chapter  16
16 Pages

Special Case Devices

There are a range of groups of medical devices that do not t in to the International Organization for Standardization (ISO) 10993 paradigm for biocompatibility testing. The previous chapters in this book have primarily addressed test needs applicable to all or broad ranges of medical devices. However, regulatory authorities (and responsible practice) have also established some specic testing requirements for a number of broad yet specialized devices such as inhalation and respiratory devices, ophthalmic devices (gels and contact lenses and their solutions [Center for Devices and Radiological Health, CDRH, 1985, 1995a]), cardiovascular devices and prostheses (ISO, 1989a, 1989b, 1989c, 1989d, 1989e, 1992; Association for the Advancement of Medical Instrumentation [AAMI], 1996), dentistry devices, and tampons (CDRH, 1995b). These evaluations require both common and specialized tests. Many of these tests are designed to evaluate local tissue responses in the specialized tissues that they have contact with or uses to which they are put. All are also covered by USP Standards (<381>, <87>, <88>, and <661>).