관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
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분야 | |
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적용범위 | Ultrasonic hazards, Voltage, Radio-wave hazards, Leakage currents, Electrical medical equipment, Defibrillators, Ultrasonic testing, Temperature, Durability, Electrical safety, Delivery, Electrostatics, Sterile equipment, Hazards, Mechanical testing, Safety measures, Accident prevention, Electromagnetic compatibility, Biological analysis and testing, Life (durability), Performance, Packaging, Thermal testing, Instructions for use, Impulse-voltage tests, Medical equipment, Electric charge, Compatibility, Electrical testing, Implants (surgical), Electrically-operated devices, Design, Prosthetic devices, Marking, Reliability, Packages, Environmental testing, Protected electrical equipment, Endurance testing, Test equipment, Dielectric-strength tests, Testing conditions |
국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
페이지수 | 64 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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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 45502-1:1998 - Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer. 상세보기
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 - 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
BS EN 61000-6-3:2007+A1:2011 - Electromagnetic compatibility (EMC). Generic standards. Emission standard for residential, commercial and light-industrial environments. 상세보기
BS EN 45502-2-3:2010 - Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems. 상세보기
BS EN 61000-4-3:2006+A2:2010 - Electromagnetic compatibility (EMC). Testing and measurement techniques. Radiated, radio-frequency, electromagnetic field immunity test. 상세보기
BS EN 61000-6-1:2007 - Electromagnetic compatibility (EMC). Generic standards. Immunity for residential, commercial and light-industrial environments. 상세보기
BS EN 61000-6-2:2005 - Electromagnetic compatibility (EMC). Generic standards. 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기