Skin sensitization testing by ISO 10993-10

Skin sensitization testing by the ISO 10993-10 standard is a key 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 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.

Suitable sample matrices
Medical devices
Available quality systems
Accredited test method, GLP test method

Questions? We're happy to help.

Questions? We're happy to help.

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Answering the following questions helps us prepare an offer for you faster:

  • What is the intended use, body contact site, and contact duration of your medical device?

  • Do you need additional biocompatibility tests for the device in addition to ISO 10993-10?

  • Do you need the tests for R&D purposes or for submission to officials?

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