Cytotoxicity testing by ISO 10993-5

Cytotoxicity is a crucial part of biocompatibility assessment, which is required to ensure that the device does not cause harm when used in contact with the body. It is 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).

Cytotoxicity testing is used to determine whether a substance or device is harmful to cells. This testing assesses the material's potential to damage or kill cells, ensuring the safety and biocompatibility of the device before it is used in humans. It involves exposing cultured cells to the material and observing any negative effects on cell health and viability.

Testing can be done by using the material directly, indirectly or extracting the test material and then added to cultured cells depending on the material to be tested.

We can provide multiple testing options for your testing needs:

Direct methods

• Neutral red uptake method (NRU)

• MTT method

• XTT method

Indirect methods

• Filter diffusion

• Agar diffusion

This example price includes commonly used NRU method performed under GLP.

Please ask for a quote for your medical device!