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Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package. |
| 국제분류(ICS)코드 |
07.100.10 : 의료 미생물학
11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 35 |
| Edition | 2 |
| 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 |
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
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