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

Current stage: 60.60 Effective date: Mar 19, 2021

Originator: ISO

Owner: ISO/TC 198

Type: Technical Specification

ICS: 11.080.01 07.100.10

Languages: English

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Status: Published

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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

NOW

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

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