

3. The adaptor (Model: GSM160A12) are evaluated and tested by CB Testing Laboratory: TUV Rheinland, to comply withthe requirements of standard EN 60601-1 and Certificate No. TA 50345678 01.

8.8.4.1 TABLE: Resistance to heat - Ball pressure test of thermoplastic parts P

Allowed impression diameter (mm) .................. : 2 mm

Force (N).................................................................... : 20

Part/material Testtemperature (C)

Impressiondiameter (mm)

Plastic Enclosure 75 1.2


8.9.2 TABLE: Short circuiting of each single one of the CREEPAGE DISTANCES andAIR CLEARANCES for insulation in the MAINS PART between parts of oppositepolarity in lieu of complying with the required measurements in 8.9.4

N

Specific areas of circuits short-circuited and test conditions

Test in lieu ofCREEPAGE

DISTANCE or AIR

CLEARANCE1)

HAZARDOUS SITUATION

observed (i.e., fire hazard,shock hazard, explosion,discharge of parts, etc.)?

Yes/No

Remarks


EN 60601-1


Supplementary information:1)Note: AC - AIR CLEARANCE CD - CREEPAGE DISTANCE

8.9.3.2 Table: Thermal cycling tests on one sample of insulating compound formingsolid insulation between conductive parts

N

Part Test

8.9.3.4 - Test duration andtemperature for 10 cycles after

which the sample was subjectedto Humidity Preconditioning per

Cl. 5.7

Dielectric testvoltage

Dielectric strength testafter humidity

preconditioning per cl.5.7 except for 48 h only,

Breakdown: Yes/No

Crack or voidsin the

insulatingcompound:

Yes/No

68 h at T1 ± 2 °C = ___°C 1)

1 h at 25 °C ± 2 °C

2 h at 0 °C ± 2 °C

1 or more h at 25 °C ± 2 °C

Supplementary information:1) T1 = 10 °C above the maximum temperature of relevant part determined per 11.1.1, or 85 °C, the higher ofthe two. 10 °C not added to T1 when temperature measured by an embedded thermocouple. Used gradualtransition from one temperature to another.

8.9.3.3 Table: Thermal cycling tests on one sample of cemented joint with otherinsulating parts (see 8.9.3.3)

N

Part tested Sample Each test duration and temperatureDielectric test

voltageDielectric strength test

Breakdown: Yes/No

Supplementary information:1) T1 = 10 °C above the maximum temperature of relevant part determined per 11.1.1, or 85 °C, the higher ofthe two. 10 °C not added to T1 when temperature measured by an embedded thermocouple. Used gradualtransition from one temperature to another.


EN 60601-1


8.10 TABLE: List of critical components P

Component/Part No.

Manufacturer/Trademark

Type No./modelNo./

Technical data Standard No./, Edition Mark(s) &Certificates

ofconformity1)

AdaptorMEAN WELL

ENTERPRISESCO., LTD.

GSM160A-12

Input: 100-240VAC,

50/60Hz, 2.0-1.0A

Output:12VDC, 11.5A

EN 60601-1

TUVRheinlandcertificateNO.: TA

50345678 01

FanDELTA

ELECTRONICSINC

AFB0712HHB 12V, 0.45A UL 507 UL E132003

Power switch

NINGBOHAISHU LIHEELECTRONICCO., LTD

RL3-4-21 250V 6A UL 61058-1 UL E208316

Power plugDongguan UbillElectrical Co.,

Ltd.YG-102 250Vac 16 A IEC 60884-1

DEKRACertificateNo.:35-102063

Power CordDongguan UbillElectrical Co.,

Ltd.H05VV-F 3G 0,75 mm2 EN 50520-1


Powerconnector

Dongguan UbillElectrical Co.,

Ltd.YG-11 250Vac 10 A EN 60320-1


Internal wire

SHENZHENCITY

WEIDAXUANWIRE & CABLE

CO LTD

16AWG 600V, 200°C ANSI/UL 758 UL E249743

Plasticenclosure

FORMOSACHEMICALS &FIBRE CORPPLASTICS DIV

AC310V-0, 85℃,

1.5mm

UL 94

UL 746UL E162823

PCB

SHENZHEN JIALI CHUANG

TECHNOLOGYDEVELOPMENT

CO LTD

FR-4 V-0, 130℃UL 94

UL 796UL E479892

Foot switchSUNS

Electric(zhangzhou) Co., Ltd.

FS-81-SP-T-2-CS

25VAC, 5A,IP68

IEC 60601-1HuatongweiTest Report

No.:


EN 60601-1


TRS12090052

Laser moduleRealLight Beijing

Ltd.

R808/980±10-15/15WD-R4W-

PFS

808nm:

voltage:4.2Vd.c.

Current: 9.5A

980nm：

voltage:3.8Vd.c.

Current: 10.5A

IEC 60601-1

IEC 60825-1

Test withequipment

See IEC60825 report:EED31K0024

67

Supplementary information:1) Indicates a mark which assures the agreed level of surveillance. See Licenses and Certificates of Conformityfor verification.

8.10 b TABLE: List of identified components with HIGH INTEGRITY CHARACTERISTICS N

Component/Part No.

Manufacturer/Trademark

Type No./modelNo./

Technical data Standard No./,Edition

Mark(s) &Certificates ofconformity1)

Supplementary information:1) Indicates a mark which assures the agreed level of surveillance. See Licenses and Certificates of Conformityfor verification.

8.11.3.5 TABLE: Cord anchorages P

Cord under test Mass ofequipment (kg)

Pull (N) Torque Nm) Remarks

Foot switch cable 0.82 30 0.1 Longitudinal displacement ofthe cord sheath：1.6 mm；

Movement distance ofconductor ends: 0 mm


8.11.3.6 TABLE: Cord guard P

Cord under test Test mass Measured curvature Remarks

Foot switch cable 168g 7.8 after the mass has beenattached, is anywhere greaterthan 6.15



EN 60601-1


9.2.2.2 TABLE: Measurement of gap “a” according to Table 20 (ISO 13852: 1996) N

Part of body Allowable adultgap1), mm

Measured adultgap, mm

Allowable childrengap1), mm

Measured childrengap, mm

Body > 500 N/A > 500 N/A

Head > 300 or < 120 N/A > 300 or < 60 N/A

Leg > 180 N/A > 180 N/A

Foot > 120 or < 35 N/A > 120 or < 25 N/A

Toes > 50 N/A > 50 N/A

Arm > 120 N/A > 120 N/A

Hand, wrist, fist > 100 N/A > 100 N/A

Finger > 25 or < 8 N/A > 25 or < 4 N/A

Supplementary information: 1) In general, gaps for adults used, except when the device is specificallydesigned for use with children, values for children applied.

9.2.3.2 TABLE: Over-travel End Stop Test N

ME EQUIPMENT end stop Test Condition (cycles, load, speed) Remarks


9.4.2.1 TABLE: Instability—overbalance in transport position P

ME EQUIPMENTpreparation

Test Condition (transport position) Remarks

Whole unit with accessory(power supply cord, footwitch, applied part) attached,and the EUT is preparedaccording to clause 9.4.2.2

Titled through an angle of 10° Not be out of balance after testing



EN 60601-1


9.4.2.2 TABLE: Instability—overbalance excluding transport position P


Test Condition (excluding transportposition) Test either 5 ° incline and verify

Warning marking or 10 ° incline)

Remarks

Whole unit with accessory(power supply cord, footwitch, applied part) attached,and the EUT is preparedaccording to clause 9.4.2.2

Titled through an angle of 10° Not be out of balance after testing


9.4.2.3 TABLE: Instability—overbalance from horizontal and vertical forces N


Test Condition (force used, direction offorce, weight of equipment, location of

force)

Remarks


9.4.2.4.2 TABLE: Castors and wheels – Force for propulsion N


Test Condition (force location and height) Remarks


9.4.2.4.3 TABLE: Castors and wheels – Movement over a threshold N

ME EQUIPMENT preparation Test Condition (speed of movement) Remarks


9.4.3.1 TABLE: Instability from unwanted lateral movement (including sliding) intransport position

N

ME EQUIPMENTPreparation

Test Condition (transport position,working load, locking device(s), caster

position)

Remarks



EN 60601-1


9.4.3.2 TABLE: Instability from unwanted lateral movement (including sliding)excluding transport position

N

ME EQUIPMENTPreparation

Test Condition (working load, lockingdevice(s), caster position, force, force

location, force direction)

Remarks


9.4.4 TABLE: Grips and other handling devices N

Clause and Name of Test Test Condition Remarks


9.7.5 TABLE: Pressure vessels N

Hydraulic,Pneumatic orSuitable Media

and Test Pressure

Vessel BurstPermanent

DeformationLeaks

Vessel fluidsubstance

Remarks


9.8.3.2 TABLE: PATIENT support/suspension system - Static forces N

ME EQUIPMENT part orarea

Position Load Area Remarks


9.8.3.3 TABLE: Support/Suspension System – Dynamic forces due to loading frompersons

N

ME EQUIPMENT partor area

PositionSafe Working

LoadArea Remarks


10.1.1 TABLE: Measurement of X - radiation N


EN 60601-1


Maximum allowable radiation pA/kg ( μSv/h) (mR/h) 36 (5 Sv/h) (0.5 mR/h)

Surface area under testSurface no./ Description1)

Measured Radiation,pA/kg (μSv/h) (mR/h)

Remarks

1/ /

2/ /

3/ /

4/ /

5/ /

6/ /

7/ /

8/ /

9/ /

10/ /

Supplementary information:1) Measurements made at a distance of 5 cm from any surface to which OPERATOR (other than SERVICE

PERSONNEL) can gain access without a TOOL, is deliberately provided with means of access, or is instructed toenter regardless of whether or not a TOOL is needed to gain access

11.1.1 TABLE: Excessive temperatures in ME EQUIPMENT

-Normal temperature rise

P

Model No........................................................ : BERYLAS-15FJ --

Test ambient (C) .........................................: See below --

Test supply voltage/frequency (V/Hz)4....... : See below --

Model No.Thermo-couple No.

Thermocouple location3

Max allowabletemperature1 fromTable 22, 23 or24 or RM file for

AP5 (C)

Max measuredtemperature2/Adjust to 30C

(C)

Remarks

Adaptor input: 264V~, 60Hz

BERYLAS-15FJ

101 Ambient -- 24.3 30.0 Pass

102 Test corner 90 24.8 30.5 Pass

103 PCB near M2 130 35.0 40.7 Pass

104 PCB near U9 130 43.0 48.7 Pass

105 PCB near Q3 130 39.5 45.2 Pass

106 PCB near U7 130 36.0 41.7 Pass

107 PCB near U4 130 34.2 39.9 Pass

108 Internal wire 105 35.0 40.7 Pass

109 Switch 71 27.1 32.8 Pass


EN 60601-1


110 Plastic enclosure 60 28.7 34.4 Pass

111 Emergency Stop Button 71 25.1 30.8 Pass

112 Screen 60 28.1 33.8 Pass

113 Foot switch enclosure 60 24.8 30.5 Pass

114 Adaptor enclosure 60 36.1 41.8 Pass

115 Applied part 41 24.9 30.6 Pass


BERYLAS-15FJ

101 Ambient -- 25.5 30.0 Pass


103 PCB near M2 130 36.0 40.5 Pass

104 PCB near U9 130 44.0 48.5 Pass

105 PCB near Q3 130 40.7 45.2 Pass

106 PCB near U7 130 36.9 41.4 Pass

107 PCB near U4 130 35.1 39.6 Pass


109 Switch 71 28.3 32.8 Pass



112 Screen 60 29.0 33.5 Pass




Supplementary information:1Maximum allowable temperature on surfaces of test corner is 90 C2 Max temperature determined in accordance with 11.1.3e)3When thermocouples used to determine temperature of windings, limits of Table 22 reduced by 10 °C.4Supply voltage:- ME EQUIPMENT with heating elements - 110 % of the maximum RATED voltage;- Combined heating and motor operated and other ME EQUIPMENT - tested both at 110 % of the maximumRATED voltage and at 90 % of the minimum RATED voltage.5 APPLIED PARTS intended to supply heat to a PATIENT - See RISK MANAGEMENT FILE containingtemperatures and clinical effects. Also, see instructions for use.


-Ventilation blocked temperature test

P

Model No........................................................ : BERYLAS-15FJ

Test ambient (C) .........................................: See below

Test supply voltage/frequency (V/Hz)4....... : See below


EN 60601-1


Model No.Thermo-coupleNo.



AP5 (C)

Max measuredtemperature2/

Adjust to 30C (C)Remarks


BERYLAS-15FJ

101 Ambient -- 24.6 30.0 Pass


103 PCB near M2 130 58.6 64.0 Pass

104 PCB near U9 130 65.5 70.9 Pass

105 PCB near Q3 130 61.7 67.1 Pass

106 PCB near U7 130 60.2 65.6 Pass

107 PCB near U4 130 58.1 63.5 Pass


109 Switch 71 27.5 32.9 Pass



112 Screen 60 35.4 40.8 Pass






-Cooling fan locked temperature test

P

Model No........................................................ : BERYLAS-15FJ

Test ambient (C) .........................................: See below

Test supply voltage/frequency (V/Hz)4....... : See below


EN 60601-1


Model No.Thermo-coupleNo.



AP5 (C)

Max measuredtemperature2/

Adjust to 30C (C)Remarks


BERYLAS-15FJ

101 Ambient -- 24.6 30.0 Pass


103 PCB near M2 130 63.7 69.1 Pass

104 PCB near U9 130 76.1 81.5 Pass

105 PCB near Q3 130 72.6 78.0 Pass

106 PCB near U7 130 59.5 64.9 Pass

107 PCB near U4 130 61.3 66.7 Pass


109 Switch 71 25.2 30.6 Pass



112 Screen 60 30.8 36.2 Pass





11.1.3d TABLE: Temperature of windings by change-of-resistance method N

Temperature T of winding: t1 (°C) R1 () t2 (°C) R2 () T (C) Allowed Tmax

(C)

Insulationclass



EN 60601-1


11.2.2.1 TABLE: Alternative method to 11.2.2.1 a) 5) to determine existence of anignition source

N

Areas where sparking might cause ignition: Remarks

1.

2.

3.

4.

5.

6.

Materials of the parts between which sparks could occur (Composition,Grade Designation, Manufacturer):

Remarks

1.

2.

3.

4.

5.

6.

Test parameters selected representing worst case conditions for ME

EQUIPMENT:Remarks

Oxygen concentration (%)..................:

Fuel.......................................................... :

Current (A)..............................................:

Voltage (V)..............................................:

Capacitance (F)...................................:

Inductance or resistance (h or )..... :

No. of trials (300 Min)...........................:

Sparks resulted in ignition (Yes/No) :

Supplementary information: Test procedure of 11.2.2.1 a) 5) & Figs 35-37 used for tests. For circuits not in Figs35-37, test voltage or current set at 3 times the worst case values with other parameters set at worst case valuesto determine if ignition can occur.

Information from Risk Management, as applicable:


EN 60601-1


11.6.1 TABLE: overflow, spillage, leakage, ingress of water, cleaning, disinfection,sterilization, compatibility with substances

P

Clause / Test Name Test Condition Part under test Remarks

11.6.5/Ingress of water IP68 Foot switch Test methods seeHUATONGWEI test reportNo.: TRS12090052

11.6.6/Cleaning andDisinfecting

Refer to the manual “DailyMaintenance”

The outer of device No breakdown duringdielectric strength testing


Information from Risk Management and user manual, as applicable;

13.1.2 TABLE: measurement of power or energy dissipation in parts & componentsto waive SINGLE FAULT CONDITIONS in 4.7, 8.1 b), 8.7.2, and 13.2.2 relative toemission of flames, molten metal, or ignitable substances

N

Power dissipated less than (W).................................. : 15

Energy dissipated less than (J).................................. : 900

Part or componenttested

Measured powerdissipated (W)

Calculated energydissipated (J)

SINGLE FAULT CONDITIONS

waived (Yes/No)Remarks


13.2 TABLE: SINGLE FAULT CONDITIONS in accordance with 13.2.2 to 13.2.13, inclusive P

Clause No. Description of SINGLE FAULT CONDITION Results observedHAZARDOUS

SITUATION

(Yes/No)

13.2.2 Electrical SINGLE FAULT CONDITIONS per Cl. 8.1: — —

The single faults of Adaptor (model: GSM160A-12) --2)

13.2.3 Overheating of transformers per Clause 15.5: — —

N/A

13.2.4 Failure of THERMOSTATS according to 13.2.13 &15.4.2, overloading - THERMOSTATS shortcircuited or interrupted, the less favourable ofthe two:

— —

N/A

13.2.5 Failure of temperature limiting devicesaccording to 13.2.13 & 15.4.2, overloading,THERMOSTATS short circuited or interrupted, theless favourable of the two:

— —

N/A


EN 60601-1




SITUATION

(Yes/No)

13.2.6 Leakage of liquid - RISK MANAGEMENT FILE

examined to determine the appropriate testconditions (sealed rechargeable batteriesexempted)

— —

N/A

13.2.7 Impairment of cooling that could result in aHAZARD using test method of 11.1:

— —

Single ventilation fans locked consecutively

(For the cooling fan of equipment)

The temperature ofcomponents not exceed limitedvalue, no fire, no damage, nohazard

See appended Table 11.1.1 fordetail

No

Ventilation openings on top and sides impaired bycovering openings on top of ENCLOSURE orpositioning of ME EQUIPMENT against walls

The temperature ofcomponents not exceed limitedvalue, no fire, no damage, nohazard

See appended Table 11.1.1 fordetail

No

13.2.8 Locking of moving parts – Only one part lockedat a time – Also see 13.2.10 below:

— —

N/A

13.2.9 Interruption and short circuiting of motorcapacitors – Motor capacitors short & opencircuited 1) – Also see 13.10

— —

V measured = N/A

V measured = N/A

13.2.10 Additional test criteria for motor operated ME

EQUIPMENT in 13.2.8 &13.2.9:— —

For every test in SINGLE FAULT CONDITION of13.2.8 and 13.2.9, motor-operated EQUIPMENT

stared from COLD CONDITION at RATED voltage orupper limit of RATED voltage range for specifiedtime:

N/A

Temperatures of windings determined at theend of specified test periods or at the instant ofoperation of fuses, THERMAL CUT-OUTS, motorprotective devices

N/A

Temperatures measured as specified in 11.1.3d)

N/A


EN 60601-1




SITUATION

(Yes/No)

Temperatures did not exceed limits of Table 26 N/A

13.2.11 Failures of components in ME EQUIPMENT used inconjunction with OXYGEN RICH ENVIRONMENTS:

— —

N/A

N/A

13.2.12 Failure of parts that might result in aMECHANICAL HAZARD (See 9 & 15.3):

— —

N/A

N/A

Supplementary information:1) Test with short-circuited capacitor not performed when motor provided with a capacitor complying with IEC 60252-1 and the ME EQUIPMENT

not intended for unattended use including automatic or remote control. See Attachment # and appended Table 8.10.2 ) The Adaptor (model: GSM160A-12), both have been evaluated and tested by CB testing laboratory: TUV Rheinland., which confirm to therelevant provisions and test requirements of EN 60601-1 (3.1rd), See their CB test report for more details, file No.: ZTW1-50041648 001.

Information from Risk Management, as applicable:

15.3 TABLE: Mechanical Strength tests 1) P

Clause Name of Test Test conditions Observed results/Remarks

15.3.2 Push Test Force = 250 N ± 10 N for 5 s No damage

15.3.3 Impact Test Steel ball (50 mm in dia., 500 g ± 25 g)falling from a 1.3 m

No damage

15.3.4.2 Drop Test (portable) Free fall height (cm) = 5 No damage

15.3.6 Mould Stress Relief 7 h in oven at temperature (°C) = 70°C No hazard.

Supplementary information: 1)As applicable, Push, Impact, Drop, Mould Stress Relief and Rough HandlingTests (delete not applicable rows or state N/A in Remarks field).

15.4.6 TABLE: actuating parts of controls of ME EQUIPMENT – torque & axial pull tests N

Rotating control undertest

Gripping diameter“d” of controlknob (mm)1)

Torque fromTable 30 (Nm)

Axial forceapplied

(N)

UnacceptableRISK occurred

Yes/No

Remarks

Supplementary information: 1)Gripping diameter (d) is the maximum width of a control knob regardless of itsshape (e.g. control knob with pointer)


EN 60601-1


15.5.1.2 TABLE: transformer short circuit test short-circuit applied at end of windingsor at the first point that could be short circuited under SINGLE FAULT CONDITION

N

Primary voltage (most adverse value from 90 % to 110 % of RATED voltage)(V)1)....: —

RATED input frequency (Hz)........................................................................................: —

Windingtested

Class ofinsulation(A, B, E, F,

or H)

Type ofprotective device

(fuse, circuitbreaker) /Ratings

Protectivedevice

operatedYes/No

Time to THERMAL

STABILITY (whenprotective device

did notoperate)(Min)

Maximumallowed

temp fromTable 31

(ºC)

Maximumwinding

tempmeasured

(ºC)

Ambient

(ºC)

Supplementary information:1) Loads on other windings between no load and their NORMAL USE load. Short-circuit applied at end of windingsor at the first point that could be short circuited under SINGLE FAULT CONDITION.

15.5.1.3 TABLE: transformer overload test – conducted only when protective deviceunder short-circuit test operated

N

Primary voltage, most adverse value between 90 % to 110 % of RATED voltage (V)1)...... :

RATED input frequency (Hz)........................................................................................................... :

Test current just below minimum current that would activate protective device and achieveTHERMAL STABILITY under method a) (A).......................................................................................:

Test current based on Table 32 when protective device that operated under method a) isexternal to transformer, and it was shunted (A)....................................................................... :

Winding testedClass of

insulation(A, B, E, F, H)

Type of protective deviceused (fuse, circuitbreaker)/Ratings

Maximum allowedtemp from

Table 31 (ºC)

Maximumwinding tempmeasured (ºC)

Ambient(ºC)

Supplementary information:1) Loads on other windings between no load and their NORMAL USE load.Time durations: - IEC 60127-1 fuse: 30 min at current from Table 32.Non IEC 60127-1 fuse: 30 min at the current based on characteristics supplied by fuse manufacturer, specifically, 30 minclearing-time current. When no 30 min clearing-time current data available, test current from Table 32 used until THERMALSTABILITY achieved.- Other types of protective devices: until THERMAL STABILITY achieved at a current just below minimum current operating theprotective device in a). This portion concluded at specified time or when a second protective device opened.

15.5.2 TABLE: Transformer dielectric strength after humidity preconditioning of 5.7 N

TransformerModel/Type/ Part

No

Test voltage applied between Testvoltage,

(V)

Testfrequency

(Hz)

BreakdownYes/No

Deterioration Yes/No

Supplementary information: Tests conducted under the conditions of 11.1, in ME EQUIPMENT or undersimulated conditions on the bench. See Clause 15.5.2 for test parameters & other details


EN 60601-1


16.6.1 TABLE: LEAKAGE CURRENTS in ME SYSTEM _ TOUCH CURRENT MEASUREMENTS N

Specific area where TOUCH

CURRENT measured (i.e., from orbetween parts of ME SYSTEM

within PATIENT ENVIRONMENT)

AllowableTOUCH CURRENT

in NORMAL

CONDITION (A)

MeasuredTOUCH

CURRENT inNORMAL

CONDITION

(A)

Allowable TOUCH CURRENT

in event of interruption ofPROTECTIVE EARTH

CONDUCTOR, (A)

Measured TOUCH

CURRENT in event ofinterruption of

PROTECTIVE EARTH

CONDUCTOR, (A)

100 500

100 500

100 500

100 500

100 500


SP TABLE: Additional or special tests conducted N

Clause and Name of Test Test type and condition Observed results



Annex 1 Photo Documentation

Picture 1 General view




Picture 6 Internal view


Picture 7 PCB view

Picture 8 PCB view


Picture 9 PCB view

Picture 10 PCB view


Picture 11 PCB view

Picture 12 PCB view


Picture 13 PCB view

Picture 14 PCB view


Picture 15 PCB view

Picture 16 Adaptor view


Picture 17 Power cord view

Picture 18 Applied part view

*** End of Report ***The test report is effective only with both signature and specialized stamp. The result(s) shown in this reportrefer only to the sample(s) tested. Without written approval of CTI, this report can’t be reproduced except infull.

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