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Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAM 1:2024); German and English version EN ISO 10993-23:2021/prA1:2024
분야 | |
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적용범위 | |
국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
페이지수 | 26 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | DIN EN ISO 10993-23/A1:2024-10 | Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAM 1:2024); German and English version EN ISO 10993-23:2021/prA1:2024 | 2024-10-01 | 초안 |
DIN EN ISO 10993-14:2009-08 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 상세보기
DIN EN ISO 10993-14:2009-08 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) 상세보기
DIN EN ISO 10993-5:2009-10 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 상세보기
DIN EN ISO 10993-5:2009-10 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 상세보기
DIN EN ISO 10993-13:2010-11 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 상세보기
DIN EN ISO 10993-6:2024-06 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024 상세보기
DIN EN ISO 10993-1:2024-07 - Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024 상세보기
DIN EN ISO 10993-12/A1:2024-07 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - AMENDMENT 1 (ISO 10993-12:2021/DAM 1:2024); German and English version EN ISO 10993-12:2021/prA1:2024 상세보기
DIN EN ISO 10993-18:2023-11 - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022) (includes Amendment A1:2023) 상세보기
DIN EN ISO 10993-5:2009-10 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
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