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Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 78 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11135:2014/Amd 1:2018 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release | 2018-10-15 | 표준 |
| 2 | 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 | 2014-07-07 | 표준 |
| 3 | ISO 11135:1994/Cor 1:1994 | 1994-10-27 | 구판 | |
| 4 | ISO 11135:1994 | Medical devices — Validation and routine control of ethylene oxide sterilization | 1994-01-27 | 구판 |
관련상품이 존재하지 않습니다.
ISO 11135:2014/Amd 1:2018 - Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release 상세보기
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ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes 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
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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