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

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, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
  • Author : Shayne Cox Gad,Samantha Gad-McDonald
  • Publisher : CRC Press
  • Release : 01 December 2015
GET THIS BOOKBiomaterials, Medical Devices, and Combination Products

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

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 29 June 2018
GET THIS BOOKSafety Risk Management for Medical Devices

Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk

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,

Biomaterials and Medical Devices

Biomaterials and Medical Devices
  • Author : Ferdyansyah Mahyudin,Hendra Hermawan
  • Publisher : Springer
  • Release : 29 March 2016
GET THIS BOOKBiomaterials and Medical Devices

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

Biomaterials and Implant Biocompatibility

Biomaterials and Implant Biocompatibility
  • Author : Anişoara Cîmpean,Florin Miculescu
  • Publisher : MDPI
  • Release : 10 March 2020
GET THIS BOOKBiomaterials and Implant Biocompatibility

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

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

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

Biomaterials Science and Biocompatibility

Biomaterials Science and Biocompatibility
  • Author : Frederick H. Silver,David L. Christiansen
  • Publisher : Springer Science & Business Media
  • Release : 06 December 2012
GET THIS BOOKBiomaterials Science and Biocompatibility

Adopting an interdisciplinary approach to the chemistry and physics of materials, their biocompatibility, and the consequences of implantation of such devices into the human body, this text introduces readers to the principles of polymer science and the study of metals, ceramics and composites, and also to the basic biology required to understand the nature of the host-transplant interface. Topics covered include the macromolecular components of cells and tissues, self-assembly processes, biological cascade systems, microscopic structure of cells and tissues, immunology,

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

Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
  • Publisher : National Academies Press
  • Release : 04 October 2010
GET THIS BOOKPublic Health Effectiveness of the FDA 510(k) Clearance Process

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.

UHMWPE Biomaterials Handbook

UHMWPE Biomaterials Handbook
  • Author : Steven M. Kurtz
  • Publisher : Academic Press
  • Release : 27 April 2009
GET THIS BOOKUHMWPE Biomaterials Handbook

UHMWPE Biomaterials Handbook describes the science, development, properties and application of of ultra-high molecular weight polyethylene (UHMWPE) used in artificial joints. This material is currently used in 1.4 million patients around the world every year for use in the hip, knee, upper extremities, and spine. Since the publication of the 1st edition there have been major advances in the development and clinical adoption of highly crosslinked UHMWPE for hip and knee replacement. There has also been a major international effort to

Comprehensive Biotechnology

Comprehensive Biotechnology
  • Author : Anonim
  • Publisher : Newnes
  • Release : 26 August 2011
GET THIS BOOKComprehensive Biotechnology

The second edition of Comprehensive Biotechnology continues the tradition of the first inclusive work on this dynamic field with up-to-date and essential entries on the principles and practice of biotechnology. The integration of the latest relevant science and industry practice with fundamental biotechnology concepts is presented with entries from internationally recognized world leaders in their given fields. With two volumes covering basic fundamentals, and four volumes of applications, from environmental biotechnology and safety to medical biotechnology and healthcare, this work