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.

Please contact us through the form below to ask for more information and request a quote for your device.

Suitable sample matrices
Medical devices
Available quality systems
Accredited test method, GLP test method

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Questions? We're happy to help.

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Answering the following questions helps us prepare an offer for you faster:

  • What is the intended use, body contact site, and contact duration of your medical device?

  • Do you need additional biocompatibility tests for the device in addition to ISO 10993-5?

  • Do you need the tests for R&D purposes or for submission to officials?

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