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Biological evaluation of medical devices — Part 2: Animal welfare requirements
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-2:2006 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. ISO 10993-2:2006 also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 13 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-2:2022 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | 2022-11-03 | 표준 |
| 2 | ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | 2006-07-06 | 구판 |
| 3 | ISO 10993-2:1992 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | 1992-12-30 | 구판 |
| 4 | ISO/DIS 10993-2 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | 초안 |
ISO/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation 상세보기
ISO/DIS 10993-1 - Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process 상세보기
ISO/DIS 10993-7 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals 상세보기
ISO/DIS 10993-2 - Biological evaluation of medical devices — Part 2: Animal welfare requirements 상세보기
ISO 10993-4:2017/PRF Amd 1 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 상세보기
ISO 10993-5:2009 - Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity 상세보기
ISO 10993-10:2010 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization 상세보기
ISO 10993-12:2012 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials 상세보기
ISO 10993-4:2017 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood 상세보기
ISO 10993-18:2020 - Biological evaluation of medical devices — Part 18: 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
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