Active standard | Published: 19/03/2021

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
(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 a base de tissus)

Available languages: English

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Detail information

Designation: ISO/TS 22456:2021

Publication date: 19/03/2021

Pages: 13

Country: International technical standard

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Anotation

Description / Abstract: 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.

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