ISO/TS 11137-4:2020

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

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

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Referenced standards

ISO 11137-1:2006ISO 11137-3:2017
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ISO/TS 11137-4:2020

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

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

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.

Edition2020
Standard Part No4
Published Date2020
Published ByISO/TS
Page Count55