January 19, 2020 – The updated version of ISO 10993-18, the standard covering the chemical characterization of the ISO 10993 biocompatibility standard for medical devices, has just published. The new version is available here.
The ISO 10993 series applies to devices where the material or medical device has direct or indirect body contact, with ISO 10993-1 providing the overview of the assessment based on body contact. The updated version of the matrix employed in ISO 10993-1:2018 is available here. ISO 10993-18 covers chemical characterization, and has received increased attention from regulatory authorities in recent years.
iuvo BioScience conducts the full gamut of ISO 10993 testing for biocompatibility including the chemistry portion covered by ISO 10993-18. If you have questions, we’d be happy to set up a call to talk through the potential impact on your testing. Feel free to drop us a note to learn more.