ISO/TS 11137-4:2020Published

Sterilization of health care products — Radiation — Part 4: Guidance on process control

Stérilisation des produits de santé — Irradiation — Partie 4: Recommandations sur le contrôle de processus

Abstract / scope

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.