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NEN - NVN-CEN ISO/TS 11137-4

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

active, Most Current
Organization: NEN
Publication Date: 1 July 2023
Status: active
Page Count: 70
ICS Code (Sterilization and disinfection in general): 11.080.01
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.

Document History

NVN-CEN ISO/TS 11137-4
July 1, 2023
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...

References

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