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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | Describes a classification of medical and dental devices that are intended for use in contact with blood, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests, together with the principles and scientific basis of these tests. Annex A describes evaluation of cardiovascular devices and prostheses during in vivo function. |
| 국제분류(ICS)코드 | 11.100 : 약실험 |
| 페이지수 | 19 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood | 2017-04-12 | 표준 |
| 2 | ISO 10993-4:2002/Amd 1:2006 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 | 2006-07-21 | 구판 |
| 3 | ISO 10993-4:2002 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood | 2002-10-22 | 구판 |
| 4 | ISO 10993-4:1992 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood | 1992-12-30 | 구판 |
| 5 | ISO 10993-4:1992/DAmd 1 | 초안 | ||
| 6 | ISO 10993-4:2017/PRF Amd 1 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 | 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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