Biocompatibility testing of medical devices according to ISO 10993-1

Do you need to confirm that materials or residues of your medical device are biologically safe? This hub helps you identify the relevant tests—and provides data that feeds directly into ISO 10993-1 Biological Evaluation.

The ISO 10993 series structures biological evaluation by contact type, contact site and duration and supports risk-based planning. HygCen performs accredited testing and provides traceable reports with professional interpretation. Role clarity: ISO 10993-1 Biological Evaluation is typically prepared by independent consulting toxicologists. As a neutral testing laboratory, HygCen does not issue the overall Biological Evaluation. However, we can coordinate the complete process—from testing and chemical characterization through to the final toxicological assessment by external experts.

Link: https://www.hygcen.de/en/services/iso-10993-1-biocompatibility-testing.html