What is ISO/TS 22456 about?
ISO/TS 22456 provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. ISO/TS 22456 is intended to be used in conjunction with 11 and ISO 117372.
Guidance in ISO/TS 22456 can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.
ISO/TS 22456 does not cover:
- Does not include guidance for validation requirements for testing, eliminating and/or inactivating viruses and prions or sterilization of tissue-based products
- Does not include guidance for containment or biosafety issues for biologics and tissue-based products
- Does not include guidance for testing biologics and tissue-based products for specific infectious agents as listed in relevant national or international guidance
- 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
- Does not include guidance for the testing associated with procurement and screening of biologics and tissue-based products.
Who is ISO/TS 22456 for?
ISO/TS 22456 on sterilization of healthcare products is applicable to:
- Healthcare facilities
- Medical device manufacturers
- Medical research scientists
- Doctors and healthcare professionals
- Medical device reprocessors
Why should you use ISO/TS 22456?
ISO/TS 22456 provides test methods for the sources and types of some microorganisms, as well as the test methods used to evaluate biologics and tissue-based products. This helps to improve the quality of healthcare product sterilization.
ISO/TS 22456 provides useful guidance to address issues that are applicable to the microbiological testing of biologics and tissue-based products, where this testing comprises, bioburden testing, or a test of sterility performed in relation to product sterilization.
