پروتکل‌های زیست‌سازگاری برای ابزار و مواد پزشکی ۲۰۲۲
Biocompatibility Protocols for Medical Devices and Materials 2022

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. Sections cover device/component selection for toxicological experiments and provide 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.

This practice guide provides step-by-step toxicological protocols, from materials selection to data interpretation for toxicologists, biomedical research and healthcare professionals, 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 different extraction processes
• Explains toxicokinetic studies, particularly those related to degradation and leachable devices
• Discusses the basic points needed to leverage data from other devices