Biocompatibility And Performance Of Medical Devices

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Biocompatibility and Performance of Medical Devices

Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 586 pages
Book Rating : 4.0/5 (81 download)

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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 586 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

Biological Performance of Materials

Author : Jonathan Black
Publisher : CRC Press
ISBN 13 : 1420057847
Total Pages : 520 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Biological Performance of Materials by : Jonathan Black

Download or read book Biological Performance of Materials written by Jonathan Black and published by CRC Press. This book was released on 2005-12-20 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Biocompatibility Testing and Management

Author : Nancy J. Stark
Publisher :
ISBN 13 : 9781889160009
Total Pages : 300 pages
Book Rating : 4.1/5 (6 download)

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Book Synopsis Biocompatibility Testing and Management by : Nancy J. Stark

Download or read book Biocompatibility Testing and Management written by Nancy J. Stark and published by . This book was released on 1996-03-01 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biological Performance of Materials

Author : Jonathan Black
Publisher : CRC Press
ISBN 13 : 9781420051971
Total Pages : 484 pages
Book Rating : 4.0/5 (519 download)

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Book Synopsis Biological Performance of Materials by : Jonathan Black

Download or read book Biological Performance of Materials written by Jonathan Black and published by CRC Press. This book was released on 1999-07-21 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Device Technologies

Author : Gail D. Baura
Publisher : Academic Press
ISBN 13 : 012374976X
Total Pages : 529 pages
Book Rating : 4.1/5 (237 download)

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Book Synopsis Medical Device Technologies by : Gail D. Baura

Download or read book Medical Device Technologies written by Gail D. Baura and published by Academic Press. This book was released on 2011-10-07 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Biocompatiblity

Author : Julian H. Braybrook
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Biocompatiblity by : Julian H. Braybrook

Download or read book Biocompatiblity written by Julian H. Braybrook and published by John Wiley & Sons. This book was released on 1997-08-04 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biological Performance of Materials

Author : Jonathan Black
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 408 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Biological Performance of Materials by : Jonathan Black

Download or read book Biological Performance of Materials written by Jonathan Black and published by Marcel Dekker. This book was released on 1992 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biomaterials, Medical Devices, and Combination Products

Author : Shayne Cox Gad
Publisher : CRC Press
ISBN 13 : 1482248387
Total Pages : 606 pages
Book Rating : 4.4/5 (822 download)

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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

Public Health Effectiveness of the FDA 510(k) Clearance Process

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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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.

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Author : Shayne C. Gad
Publisher : Springer Nature
ISBN 13 : 3030352412
Total Pages : 490 pages
Book Rating : 4.0/5 (33 download)

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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 490 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.

Handbook of Biomaterials Biocompatibility

Author : Masoud Mozafari
Publisher : Woodhead Publishing
ISBN 13 : 9780081029671
Total Pages : 0 pages
Book Rating : 4.0/5 (296 download)

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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 2020-06-16 with total page 0 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.

Biomaterials in the Design and Reliability of Medical Devices

Author : Michael N. Helmus
Publisher : Springer Science & Business Media
ISBN 13 : 9780306476907
Total Pages : 240 pages
Book Rating : 4.4/5 (769 download)

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Book Synopsis Biomaterials in the Design and Reliability of Medical Devices by : Michael N. Helmus

Download or read book Biomaterials in the Design and Reliability of Medical Devices written by Michael N. Helmus and published by Springer Science & Business Media. This book was released on 2003-01-31 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biomaterials and Medical Devices

Author : Ferdyansyah Mahyudin
Publisher : Springer
ISBN 13 : 3319148451
Total Pages : 242 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Biomaterials and Medical Devices by : Ferdyansyah Mahyudin

Download or read book Biomaterials and Medical Devices written by Ferdyansyah Mahyudin and published by Springer. This book was released on 2016-02-26 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Trends in Development of Medical Devices

Author : Prakash Srinivasan Timiri Shanmugam
Publisher : Academic Press
ISBN 13 : 0128209615
Total Pages : 218 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Trends in Development of Medical Devices by : Prakash Srinivasan Timiri Shanmugam

Download or read book Trends in Development of Medical Devices written by Prakash Srinivasan Timiri Shanmugam and published by Academic Press. This book was released on 2020-01-25 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Design Controls for the Medical Device Industry

Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 0824743555
Total Pages : 253 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie B. Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biomaterials and Implant Biocompatibility

Author : Anişoara Cîmpean
Publisher : MDPI
ISBN 13 : 3039282166
Total Pages : 420 pages
Book Rating : 4.0/5 (392 download)

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Book Synopsis Biomaterials and Implant Biocompatibility by : Anişoara Cîmpean

Download or read book Biomaterials and Implant Biocompatibility written by Anişoara Cîmpean and published by MDPI. This book was released on 2020-03-10 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.