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)
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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:
Active implantable medical devices. Medical devices
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
SS-EN ISO 11137-1:2015
July 6, 2015
EN ISO 11137-1:2015(IDT); ISO 11137-1:2006(IDT)