Acute intracutaneous irritation test (Draize Skin test). ISO 10993-23: 2021 - Biological Evaluation of Medical Devices. Part 23: Irritation tests.

Test accredited by ENAC (Spanish National Accreditation Entity).

Test with the Certificate of Good Laboratory Practices (GLPs).

The acute intracutaneous irritation test evaluates the potential of the material under test to produce irritation upon intradermal injection of extracts of the material. It is indicated for the evaluation of medical devices that are in contact with a breached or compromised surface, externally communicating, or are used as an implant. Certain medical devices, such as dermal fillers, can be dosed neat.

The ISO 10993-23 standard requires the use of three experimental animals (rabbits) to be administered, intracutaneously, with the medical device or an extract of the medical device, at five different points, as well as control inoculations, using the solvents used to prepare the product extracts. To prepare the extracts, polar solvents (physiological saline solution, distilled water, hydroalcoholic solution...) and non-polar (vegetable oil) are used.

The appearance of the inoculation sites, compared with the inoculation sites of the controls, is observed daily for 3 days, assigning a qualitative and quantitative assessment (0 to 4) based on the erythema and oedema reactions observed at 24, 48 and 72 hours. With these scores, the final gradation of the test sample is determined. The requirements of the 10993-23 standard are met when the final gradation of the test product is 1 or less.

Materials known for their irritant effect, which shown to be irritating to the skin, eyes or mucous membranes in preliminary tests, or strongly acidic or alkaline substances (with pH 2 or less, or pH 11.5 or higher) will not be tested intradermally.