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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

Polymer Additive Analytics

Polymer Additive Analytics
Industrial Practice and Case Studies

by Jan C. J. Bart

  • Publisher : Firenze University Press
  • Release : 2006
  • Pages : 378
  • ISBN : 8884533791
  • Language : En, Es, Fr & De
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Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition
A Book

by Shayne C. Gad,Marian G. McCord

  • Publisher : CRC Press
  • Release : 2008-10-20
  • Pages : 504
  • ISBN : 1439809488
  • Language : En, Es, Fr & De
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Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

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

Biological Safety & European Medical Device Regulations

Biological Safety & European Medical Device Regulations
A Book

by Anonim

  • Publisher : Quality First International
  • Release : 2022
  • Pages : 129
  • ISBN : 1903757002
  • Language : En, Es, Fr & De
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Polymers in Medical Applications

Polymers in Medical Applications
A Book

by B.J. Lambert,F.-W. Tang,W. J. Rogers

  • Publisher : iSmithers Rapra Publishing
  • Release : 2001
  • Pages : 146
  • ISBN : 9781859572597
  • Language : En, Es, Fr & De
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The use of polymers in medical devices is growing at a steady rate. These materials are generally relatively cheap and versatile, qualities required in many bulk applications. In more specialised medical devices, polymeric components have been developed to meet challenging property and performance requirements. This review describes the process of developing polymeric products for medical applications from design requirements through to specific examples of medical devices and packaging. An additional indexed section containing several hundred abstracts from the Rapra Polymer Library database gives useful references for further reading.

Biological Evaluation of Medical Devices. Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity

Biological Evaluation of Medical Devices. Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
A Book

by Bristish Standards Institution,British Standards Institute Staff

  • Publisher : Unknown Publisher
  • Release : 2009-06-30
  • Pages : 26
  • ISBN : 9780580656651
  • Language : En, Es, Fr & De
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Medical equipment, Biological analysis and testing, Medical instruments, Dental equipment, Implants (surgical), Biological hazards, Toxic materials, Toxicity, Genotoxicity tests, Cytotoxicity tests, Reproductive system

Nanomedicine Design of Particles, Sensors, Motors, Implants, Robots, and Devices

Nanomedicine Design of Particles, Sensors, Motors, Implants, Robots, and Devices
A Book

by Mark J. Schulz,Vesselin N. Shanov,Yeoheung Yun

  • Publisher : Artech House
  • Release : 2009
  • Pages : 549
  • ISBN : 1596932805
  • Language : En, Es, Fr & De
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Annotation This resource outlines the new tools that are becoming available in nanomedicine. The book presents an integrated set of perspectives that describe where advancements are now and where they should be headed to put nanomedicine devices into applications as quickly as possible

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
Biocompatibility Testing and Safety Assessment

by Shayne Cox Gad,Samantha Gad-McDonald

  • Publisher : CRC Press
  • Release : 2015-12-01
  • Pages : 606
  • ISBN : 1482248387
  • Language : En, Es, Fr & De
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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

Regulatory Toxicology, Second Edition

Regulatory Toxicology, Second Edition
A Book

by Shayne C. Gad

  • Publisher : CRC Press
  • Release : 2001-07-19
  • Pages : 408
  • ISBN : 9781420025187
  • Language : En, Es, Fr & De
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This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.

Handbook on the Toxicology of Metals

Handbook on the Toxicology of Metals
A Book

by Gunnar F. Nordberg,Bruce A. Fowler,Monica Nordberg

  • Publisher : Academic Press
  • Release : 2014-08-07
  • Pages : 1542
  • ISBN : 0123973392
  • Language : En, Es, Fr & De
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Handbook on the Toxicology of Metals, Fourth Edition bridges the gap between established knowledgebase and new advances in metal toxicology to provide one essential reference for all those involved in the field. This book provides comprehensive coverage of basic toxicological data, emphasizing toxic effects primarily in humans, but also those of animals and biological systems in vitro. The fourth edition also contains several new chapters on important topics such as nanotoxicology, metals in prosthetics and dental implants, gene-environment interaction, neurotoxicology, metals in food, renal, cardiovascular, and diabetes effects of metal exposures and more. Volume I covers “General Considerations and Volume II is devoted to “Specific Metals. A multidisciplinary resource with contributions from internationally-recognized experts, the fourth edition of the Handbook on the Toxicology of Metals is a prominent and indispensable reference for toxicologists, physicians, pharmacologists, engineers, and all those involved in the toxicity of metals. Contains 61 peer reviewed chapters dealing with the effects of metallic elements and their compounds on biological systems Includes information on sources, transport and transformation of metals in the environment and on certain aspects of the ecological effects of metals to provide a basis for better understanding of the potential for adverse effects on human health Covers the toxicology of metallic nanomaterials in a new comprehensive chapter Metal toxicology in developing countries is dealt with in another new chapter emphasizing the adverse effects on human health by the inadequate handling of "ewaste Other new chapters in the 4th edition include: Toxic metals in food; Toxicity of metals released from medical devices; Gene-environment interactions; Neurotoxicology of metals; Cardiovascular disease; Renal effects of exposure to metals; Gold and gold mining; Iridium; Lanthanum; Lithium and Rhodium

Handbook on the Toxicology of Metals

Handbook on the Toxicology of Metals
Volume I: General Considerations

by Gunnar F. Nordberg,Max Costa

  • Publisher : Academic Press
  • Release : 2021-12-10
  • Pages : 796
  • ISBN : 0128232935
  • Language : En, Es, Fr & De
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Handbook on the Toxicology of Metals, Fifth Edition, Volume I: General Considerations is the first volume of a two-volume work that gives an overview and reviews topics of general importance including reviews of various health effects of trace metals. The book emphasizes toxic effects in humans, along with discussions on the toxic effects of animals and biological systems in vitro when relevant. The book has been systematically updated with the latest studies and advances in technology and contains several new chapters. As a multidisciplinary resource that integrates both human and environmental toxicology, the book is a comprehensive and valuable reference for toxicologists, physicians, pharmacologists, and environmental scientists in the fields of environmental, occupational and public health. Contains peer-reviewed chapters that deal with the effects of metallic elements and their compounds on biological systems Includes information on sources, transport and the transformation of metals in the environment Covers the ecological effects of metals to provide a basis for better understanding of the potential for adverse effects on human health Provides critical information on the properties, use, biological monitoring, dose-response relationships, diagnosis, treatment and prevention of metallic elements and compounds

Toxicology and Risk Assessment

Toxicology and Risk Assessment
A Comprehensive Introduction

by Helmut Greim,Robert Snyder

  • Publisher : John Wiley & Sons
  • Release : 2018-08-10
  • Pages : 840
  • ISBN : 1119135923
  • Language : En, Es, Fr & De
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Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.

Handbook of Toxicology, Second Edition

Handbook of Toxicology, Second Edition
A Book

by Michael J. Derelanko,Mannfred A. Hollinger

  • Publisher : CRC Press
  • Release : 2001-08-29
  • Pages : 1440
  • ISBN : 9780849303708
  • Language : En, Es, Fr & De
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LOCATE FREQUENTLY USED INFORMATION EASILY AND QUICKLY Working in the laboratory or office, you use a diverse assortment of basic information to design, conduct, and interpret toxicology studies and to perform risk assessments. The Second Edition of the best-selling Handbook of Toxicology gives you the information you need in a single reference source. NEW IN THIS EDITION: Expanded coverage of inhalation toxicology, neurotoxicology, and histopathology Additional regulatory chapters dealing with pesticides, medical devices, consumer products, and world-wide notification of new chemicals Areas of toxicology missing from the first edition such as ecotoxicology and in vitro toxicology A chapter providing extensive overview of the toxicology of metals Two chapters on basic male and female endocrinology and related toxicology Information on differences in physiological and biochemical parameters between children and adults References to Web site sources of valuable information Over 200 new tables and figures THE SINGLE SOURCE FOR THE INFORMATION YOU USE MOST FREQUENTLY Updated and expanded, this unique book includes practical reference information useful to toxicologists in the chemical and pharmaceutical industries, contract laboratories, regulatory agencies, and academia. To help you find information quickly and easily, data is arranged by toxicology subspecialty and each chapter begins with a detailed listing of information presented. Containing over 700 tables and figures, Handbook of Toxicology, Second Edition gives you a single source for the information you use most often.

Principles and Methods of Toxicology, Fifth Edition

Principles and Methods of Toxicology, Fifth Edition
A Book

by A. Wallace Hayes

  • Publisher : CRC Press
  • Release : 2007-09-25
  • Pages : 2296
  • ISBN : 1420005421
  • Language : En, Es, Fr & De
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Founded on the paradox that all things are poisons and the difference between poison and remedy is quantity, the determination of safe dosage forms the base and focus of modern toxicology. In order to make a sound determination there must be a working knowledge of the biologic mechanisms involved and of the methods employed to define these mechanisms. While the vastness of the field and the rapid accumulation of data may preclude the possibility of absorbing and retaining more than a fraction of the available information, a solid understanding of the underlying principles is essential. Extensively revised and updated with four new chapters and an expanded glossary, this fifth edition of the classic text, Principles and Methods of Toxicology provides comprehensive coverage in a manageable and accessible format. New topics include 'toxicopanomics', plant and animal poisons, information resources, and non-animal testing alternatives. Emphasizing the cornerstones of toxicology-people differ, dose matters, and things change, the book begins with a review of the history of toxicology and followed by an explanation of basic toxicological principles, agents that cause toxicity, target organ toxicity, and toxicological testing methods including many of the test protocols required to meet regulatory needs worldwide. The book examines each method or procedure from the standpoint of technique and interpretation of data and discusses problems and pitfalls that may be associated with each. The addition of several new authors allow for a broader and more diverse treatment of the ever-changing and expanding field of toxicology. Maintaining the high-quality information and organizational framework that made the previous editions so successful, Principles and Methods of Toxicology, Fifth Edition continues to be a valuable resource for the advanced practitioner as well as the new disciple of toxicology.

Stem Cells in Toxicology and Medicine

Stem Cells in Toxicology and Medicine
A Book

by Saura C. Sahu

  • Publisher : John Wiley & Sons
  • Release : 2016-10-13
  • Pages : 560
  • ISBN : 1119135427
  • Language : En, Es, Fr & De
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A comprehensive and authoritative compilation of up-to-date developments in stem cell research and its use in toxicology and medicine Presented by internationally recognized investigators in this exciting field of scientific research Provides an insight into the current trends and future directions of research in this rapidly developing new field A valuable and excellent source of authoritative and up-to-date information for researchers, toxicologists, drug industry, risk assessors and regulators in academia, industry and government

Practical Toxicology

Practical Toxicology
Evaluation, Prediction, and Risk, Third Edition

by David Woolley,Adam Woolley

  • Publisher : CRC Press
  • Release : 2017-03-16
  • Pages : 528
  • ISBN : 149870932X
  • Language : En, Es, Fr & De
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Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future. New Chapters in the Third Edition: Toxicology in silico Errors in Toxicology Safety Assessment of Extractables and Leachables. This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world. Completely revised and written in an easily accessible style, the text address several audiences—from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.

Hayes' Principles and Methods of Toxicology

Hayes' Principles and Methods of Toxicology
A Book

by A. Wallace Hayes,Claire L. Kruger

  • Publisher : CRC Press
  • Release : 2014-10-10
  • Pages : 2184
  • ISBN : 1842145371
  • Language : En, Es, Fr & De
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Hayes' Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chap

Carbon Nanotubes

Carbon Nanotubes
Angels or Demons?

by Silvana Fiorito

  • Publisher : CRC Press
  • Release : 2019-04-30
  • Pages : 164
  • ISBN : 0429533608
  • Language : En, Es, Fr & De
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The field of C-nanoparticles toxicity is, at present, fragmented and contradictory, oscillating between enthusiastic raptures and bitter disappointments. This important book presents an overall, unitary view of the carbon nanoparticle world, in which both the positive and negative aspects of these recently discovered nanomaterials are critically de

Silver Nanoparticles for Antibacterial Devices

Silver Nanoparticles for Antibacterial Devices
Biocompatibility and Toxicity

by Huiliang Cao

  • Publisher : CRC Press
  • Release : 2017-05-18
  • Pages : 464
  • ISBN : 1315353474
  • Language : En, Es, Fr & De
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Since the potential toxicity of silver nanoparticles (Ag NPs) has raised serious concerns in the biomaterials and biomedical engineering community, Silver Nanoparticles for Antibacterial Devices: Biocompatibility and Toxicity brings together the synthesis, the physicochemical properties and the biological actions of Ag NPs, as well as the clinical demands for fabricating antibacterial medical devices, discussing how to suppress the side effects of nanomaterials and how to impart to them the selective toxicity. This book presents the two primary paradigms that have emerged in probing the antibacterial applications of Ag NPs, i.e. the active attacking releasing way and the conservative defending approach by taking advantage of various short-range actions; it shows readers how the ways in which Ag NPs have behaved can be engineered purposively. With contributions from leading international experts and extensive references listed in each chapter, this volume provides the general principles on controlling the physicochemical behaviors of nanomaterials and managing their toxicity risks.