Skin sensitization testing by ISO 10993-10

Skin sensitization testing by the ISO 10993-10 standard is part of assessing the biocompatibility of medical devices. Testing is required for all medical devices that come into contact with the human body regardless of the duration and type of contact.

The testing procedure by ISO 10993-10 can include both in vitro tests and in vivo tests. In vitro tests should be preferred where appropriate to minimize the extent of animal testing, but some in vivo skin sensitization testing is generally required for the approval of medical devices.

The testing plan is customized for each device, so please provide adequate information about the device when requesting a quote.