ABSTRACT
What Is Device Biocompatibility?............................................................. 268 What Are the FDA and EU/ISO Requirements for Biocompatibility Testing? ..................................................................................................... 268
Do I Need Biocompatibility Data? ........................................................... 269 How Do I Determine Which Tests I Need? ............................................ 270 Should I Test Device Materials, or Only a Composite of the Finished Device?...................................................................................................... 270
Is GLP Treatment Required for Biocompatibility Testing? ..................... 271 Designing Your Biocompatibility Program .............................................. 271 All About Extracts ...................................................................................... 272 Sample Preparation.................................................................................... 274 Noncontact Devices ................................................................................... 277 Biological Tests Methods........................................................................... 280
Cytotoxicity (Tissue Culture) ................................................................ 280 Sensitization Assays ............................................................................... 284 Irritation Tests ........................................................................................ 284 Acute Systemic Toxicity ........................................................................ 285 Subchronic Toxicity............................................................................... 285 Genotoxicity........................................................................................... 286 Implantation Tests ................................................................................. 286 Hemocompatibility ................................................................................ 287 Carcinogenesis Bioassay ....................................................................... 288 Reproductive and Developmental Toxicity ......................................... 288 Pharmacokinetics................................................................................... 289
Preclinical Safety Testing ...................................................................... 289 Histopathology Services ........................................................................ 290
Analytical Testing of Biomaterials ............................................................ 290 Material Characterization ........................................................................... 291
Extractable Material Characterization................................................... 291 Tests on Extracting Media .................................................................... 292 Bulk Material Characterization ............................................................. 292 Surface Characterization........................................................................ 292
References .................................................................................................. 293 About This Chapter ................................................................................... 294 Acknowledgments...................................................................................... 294
The word biocompatibility refers to the interaction between a medical device and the tissues and physiological systems of the patient treated with the device. An evaluation of biocompatibility is one part of the overall safety assessment of a device. Biocompatibility of devices is investigated using analytical chemistry, in vitro tests, and animal models. The biocompatibility of a device depends on several factors, including:
The chemical and physical nature of its component materials The types of patient tissue that will be exposed to the device The duration of that exposure.
