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EVS-EN ISO 11137-1:2015

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)

General information
Valid from 02.07.2015
Base Documents
EN ISO 11137-1:2015; ISO 11137-1:2006; ISO 11137-1:2006/Amd 1
Standard history
Status
Date
Type
Name
02.12.2019
Amendment
02.07.2015
Main
09.09.2013
Amendment
06.06.2006
Main
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.
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