ISO-22456 › Sterilization of healthcare products - Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

ISO-22456 - 1ST EDITION - CURRENT


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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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07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO/TS 22456:2021

Revision Level

1ST EDITION

Status

Current

Publication Date

March 1, 2021

Committee Number

ISO/TC 198