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DS 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

Sep 29, 2023

General information

60.60     Sep 29, 2023

DPS

DPS/KT 205

Technical Specification

11.080.01     07.100.10  

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Scope

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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PUBLISHED
DS ISO/TS 22456:2021
60.60 Standard published
Sep 29, 2023

Related project

Adopted from ISO/TS 22456:2021