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Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 9 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-9:2019 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products | 2019-11-26 | 표준 |
| 2 | ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products | 2009-11-30 | 구판 |
| 3 | ISO 10993-9:1999 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products | 1999-03-04 | 구판 |
| 4 | ISO/TR 10993-9:1994 | Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing | 1994-07-14 | 구판 |
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
ISO 10993-13:2010 - Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices 상세보기
ISO 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity 상세보기
ISO 10993-12:2012 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials 상세보기
ISO 10993-6:2016 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation 상세보기
ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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