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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 | This document 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. It 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 that of the medical devices themselves. This document 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. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 15 |
| Edition | 4 |
| 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 10993-4:2017/PRF Amd 1 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 상세보기
ISO 10993-23:2021/DAmd 1 - Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models 상세보기
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