CSA ISO/TS 11137-4:21

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

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 a radiation sterilization process using gamma, electron beam, and X-irradiation.

OEN:

CSA

Langue:

English

Code(s) de l'ICS:

11.080.01

Statut:

Norme

Date de Publication:

2021-04-30

Numéro Standard:

CSA ISO/TS 11137-4:21