ADOPTED_FROM:ISO/TR 15499:2012 <p>This Technical Report is applicable to the conduct of biological evaluation of medical devices according to the requirements of <std std-id="iso:std:iso:10993:-1:en" type="undated"><std-ref>ISO 10993-1</std-ref></std>. It does not add to, or otherwise change, the requirements of <std std-id="iso:std:iso:10993:-1:en" type="undated"><std-ref>ISO 10993-1</std-ref></std>. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.</p><p>This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.</p>