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DIN EN ISO 11137-1:2026-10
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)- 발행일 : 2026-10-01
- 발행기관 : DIN
상세정보
| 분야 | |
|---|---|
| 적용범위 | This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of DIN EN ISO 11137 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. This document does not detail specified requirements for designating a medical device as sterile, specify a quality management system for the control of all stages of production of medical devices, specify requirements for occupational safety associated with the design and operation of irradiation facilities or specify requirements for the sterilization of used or reprocessed devices. * keyword : Acceptance (approval)*Biological hazards*Calibration*Characterisations*Checks*Clearing*Containers*Definitions*Developments*Dose*Dosimeters*Dosimetry*Efficiency*Electron beams*Evaluations*Gamma-radiation*Germicides*Guide books*Health protection*Hygiene*Inspection*Ionizing radiation*Irradiation apparatus*Jets*Maintenance*Medical devices*Medical equipment*Medical products*Medical sciences*Medical technology*Methods*Performance*Personnel*Phototherapy*Plant*Product information*Public health*Qualifications*Quality management*Radiation*Radionuclides*Ray treatment*Routine tests*Specification (approval)*Sterilization by irradiation*Sterilization (hygiene)*Surveillance (approval)*Validation*Verification*X-rays |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 63 |
| Edition |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | DIN EN ISO 11137-1:2026-10상세보기 | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025); German version EN ISO 11137-1:2026 | 2026-10-01 | 표준 |
| 2 | DIN EN ISO 11137-1:2026-10상세보기 | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025) | 2026-10-01 | 표준 |
| 3 | DIN EN ISO 11137-1:2023-05상세보기 | 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 | 구판 |
| 4 | DIN EN ISO 11137-1:2020-04상세보기 | 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 | 구판 |
| 5 | DIN EN ISO 11137-1:2020-04상세보기 | 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 |
| 6 | DIN EN ISO 11137-1:2015-11상세보기 | 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 |
| 7 | DIN EN ISO 11137-1:2015-11상세보기 | 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 |
| 8 | DIN EN ISO 11137-1:2013-12상세보기 | 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 |
| 9 | DIN EN ISO 11137-1:2013-12상세보기 | 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 |
| 10 | DIN EN ISO 11137-1:2006-07상세보기 | 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 |
| 11 | DIN EN ISO 11137-1:2006-07상세보기 | 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 |
| 12 | DIN EN ISO 11137-1:2004-07상세보기 | 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 | 구판 |
관련상품
- 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
- 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)
- 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)
- 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
- 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) (includes Amendment A1:2023)
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