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Prakash SrinivasanTimiri Shanmugam,ThamizharasanSampath,IndumathyJagadeeswaran

Biocompatibility Protocols for Medical Devices and Materials

Biocompatibility Protocols for Medical Devices and Materials

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  • More about Biocompatibility Protocols for Medical Devices and Materials

Biocompatibility Protocols for Medical Devices and Materials is a comprehensive guide that provides step-by-step toxicological protocols for the risk assessment and safety analysis of medical devices and materials. It covers device/component selection, sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity, as well as cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing.

Format: Paperback / softback
Length: 262 pages
Publication date: 11 April 2023
Publisher: Elsevier Science & Technology


Biocompatibility Protocols for Medical Devices and Materials is a comprehensive resource that delves into the fundamental science and toxicological testing protocols essential for conducting risk assessments and safety analyses of medical devices and materials. These protocols are based on the ISO guidelines for body contact and duration of contact. The book begins by guiding the selection of devices and components for toxicological experiments, providing an introduction to key topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. In subsequent chapters, toxicology-related protocols are detailed, encompassing cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing. This practical guide offers step-by-step toxicological protocols, ranging from materials selection to data interpretation, catering to toxicologists, biomedical researchers, healthcare professionals, product developers, and individuals involved in risk assessment and safety analysis of medical devices. By adhering to these protocols, stakeholders can ensure the safety and efficacy of medical products while minimizing the potential risks associated with their use.

Weight: 440g
Dimension: 152 x 230 x 17 (mm)
ISBN-13: 9780323919524

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