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The Biocompatibility Sensitization test evaluates the potential of a material or product to cause a sensitizing effect or allergenic reaction in a patient over an extended period of exposure. Sensitization or hypersensitivity is tested by exposing an animal’s skin to the material, or taking extracts from the device/material and injecting and/or topically applying them, and looking for adverse reactions. Sensitization reactions are noted by observing redness and swelling as it interacts with the body’s immune system. This test complies with ISO 10993-10 and ISO 10993-12 standards.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]

Applicable Standards

  • ISO 10993

Testing Locations

Study Outline

In the Biocompatibility Sensitization test, guinea pigs will be exposed in two induction phases to extracts of the test article or control. Following induction phases, the animals will be on a rest period after which they are challenged at a naïve skin site with the test article extracts or control vehicles. The challenge sites of each animal will be observed for evidence of skin sensitization 24 ± 2 and 48 ± 2 hours after removal of the test article extracts or control vehicles.

If you have additional questions about Sensitization Testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.