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ISO/TS 11137-4:2020

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO/TS 11137-4:2020
Document Year: 2020
Pages: 55
Edition: 1
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

Life Cycle

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ISO/TS 11137-4:2020
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