CEN ISO/TS 11137-4:2023

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)

ACTIVE

About this standard

Languages
German and English
Type
NBN
Standards committee
CEN/TC 204 (Sterilization of medical devices)
Status
ACTIVE
Publication date
21 June 2023
ICS Code
11.080.01 (Sterilization and disinfection in general)
Withdrawn Date
Price
€ 184,00

About this training

Summary

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.