Download or read book Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials ISO 10993 12 2021 written by Polska. Polski Komitet Normalizacyjny. Wydział Wydawnictw Normalizacyjnych and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials ISO 10993 12 1996 written by Polska. Polski Komitet Normalizacyjny and published by . This book was released on 2002 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biocompatibility Protocols for Medical Devices and Materials written by Prakash Srinivasan Timiri Shanmugam and published by Elsevier. This book was released on 2023-04-07 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Biological evaluation of medical devices Part 12 Sample preparation and reference materials written by and published by . This book was released on 2008 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biological Evaluation of Medical Devices written by International Organization for Standardization and published by . This book was released on 2007 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Principles of Biomedical Sciences and Industry written by Markus Hinder and published by John Wiley & Sons. This book was released on 2022-07-22 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Planning Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports CERs PERs written by Joy Frestedt and published by Elsevier. This book was released on 2024-09-27 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing
Download or read book Handbook of Metrology and Applications written by Dinesh K. Aswal and published by Springer Nature. This book was released on 2023-08-23 with total page 2504 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book 3D Printing in Radiation Oncology written by James Robar and published by CRC Press. This book was released on 2024-07-05 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D Printing in Radiation Oncology: Personalization of Patient Treatment Through Digital Fabrication presents a comprehensive and practical view of the many forms in which 3D printing is being integrated into radiation oncology practice. Radiation oncology employs among the most sophisticated digital technologies in medicine. Until recently, however, the “last mile” of treatment has required manually produced or generic devices for patient set up, positioning, control of surface dose, and delivery of brachytherapy treatment. 3D printing is already offering enhancements in both precision and efficiency through the digital design and fabrication of patient photon and electron bolus, customized surface and gynecological brachytherapy applicators, proton beam compensators and range shifters, patient immobilization, novel radiation detectors, and phantoms. Various innovations are disrupting decades-old practices in radiation therapy (RT) facilities, resulting in vital improvements in personalization of treatment and patient experience. An essential read for radiation oncologists, medical physicists, radiation therapists, oncology nurses, hospital administrators, engineers, and medical educators, this book is an indispensable resource for those bringing 3D printing to the RT clinic, looking to expand the role of 3D printing in their practice, or embarking upon related research and development.
Download or read book Silk Based Biomaterials for Tissue Engineering Regenerative and Precision Medicine written by Subhas C. Kundu and published by Elsevier. This book was released on 2023-12-08 with total page 908 pages. Available in PDF, EPUB and Kindle. Book excerpt: Silk-based Biomaterials for Tissue Engineering, Regenerative and Precision Medicine, Second Edition is a must-have reference, providing comprehensive coverage of silk-based biomaterials and their importance in translational uses and biomedicine. This new edition considers the progress made in the past eight years, featuring many new chapters, including a discussion of cutting-edge fabrication methods and techniques, new and improved blends/composites, and an expanded range of applications in tissue engineering, regenerative and precision medicine. The book holistically reviews the types, structure and properties, processing methods, and specific biomedical applications for silk-based biomaterials. This will be a vital resource for materials and tissue engineering scientists, R&D departments in industry and academia, and academics interested in biomaterials, regenerative, and precision medicine. - Covers all key silk biomaterial types, including mulberry, Bombyx mori and nonmulberry/wild silk protein fibroins, sericins and spider silk, as well as their composite blends and various structures and scaffold platforms - Describes the cutting-edge processing techniques for each silk type, from traditional to nonconventional methods, such as using ionic liquids and engineering nanofibers and other biomedical matrices - Explores a range of applications in tissue engineering and regenerative and precision medicine, including bioprinting, bioelectronics and medical devices
Download or read book Advanced Manufacturing Processes III written by Volodymyr Tonkonogyi and published by Springer Nature. This book was released on 2021-11-17 with total page 728 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a timely snapshot of innovative research and developments at the interface between manufacturing, materials and mechanical engineering, and quality assurance. It covers a wide range of manufacturing processes, such as grinding, boring, milling, turning, woodworking, coatings, including additive manufacturing. It focuses on laser, ultrasonic, and combined laser–ultrasonic hardening treatments, and dispersion hardening. It describes tribology and functional analysis of coatings, separation, purification and filtration processes, as well as ecological recirculation and electrohydraulic activation, highlighting the growing role of digital twins, optimization and lifecycle management methods, and quality inspection processes. It also covers cutting-edge heat and mass transfer technologies and energy management methods. Gathering the best papers presented at the 3rd Grabchenko’s International Conference on Advanced Manufacturing Processes (InterPartner-2021), held in Odessa, Ukraine, on September 7–10, 2021, this book offers a timely overview and extensive information on trends and technologies in manufacturing, mechanical, and materials engineering, and quality assurance. It is also intended to facilitate communication and collaboration between different groups working on similar topics and to offer a bridge between academic and industrial researchers.
Download or read book Medical Devices written by Carlo Boccato and published by Springer Nature. This book was released on 2022-02-24 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Download or read book Biological Evaluation of Medical Devices written by British Standards Institution and published by . This book was released on 1997 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Download or read book Animal Models in Research written by Harikrishnan Vijayakumar Sreelatha and published by Springer Nature. This book was released on with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biological Evaluation of Medical Devices written by Singapore Standards Council and published by . This book was released on 2017 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Advanced Biomaterials and 3D Printing Technologies in Bone Repair written by Yanjin Lu and published by Frontiers Media SA. This book was released on 2024-01-15 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt:
