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Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
A Book

by Jean-Pierre Boutrand

  • Publisher : Woodhead Publishing
  • Release : 2019-11-21
  • Pages : 586
  • ISBN : 0081026447
  • Language : En, Es, Fr & De
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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
Safety, Efficacy and Performance of Medical Devices

by Nancy J. Stark

  • Publisher : Unknown Publisher
  • Release : 1996-03-01
  • Pages : 300
  • ISBN : 9781889160009
  • Language : En, Es, Fr & De
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Biocompatiblity

Biocompatiblity
Assessment of Medical Devices and Materials

by Julian H. Braybrook

  • Publisher : Wiley
  • Release : 1997-08-04
  • Pages : 248
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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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.

Biomaterials and Implant Biocompatibility

Biomaterials and Implant Biocompatibility
A Book

by Anişoara Cîmpean,Florin Miculescu

  • Publisher : MDPI
  • Release : 2020-03-10
  • Pages : 420
  • ISBN : 3039282166
  • Language : En, Es, Fr & De
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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.

Biological Performance of Materials

Biological Performance of Materials
Fundamentals of Biocompatibility, Fourth Edition

by Jonathan Black

  • Publisher : CRC Press
  • Release : 2005-12-20
  • Pages : 520
  • ISBN : 1420057847
  • Language : En, Es, Fr & De
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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

Durability and Reliability of Medical Polymers

Durability and Reliability of Medical Polymers
A Book

by Mike Jenkins,Artemis Stamboulis

  • Publisher : Elsevier
  • Release : 2012-08-13
  • Pages : 296
  • ISBN : 0857096516
  • Language : En, Es, Fr & De
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Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers. Part one provides a review of the types and properties of bioresorbable medical polymers. The effect of molecular structure on properties is discussed, along with the processing of bioresorbable and other polymers for medical applications. Transport phenomena and the degradation of bioresorbable medical polymers are reviewed, before an exploration of synthetic bioresorbable polymers and their use in orthopaedic tissue regeneration. Part two goes on to explore the durability and reliability of non-bioresorbable medical polymers, and wear processes in polymer implants and ageing processes of biomedical polymers in the body are discussed in depth, before an investigation into manufacturing defects and the failure of synthetic polymeric medical devices. With its distinguished editors and international team of expert contributors, Durability and reliability of medical polymers is an essential tool for all materials scientists, researchers and engineers involved in the design, development and application of medical polymers, whilst also providing a helpful overview of the subject for biologists, chemist and clinicians. Comprehensively examines the performance of both bioresorbable and non-bioresorbable medical polymers Discusses the processing of bioresorbable and other polymers for medical applications, before reviewing the degradation of bioresorbable medical polymers Explores the durability and reliability of non-bioresorbable medical polymers and discusses wear processes in polymer implants and ageing processes of biomedical polymers in the body

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
A Book

by Beth Ann Fiedler

  • Publisher : Elsevier
  • Release : 2016-09-10
  • Pages : 380
  • ISBN : 0128041927
  • Language : En, Es, Fr & De
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Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Biomaterials in Plastic Surgery

Biomaterials in Plastic Surgery
Breast Implants

by W Peters,H Brandon,K L Jerina,C Wolf,V L Young

  • Publisher : Elsevier
  • Release : 2012-07-02
  • Pages : 240
  • ISBN : 0857096419
  • Language : En, Es, Fr & De
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Employed for both cosmetic and reconstructive purposes, breast implants are one of the most widely-used and controversial prostheses available. The development of safe, reliable products is vital to the future of this important field of surgery. Biomaterials in plastic surgery reviews the history, materials and safety issues associated with breast implants. Beginning with an introduction to the history of biomaterials used for breast augmentation, Biomaterials in plastic surgery goes on to discuss development issues. It then discusses the chemistry and physical properties of biomedical silicones before reviewing cohesive gel and polyurethane foam implants. The book concludes by analysing the epidemiological evidence on the safety issues relating to breast implants, followed by a review of retrieval and analysis of breast implants emphasizing strength, durability and failure mechanisms. With its distinguished editors and international team of expert contributors, Biomaterials in plastic surgery is an important guide for surgeons, manufacturers and all those researching this important field. Comprehensively examines the history, materials and safety issues associated with breast implants Provides an overview of the history of biomaterials used for breast augmentation and goes on to discuss the development and chemical and physical properties of biomedical silicones Reviews cohesive gel breast implants and polyurethane foam breast implants

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
A Book

by Marie B. Teixeira,Richard Bradley

  • Publisher : CRC Press
  • Release : 2002-09-20
  • Pages : 254
  • ISBN : 0824743555
  • Language : En, Es, Fr & De
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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.

Polymers in Disposable Medical Devices

Polymers in Disposable Medical Devices
A European Perspective

by Colin R. Blass

  • Publisher : iSmithers Rapra Publishing
  • Release : 1999
  • Pages : 104
  • ISBN : 9781859571828
  • Language : En, Es, Fr & De
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Biomedical Devices

Biomedical Devices
Materials, Design, and Manufacturing

by Raymond H. W. Lam,Weiqiang Chen

  • Publisher : Springer
  • Release : 2019-08-16
  • Pages : 379
  • ISBN : 3030242374
  • Language : En, Es, Fr & De
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This textbook provides essential knowledge for biomedical product development, including material properties, fabrication processes and design techniques for different applications, as well as process design and optimization. This book is multidisciplinary and readers can learn techniques to apply acquired knowledge for various applications of biomedical design. Further, this book encourages readers to discover and convert newly reported technologies into products and services for the future development of biomedical applications. This is an ideal book for upper-level undergraduate and graduate students, engineers, technologists, and researchers working in the area of biomedical engineering and manufacturing. This book also: Provides a comprehensive set of fundamental knowledge for engineering students and entry level engineers to design biomedical devices Offers a unique approach to manufacturing of biomedical devices by integrating and formulating different considerations in process design tasks into optimization problems Provides a broad range of application examples to guide readers through the thinking process of designing and manufacturing biomedical devices, from basic understanding about the requirements and regulations to a set of manufacturing parameters

Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants
A Book

by Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam

  • Publisher : Academic Press
  • Release : 2020-06-10
  • Pages : 330
  • ISBN : 0128209208
  • Language : En, Es, Fr & De
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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

Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
A Book

by Stephen F. Amato,Robert M. Ezzell Jr

  • Publisher : Elsevier
  • Release : 2014-10-27
  • Pages : 202
  • ISBN : 0857099205
  • Language : En, Es, Fr & De
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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Joining and Assembly of Medical Materials and Devices

Joining and Assembly of Medical Materials and Devices
A Book

by Y N Zhou,M D Breyen

  • Publisher : Elsevier
  • Release : 2013-05-31
  • Pages : 574
  • ISBN : 0857096427
  • Language : En, Es, Fr & De
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As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications. Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications. Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives

Medical Device Materials IV

Medical Device Materials IV
Proceedings of the Materials & Processes for Medical Devices Conference 2007, September 23-27, 2007, Palm Desert, California, USA

by Jeremy Gilbert

  • Publisher : ASM International
  • Release : 2008-01-01
  • Pages : 250
  • ISBN : 1615031243
  • Language : En, Es, Fr & De
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"Proceedings from the only conference on medical devices that brings together scientists and product, research, design and development engineers from around the globe to present the latest developments in materials, processes, product performance and new technologies for medical/dental devices." "This volume includes contributions from the world's foremost experts from academia, industry, and national laboratories involved in cardiac, vascular, neurological, and orthopaedic implants, dental devices, and surgical instrumentation/devices." "Materials addressed include biomedical alloys (stainless steels, titanium alloys, cobalt-chromium alloys, nickel-titanium alloys, noble and refractory metals) biopolymers, bioceramics, surface coatings, and nanomaterials." "Topics covered include: degradation, wear fracture, corrosion, processing, biomimetics, biocompatibility, bioelectric phenomena and electrode behavior, surface engineering, and cell-material interactions."--BOOK JACKET.

Biomaterials Science

Biomaterials Science
An Introduction to Materials in Medicine

by Buddy D. Ratner,Allan S. Hoffman,Frederick J. Schoen,Jack E. Lemons

  • Publisher : Elsevier
  • Release : 1996
  • Pages : 484
  • ISBN : 9780125824613
  • Language : En, Es, Fr & De
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This book introduces a subject that has profound impact on human health and considerable economic importance. The issues addressed include the biology, medical applications, markets, regulation, and ethical issues involved in biomaterials science. This spectrum of issues reflects the interdisciplinary nature of the field. Key Features * Provides a strong, cohesive compilation unlike any other currently on the market * Covers the entire spectrum of biomaterials and their use in medicine * Contributions of leaders in the biomaterials field

Medical Coatings and Deposition Technologies

Medical Coatings and Deposition Technologies
A Book

by David Glocker,Shrirang Ranade

  • Publisher : John Wiley & Sons
  • Release : 2016-06-24
  • Pages : 800
  • ISBN : 1119308674
  • Language : En, Es, Fr & De
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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.

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
Second Edition

by Jack Wong,Raymond Tong

  • Publisher : CRC Press
  • Release : 2018-03-28
  • Pages : 620
  • ISBN : 0429996772
  • Language : En, Es, Fr & De
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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Biological Performance of Materials

Biological Performance of Materials
Fundamentals of Biocompatibility

by Jonathan Black

  • Publisher : Marcel Dekker Incorporated
  • Release : 1992
  • Pages : 390
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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The Complete Book on Medical Plastics

The Complete Book on Medical Plastics
A Book

by NIIR Board of Consultants and Engineers

  • Publisher : ASIA PACIFIC BUSINESS PRESS Inc.
  • Release : 2006-10-01
  • Pages : 368
  • ISBN : 8178330008
  • Language : En, Es, Fr & De
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Plastics currently form one of the most important components of the medical industry. Medical device designers and engineers increasingly prefer plastics to conventional packaging materials such as metals owing to superior flexibility offered by plastics in fabrication process. Advancements in sterilization techniques shift towards disposable devices, development of enhanced plastic materials, and technological innovations are factors driving the overall market growth and expansion. The development of novel materials such as biocompatible polymers for use in medical implants will furthermore provide the required impetus for the global medical plastics market. Every day, plastics are involved in critical surgeries, life saving efforts, and routine medical procedures. Plastic materials can be sterilized hundreds of times without degradation. Lightweight plastics are used to form replacement joints, non surgical supports, and therapy equipment. Clear plastics provide visibility for transfusions, surgeries, and diagnostic equipment of all kinds and plastics can be machined, molded, or formed into almost any shape imaginable. The use of plastics in health care field encompasses several distinct markets. Plastic is used on a large scale as medical devices like disposable syringes, optical and dental products, heart valves, contact lenses and many more medical products. This way plastic has very importance in making medical devices. The medical plastics industry is set to expand rapidly over the next decade taking up increasing proportions of GDP, as countries provide healthcare to an ageing population, access to medicine expands in developing regions and new technology is developed. This book basically deals with significance of packaging for pharmaceuticals & medical industry, tablets & capsules liquids, creams and ointments, OPVC, OPP and oriented and non oriented pet containers, blister trays for ampoules, cartridge tubes etc., shrink packaging and stretch wrapping, conducting health based risk assessments of medical materials, performance properties of metallocene polyethylene, EVA, and flexible PVC films, polyurethane thin film welding for medical device applications, polyurethane film as an alternative to PVC and latex, opportunities for PVC replacement in medical solution containers, thermoplastic silicone urethane copolymers : a new class of biomedical elastomers, selecting materials for medical products : from PVC to metallocene polyolefins, injection molding engineering plastics, assessing the performance and suitability of parylene coating etc. The present book contains the important information of plastics in medical field and their uses in various ways. This is very useful book for entrepreneurs, researchers, technocrats and technical institutions.