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 11137-1:2015 + A2:2019 / Note: To be replaced by DIN EN ISO 11137-1 (2023-05).
| Fecha edición: |
2020-04-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 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. ISO 11137-1:2006 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; 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;specify requirements for the sterilization of used or reprocessed devices. |
| Keywords: | Acceptance (approval)|Biological hazards|Calibration|CE marking|Characterisations|Checks|Clearing|Containers|Definitions|Dose|Dosimeters|Dosimetry|Efficiency|Elections|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|Ray treatment|Routine tests|Specification (approval)|Sterilization by irradiation|Sterilization (hygiene)|Surveillance (approval)|Validation|Verification|X-rays |
| ICS: | 11.080.99 - Otras normas relativas a esterilización y desinfección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11137-1:2015/A2:2019 Idéntica ISO 11137-1:2006/Amd 2:2018 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11137-1:2015-11 Reemplaza a DIN EN ISO 11137-1/A2:2017-10 |
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