The sensitization test

The sensitization test is the second, except for the irritation test, in vivo biological endpoint to be evaluated any type of medical device required by ISO 10993-1: 2018.

In ISO 10993-10 three types of sensitization tests are mentioned: Guinea pig maximization test (GPMT), Buehler test, and Local lymph node assay (LLNA). The appropriate method should be chosen taking into account the application, properties, and intended region of registration of the medical device.

We carry out all of the mentioned methods for testing sensitization. Contact us to choose the right method for your device!