Finally it’s here: the new ISO 10993-23 irritation standard, presenting a real effort regarding the 3R’s in the field of medical device testing. As a member of ISO/TC 194/WG8 I have been involved in reviewing the proceeding draft versions of the standard, and my former colleagues at RISE did a great job in the underlying round robin study evaluating the new in vitro test for skin irritation.
In addition, de Jong et al (2020) recently published a great paper comparing the new in vitro skin irritation test with the corresponding in vivo tests as well as human tests. This clearly shows that the in vitro test provides equally valid results!
At Key2Compliance we are happy to help you with all parts of the biological evaluation of medical devices.