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What is ISO/TS 11137-4 about? ISO/TS 11137 discusses the process of radiation sterilization of health care products. ISO/TS 11137-4 outlines additional guidance to that given in ISO 111373 on meeting…
Overview CEN ISO/TS 11137-4:2023 (adoption of ISO/TS 11137-4:2020) provides guidance on process control for radiation sterilization of health care products. It supplements ISO 11137-3 and helps organ…
1 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…
Overview ISO/TS 11137-4:2020 - "Sterilization of health care products - Radiation - Part 4: Guidance on process control" is a technical specification that provides non‑normative guidance for establis…