On December 1, 2016, ISO issued ISO/TR 15499:2016 Biological Evaluation of Medical Devices — Guidance on the Conduct of Biological Evaluation within a Risk Management Process. This is second edition, replacing ISO/TR 15499:2016.
The technical applies to activities to meet the requirements of ISO 10993-1:2009, Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing within a Risk Management Process.
Biological evaluation is part of the risk management process. The technical report sets ISO 10993-1:2009 in the context of ISO 14971:2007. It provides method and concepts applicable to medical device development.