Biocompatibility Testing

Biocompatibility Testing. An adhesive selected for use on human skin requires safety testing in accordance with FDA guidelines and ISO 10993 standards. Any adhesive placed in direct contact with the skin should be safety tested using RIPT (repeat-insult patch testing), the Draize test (dermal irritation in albino rabbits), or other tests that can be performed depending on application requirements. Performance results for medical adhesives should remain with FDA in drug master files and be available to customers on request. More detailed information on biocompatibility testing can be found in the ISO 10993/EN 30993 standard and the FDA blue book memorandum G95-1.