Skin sensitization testing by ISO 10993-10

Sensitization assessment by ISO 10993-10 is a crucial part of biocompatibility testing and one of the most common tests required to ensure the safety and compliance of medical devices. The goal is to show that medical devices do not cause skin sensitization, such as allergic responses or immunological reactions, when in contact with the body. A sensitization assessment is required for new medical devices to be approved in the EU (under the MDR) and the USA (510(k) submission to the FDA).

Sensitization tests can be performed on the material, the device itself, or an extract, depending on the device and test method type.

ISO 10993-10 lists several in vitro and in vivo assays to assess the sensitization potential of medical devices and chemicals extracted from them.

In vitro assays evaluate the skin sensitization potential by detecting chemical reactions or cell responses to the chemicals. Conversely, in vivo assays expose animals to the test sample or extract, which is typically applied by induction and challenge phases. Sensitization potential is then evaluated by observing possible reactions to the exposure. The sensitization reaction to the medical device is scored based on the evaluation criteria defined in ISO 10993-10.

We can provide sensitization tests using several methods. A few examples are outlined below.

In vivo methods:

• Guinea pig maximization test (GPMT)

• Closed-patch test (Buehler)

• Murine local lymph node assay (LLNA)

In vitro methods:

• ARE-Nrf2 Luciferase test

• Direct peptide reactivity assay (DPRA)

The displayed example price covers testing with the commonly used GPMT method for liquid medical devices, performed under GLP.

Please ask for a quote for your medical device.