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Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
  • Author : Jean-Pierre Boutrand
  • Publsiher : Woodhead Publishing
  • Release : 21 November 2019
  • ISBN : 0081026447
  • Pages : 586 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKBiocompatibility and Performance of Medical Devices

Summary:
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 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

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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

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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

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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 consult

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Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release : 11 November 2021
GET THIS BOOKSafety Risk Management for Medical Devices

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to

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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

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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.

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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

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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.

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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

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Plastics in Medical Devices

Plastics in Medical Devices
  • Author : Vinny R. Sastri
  • Publisher : Elsevier
  • Release : 05 March 2010
GET THIS BOOKPlastics in Medical Devices

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the

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Biomaterials and Medical Devices

Biomaterials and Medical Devices
  • Author : Ferdyansyah Mahyudin,Hendra Hermawan
  • Publisher : Springer
  • Release : 26 February 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

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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

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