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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
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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

PUBLISH DATE 2021
ISO/TS 22456:2021

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.

SDO ISO: International Organization for Standardization
Document Number ISO/TS 22456
Publication Date March 1, 2021
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 198
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