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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

Mar 19, 2021

General information

60.60     Mar 19, 2021

ISO

ISO/TC 198

Technical Specification

11.080.01     07.100.10  

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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
ISO/TS 22456:2021
60.60 Standard published
Mar 19, 2021

National adoptions

DS ISO/TS 22456:2021  
DPS

Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

60.60 Standard published

DPS/KT 205 more

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