BS EN ISO 11137-1:2015+A2:2019 - Page 2

Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices | Status: Current, Work in hand

1 Scope 1.1 This part of ISO 11137specifies 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,

1. a) the radionuclide 60Co or 137Cs,
2. b) a beam from an electron generator or
3. c) a beam from an X-ray generator.