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Sterilization of health care products — Biological indicators — Part 1: General requirements
| 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 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2017-03-03 | 표준 |
| 2 | 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) | 2017-01-01 | 표준 |
| 3 | ISO 11138-1:2006 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2006-06-26 | 구판 |
| 4 | ISO 11138-1:1994 | Sterilization of health care products — Biological indicators — Part 1: General | 1994-10-06 | 구판 |
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) 상세보기
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) 상세보기
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) 상세보기
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) 상세보기
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) 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 11138-2:2017 - Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes 상세보기
ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
ISO 11135:2014 - Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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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
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