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Toxicological Aspects Of Medical Device Implants

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Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-06-10
ISBN : 0128209208
Language : En, Es, Fr & De

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Book Description :

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

Biological Safety European Medical Device Regulations

Biological Safety   European Medical Device Regulations Book
Author : Anonim
Publisher : Quality First International
Release : 2021-10-24
ISBN : 1903757002
Language : En, Es, Fr & De

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Book Description :

Download Biological Safety European Medical Device Regulations book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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 Book
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Release : 2008-10-20
ISBN : 1439809488
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Release : 2019-11-21
ISBN : 0081026447
Language : En, Es, Fr & De

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Book Description :

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

Polymer Additive Analytics

Polymer Additive Analytics Book
Author : Jan C. J. Bart
Publisher : Firenze University Press
Release : 2006
ISBN : 8884533791
Language : En, Es, Fr & De

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Book Description :

Download Polymer Additive Analytics book written by Jan C. J. Bart, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products Book
Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Release : 2015-12-01
ISBN : 1482248387
Language : En, Es, Fr & De

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Book Description :

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

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

Biological Evaluation of Medical Devices  Tests for Genotoxicity  Carcinogenicity and Reproductive Toxicity Book
Author : Bristish Standards Institution,British Standards Institute Staff
Publisher : Unknown
Release : 2009-06-30
ISBN : 9780580656651
Language : En, Es, Fr & De

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Book Description :

Medical equipment, Biological analysis and testing, Medical instruments, Dental equipment, Implants (surgical), Biological hazards, Toxic materials, Toxicity, Genotoxicity tests, Cytotoxicity tests, Reproductive system

Polymers in Medical Applications

Polymers in Medical Applications Book
Author : B.J. Lambert,F.-W. Tang,W. J. Rogers
Publisher : iSmithers Rapra Publishing
Release : 2001
ISBN : 9781859572597
Language : En, Es, Fr & De

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Book Description :

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.

Silver in Healthcare

Silver in Healthcare Book
Author : Alan B. G. Lansdown
Publisher : Royal Society of Chemistry
Release : 2010-05-07
ISBN : 1849731799
Language : En, Es, Fr & De

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Book Description :

Silver in healthcare has many different facets and since the early concepts of microbiology of the 1880's, has been developed from usage in surgical clips, staples, foil wound dressings and surgical implants, to the widespread and clinically effective antiseptic wound dressings, sutures, catheters, bone and dental implants, and cardiovascular devices of today. From the dawn of human civilisation, silver has had a role of water purification and even now has a role in hospital water systems for control of MRSA and legionnaires disease. Biotechnological advances in recent years have extended the antimicrobial properties of silver into production of hygiene textiles and use in domestic products. Important advances have been made in understanding mechanisms of antimicrobial action of silver, the central importance of ionisation patterns in the presence of body fluids and secretion, and the genetical and molecular profiles of silver resistance. This publication is a comprehensive account of the history of silver in medicine, its clinical benefits and wide advantages as a broad spectrum antimicrobial agent. It is clear from the extensive array of publications in recognised and unofficial press, that many misconceptions and misleading conceptions have been perpetuated, leading to errors in evaluation of the safety of the metal in occupational, domestic and therapeutic situations. The book is unique in that it is the only comprehensive presentation of the toxicology of silver and it identifies the major misconceptions in the safety of silver and interpretation of argyria and argyrosis as central features of silver toxicity. In this book, Dr Lansdown reviews the literature from a clinical and experimental viewpoint, with the benefit of his many years research on silver and experience gained in working with clinicians, healthcare product manufacturers and microbiologists. There is also discussion in the book on the relevance of antimicrobial resistance to silver and deficiencies in present day clinical practice in not evaluating incidences of resistance on a routine basis. The subject matter is presented in a readable fashion and includes reference to use of the metal in such practices as acupuncture and treatment of tropical diseases as practised in some parts of the world, each of which is accompanied by special clinical risk. It is also a collation of current views on the use and efficacy of silver as a broad spectrum antibiotic. The chapters which deal specifically with toxicological aspects of silver in clinical, occupational and environmental issues are central to the book's value. The book is aimed at clinicians, research scientists and product manufacturers and will provide ideas for new research and academic endeavour. It is also essential reading for research students with an interest in metal toxicity and its management in mammalian tissues.

Trends in Development of Medical Devices

Trends in Development of Medical Devices Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-01-25
ISBN : 0128209615
Language : En, Es, Fr & De

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Book Description :

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 book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Handbook on the Toxicology of Metals

Handbook on the Toxicology of Metals Book
Author : Gunnar F. Nordberg,Bruce A. Fowler,Monica Nordberg
Publisher : Academic Press
Release : 2014-08-07
ISBN : 0123973392
Language : En, Es, Fr & De

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Book Description :

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

Safety of Silicone Breast Implants

Safety of Silicone Breast Implants Book
Author : Institute of Medicine,Committee on the Safety of Silicone Breast Implants
Publisher : National Academies Press
Release : 2000-02-06
ISBN : 0309157404
Language : En, Es, Fr & De

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Book Description :

The Dow Corning case raised serious questions about the safety of silicone breast implants and about larger issues of medical device testing and patient education. Safety of Silicone Breast Implants presents a well-documented, thoughtful exploration of the safety of these devices, drawing conclusions from the available research base and suggesting further questions to be answered. This book also examines the sensitive issues surrounding women's decisions about implants. In reaching conclusions, the committee reviews: The history of the silicone breast implant and the development of its chemistry. The wide variety of U.S.-made implants and their regulation by the Food and Drug Administration. Frequency and consequences of local complications from implants. The evidence for and against links between implants and autoimmune disorders, connective tissue disease, neurological problems, silicone in breast milk, or a proposed new syndrome. Evidence that implants may be associated with lower frequencies of breast cancer. Safety of Silicone Breast Implants provides a comprehensive, well-organized review of the science behind one of the most significant medical controversies of our time.

Toxicology and Risk Assessment

Toxicology and Risk Assessment Book
Author : Helmut Greim,Robert Snyder
Publisher : John Wiley & Sons
Release : 2018-08-10
ISBN : 1119135923
Language : En, Es, Fr & De

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Book Description :

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.

Regulatory Toxicology Second Edition

Regulatory Toxicology  Second Edition Book
Author : Shayne C. Gad
Publisher : CRC Press
Release : 2001-07-19
ISBN : 9781420025187
Language : En, Es, Fr & De

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Book Description :

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.

Silver Nanoparticles for Antibacterial Devices

Silver Nanoparticles for Antibacterial Devices Book
Author : Huiliang Cao
Publisher : CRC Press
Release : 2017-05-18
ISBN : 1315353474
Language : En, Es, Fr & De

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Book Description :

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.

Handbook of Toxicology Second Edition

Handbook of Toxicology  Second Edition Book
Author : Michael J. Derelanko,Mannfred A. Hollinger
Publisher : CRC Press
Release : 2001-08-29
ISBN : 9780849303708
Language : En, Es, Fr & De

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Book Description :

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.

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework Book
Author : Beth Ann Fiedler
Publisher : Elsevier
Release : 2016-09-10
ISBN : 0128041927
Language : En, Es, Fr & De

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Book Description :

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, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Carbon Nanotubes

Carbon Nanotubes Book
Author : Silvana Fiorito
Publisher : CRC Press
Release : 2019-04-30
ISBN : 0429533608
Language : En, Es, Fr & De

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Book Description :

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

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products Book
Author : Shayne C. Gad
Publisher : Springer Nature
Release : 2020-02-24
ISBN : 3030352412
Language : En, Es, Fr & De

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Book Description :

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 combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Practical Toxicology

Practical Toxicology Book
Author : David Woolley,Adam Woolley
Publisher : CRC Press
Release : 2017-03-16
ISBN : 149870932X
Language : En, Es, Fr & De

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Book Description :

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.