Cytotoxicity testing by ISO 10993-5

Cytotoxicity assessment is a crucial part of biocompatibility testing, which ensures that medical devices do not cause adverse reactions when in contact with the body. The assessment is required for new medical devices to be approved in the EU (under the MDR) and the US (510(k) submission to the FDA).

During cytotoxicity testing, the material's potential to damage or kill cells is assessed using in vitro methods. This involves exposing cultured cells to the material and observing any negative effects on cell health and viability.

According to ISO 10993-5, cytotoxicity testing can be performed on an extract of the test material or the material itself, depending on the device type. The standard also lists several direct and indirect test methods.

We can provide cytotoxicity tests using the methods outlined below.

Direct methods:

• Neutral red uptake (NRU) method

• MTT method

• XTT method

Indirect methods:

• Filter diffusion

• Agar diffusion

The displayed example price covers testing with the commonly used NRU method, performed under GLP.

Please ask for a quote for your medical device.