Biocompatibility and Performance of Medical Devices

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

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  • Author : Jean-Pierre Boutrand
  • Publisher : Woodhead Publishing
  • Pages : 586 pages
  • ISBN : 0081026447
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKBiocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publisher : Woodhead Publishing
  • Release : 21 November 2019
GET THIS BOOKBiocompatibility and Performance of Medical Devices

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

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publisher : Elsevier
  • Release : 26 October 2012
GET THIS BOOKBiocompatibility and Performance of Medical Devices

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

Joining and Assembly of Medical Materials and Devices

Joining and Assembly of Medical Materials and Devices
  • Author : Y N Zhou,M D Breyen
  • Publisher : Elsevier
  • Release : 31 May 2013
GET THIS BOOKJoining and Assembly of Medical Materials and Devices

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

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
  • Author : Shayne C. Gad
  • Publisher : Springer Nature
  • Release : 24 February 2020
GET THIS BOOKIntegrated Safety and Risk Assessment for Medical Devices and Combination Products

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

Durability and Reliability of Medical Polymers

Durability and Reliability of Medical Polymers
  • Author : Mike Jenkins,Artemis Stamboulis
  • Publisher : Elsevier
  • Release : 13 August 2012
GET THIS BOOKDurability and Reliability of Medical Polymers

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

Biomaterials in Plastic Surgery

Biomaterials in Plastic Surgery
  • Author : W Peters,H Brandon,K L Jerina,C Wolf,V L Young
  • Publisher : Elsevier
  • Release : 02 July 2012
GET THIS BOOKBiomaterials in Plastic Surgery

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

Handbook of Biomaterials Biocompatibility

Handbook of Biomaterials Biocompatibility
  • Author : Masoud Mozafari
  • Publisher : Woodhead Publishing
  • Release : 17 June 2020
GET THIS BOOKHandbook of Biomaterials Biocompatibility

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

Biocompatiblity

Biocompatiblity
  • Author : Julian H. Braybrook
  • Publisher : Wiley-Blackwell
  • Release : 04 August 1997
GET THIS BOOKBiocompatiblity

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

Biological Performance of Materials
  • Author : Jonathan Black
  • Publisher : CRC Press
  • Release : 20 December 2005
GET THIS BOOKBiological Performance of Materials

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

Applications of Polyurethanes in Medical Devices

Applications of Polyurethanes in Medical Devices
  • Author : Ajay Padsalgikar
  • Publisher : William Andrew
  • Release : 01 June 2022
GET THIS BOOKApplications of Polyurethanes in Medical Devices

Applications of Polyurethanes in Medical Devices provides detailed coverage of polyurethane (PU) chemistry, processing and preparation for performant medical devices. Polyurethanes have found many uses in medical applications, due to their biocompatibility, biostability, physical properties, surface polarity, and the ability to suit the field of application. This book enables the reader to understand polyurethane and how this valuable material can be used in medical devices. Sections cover the chemistry, structure, and properties of polyurethane, with in-depth sections examining raw materials,

Plastics in Medical Devices for Cardiovascular Applications

Plastics in Medical Devices for Cardiovascular Applications
  • Author : Ajay Padsalgikar
  • Publisher : William Andrew
  • Release : 01 February 2017
GET THIS BOOKPlastics in Medical Devices for Cardiovascular Applications

Plastics in Medical Devices for Cardiovascular Applications enables designers of new cardiovascular medical devices to make decisions about the kind of plastics that can go into the manufacture of their device by explaining the property requirements of various applications in this area, including artificial valves, lead insulation, balloons, vascular grafts, and more. Enables designers to improve device performance and remain compliant with regulations by selecting the best material for each application Presents a range of applications, including artificial valves, stents,

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
  • Author : Beth Ann Fiedler
  • Publisher : Elsevier
  • Release : 10 September 2016
GET THIS BOOKManaging Medical Devices within a Regulatory Framework

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,

Trends in Development of Medical Devices

Trends in Development of Medical Devices
  • Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
  • Publisher : Academic Press
  • Release : 25 January 2020
GET THIS BOOKTrends in Development of Medical Devices

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

Biomaterials Science

Biomaterials Science
  • Author : Buddy D. Ratner
  • Publisher : Academic Press
  • Release : 07 August 2022
GET THIS BOOKBiomaterials Science

"... 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