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Biological evaluation of medical devices. Evaluation and testing within a risk management process.
| 분야 | |
|---|---|
| 적용범위 | Cytotoxicity tests, Bioassay, Clinical investigation instruments, Dental materials, Medical equipment, Compatibility, Implants (surgical), Biological hazards, Biological analysis and testing, Medical instruments, Dental equipment, Contaminants, Medical technology |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 32 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN ISO 10993-1:2020 - TC | Tracked Changes. Biological evaluation of medical devices. Evaluation and testing within a risk management process. | 2020-12-21 | 표준 |
| 2 | BS EN ISO 10993-1:2020 | Biological evaluation of medical devices. Evaluation and testing within a risk management process. | 2020-12-16 | 표준 |
| 3 | BS EN ISO 10993-1:October 2009 | Biological evaluation of medical devices. Evaluation and testing within a risk management process. | 2017-01-31 | 폐지 |
| 4 | BS EN ISO 10993-1:2009 | Biological evaluation of medical devices. Evaluation and testing within a risk management process. | 2010-06-30 | 폐지 |
| 5 | BS EN ISO 10993-1:June 2009 | Biological evaluation of medical devices. Evaluation and testing. | 2010-04-30 | 폐지 |
| 6 | BS EN ISO 10993-1:2003 | Biological evaluation of medical devices. Evaluation and testing. | 2003-10-09 | 폐지 |
| 7 | BS EN ISO 10993-1:1998 | Biological evaluation of medical devices. Evaluation and testing. | 1998-03-15 | 폐지 |
BS EN ISO 10993-7:1996 - Biological evaluation of medical devices. Ethylene oxide sterilization residuals. 상세보기
BS EN ISO 10993-11:1996 - Biological evaluation of medical devices. Tests for systemic toxicity. 상세보기
BS EN ISO 10993-10:1996 - Biological evaluation of medical devices. Tests for irritation and sensitization. 상세보기
BS EN ISO 10993-12:1997 - Biological evaluation of medical devices. Sample preparation and reference materials. 상세보기
BS EN ISO 10993-16:1997 - Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables. 상세보기
KS P ISO 15223(2012 확인) - 의료기기 - 의료기기의 라벨, 라벨링 및 제공해야할 정보에 사용하는 기호 상세보기
NF EN 61000-3-2:2014 - Electromagnetic compatibility (EMC) - Part 3-2 : limits - Limits for harmonic current emissions (equipment input current < or = 16 A per phase) 상세보기
ISO 14971:2007 - Medical devices — Application of risk management to medical devices 상세보기
IEC 61000-3-3:2013 - Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection 상세보기
IEC 62366:2007 - Medical devices - Application of usability engineering to medical devices 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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