관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
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분야 | |
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적용범위 | Biological analysis and testing, Laboratory animals, Skin (body), Medical equipment, Human biology, Allergies, Human body, Bioassay |
국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
페이지수 | 64 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | BS EN ISO 10993-10:2023 - TC | Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization. | 2023-02-17 | 표준 |
2 | BS EN ISO 10993-10:2023 | Biological evaluation of medical devices. Tests for skin sensitization. | 2023-02-08 | 표준 |
3 | BS EN ISO 10993-10:2013 | Biological evaluation of medical devices. Tests for irritation and skin sensitization. | 2014-02-28 | 폐지 |
4 | BS EN ISO 10993-10:2010 | Biological evaluation of medical devices. Tests for irritation and skin sensitization. | 2012-04-30 | 폐지 |
5 | BS EN ISO 10993-10:2009 | Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity. | 2010-02-28 | 폐지 |
6 | BS EN ISO 10993-10:2002 | Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity. | 2006-09-29 | 폐지 |
7 | BS EN ISO 10993-10:1996 | Biological evaluation of medical devices. Tests for irritation and sensitization. | 1996-05-15 | 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
IEC 62366-1:2015/AMD1:2020 - Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
BS EN 556-1:2024 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. 상세보기
BS EN ISO 10993-18:2020+A1:2023 - Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process. 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