FDC
6 12 , 79-84, 2011
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Kbps Mbps
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Active Implantable Medical Device(
) .
2. Implantable Cardioverter Defibrillator 1. Implantable Cardiac Pacemaker
81
2.2
ISO, IEC, ASTM, BS, ANSI
ISO 14708, ISO 5841, EN
45502
. ISO 14708-1: 2000 Implants for
surgery - Active implantable medical device
.
14 .10)
ISO 14708-2:2005 BS
EN 45502-2-1: 2003
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ISO 14708-6: 2010 BS EN 45502-2-2:2008
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1. International standard of implantable medical device
ISO 14708-1: 2000
Implants for surgery - Active implantable medical devices
- Part 1: General requirements for safety, marking and for information to be provided by the
manufacturer
ISO 1708-2: 2005Implants for surgery - Active implantable medical devices
- Part 2: Cardiac pacemakers
BS EN 45502-2-1: 2003Active implantable medical devices. Particular requirements for active implantable medical
devices intended to treat bradyarrhythmia (cardiac pacemakers)
ISO 14708-1: 2000
Implants for surgery - Active implantable medical devices
- Part 1: General requirements for safety, marking and for information to be provided by the
manufacturer
ISO 1708-6: 2010
Implants for surgery - Active implantable medical devices
- Part 6: Particular requirements for active implantable medical devices intended to treat
tachyarrhythmia (including implantable defibrillators)
BS EN 45502-2-2: 2008Active implantable medical devices. Particular requirements for active implantable medical
devices intended to treat tachyarrhythmia (includes implantable defibrillators)
2. Performance evaluation of implantable cardiac pacemaker
1 ms 1/3
2 V, mA
3 /min 20
4 ms (trigger)
5 V / 201 1 M 1 K
6 K 1 M
, 1 k
7 ms
8 ms
9 ms 4()
10 ms
82
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.
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.12)
.
3.2
M
4, 5 .
. 1
(%) .11-12)
4.
14
.
,
,
3. Performance evaluation of implantable cardioverter defibrillator
1 ms 1/3
2 V, mA
3 /min 20
4 ms (trigger)
5 V / 201 1 M 1 K
102
6 K 1 M, 30pF
7 ICD V
8 /
J ICD
4. Test result of implantable cardiac pacemaker
()
1 0.49 ms(0.5 ms)
2 1.23 V(1 V)
3 665.96 mHz
(35 min1)
4 1485 ms (1.5 s)
5 1.1(1)
1.05 (1)
6 362
7 1000 ms
420 ms
8 25 ms
20 ms
9 200 ms
10
5. Test result of implantable cardioverter defibrillator
()
1 4 ms (4 ms)
2 250 mV (0.2 V)
3 831.22 mHz
(50 min1)
4 1024 ms (1 s)
5 1.1 (1)
1.05 (1)
6 362
7 ICD
8 /
W220mV2 t( )
50-----------------------------
0
0.004 sec
dt=
83
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IV.
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.
.
.
2010
(10172465)
.
1) O. N. Kim., u-Healthcare , LG Business
Insight, pp. 23-41, 2009.
2) Jacob Basham, Implatable Medical Devices: Challenges
and Opportunities, 2011.
3) Korea Health Industry Development Institute, Korea
Health Industry Development Institute, Vol. 05, 2010.
4) ,
, 2009.
5) 2009 ,
Korea Food & Drug Administration, 2010.
6) W. H. Maisel. Safety issues involving medical devices.
Journal of theAmerican Medical Association, Vol. 08, pp.
955-958, 2005.
7) Myeong Sang Kong, EMC Study of the Pacemaker and
Implantable Cardioverter-Defibrillator in Saloon Area, The
Korea Society for Railway, Vol. 2, pp. 741-1120, 2002.
8) K. David Steidley, Eric Steidley, "Pacemaker/ ICD Irradi-
ation Policies in Radiation Oncology, Radiation Oncology
Dept., St. Barnabas Medical Center
9) Dong-il Lee, Shinki Ahn, Jong Youn Kim, Myounghee Kim,
Sooyoung Kim, Moon Hyoung Lee, Sung Soon Kim,
Implantable Cardioverter-Defibrillator (ICD) TherapyInitial
Clinical Experience in 6 Patients, Korean Circulation J, Vol.
9, pp.999-1015, 1999
10) ISO 14708-1: 2000, Implants for surgery - Active implantable
medical device - Part 1: General requirements for safety,
marking and for information to be provided by the manu-
facturer
11) ISO 14708-2: 2005, Implants for surgery - Active im-
plantable medical device - Part 2: Cardiac pacemakers
12) ISO 14708-6: 2010, Implants for surgery - Active im-
plantable medical device - Part 6: Particular requirements for
active implantable medical devices intended to treat tachyar-
rhythmia (including implantable defibrillators).
(: 2011. 11. 5 /: 2011. 12. 16)
84
Abstract
Study on the Test for Implantable U-Health Device
Jae Hoon Jeong1, Sung Yun Park1, Eun Jeong Cho2, Chan Hoi Hur2, Ki Jung Park2, Dong Sup Kim3 and Sung Min Kim1
1Department of Medical Bio Engineering, Dongguk Univ.-Seoul2Fusion Technology Medical Devices Team, Pharmaceuticals and Medical Devices Research Department
National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration3Pharmaceuticals and Medical Devices Research Department National Institute of Food and Drug Safety Evaluation,
Korea Food and Drug Administration
The purpose of this study is to survey the technology and to investigate the standard about the 'Implantable
u-health devices (implantable cardiac pacemakers, implantable defibrillators) in domestic and foreign. As results,
the evaluation guideline has been made for each device (implantable cardiac pacemakers, implantable
defibrillators). The evaluation guideline is included scope, normative references, term and definitions, method of
performance evaluation, test configuration, figure of test result. We have taken a detailed assessment of safety
and effectiveness about the guideline for performance evaluation. The evaluation guideline has made based on
the international guideline which have internationally credibility.
Key words : Implantable Medical Device, Implantable Cardiac Pacemaker, Implantable Cardioverter Defibrillator,
Safety, Performance, Test Methods
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