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BSI PD ISO/TS 22456:2021

BSI PD ISO/TS 22456:2021

$102.76

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

Published By Publication Date Number of Pages
BSI 2021 22
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
10 3 Terms and definitions
11 4 Definition and maintenance of product families
5 Selection and testing of product for bioburden and tests of sterility
5.1 General
12 5.2 Nature of product
5.3 Sample Item Portion (SIP)
5.4 Sampling conditions
5.4.1 General
5.4.2 Considerations for human tissue donor batches in sterilization
13 5.4.3 Use of multiple batches
5.4.4 Considerations for packaging
5.5 Microbiological testing
5.5.1 Bioburden test considerations for biologics/tissues
16 5.5.2 Test of sterility considerations for biologics/tissues
18 5.5.3 Verification of microbiological methods
19 5.5.4 Rapid microbiology tests
20 Bibliography

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BSI PD ISO/TS 22456:2021
$102.76