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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

Publication date:   Mar 19, 2021

General information

90.93 Standard confirmed   Jul 5, 2024

ISO

ISO/TC 198 Sterilization of health care products

Technical Specification

11.080.01   Sterilization and disinfection in general | 07.100.10   Medical microbiology

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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.

Life cycle

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PUBLISHED
ISO/TS 22456:2021
90.93 Standard confirmed
Jul 5, 2024