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ISO 11138-1:2017
Sterilization of health care products — Biological indicators — Part 1: General requirements- 발행일 : 2017-03-03
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies. NOTE National or regional regulations can apply. ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 41 |
| Edition | 3 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11138-1:2017상세보기 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2017-03-03 | 표준 |
| 2 | CAN/CSA-ISO 11138-1:17 (R2022)상세보기 | Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03) | 2017-01-01 | 표준 |
| 3 | ISO 11138-1:2006상세보기 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2006-06-26 | 구판 |
| 4 | ISO 11138-1:1994상세보기 | Sterilization of health care products — Biological indicators — Part 1: General | 1994-10-06 | 구판 |
관련상품
- CAN/CSA-ISO 11138-3:17 (R2022) - Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes (Adopted ISO 11138-3:2017, third edition, 2017-03)
- CAN/CSA-ISO 11138-4:17 (R2022) - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03)
- CAN/CSA-ISO 11138-5:17 (R2022) - Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (Adopted ISO 11138-5:2017, second edition, 2017-03)
- CAN/CSA-ISO 11138-2:17 (R2022) - Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03)
- CAN/CSA-ISO 11138-1:17 (R2022) - Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)
다른 사람이 함께 구입한 상품
- 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
- ISO 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
- ISO 11138-3:2017 - Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
- ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice
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