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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: 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: 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: 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:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 426
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Book Description
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: Mark Van Helvoort
Publisher: CRC Press
ISBN: 1351645668
Category : Technology & Engineering
Languages : en
Pages : 276
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Book Description
The integration of electronics in large systems and installations steadily increases, consider for example the emergence of the Industrial Internet of Things. Power consumption decreases while the operating speed increases making equipment potentially more vulnerable for interference. The responsibility of the installer is shifting towards that of the system integrator, requiring more in-depth knowledge to achieve and maintain EMC during the technical and economical lifespan of the system or installation and the distinction between both diminishes. EMC for Installers: Electromagnetic Compatibility of Systems and Installations combines an integral risk based approached to EMC design and management with robust technical measures. Written by two experts, who both started nearly three decades ago in EMC, it provides guidance to those new in the field and servers as reference to those with experience. The book starts with the basic concept of EMC and evolves gradually towards more difficult topics. Particular attention is given to grounding concepts and the protection of cabling and wiring. This book puts a strong focus on passive means that are widely available for each installer: cable conduits used for cable routing can be exploited for significant improvement of the EMC-behavior of the system or installation. In addition, it will be explained how to use standard metallic enclosures to enhance the EMC-performance. For most demanding situations shielded rooms and shielding cabinets are explained. This book describes pre-compliance and full-compliance testing tailored to large systems. Templates and checklists are provided for both risk and management and test management. Electromagnetic compatibility explained as simple as possible, without over-simplifying. Practical approach, with hands-on demonstrations based on an example installation. Learn how to exploit cable conduits, used for cable routing anyway, to improve the EMC performance of an installation. Learn how to exploit standard metallic enclosures to improve EMC in systems. Design of power distribution networks to minimize disturbing fields. Toolbox and templates for managing and sustaining EMC over a long lifetime.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 137
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Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2005.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 14
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Book Description
This Standard specifies terms and definitions, product classification, technical requirements, test methods for electrical surgical equipment for osseous tissue. This Standard is applicable to electrical surgical equipment for osseous tissue powered by network power supply.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 20
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Book Description
This Standard specifies the terms and definitions, classification, composition, requirements and test methods of X-ray equipment for computed tomography (CT scanner). This Standard is applicable to CT scanner, including CT scanner which provides image data for radiation treatment planning.
