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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018) (includes Amendment A2:2019)
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| 국제분류(ICS)코드 | |
| 페이지수 | 63 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | DIN EN ISO 11137-1:2023-05 | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 | 2023-05-01 | 초안 |
| 2 | DIN EN ISO 11137-1:2020-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:20 | 2020-04-01 | 표준 |
| 3 | DIN EN ISO 11137-1:2020-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018) (includes Amendment A2:2019) | 2020-04-01 | 표준 |
| 4 | DIN EN ISO 11137-1:2015-11 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013); German version EN ISO 11137-1:2015 | 2015-11-01 | 구판 |
| 5 | DIN EN ISO 11137-1:2015-11 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) | 2015-11-01 | 구판 |
| 6 | DIN EN ISO 11137-1:2013-12 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013 | 2013-12-01 | 구판 |
| 7 | DIN EN ISO 11137-1:2013-12 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013) (includes Amendment A1:2013) | 2013-12-01 | 구판 |
| 8 | DIN EN ISO 11137-1:2006-07 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006); German version EN ISO 11137-1:2006 | 2006-07-01 | 구판 |
| 9 | DIN EN ISO 11137-1:2006-07 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) | 2006-07-01 | 구판 |
| 10 | DIN EN ISO 11137-1:2004-07 | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical products (ISO/DIS 11137-1:2004); German version prEN ISO 11137-1:2004 | 2004-07-01 | 초안 |
DIN EN ISO 11137-3:2017-11 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 상세보기
DIN EN ISO 11137-3:2017-11 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) 상세보기
DIN EN ISO 11137-1:2020-04 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:20 상세보기
DIN EN ISO 11137-1:2023-05 - Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 상세보기
DIN EN ISO 11137-2:2023-08 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023 상세보기
DIN EN ISO 11737-2:2020-07 - Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) 상세보기
DIN EN ISO 11607-1:2020-05 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) 상세보기
DIN EN ISO 11135:2020-04 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019) 상세보기
DIN EN ISO 14602:2012-06 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) 상세보기
DIN EN ISO 11137-2:2015-11 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) 상세보기
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