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ONR CEN ISO/TS 11137-4:2023

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

This document provides an additional guide to the instructions in ISO 11137-3 to fulfill the requirements specified in ISO 11137-2 and ISO/TS 13004 for the development and steering of a radiation sterilization procedure with the application of gamma, electron or X-ray radiation.

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