ISO/TS 22456:2021

Sterilization of healthcare products -- Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Autor: ISO
Código ICS: 07.100.10
Vigente
$75.000

Alcance

1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2.1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

Especificaciones de la Norma
Fecha de Publicación 19/03/2021
Título Secundario Stérilisation des produits de santé -- Méthodes microbiologiques -- Recommandations pour la réalisation de déterminations de la charge biologique et de contrôles de stérilité des produits biologiques et des produits à base de tissus
Páginas Técnicas 13
Idioma Inglés