ISO 10993-1:2018. Is it Harmonized?
FDA Consultants – CE marking Consultants
Reghelps
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The ISO 10993-1:2018 standard defines Biocompatibility as the ability of a medical device or material to perform with an appropriate host response in a specific application.
Which means the compatibility of a device to a biological system. That is in simple words a state in which Biological system (living thing) and a medical device or material are able to exist or occur together without any toxicological or undesirable problems or conflict.