International Standard
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
Reference number
ISO/TS 22456:2021
ISO/TS 22456:2021
Edition 1
2021-03
2021-03
© ISO 2024
International Standard
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.
General information
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Status: PublishedPublication date: 2021-03Stage: International Standard under systematic review [90.20]
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Edition: 1Number of pages: 13
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Technical Committee :ISO/TC 198
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