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Author: Norbert Leitgeb
Publisher: Springer Science & Business Media
ISBN: 3211996834
Category : Technology & Engineering
Languages : en
Pages : 235
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Book Description
Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.
Author: Norbert Leitgeb
Publisher: Springer Science & Business Media
ISBN: 3211996834
Category : Technology & Engineering
Languages : en
Pages : 235
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Book Description
Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.
Author: International Electrotechnical Commission
Publisher:
ISBN: 9782831876955
Category : Electromagnetic compatibility
Languages : en
Pages : 103
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Book Description
Author: Rommel Garcia
Publisher: Xlibris Corporation
ISBN: 1524589209
Category : Medical
Languages : en
Pages : 403
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Book Description
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
Author: Hans-Robert Metelmann
Publisher: Springer
ISBN: 331967627X
Category : Medical
Languages : en
Pages : 512
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Book Description
This book presents the state of the art in clinical plasma medicine and outlines translational research strategies. Written by an international group of authors, it is divided into four parts. Part I is a detailed introduction and includes basic and recent research information on plasma sciences, plasma devices and mechanisms of biological plasma effects. Parts II and III provide valuable clinical insights f.e. into the treatment of superficial contaminations, ulcerations, wounds, treatment of cells in cancer, special indications like in heart surgery, dentistry, palliative treatment in head and neck cancer or the use of plasma in hygiene. Part IV offers information on how and where to qualify in plasma medicine and which companies produce and supply medical devices and is thus of particular interest to medical practitioners. This comprehensive book offers a sciences based practical to the clinical use of plasma and includes an extended selection of scientific medical data and translational literature.
Author: CHETAN KATHALAY
Publisher: CHETAN KATHALAY
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 157
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Book Description
Buy CE marking book in India.This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.
Author: Ray Tricker
Publisher: Elsevier
ISBN: 0080505813
Category : Technology & Engineering
Languages : en
Pages : 409
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Book Description
Environmental Requirements for Electromechanical and Electrical Equipment is the definitive reference containing all of the background guidance, typical ranges, details of recommended test specifications, case studies and regulations covering the environmental requirements on designers and manufacturers of electrical and electromechanical equipment worldwide. The recent introduction of the European EMC directive is just one aspect of the requirements placed upon manufacturers and designers of electrical equipment. There are numerous national and international standards and specifications that describe the application environment in which equipment must function. Factors that must be taken into account include temperature, solar radiation, humidity, pressure, weather and the effects of water and salt, pollutants and contaminants, mechanical stresses and vibration, ergonomic considerations, electrical safety including EMC, reliability and performance. A broad range of standard tests exist which must be passed by equipment if it is to fulfil the requirements placed upon it. Ray Tricker is the author of a number of books describing the regulatory framework within which the electronics and electrical equipment industry must function, including Quality and Standards in Electronics, also published by Newnes. This latest volume will give the designer or manufacturer a first point of reference when negotiating the minefield that is the global market for their products. - Companion to 'Quality and Standards in Electronics' - Covers essential tests and regulations for equipment designers and manufacturers - Likely to be of interest to major companies worldwide
Author: Gennadi Saiko
Publisher: CRC Press
ISBN: 1000632180
Category : Medical
Languages : en
Pages : 274
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Book Description
Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.
Author: Kim Fowler
Publisher: Newnes
ISBN: 0080942555
Category : Technology & Engineering
Languages : en
Pages : 593
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Book Description
This handbook provides a consolidated, comprehensive information resource for engineers working with mission and safety critical systems. Principles, regulations, and processes common to all critical design projects are introduced in the opening chapters. Expert contributors then offer development models, process templates, and documentation guidelines from their own core critical applications fields: medical, aerospace, and military. Readers will gain in-depth knowledge of how to avoid common pitfalls and meet even the strictest certification standards. Particular emphasis is placed on best practices, design tradeoffs, and testing procedures. - Comprehensive coverage of all key concerns for designers of critical systems including standards compliance, verification and validation, and design tradeoffs - Real-world case studies contained within these pages provide insight from experience
Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 426
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Book Description
Author: Derek Clements-Croome
Publisher: Taylor & Francis
ISBN: 9780415316569
Category : Buildings
Languages : en
Pages : 572
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Book Description
Electromagnetic Environments and Health in Buildings brings together the work of an international group of specialists in this fragmented subject area. The book covers health effects of electromagnetic fields, emission standards and offers some
