Biocompatibility And Performance Of Medical Devices

Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Page : 586 pages
File Size : 52,9 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9780081026441

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Biocompatibility and Performance of Medical Devices by Jean-Pierre Boutrand Pdf

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

Author : Jonathan Black
Publisher : CRC Press
Page : 520 pages
File Size : 48,7 Mb
Release : 2005-12-20
Category : Medical
ISBN : 9781420057843

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Biological Performance of Materials by Jonathan Black Pdf

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 consult

Author : Nancy J. Stark
Publisher : Unknown
Page : 300 pages
File Size : 41,8 Mb
Release : 1996-03-01
Category : Electronic
ISBN : 1889160008

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Biocompatibility Testing and Management by Nancy J. Stark Pdf

Author : Jonathan Black
Publisher : CRC Press
Page : 484 pages
File Size : 53,6 Mb
Release : 1999-07-21
Category : Medical
ISBN : 1420051970

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Biological Performance of Materials by Jonathan Black Pdf

A balanced approach to understanding the response of living tissues and systems to manufactured biomaterials and the effect of life processes on the properties and behaviour of successful and unsuccessful biomaterials. This third edition contains a glossary of specialized terms; discussion of the emerging area of tissue engineering; more sources; and more tables to additional generic biomaterials properties.

Author : Jonathan Black
Publisher : Marcel Dekker
Page : 408 pages
File Size : 44,9 Mb
Release : 1992
Category : Medical
ISBN : UOM:39015029233353

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Biological Performance of Materials by Jonathan Black Pdf

Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Page : 606 pages
File Size : 49,7 Mb
Release : 2015-12-01
Category : Medical
ISBN : 9781482248388

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Biomaterials, Medical Devices, and Combination Products by Shayne Cox Gad,Samantha Gad-McDonald Pdf

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

Author : Gail D. Baura,Gail Baura
Publisher : Academic Press
Page : 529 pages
File Size : 41,5 Mb
Release : 2011-10-07
Category : Science
ISBN : 9780123749765

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Medical Device Technologies by Gail D. Baura,Gail Baura Pdf

Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

Author : Anişoara Cîmpean,Florin Miculescu
Publisher : MDPI
Page : 420 pages
File Size : 42,5 Mb
Release : 2020-03-10
Category : Technology & Engineering
ISBN : 9783039282166

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Biomaterials and Implant Biocompatibility by Anişoara Cîmpean,Florin Miculescu Pdf

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.

Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Page : 218 pages
File Size : 50,6 Mb
Release : 2020-01-25
Category : Technology & Engineering
ISBN : 9780128209615

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Trends in Development of Medical Devices by Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam Pdf

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Author : Michael N. Helmus
Publisher : Springer Science & Business Media
Page : 240 pages
File Size : 51,8 Mb
Release : 2003-01-31
Category : Technology & Engineering
ISBN : 0306476908

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Biomaterials in the Design and Reliability of Medical Devices by Michael N. Helmus Pdf

This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.

Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Page : 253 pages
File Size : 44,5 Mb
Release : 2002-09-20
Category : Medical
ISBN : 9780824743550

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Design Controls for the Medical Device Industry by Marie B. Teixeira,Richard Bradley Pdf

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.

Author : Jean-Pierre Boutrand
Publisher : Elsevier
Page : 544 pages
File Size : 52,8 Mb
Release : 2012-10-26
Category : Medical
ISBN : 9780857096456

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Biocompatibility and Performance of Medical Devices by Jean-Pierre Boutrand Pdf

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance

Author : Julian H. Braybrook
Publisher : John Wiley & Sons
Page : 256 pages
File Size : 54,7 Mb
Release : 1997-08-04
Category : Medical
ISBN : UOM:39015041353999

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Biocompatiblity by Julian H. Braybrook Pdf

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.

Author : Masoud Mozafari
Publisher : Woodhead Publishing
Page : 0 pages
File Size : 50,9 Mb
Release : 2020-06-16
Category : Technology & Engineering
ISBN : 0081029675

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Handbook of Biomaterials Biocompatibility by Masoud Mozafari Pdf

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.

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 46,6 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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Reliable Design of Medical Devices by Richard C. Fries Pdf

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.