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ISO, IEC, ASTM, BS, ANSI

ISO 14708, ISO 5841, EN

45502

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surgery - Active implantable medical device

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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)

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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

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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)

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7 1000 ms

420 ms

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5. Test result of implantable cardioverter defibrillator

()

1 4 ms (4 ms)

2 250 mV (0.2 V)

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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