ABSTRACT
The previous chapters in this book have primarily addressed tests which are applicable to all or broad ranges of medical devices. However, regulatory authorities (and responsible practice) have also established some specific testing requirements for a number of broadly utilized but somewhat specialized devices such as cardiovascular devices and prostheses (ISO, 1989a, 1989b, 1989c, 1989d, 1989e, 2000; AAMI, 1996), contact lenses and their solutions (CRDH, 1985, 1995a), and tampons (CDRH, 1995b). These evaluations require some specialized tests. In addition, there is one promulgated (but now infrequently used) test, the “mouse safety” or systemic injection test, which fits none of the previous classifications and needs to be briefly considered here. Many of these tests are designed to evaluate local tissue responses in the specialized tissues or uses that they have contact with.
