ISO/TR 15499:2016 Biological Evaluation of Medical Devices – Guidance on the Conduct of Biological Evaluation within a Risk Management Process replaces the 2012 version. This new version applies to biological evaluation of medical devices according to the requirements of ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process.
One aspect of biological evaluation is to reduce the risk the risk of patient harm. The technical report bridges the gap to ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices, explaining how these two standards work together.