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Biological evaluation of medical devices — Part 10: Tests for skin sensitization
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 48 |
| Edition | 4 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-10:2021 | Biological evaluation of medical devices — Part 10: Tests for skin sensitization | 2021-11-16 | 표준 |
| 2 | ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | 2010-07-27 | 구판 |
| 3 | ISO 10993-10:2002/Amd 1:2006 | Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity — Amendment 1 | 2006-07-06 | 구판 |
| 4 | ISO 10993-10:2002 | Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity | 2002-09-26 | 구판 |
| 5 | ISO 10993-10:1995 | Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization | 1995-03-09 | 구판 |
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