ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process
This guidance is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This guidance does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non- implantable medical devices.
ANSI/AAMI/ISO TIR15499:2012 history
2012ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process