scope:

Inclusions

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.

Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

Exclusions

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.

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

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).

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

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