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분야 | ISO/TC 198 : Sterilization of health care products |
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적용범위 | ISO 11737-3:2004 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices. ISO 11737-3:2004 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process. ISO 11737-3:2004 is not applicable to microbiological data generated from sampling the environment in manufacturing areas. |
국제분류(ICS)코드 |
07.100.10 : 의료 미생물학
11.080.01 : 일반 살균 및 소독 |
페이지수 | 8 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
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 14644-3:2005 - Cleanrooms and associated controlled environments — Part 3: Test methods 상세보기
ISO 7888:1985 - Water quality — Determination of electrical conductivity 상세보기
ASTM F1886/F1886M-16 - Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection 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 2768-1:1989 - General tolerances -- Part 1: Tolerances for linear and angular dimensions without individual tolerance indications 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