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