chapter  8
28 Pages

Local Tissue Tolerance

Most commonly recognized is the use of this scale in the primary dermal irritation (PDI) test, which is performed for those agents that are to be administered to patients by application to the skin. As with all local tolerance tests, it is essential that the material be evaluated in “condition of use”—that is, in the nal product ready for human use, applied to test animals in the same manner that the device or biomaterial is to be used clinically. If appropriate (under applicable regulations) or necessary due to the nature or mode of use of the device, an extract can be evaluated. Such extracts are generally evaluated in the intracutaneous reactivity test.