Sensitisation

Sensitisation is one of the three most common tests required to ensure the safety of medical devices. This test is essential in evaluating the potential of a device to cause an allergic response following (repeat) exposure. There are in vivo and in vitro assays available which are selected based upon the specific route of exposure to the body and acceptance of notified body.

Eurofins Medical Device Testing network of laboratories has more than 30 years of experience performing biological safety testing of medical devices.

Choose Eurofins Medical Device Testing to help you:

• Understand testing and the regulatory requirements for Sensitisation
• Choose the right test method for your device according to ISO 10993-10
• Identify the risk of allergic response caused by a device

Regulatory:

• ISO 10993-10:2021 "Biological evaluation of medical devices Part 10: Tests for skin sensitisation" provides the general requirements for evaluating the sensitising potential of a medical device."
• ISO 10993-1 Table A.1 – "Endpoints to be addressed in a biological risk assessment”

Testing Available

• Murine Local Lymph Node Assay (LLNA)*
• Magnusson/Kligman Test (Maximisation Test)*
• Buehler Closed Patch Method*
• In Vitro Sensitisation

*Test done by: 

• our EU partner lab
• our US partner lab