Biocompatibility Protocols for Medical Devices and Materials

Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety of medical devices and materials which are based on ISO guidelines for body contact and duration of contact. The book begins with coverage of device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain protocols around cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity. Biocompatibility Protocols for Medical Devices and Materials is a practice guide that provides step-by-step toxicological protocols from materials selection to data interpretation for toxicologists, biomedical research and healthcare professionals, and product developers, and others working in risk assessment and the safety of medical devices. Explains representative products for toxicological experiments and how to choose the worst-case for toxicological analysis Provides an overview of the different extraction processes Explains toxicokinetic studies particularly those related to degradation and leachable devices Discusses about the basic points needed to leverage the data from another device