ISO/TS 11137-4:2020

Sterilization of health care products -- Radiation -- Part 4: Guidance on process control
Autor: ISO
Código ICS: 11.080.01
Vigente
$290.360

Alcance

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.

Especificaciones de la Norma
Fecha de Publicación 30/06/2020
Título Secundario Stérilisation des produits de santé -- Irradiation -- Partie 4: Recommandations sur le contrôle de processus
Páginas Técnicas 55
Idioma Inglés