July 11, 2016
For medical devices that are used as an implant, the use of an intracutaneous (intradermal) reactivity test is indicated. The aim is to assess the irritation potency of the medical device following intradermal injection of extracts of the material.
Albino rabbits of either sex.
The extract is injected intracutaneously on the back of the animal on one side of the spine. The solvent controls are injected on the contralateral side of each rabbit.
In an initial step the test will be performed in one animal. If no well-defined response is observed in the initial test, two addition animals are tested.
Each injection site is evaluated and scored for tissue reactions at defined time points after injection.
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