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Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
| 분야 | ISO/TC 194 : Biological and clinical evaluation of medical devices |
|---|---|
| 적용범위 | ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 34 |
| Edition | 3 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 10993-5:2009 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | 2009-05-20 | 표준 |
| 2 | ISO 10993-5:1999 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | 1999-05-20 | 구판 |
| 3 | ISO 10993-5:1992 | Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods | 1992-12-30 | 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 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
ISO 10993-10:2021 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization 상세보기
ISO 10993-10:2010 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization 상세보기
ISO 10993-3:2014 - Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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