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Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer.
| 분야 | |
|---|---|
| 적용범위 | Voltage, Life (durability), Radio-wave hazards, Sterile equipment, Protected electrical equipment, Testing conditions, Design, Compatibility, Electrical testing, Ultrasonic testing, Medical equipment, Delivery, Packaging, Dielectric-strength tests, Safety measures, Prosthetic devices, Ultrasonic hazards, Electrical safety, Implants (surgical), Impulse-voltage tests, Performance, Instructions for use, Marking, Electromagnetic compatibility, Electrically-operated devices, Temperature, Biological analysis and testing, Defibrillators, Mechanical testing, Endurance testing, Thermal testing, Test equipment, Environmental testing, Packages, Durability, Electrostatics, Reliability, Leakage currents, Hazards, Accident prevention, Electrical medical equipment, Electric charge |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 30 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN 45502-1:2015 - TC | Tracked Changes. Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer. | 2020-02-25 | 표준 |
| 2 | BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer. | 2015-06-30 | 표준 |
| 3 | BS EN 45502-1:1998 | Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer. | 1998-02-15 | 폐지 |
BS EN 45502-2-1:2003 - Active implantable medical devices. Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers). 상세보기
BS EN 45502-2-2:2008 - Active implantable medical devices. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators). 상세보기
BS EN 45502-2-3:2010 - Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems. 상세보기
BS EN 45502-1:2015 - Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer. 상세보기
BS EN 45502-1:2015 - TC - Tracked Changes. Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer. 상세보기
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