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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
| 분야 | |
|---|---|
| 적용범위 | |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 119 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | 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 | 2024-07-01 | 초안 |
| 2 | DIN EN ISO 10993-1:2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 | 2021-05-01 | 표준 |
| 3 | DIN EN ISO 10993-1:2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10) | 2021-05-01 | 표준 |
| 4 | DIN EN ISO 10993-1:2017-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017 | 2017-04-01 | 구판 |
| 5 | DIN EN ISO 10993-1:2010-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) | 2010-04-01 | 구판 |
| 6 | DIN EN ISO 10993-1:2010-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009 | 2010-04-01 | 구판 |
| 7 | DIN EN ISO 10993-1:2009-10 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003) | 2009-10-01 | 구판 |
| 8 | DIN EN ISO 10993-1:2009-10 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); German version EN ISO 10993-1:2009 | 2009-10-01 | 구판 |
| 9 | DIN EN ISO 10993-1:2007-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO/DIS 10993-1:2006); German version prEN ISO 10993-1:2007 | 2007-04-01 | 초안 |
| 10 | DIN EN ISO 10993-1:2003-12 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003) | 2003-12-01 | 구판 |
| 11 | DIN EN ISO 10993-1:2003-12 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); German version EN ISO 10993-1:2003 | 2003-12-01 | 구판 |
| 12 | DIN EN ISO 10993-1:2003-07 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO/FDIS 10993-1:2003); German Version prEN ISO 10993-1:2003 | 2003-07-01 | 초안 |
| 13 | DIN EN ISO 10993-1 Berichtigung 1:1999-06 | Corrigenda to DIN EN ISO 10993-1:1998-06 | 1999-06-01 | 구판 |
| 14 | DIN EN ISO 10993-1:1998-06 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997); German version EN ISO 10993-1:1997 | 1998-06-01 | 구판 |
| 15 | DIN EN ISO 10993-1:1998-06 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997); German version EN ISO 10993-1:1997 | 1998-06-01 | 구판 |
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 10993-23/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 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
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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