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표준
판매
Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process.
| 분야 | |
|---|---|
| 적용범위 | Health and safety requirements, Conformity, Chemical properties, Biological analysis and testing, Medical equipment, Ceramics, Safety measures, Alloys, Chemical composition, Identification methods, Chemical analysis and testing, Quality assurance, Equipment safety, Metals, Polymers |
| 국제분류(ICS)코드 | 11.100.20 : 의료 장비의 생물학적 평가 |
| 페이지수 | 86 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN ISO 10993-18:2020+A1:2023 | Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process. | 2023-07-27 | 표준 |
| 2 | BS EN ISO 10993-18:2020 | Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process. | 2020-12-14 | 폐지 |
| 3 | BS EN ISO 10993-18:2009 | Biological evaluation of medical devices. Chemical characterization of materials. | 2009-06-30 | 폐지 |
| 4 | BS EN ISO 10993-18:2005 | Biological evaluation of medical devices. Chemical characterization of materials. | 2005-11-17 | 폐지 |
BS EN ISO 10993-7:1996 - Biological evaluation of medical devices. Ethylene oxide sterilization residuals. 상세보기
BS EN ISO 10993-11:1996 - Biological evaluation of medical devices. Tests for systemic toxicity. 상세보기
BS EN ISO 10993-10:1996 - Biological evaluation of medical devices. Tests for irritation and sensitization. 상세보기
BS EN ISO 10993-12:1997 - Biological evaluation of medical devices. Sample preparation and reference materials. 상세보기
BS EN ISO 10993-16:1997 - Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables. 상세보기
IEC 62366-1:2015/AMD1:2020 - Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
BS EN 556-1:2024 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. 상세보기
BS EN ISO 10993-10:2023 - Biological evaluation of medical devices. Tests for skin sensitization. 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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