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분야 | ISO/TC 198 : Sterilization of health care products |
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적용범위 | ISO/TS 17665-2:2009 provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. |
국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
페이지수 | 47 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 | 2009-01-05 | 폐지 |
ISO 17665-1:2006 - Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 상세보기
ISO/TS 17665-3:2013 - Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization 상세보기
ISO 17665-1:2006 - Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 상세보기
ISO/TS 17665-3:2013 - Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization 상세보기
ISO 11137-1:2006/Amd 2:2018 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
ISO 11137-3:2017 - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control 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