PD ISO/TS 22456:2021

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.