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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for work place safety. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 6 |
| Edition | 3 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes | 2017-03-03 | 표준 |
| 2 | 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) | 2017-01-01 | 표준 |
| 3 | ISO 11138-2:2006 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes | 2006-06-26 | 구판 |
| 4 | ISO 11138-2:1994 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization | 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 11138-1:2017 - Sterilization of health care products — Biological indicators — Part 1: General requirements 상세보기
ISO 11138-3:2017 - Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat 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 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems 상세보기
ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 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
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KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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