Sterilization of health care products. Radiation - Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products. Radiation - Requirements for the development, validation and routine control of a sterilization process for medical devices

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1   Scope

1.1   This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.

This document 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.