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)

SS-EN-ISO-11137-1 - 2015 EDITION - CURRENT
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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

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.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.080.99 (Other standards related to sterilization and disinfection)

Active implantable medical devices. Medical devices

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Designation Name

SS-EN ISO 11137-1:2015

Revision Level




Publication Date

June 7, 2015



Page Count


International Equivalent

EN ISO 11137-1:2015(IDT); ISO 11137-1:2006(IDT)