Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2023); German and English version FprEN ISO 11137-1:2023
Abstract
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.
Begin
2020-09-21
WI
00204083
Planned document number
DIN EN ISO 11137-1
Project number
06302053
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible european committee
CEN/TC 204 - Sterilization of medical devices
Responsible international committee
ISO/TC 198/WG 2 - Radiation sterilization
draft standard
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
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