Biocompatibility Protocols for Medical Devices and Materials

Biocompatibility Protocols for Medical Devices and Materials PDF Author: Prakash Srinivasan Timiri Shanmugam
Publisher: Elsevier
ISBN: 0323984924
Category : Medical
Languages : en
Pages : 264

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Book Description
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

Biopolymers for Biomedical and Biotechnological Applications

Biopolymers for Biomedical and Biotechnological Applications PDF Author: Bernd H. A. Rehm
Publisher: John Wiley & Sons
ISBN: 3527818308
Category : Science
Languages : en
Pages : 400

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Book Description
Provides insight into biopolymers, their physicochemical properties, and their biomedical and biotechnological applications This comprehensive book is a one-stop reference for the production, modifications, and assessment of biopolymers. It highlights the technical and methodological advancements in introducing biopolymers, their study, and promoted applications. "Biopolymers for Biomedical and Biotechnological Applications" begins with a general overview of biopolymers, properties, and biocompatibility. It then provides in-depth information in three dedicated sections: Biopolymers through Bioengineering and Biotechnology Venues; Polymeric Biomaterials with Wide Applications; and Biopolymers for Specific Applications. Chapters cover: advances in biocompatibility; advanced microbial polysaccharides; microbial cell factories for biomanufacturing of polysaccharides; exploitation of exopolysaccharides from lactic acid bacteria; and the new biopolymer for biomedical application called nanocellulose. Advances in mucin biopolymer research are presented, along with those in the synthesis of fibrous proteins and their applications. The book looks at microbial polyhydroxyalkanoates (PHAs), as well as natural and synthetic biopolymers in drug delivery and tissue engineering. It finishes with a chapter on the current state and applications of, and future trends in, biopolymers in regenerative medicine. * Offers a complete and thorough treatment of biopolymers from synthesis strategies and physiochemical properties to applications in industrial and medical biotechnology * Discusses the most attracted biopolymers with wide and specific applications * Takes a systematic approach to the field which allows readers to grasp and implement strategies for biomedical and biotechnological applications "Biopolymers for Biomedical and Biotechnological Applications" appeals to biotechnologists, bioengineers, and polymer chemists, as well as to those working in the biotechnological industry and institutes.

Biocompatibility Protocols for Medical Devices and Materials

Biocompatibility Protocols for Medical Devices and Materials PDF Author: Prakash Srinivasan Timiri Shanmugam
Publisher: Elsevier
ISBN: 0323984924
Category : Medical
Languages : en
Pages : 264

Get Book Here

Book Description
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

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices PDF Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
ISBN: 0081026447
Category : Technology & Engineering
Languages : en
Pages : 592

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Book Description
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

Biocompatiblity

Biocompatiblity PDF Author: Julian H. Braybrook
Publisher: John Wiley & Sons
ISBN:
Category : Medical
Languages : en
Pages : 256

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Book Description
This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.

Biocompatibility of Dental Materials

Biocompatibility of Dental Materials PDF Author: Gottfried Schmalz
Publisher: Springer Science & Business Media
ISBN: 3540777822
Category : Medical
Languages : en
Pages : 392

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Book Description
This book provides a comprehensive and scientifically based overview of the biocompatibility of dental materials. Up-to-date concepts of biocompatibility assessment are presented, as well as information on almost all material groups used in daily dentistry practice. Furthermore, special topics of clinical relevance (e.g,, environmental and occupational hazards and the diagnosis of adverse effects) are covered. The book will: improve the reader’s ability to critically analyze information provided by manufacturers supply a better understanding of the biocompatibility of single material groups, which will help the reader choose the most appropriate materials for any given patient and thus prevent adverse effects from developing provide insights on how to conduct objective, matter-of-fact discussions with patients about the materials to be used in dental procedures advise readers, through the use of well-documented concepts, on how to treat patients who claim adverse effects from dental materials feature clinical photographs that will serve as a reference when analyzing clinical symptoms, such as oral mucosa reactions.

Biomaterials and Medical Devices

Biomaterials and Medical Devices PDF Author: Ferdyansyah Mahyudin
Publisher: Springer
ISBN: 3319148451
Category : Technology & Engineering
Languages : en
Pages : 249

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Book Description
This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants, which include biodegradable polymers, biodegradable metals, degradation assessment techniques and future directions. Chapter five focuses on animal models for biomaterial research, ethics, care and use, implantation study and monitoring and studies on medical implants in animals in Indonesia. Chapter six covers biomimetic bioceramics, natural-based biocomposites and the latest research on natural-based biomaterials in Indonesia. Chapter seven describes recent advances in natural biomaterial from human and animal tissue, its processing and applications. Chapter eight discusses orthopedic applications of biomaterials focusing on most common problems in Indonesia, and surgical intervention and implants. Chapter nine describes biomaterials in dentistry and their development in Indonesia.

Medical Device Design

Medical Device Design PDF Author:
Publisher: Academic Press
ISBN: 0123919436
Category : Technology & Engineering
Languages : en
Pages : 369

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Book Description
This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Toxicity Testing in the 21st Century

Toxicity Testing in the 21st Century PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309109922
Category : Nature
Languages : en
Pages : 217

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Book Description
Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.

Materials for Biomedical Engineering

Materials for Biomedical Engineering PDF Author: Mohamed N. Rahaman
Publisher: John Wiley & Sons
ISBN: 1119551080
Category : Science
Languages : en
Pages : 724

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Book Description
MATERIALS FOR BIOMEDICAL ENGINEERING A comprehensive yet accessible introductory textbook designed for one-semester courses in biomaterials Biomaterials are used throughout the biomedical industry in a range of applications, from cardiovascular devices and medical and dental implants to regenerative medicine, tissue engineering, drug delivery, and cancer treatment. Materials for Biomedical Engineering: Fundamentals and Applications provides an up-to-date introduction to biomaterials, their interaction with cells and tissues, and their use in both conventional and emerging areas of biomedicine. Requiring no previous background in the subject, this student-friendly textbook covers the basic concepts and principles of materials science, the classes of materials used as biomaterials, the degradation of biomaterials in the biological environment, biocompatibility phenomena, and the major applications of biomaterials in medicine and dentistry. Throughout the text, easy-to-digest chapters address key topics such as the atomic structure, bonding, and properties of biomaterials, natural and synthetic polymers, immune responses to biomaterials, implant-associated infections, biomaterials in hard and soft tissue repair, tissue engineering and drug delivery, and more. Offers accessible chapters with clear explanatory text, tables and figures, and high-quality illustrations Describes how the fundamentals of biomaterials are applied in a variety of biomedical applications Features a thorough overview of the history, properties, and applications of biomaterials Includes numerous homework, review, and examination problems, full references, and further reading suggestions Materials for Biomedical Engineering: Fundamentals and Applications is an excellent textbook for advanced undergraduate and graduate students in biomedical materials science courses, and a valuable resource for medical and dental students as well as students with science and engineering backgrounds with interest in biomaterials.

Dental Biomaterials

Dental Biomaterials PDF Author: Edward Sacher
Publisher: World Scientific
ISBN: 9813225696
Category : Medical
Languages : en
Pages : 491

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Book Description
The contents of this book touch on the all major dental biomaterials: polymers, composites, ceramics and metals. The first part introduces the readers to the surface physicochemical and mechanical characterizations at the nanoscopic level, and the use of finite element analysis. The second part discusses dental adhesion, resin-based composites, polymerization contraction stress, impression materials and soft liners for total prosthesis. The third part deals with ceramics in restorative dentistry: zirconia and lithium disilicate, the fractography of dental ceramics, as well as bioglass for bone growth. The fourth part discusses the toxicity of mercury in dentistry, and the use of preventive materials for dental diseases. The concluding part identifies imminent techniques for dental biomaterials, such as additive manufacturing (3D printing), and bioprinting in dentistry.