ISO TS 11137-4
Sterilization of health care products — Radiation — Part 4: Guidance on process control
|Publication Date:||1 June 2020|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.