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 / Note: Date of issue 2023-04-07*Intended as replacement for DIN EN ISO 11137-1 (2020-04).
| Fecha edición: |
2023-05-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| Keywords: | Acceptance (approval)|Biological hazards|Calibration|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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