Acute intracutaneous irritation test. UNE-EN-ISO 10993-10: 2013 - Biological evaluation of medical devices - Part 10: Irritation and skin sensitization tests.
Test accredited by ENAC (Spanish National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
The intradermal irritation test is used to assess the irritant potential of medical devices used as implants.
The standard UNE-EN ISO 10993-10, requires the use of three experimental animals (rabbits) that will be administered intracutaneously, the product or an extract of it in five different points, as well as many control inoculations, using the solvents used to prepare the extracts of the product. To prepare the extracts, polar solvents (physiological saline solution, distilled water, 5% hydroalcoholic solution), and non-polar (vegetable oil) are used.
The appearance of the inoculation sites, compared to the inoculation sites of the controls, should be observed daily for 3 days, assigning a qualitative and quantitative assessment (0 to 4), to describe and quantify the type of erythema or edema, that could appear. An assay sample accomplish the requirements of the assay if the final grade is ≤ 1. Material that have shown irritation for skin, eyes or mucosa neither highly acidic or alkaline (pH 2 or lower, or pH 11.5 or higher) should not be tested, since its corrosive capacity is predicted.