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10993-10

Biological evaluation of medical devices

Irritation and Skin Sensitization Tests

Sensitization test evaluates the potential of a material or product to cause sensitization or allergic reactions. The test is performed according to ISO 10993-10 and the Magnusson and Kligman classification.

Irritation tests are performed according to the ISO 10993-10 standard. Although the ISO 10993-23 standard has also been published for irritation tests, ISO 10993-10 remains valid and compatible. The purpose of irritation tests is to determine whether the product causes sensitivity or irritation to skin or mucosal tissues.

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