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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 | Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks). |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 11 |
| Edition | 1 |
| 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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