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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-12:2002 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically, ISO 10993-12:2002 addresses:
The applicability of ISO 10993-12:2002 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 15 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-12:2021 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2021-01-20 | 표준 |
| 2 | ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2012-06-29 | 구판 |
| 3 | ISO 10993-12:2007 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2007-10-31 | 구판 |
| 4 | ISO 10993-12:2002 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 2002-12-11 | 구판 |
| 5 | ISO 10993-12:1996 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | 1996-09-05 | 구판 |
| 6 | ISO 10993-12:2021/DAmd 1 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — 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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