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Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes:
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 67 |
| Edition | 3 |
| 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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