Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
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.
ΚΩΔΙΚΟΣ ΠΡΟΪΟΝΤΟΣ:
CYS CEN ISO/TS 11137-4:2023
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.