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표준
판매
Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems.
| 분야 | |
|---|---|
| 적용범위 | Hearing aids, Environmental testing, Medical equipment, Brain, Signal generators, Implants (surgical), Electrical medical equipment, Test equipment, Neural stimulators, Electrical impedance, Electrodes, Surgical equipment, Prosthetic devices, Ears, Testing conditions |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 48 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN 45502-2-3:2010 | Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems. | 2010-03-31 | 표준 |
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 45502-1:2015 - 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
BS EN 61000-4-11:2004+A1:2017 - Electromagnetic compatibility (EMC). Testing and measurement techniques. Voltage dips, short interruptions and voltage variations immunity tests. 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 45502-1:2015 - Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer. 상세보기
BS EN 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
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
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