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분야 | ISO/TC 198 : Sterilization of health care products |
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적용범위 | This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications. |
국제분류(ICS)코드 |
07.100.10 : 의료 미생물학
11.080.01 : 일반 살균 및 소독 |
페이지수 | 62 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 11737-3:2023 | Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing | 2023-06-26 | 표준 |
2 | ISO 11737-3:2004 | Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data | 2004-07-13 | 구판 |
ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products 상세보기
CSA ISO 11737-1:19 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted ISO 11737-1:2018, third edition, 2018-01) 상세보기
ISO 11737-2:2019 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process 상세보기
CSA ISO 11737-2:21 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (Adopted ISO 11737-2:2019, third edition, 2019-12) 상세보기
ISO 11737-1:2018/Amd 1:2021 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1 상세보기
ISO 11737-2:2019 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process 상세보기
ISO 13408-2:2018 - Aseptic processing of health care products — Part 2: Sterilizing filtration 상세보기
ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 상세보기
BS EN ISO 11137-1:2015+A2:2019 - Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices. 상세보기
BS EN ISO 11137-2:2015+A1:2023 - Sterilization of health care products. Radiation. Establishing the sterilization dose. 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