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 analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with 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 the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing. Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices. Explains the biocompatibility test protocols for medical devices Provides an overview about chemical characterization Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies Discusses the basic points needed to leverage the data from another device

Medical equipment, Biological analysis and testing, Test specimens, Specimen preparation, Control samples, Extraction, Selection, Extraction methods of analysis

Principles of Biomedical Sciences and Industry Improve your product development skills to bring new ideas to biomedicine The development of innovative healthcare products, such as biodegradable implants, biopharmaceuticals, or companion diagnostics, requires a multi-disciplinary approach that incorporates scientific evidence with novel and innovative ideas to create new and improved products and treatments. Indeed, product development and the integration of science with commercial aspects have become key challenges for scientists working in the pharmaceutical, biotech, and medtech industries. Using a multi-pronged approach to development, Principles of Biomedical Sciences and Industry combines ideas and methodologies from four of the central areas of focus in the biomedical arena: pharmaceuticals, diagnostics, biomaterials, and medical devices. In doing so, the book covers the entire product lifecycle, from translating a scientific idea into a prototype to product development, launch, and management. Principles of Biomedical Sciences and Industry readers will also find: Several case studies from the most important product categories (pharmaceuticals, diagnostics, medical devices, combination products) Chapters dealing with toxicology and safety risks in development, as well as regulatory approval Key business aspects including how to secure funding, managing intellectual property, and price regulation in the market An ideal resource for teachers and students that conveys the information in an easily-digestible format Ideal for advanced students and young professionals pursuing a career in the biomedical and healthcare industries, Principles of Biomedical Sciences and Industry is an essential reference for those in pharmaceutical industry, biotechnologists, medicinal chemists, bio-engineers, pharma engineers, and management consultants.

​This handbook provides comprehensive and up-to-date information on the topic of scientific, industrial and legal metrology. It discusses the state-of-art review of various metrological aspects pertaining to redefinition of SI Units and their implications, applications of time and frequency metrology, certified reference materials, industrial metrology, industry 4.0, metrology in additive manufacturing, digital transformations in metrology, soft metrology and cyber security, optics in metrology, nano-metrology, metrology for advanced communication, environmental metrology, metrology in biomedical engineering, legal metrology and global trade, ionizing radiation metrology, advanced techniques in evaluation of measurement uncertainty, etc. The book has contributed chapters from world’s leading metrologists and experts on the diversified metrological theme. The internationally recognized team of editors adopt a consistent and systematic approach and writing style, including ample cross reference among topics, offering readers a user-friendly knowledgebase greater than the sum of its parts, perfect for frequent consultation. Moreover, the content of this volume is highly interdisciplinary in nature, with insights from not only metrology but also mechanical/material science, optics, physics, chemistry, biomedical and more. This handbook is ideal for academic and professional readers in the traditional and emerging areas of metrology and related fields.