Cytotoxicity testing by ISO 10993-5

Cytotoxicity tests by ISO 10993-5 are performed to assess the impacts that a medical device has on cell viability.

In vitro cytotoxicity tests are necessary for the approval of any medical device that comes into contact with the body, both in the EU (according to the MDR) and the US (for 510(k) submission to the FDA).

There are several options for how testing is conducted, depending on the type and intended use of the device. For this reason, the testing plan is always customized on a case-by-case basis.

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