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Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured. |
| 국제분류(ICS)코드 |
07.100.10 : 의료 미생물학
11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 48 |
| Edition | 3 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | 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 | 2021-05-19 | 표준 |
| 2 | 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) | 2019-01-01 | 표준 |
| 3 | ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products | 2018-01-12 | 표준 |
| 4 | ISO 11737-1:2006/Cor 1:2007 | 2007-05-11 | 구판 | |
| 5 | ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products | 2006-03-20 | 구판 |
| 6 | ISO 11737-1:1995 | Sterilization of medical devices — Microbiological methods — Part 1: Estimation of population of microorganisms on products | 1995-11-30 | 구판 |
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
CSA ISO 11737-1:19/A1:23 - Amendment 1:2023 to CSA ISO 11737-1:19, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted amendment 1:2021 to ISO 11737-1:2018) 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 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems 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 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
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