Biocompatibility And Performance Of Medical Devices
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Biocompatibility And Performance Of Medical Devices
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Author : Jean-Pierre Boutrand
language : en
Publisher: Woodhead Publishing
Release Date : 2019-11-21
Biocompatibility And Performance Of Medical Devices written by Jean-Pierre Boutrand and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-21 with Medical categories.
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
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Author : Nancy J. Stark
language : en
Publisher:
Release Date : 1996-03-01
Biocompatibility Testing And Management written by Nancy J. Stark and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-03-01 with categories.
Biological Performance Of Materials
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Author : Jonathan Black
language : en
Publisher: CRC Press
Release Date : 1999-07-21
Biological Performance Of Materials written by Jonathan Black and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-07-21 with Medical categories.
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.
Biological Performance Of Materials
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Author : Jonathan Black
language : en
Publisher: CRC Press
Release Date : 2005-12-20
Biological Performance Of Materials written by Jonathan Black and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-12-20 with Medical categories.
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
Biological Performance Of Materials
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Author : Jonathan Black
language : en
Publisher: Marcel Dekker
Release Date : 1992
Biological Performance Of Materials written by Jonathan Black and has been published by Marcel Dekker this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Medical categories.
Biomaterials Medical Devices And Combination Products
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Author : Shayne Cox Gad
language : en
Publisher: CRC Press
Release Date : 2015-12-01
Biomaterials Medical Devices And Combination Products written by Shayne Cox Gad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-12-01 with Medical categories.
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
Biomaterials And Implant Biocompatibility
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Author : Anişoara Cîmpean
language : en
Publisher: MDPI
Release Date : 2020-03-10
Biomaterials And Implant Biocompatibility written by Anişoara Cîmpean and has been published by MDPI this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-10 with Technology & Engineering categories.
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.
Design Controls For The Medical Device Industry
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Author : Marie B. Teixeira
language : en
Publisher: CRC Press
Release Date : 2002-09-20
Design Controls For The Medical Device Industry written by Marie B. Teixeira and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-09-20 with Medical categories.
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.
Biocompatiblity
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Author : Julian H. Braybrook
language : en
Publisher: John Wiley & Sons
Release Date : 1997-08-04
Biocompatiblity written by Julian H. Braybrook and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-08-04 with Medical categories.
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 In The Design And Reliability Of Medical Devices
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Author : Michael N. Helmus
language : en
Publisher: Springer Science & Business Media
Release Date : 2003-01-31
Biomaterials In The Design And Reliability Of Medical Devices written by Michael N. Helmus and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-01-31 with Technology & Engineering categories.
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.