DIN EN ISO 11137-1:2020 Edition

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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

Published By	Publication Date	Number of Pages
DIN	2020-04	63

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Categories: 11.080.99 - Other standards related to sterilization and disinfection, DIN

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Description

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.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2020-04
Pages Count	63
Language	Germany
Descriptors	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, Procedures, Tanks, Release, Processes
File Size	1.6 MB
ICS Codes	11.080.99 - Other standards related to sterilization and disinfection

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DIN EN ISO 11137-1:2020 Edition

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