[A proposal for test guidelines to identify contact allergens in medical materials and devices]

A proposal of test guidelines for identifying contact allergens in medical materials and devices and for evaluation of their potentials are described. The adjuvant tests, Maximization Test and Adjuvant and Patch Test, are recommended as a test method for identifying contact allergens in medical materials and devices. To evaluate the potency of the allergen, initially, it is necessary to determine the threshold contact allergenic dose (a lowest concentration at which a positive dermal response is attained). This approach gives an essential basis to predict risks of contact allergy in humans and to plan adequate strategies for reducing the risks.