SS-EN-ISO-11137-1 › 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)
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Included in this current edition are the following subparts:
2015 EDITION - June 7, 2015
FOR 2015 EDITION AMENDMENT 2 SEE - Nov. 28, 2019
FOR 2015 EDITION AMENDMENT 2 SEE - Nov. 28, 2019
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of ISO 11137 covers radiation processes employing irradiators using, a) the radionuclide 60Co or 137Cs, b) a beam from an electron generator or c) a beam from an X-ray generator.
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Designation Name
SS-EN ISO 11137-1:2015
Revision Level
2015 EDITION
Status
Current
Publication Date
June 7, 2015
Language(s)
English
Page Count
60
International Equivalent
EN ISO 11137-1:2015(IDT); ISO 11137-1:2006(IDT)