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

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

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1   Scope

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.