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Biocompatibility And Performance Of Medical Devices

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Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices Book
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Release : 2019-11-21
ISBN : 0081026447
Language : En, Es, Fr & De

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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

Biocompatibility Testing and Management

Biocompatibility Testing and Management Book
Author : Nancy J. Stark
Publisher : Unknown
Release : 1996-03-01
ISBN : 9781889160009
Language : En, Es, Fr & De

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Book Description :

Download Biocompatibility Testing and Management book written by Nancy J. Stark, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Biological Performance of Materials

Biological Performance of Materials Book
Author : Jonathan Black
Publisher : CRC Press
Release : 2005-12-20
ISBN : 9780849339592
Language : En, Es, Fr & De

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Book Description :

Bioengineers need a thorough grounding in biocompatibility - the biological performance of materials. Until now, there were no publications suitable for a neophyte in the field; prior publications were either not comprehensive or focused on rather narrow interests. Drawing on the author's 35 years of experience as a teacher, researcher, and consultant in biomaterials science and engineering (BSE), Biological Performance of Materials: Fundamentals of Biocompatibility, Fourth Edition focuses primarily on principles of biological performance at a relatively fundamental level, analyzing interactions between living organisms and nonliving materials used in medical devices - the subject that sets BSE apart as a distinct field of investigation. Following an introductory section, the book is divided into three sections: the material response to biological systems, host response to biomaterials, and test methods for determining biological response in vitro as well as in animal models and clinical settings. Supplemental "Interparts" summarize the physical properties of commonly used metallic, polymeric, and ceramic biomaterials. They also provide a guide to understanding the clinical performance of implanted biomaterials.

Biocompatiblity

Biocompatiblity Book
Author : Julian H. Braybrook
Publisher : Wiley-Blackwell
Release : 1997-08-04
ISBN : 0987650XXX
Language : En, Es, Fr & De

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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.

Toxicologic Pathology

Toxicologic Pathology Book
Author : Pritam S. Sahota,James A. Popp,Jerry F. Hardisty,Chirukandath Gopinath,Page Bouchard
Publisher : CRC Press
Release : 2018-08-14
ISBN : 0429997469
Language : En, Es, Fr & De

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Book Description :

Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

Biomaterials and Implant Biocompatibility

Biomaterials and Implant Biocompatibility Book
Author : Anişoara Cîmpean,Florin Miculescu
Publisher : MDPI
Release : 2020-03-10
ISBN : 3039282166
Language : En, Es, Fr & De

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Book Description :

The scientific advances in life sciences and engineering are constantly challenging, expanding, and redefining concepts related to the biocompatibility and safety of medical devices. New biomaterials, new products, and new testing regimes are being introduced to scientific research practices. In order to provide clinically predictive results and to ensure a high benefit–risk ratio for patients, we need to optimize material and implant characteristics, and to adapt performance and safety evaluation practices for these innovative medical devices. Various characteristics related to materials and implant development such as raw materials composition, implant surface morphology, design, geometry, porosity, and mechanical properties need to be thoroughly characterized before evaluating the biological performance of implants. Furthermore, with the increase of regulatory demands, biological evaluation needs to ensure appropriate models and methods for each implant development stage. This book is a result of the Special Issue of Materials on "Biomaterials and Implant Biocompatibility”, which focused on the recent progress in development, material testing, and the biocompatibility and bioactivity evaluation of various materials including, but not limited to, bioceramics, biopolymers, biometals, composite materials, biomimetic materials, hybrid biomaterials, and drug/device combinations for implants and prostheses with medical applications spanning from soft to hard tissue regeneration. The book covers aspects ranging from investigations into material characterization to in vitro and in vivo testing for the assessment of biological performance of advanced, novel biomaterials and implants.

Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-07-03
ISBN : 0128207280
Language : En, Es, Fr & De

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Book Description :

Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks. Discusses the adverse toxicological effects of medical devices Covers a broad range of disease topics and disease specific implants Offers contributions from experts from across several disciplines

Medical Coatings and Deposition Technologies

Medical Coatings and Deposition Technologies Book
Author : David Glocker,Shrirang Ranade
Publisher : John Wiley & Sons
Release : 2016-06-24
ISBN : 1119308674
Language : En, Es, Fr & De

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Book Description :

Medical Coatings and Deposition Technologies is an important new addition to the libraries of medical device designers and manufacturers. Coatings enable the properties of the surface of a device to be controlled independently from the underlying bulk properties; they are often critical to the performance of the device and their use is rapidly growing. This book provides an introduction to many of the most important types of coatings used on modern medical devices as well as descriptions of the techniques by which they are applied and methods for testing their efficacy. Developers of new medical devices and those responsible for producing them will find it an important reference when deciding if a particular functionality can be provided by a coating and what limitations may apply in a given application. Written as a practical guide and containing many specific coating examples and a large number of references for further reading, the book will also be useful to students in materials science & engineering with an interest in medical devices. Chapters on antimicrobial coatings as well as coatings for biocompatibility, drug delivery, radiopacity and hardness are supported by chapters describing key liquid coating processes, plasma-based processes and chemical vapor deposition. Many types of coatings can be applied by more than one technique and the reader will learn the tradeoffs given the relevant design, manufacturing and economic constraints. The chapter on regulatory considerations provides important perspectives regarding the marketing of these coatings and medical devices.

The Medical Device R D Handbook

The Medical Device R D Handbook Book
Author : Theodore R. Kucklick
Publisher : CRC Press
Release : 2005-11-21
ISBN : 1420038354
Language : En, Es, Fr & De

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Book Description :

The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha

Bureau of Medical Devices Standards Survey

Bureau of Medical Devices Standards Survey Book
Author : United States. Bureau of Medical Devices
Publisher : Unknown
Release : 1979
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Bureau of Medical Devices Standards Survey book written by United States. Bureau of Medical Devices, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

New Scientist

New Scientist Book
Author : Anonim
Publisher : Unknown
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download New Scientist book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Szycher s Handbook of Polyurethanes First Edition

Szycher s Handbook of Polyurethanes  First Edition Book
Author : Michael Szycher, Ph.D
Publisher : CRC Press
Release : 1999-04-23
ISBN : 9780849306020
Language : En, Es, Fr & De

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Book Description :

Handbook of Polyurethanes serves as the first source of information of useful polymers. This new book thoroughly covers the entire spectrum of polyurethanes - from current technology to buyer's information. Discussions include: block and heteroblock systems rubber plasticity structure-property relations microphase separation catalysis of isocyanate reactions synthesis of polyurethanes for thermoplastics, thermosets, and curable compositions by either heat or U.V. energy biomedical applications of urethane elastomers castables, sealants, and caulking compounds flexible and semi-flexible foams health and safety This handbook compiles data from many sources, exhaustively illustrating the complex principles involved in polyurethane chemistry and technology. Handbook of Polyurethanes represents invaluable information for corporations, universities, or independent inventors.

Materials for Medical Application

Materials for Medical Application Book
Author : Robert B. Heimann
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2020-08-24
ISBN : 3110619245
Language : En, Es, Fr & De

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Book Description :

This book gives an introduction to the highly interdisciplinary field of biomaterials. It concisely summarizes properties, synthesis and modification of materials such as metals, ceramics, polymers or composites. Characterization, in vitro and in vivo testing as well as a selection of various applications are also part of this inevitable guide.

PEEK Biomaterials Handbook

PEEK Biomaterials Handbook Book
Author : Steven M. Kurtz
Publisher : William Andrew
Release : 2019-03-15
ISBN : 012812525X
Language : En, Es, Fr & De

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Book Description :

PEEK biomaterials are currently used in hundreds of thousands of spinal fusion patients around the world every year. Durability, biocompatibility, and excellent resistance to aggressive sterilization procedures make PEEK a polymer of choice, replacing metal in orthopedic implants, from spinal implants and knee replacements to finger joints and dental implants. The new edition of this authoritative work sees the book expand from 17 chapters to 26 chapters to match the expansion in applications in PEEK—from spinal cages to spinal rods and disc replacements; hip and knee joint replacement; dental; trauma; and sports medicine. New PEEK formulations have been developed incorporating hydroxyapatite, additives to combat infection, and surface grafted polymers to improve lubrication. The book also covers additive manufacturing, which has made significant inroads with PEEK in the past 5 years as well by introducing the prospect of patient-specific implants. Like the 1st edition, the updated Handbook brings together experts in many different facets related to PEEK clinical performance as well as in the areas of materials science, tribology, and biology to provide a complete reference for specialists in the field of plastics, biomaterials, medical device design, and surgical applications. Useful for materials scientists and biomedical engineers, both in industry and academia, the book is a one-stop shop for information on PEEK as a biomaterial—including in-depth coverage of materials properties—while also providing cutting-edge information on applications and combinations of the material. Presents a complete reference work covering PEEK, the leading polymer for spinal implants and a range of other biomedical applications Covers a range of new formulations and applications, including in-depth coverage of the additive manufacturing of PEEK Provides a vital source of supporting information for materials selection decisions and regulatory submissions

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry Book
Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Release : 2002-09-20
ISBN : 0824743555
Language : En, Es, Fr & De

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Book Description :

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Materials and Coatings for Medical Devices

Materials and Coatings for Medical Devices Book
Author : Anonim
Publisher : ASM International
Release : 2009-01-01
ISBN : 1615031359
Language : En, Es, Fr & De

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Book Description :

"The Materials Information Society, MPMD-Materials and Processes for Medical Devices."

Biomedical Devices

Biomedical Devices Book
Author : Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Release : 2016-09-13
ISBN : 1119267056
Language : En, Es, Fr & De

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Book Description :

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Mechanics of Biomaterials

Mechanics of Biomaterials Book
Author : Lisa A. Pruitt,Ayyana M. Chakravartula
Publisher : Cambridge University Press
Release : 2011-10-20
ISBN : 1107376564
Language : En, Es, Fr & De

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Book Description :

Teaching mechanical and structural biomaterials concepts for successful medical implant design, this self-contained text provides a complete grounding for students and newcomers to the field. Split into three sections: Materials, Mechanics and Case Studies, it begins with a review of sterilization, biocompatibility and foreign body response before presenting the fundamental structures of synthetic biomaterials and natural tissues. Mechanical behavior of materials is then discussed in depth, covering elastic deformation, viscoelasticity and time-dependent behavior, multiaxial loading and complex stress states, yielding and failure theories, and fracture mechanics. The final section on clinical aspects of medical devices provides crucial information on FDA regulatory issues and presents case studies in four key clinical areas: orthopedics, cardiovascular devices, dentistry and soft tissue implants. Each chapter ends with a list of topical questions, making this an ideal course textbook for senior undergraduate and graduate students, and also a self-study tool for engineers, scientists and clinicians.

Biomaterials Science

Biomaterials Science Book
Author : Buddy D. Ratner
Publisher : Academic Press
Release : 2004
ISBN : 0125824637
Language : En, Es, Fr & De

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Book Description :

"... This reference integrates a historical perspective of materials engineering principles with biological interactions of biomaterials. Also provided within are regulatory and ethical issues in addition to future directions of the field, and a state-of-the-art update of medical and biotechnological applications. All aspects of biomaterials science are thoroughly addressed, from tissue engineering to cochlear prostheses and drug delivery systems. Over 80 contributors from academia, government and industry detail the principles of cell biology, immunology, and pathology. Focus within pertains to the clinical uses of biomaterials as components in implants, devices, and artificial organs. This reference also touches upon their uses in biotechnology as well as the characterization of the physical, chemical, biochemical and surface properties of these materials." -- Publisher's description.

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products Book
Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Release : 2015-12-01
ISBN : 1482248387
Language : En, Es, Fr & De

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Book Description :

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