ISO 22456:2021
ISO 22456:2021 Sterilization of healthcare products – Microbiological methods- Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
CDN $192.00
Description
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.
Edition
1
Published Date
2021-03-19
Status
PUBLISHED
Pages
13
Language
English
Format
Secure PDF
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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.
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