Monthly Archives: February 2019

The International Standards Organisation (ISO) recently published a new technical standard, ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents.  The TTC is a recognized tool for evaluating the biological risks of impurities when they are present at low levels and […]

On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. In the Supplementary Information Sheet (SIS), it was noted that the FDA does not recognize Table A.1 in Annex A of the standard as it is in […]