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  • BSI
    PD 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
    Edition: 2021
    $316.70
    / user per year

Description of PD ISO/TS 22456:2021 2021

1.1 Inclusions

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.

1.2 Exclusions

1.2.1

This document does not include guidance for validation requirements for testing, eliminating and/or inactivating viruses and prions or sterilization of tissue-based products.

NOTE Guidance on inactivating viruses and prions can be found in ISO 22442‑3.

1.2.2

This document does not include guidance for containment or biosafety issues for biologics and tissue-based products.

1.2.3

This document does not include guidance for testing biologics and tissue-based products for specific infectious agents as listed in relevant national or international guidance (e.g. viruses/protozoa/parasites, intracellular microorganisms or mycoplasma screening).

1.2.4

This document does not include guidance for the acceptance criteria for biologics and tissue-based products during procurement or tissue to be processed and/or released for use.

1.2.5

This document does not include guidance for the testing associated with procurement and screening of biologics and tissue-based products.



Standard NumberPD ISO/TS 22456:2021
TitleSterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
StatusUnder Review
Publication Date2021-03-22
Identical National Standard OfISO/TS 22456
DescriptorsTests, Biological tests, Tissue biology, Products, Biological analysis and testing
ICS07.100.10 Medical microbiology, 11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 539 02803 4
PublisherBSI
Pages22

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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