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Cardiovascular Biological Evaluation Of Medical Devices Guidance For Absorbable Implants
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Book Synopsis Integrated Safety and Risk Assessment for Medical Devices and Combination Products by : Shayne C. Gad
Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Book Synopsis Handbook of Biomaterials Biocompatibility by : Masoud Mozafari
Download or read book Handbook of Biomaterials Biocompatibility written by Masoud Mozafari and published by Woodhead Publishing. This book was released on 2020-06-17 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Biomaterials Biocompatibility is a systematic reference on host response to different biomaterials, taking into account their physical, mechanical and chemical properties. The book reviews recent progress in the design and study of biomaterials biocompatibility, along with current understanding on how to control immune system response. Sections provide the fundamental theories and challenges of biomaterials biocompatibility, the role of different biomaterials physicochemical surface properties on cell responses, cell responses to different physicochemical properties of polymers, ceramics, metals, carbons and nanomaterials, and biomaterials in different tissues, such as the cardiac, nervous system, cartilage and bone. This resource will be suitable for those working in the fields of materials science, regenerative engineering, medicine, medical devices and nanotechnology. - Reviews the fundamental theories and challenges of biomaterials biocompatibility, including an overview of the standards and regulations - Provides an overview on the cellular and molecular mechanisms involved in host responses to biomaterials - Systematically looks at cellular response and tissue response to a wide range of biomaterials, including polymers, metals, ceramics, alloys and nanomaterials
Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Book Synopsis Bioresorbable Polymers for Biomedical Applications by : Giuseppe Perale
Download or read book Bioresorbable Polymers for Biomedical Applications written by Giuseppe Perale and published by Woodhead Publishing. This book was released on 2016-08-24 with total page 630 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioresorbable Polymers for Biomedical Applications: From Fundamentals to Translational Medicine provides readers with an overview of bioresorbable polymeric materials in the biomedical field. A useful resource for materials scientists in industry and academia, offering information on the fundamentals and considerations, synthesis and processing, and the clinical and R and D applications of bioresorbable polymers for biomedical applications. - Focuses on biomedical applications of bioresorbable polymers - Features a comprehensive range of topics including fundamentals, synthesis, processing, and applications - Provides balanced coverage of the field with contributions from academia and industry - Includes clinical and R and D applications of bioresorbable polymers for biomedical applications
Book Synopsis Metals for Biomedical Devices by : Mitsuo Niinomi
Download or read book Metals for Biomedical Devices written by Mitsuo Niinomi and published by Woodhead Publishing. This book was released on 2019-05-17 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Metals for Biomedical Devices, Second Edition, has been fully updated and builds upon the success of its first edition, discussing the latest techniques in metal processing methods and the behavior of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Subsequent chapters cover mechanical behavior, degradation and testing, corrosion, wear testing and biocompatibility, the processing of metals for biomedical applications, including topics such as forging metals and alloys, surface treatment, coatings and sterilization. Chapters in the final section discuss the clinical applications of metals, such as cardiovascular, orthopedic and new generation biomaterials. With its distinguished editor and team of expert contributors, this book is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. - Reviews the latest techniques in metal processing methods, including surface treatment and sterilization - Examines metal selection for biomedical devices, considering the biocompatibility of various metals - Assesses mechanical behavior and the testing of metals, featuring the latest information on corrosion, fatigue and wear - Discusses biodegradable alloys, including a new section on Mg alloys - Includes a new section that discusses the use of additive manufacturing in the production of medical devices
Book Synopsis Magnesium Technology 2016 by : Alok Singh
Download or read book Magnesium Technology 2016 written by Alok Singh and published by Springer. This book was released on 2016-12-12 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Magnesium Technology Symposium, the event on which this collection is based, is one of the largest yearly gatherings of magnesium specialists in the world. Papers represent all aspects of the field, ranging from primary production to applications to recycling. Moreover, papers explore everything from basic research findings to industrialization. Magnesium Technology 2016 covers a broad spectrum of current topics, including alloys and their properties; cast products and processing; wrought products and processing; forming, joining, and machining; corrosion and surface finishing; ecology; and structural applications. In addition, there is coverage of new and emerging applications.
Book Synopsis Medical Textiles from Natural Resources by : Md. Ibrahim H. Mondal
Download or read book Medical Textiles from Natural Resources written by Md. Ibrahim H. Mondal and published by Woodhead Publishing. This book was released on 2022-06-15 with total page 936 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Textiles from Natural Resources provides systematic and comprehensive coverage of the fundamentals, production methods, processing techniques, characterization techniques, properties and applications of medical textile materials from natural resources. Medical textiles offer a variety of technical and functional properties valued in medical and healthcare sectors, often relating to hygiene. As medical textile products remain in close contact with the human body, the fibre must have characteristics such as biological compatibility, biological degradability, permeability and nontoxicity. Only materials from natural renewable sources have such characteristics. This book provides the latest information on a wide range of medical applications, from single suture and wound dressings, to implants and tissue scaffolds. It also offers a systematic review of the manufacture, properties and applications of technical textiles for medical use. - Explains the latest technologies related to fibre extraction from natural sources, chemical treatments, weave constructions, fabric finishes and coatings. - Describes innovative applications of nanomaterials in the treatment of textile fabric and the utilization of carbohydrate polymers in the preparation of nanoparticles deposited in nonwoven fabrics. - Helps product designers to find appropriate materials from natural resources with the characteristics of biodegradability, renewability, biocompatibility and nontoxicity.
Book Synopsis Surface Modification of Magnesium and its Alloys for Biomedical Applications by : T.S.N. Sankara Narayanan
Download or read book Surface Modification of Magnesium and its Alloys for Biomedical Applications written by T.S.N. Sankara Narayanan and published by Elsevier. This book was released on 2015-01-08 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surface modification of magnesium and its alloys for biomedical applications: Biological interactions, mechanical properties and testing, the first of two volumes, is an essential guide on the use of magnesium as a degradable implant material. Due to their excellent biocompatibility and biodegradability, magnesium based degradable implants provide a viable option for the permanent metallic implants. This volume focuses on the fundamental concepts of surface modification of magnesium, its biological interactions, mechanical properties and, in vitro and in vivo testing. The contents of volume 1 is organized and presented in three parts. Part 1 reviews the fundamental aspects of surface modification of magnesium, including surface design, opportunities, challenges and its role in revolutionizing biodegradable biomaterials. Part 2 addresses the biological and mechanical properties covering an in vivo approach to the bioabsorbable behavior of magnesium alloys, mechanical integrity and, the effects of amino acids and proteins on the performance of surface modified magnesium. Part 3 delves in to testing and characterization, exploring the biocompatibility and effects on fatigue life alongside the primary characteristics of surface modified magnesium. All chapters are written by experts, this two volume series provides systematic and thorough coverage of all major modification technologies and coating types of magnesium and its alloys for biomedical applications. - Expert analysis of the fundamentals in surface modification of magnesium and its alloys for biomedical applications - Includes biological interactions and mechanical properties - Focuses on testing and characterisation, as well as biocompatibility
Book Synopsis Biomaterials Science by : William R Wagner
Download or read book Biomaterials Science written by William R Wagner and published by Academic Press. This book was released on 2020-05-23 with total page 1612 pages. Available in PDF, EPUB and Kindle. Book excerpt: The revised edition of the renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science from principles to applications. Biomaterials Science, fourth edition, provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine.This new edition incorporates key updates to reflect the latest relevant research in the field, particularly in the applications section, which includes the latest in topics such as nanotechnology, robotic implantation, and biomaterials utilized in cancer research detection and therapy. Other additions include regenerative engineering, 3D printing, personalized medicine and organs on a chip. Translation from the lab to commercial products is emphasized with new content dedicated to medical device development, global issues related to translation, and issues of quality assurance and reimbursement. In response to customer feedback, the new edition also features consolidation of redundant material to ensure clarity and focus. Biomaterials Science, 4th edition is an important update to the best-selling text, vital to the biomaterials' community. - The most comprehensive coverage of principles and applications of all classes of biomaterials - Edited and contributed by the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials - Fully revised and updated to address issues of translation, nanotechnology, additive manufacturing, organs on chip, precision medicine and much more. - Online chapter exercises available for most chapters
Book Synopsis Biomedical Engineering Design by : Joseph Tranquillo
Download or read book Biomedical Engineering Design written by Joseph Tranquillo and published by Academic Press. This book was released on 2022-02-19 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. - Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods - Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process - Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions - Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for 'X', and incorporating standards and design controls - Discusses topics that prepare students for careers in medical device design or other related medical fields
Book Synopsis Engineered Biomaterials: Progress And Prospects by : P A Hassan
Download or read book Engineered Biomaterials: Progress And Prospects written by P A Hassan and published by World Scientific. This book was released on 2023-08-02 with total page 968 pages. Available in PDF, EPUB and Kindle. Book excerpt: Engineered Biomaterials: Progress and Prospects presents state-of-the-art developments in the area of biomaterials research exemplified by experts in the fields of tissue engineering, wound healing, bio-diagnostics, novel therapeutics and advanced drug delivery systems.It provides a comprehensive account of preparation, characterisation, properties, processing, biological and clinical evaluation of a large variety of materials for specific biomedical applications. Basic concepts related to wound healing, tissue engineering and drug delivery systems, and the principal role played by macro, micro and nano scaled structures in biomaterials are presented in a clear manner. Developments in the area of conventional and advanced wound care strategies, materials for periodontal therapeutics, in-situ gelling tissue adhesives, biodegradable composites etc are illustrated in a lucid manner. Advanced processing techniques explored for the fabrication of micro-needles for vaccine delivery, 3D printing of personalized pharmaceuticals, bio-resorbable coatings, metallosurfactants and surface engineering of nanosystems are depicted in a straightforward and reasonable way.This book also discusses various advanced therapeutic and diagnostic systems such as magnetic nanoparticle based hyperthermia and their surface functionalization techniques. Lipid-based nano delivery systems for psoriasis, irritable bowel syndrome and pain management, polyrotaxane polymers, wearable devices for sensing etc are also depicted in this book. The contents are designed in a manner that will be highly suited for academic researchers, clinicians and industrialists who wish to explore in the versatile field of biomaterials as it contains a wealth of valuable information that will be equally useful to both beginners as well as established researchers.
Book Synopsis Chinese Standard. GB; GB/T; GBT; JB; JB/T; YY; HJ; NB; HG; QC; SL; SN; SH; JJF; JJG; CJ; TB; YD; YS; NY; FZ; JG; QB; SJ; SY; DL; AQ; CB; GY; JC; JR; JT by : https://www.chinesestandard.net
Download or read book Chinese Standard. GB; GB/T; GBT; JB; JB/T; YY; HJ; NB; HG; QC; SL; SN; SH; JJF; JJG; CJ; TB; YD; YS; NY; FZ; JG; QB; SJ; SY; DL; AQ; CB; GY; JC; JR; JT written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 7263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).
Book Synopsis GB/T-2021, GB-2021 -- Chinese National Standard PDF-English, Catalog (year 2021) by : https://www.chinesestandard.net
Download or read book GB/T-2021, GB-2021 -- Chinese National Standard PDF-English, Catalog (year 2021) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-06-02 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2021.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Book Synopsis Biomaterials, Medical Devices, and Combination Products by : Shayne Cox Gad
Download or read book Biomaterials, Medical Devices, and Combination Products written by Shayne Cox Gad and published by CRC Press. This book was released on 2015-12-01 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical
Book Synopsis Handbook of Polymer Applications in Medicine and Medical Devices by : Sina Ebnesajjad
Download or read book Handbook of Polymer Applications in Medicine and Medical Devices written by Sina Ebnesajjad and published by Elsevier Inc. Chapters. This book was released on 2013-12-05 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt: This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.
Book Synopsis YB; YB/T; YBT - Product Catalog. Translated English of Chinese Standard. (YB; YB/T; YBT) by : https://www.chinesestandard.net
Download or read book YB; YB/T; YBT - Product Catalog. Translated English of Chinese Standard. (YB; YB/T; YBT) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese Industry Standards - Category: YB; YB/T; YBT.
