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Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-6:2007 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. ISO 10993-6:2007 applies to materials that are:
ISO 10993-6:2007 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses. This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of ISO 10993-6:2007. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 21 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 2016-11-28 | 표준 |
| 2 | ISO 10993-6:2007 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 2007-04-04 | 구판 |
| 3 | ISO 10993-6:1994 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 1994-07-07 | 구판 |
| 4 | ISO/DIS 10993-6 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | 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
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