Recently the medical device biocompatibility standards committee (ISO 10993) met to review and discuss proposed changes for hemocompatibility and genotoxicity testing. This webinar will discuss these proposed changes along with chemical characterization, evaluation of leachables, and the effect on the body. These currently require costly and time consuming animal testing; however current testing procedures are being evaluated and in vitro methods are being considered. The presentation will also focus on proposed changes in the ISO 10993 standard and help users be aware and prepare for these changes. Along with the changes, we will discuss the latest points from the ISO committee members on ISO 10993-3 and ISO 10993-4, including:
- An overview of the testing in ISO 10993-4: Selection of tests for interactions with blood and ISO 10993-3:
- Inspection and audit timelines
- Tests for genotoxicity, carcinogenicity and reproductive toxicity, specifically the hemocompatibility and when to perform the direct and indirect methods.
- The complement activation test and why the FDA has been requiring this test and future considerations.