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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
Get Book Here
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:
Publisher: IOS Press
ISBN:
Category :
Languages : en
Pages : 6097
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Book Description
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: 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: Gaetano D. Gargiulo
Publisher: Springer Nature
ISBN: 9811653240
Category : Technology & Engineering
Languages : en
Pages : 298
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Book Description
This book discusses recent advances in wearable technologies and personal monitoring devices, covering topics such as skin contact-based wearables (electrodes), non-contact wearables, the Internet of things (IoT), and signal processing for wearable devices. Although it chiefly focuses on wearable devices and provides comprehensive descriptions of all the core principles of personal monitoring devices, the book also features a section on devices that are embedded in smart appliances/furniture, e.g. chairs, which, despite their limitations, have taken the concept of unobtrusiveness to the next level. Wearable and personal devices are the key to precision medicine, and the medical community is finally exploring the opportunities offered by long-term monitoring of physiological parameters that are collected during day-to-day life without the bias imposed by the clinical environment. Such data offers a prime view of individuals’ physical condition, as well as the efficacy of therapy and occurrence of events. Offering an in-depth analysis of the latest advances in smart and pervasive wearable devices, particularly those that are unobtrusive and invisible, and addressing topics not covered elsewhere, the book will appeal to medical practitioners and engineers alike.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 86
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Book Description
This document provides the comprehensive list of Chinese Industry Standards - Category: YY; YY/T; YYT.
Author: Francis Hegarty
Publisher: CRC Press
ISBN: 1498703550
Category : Business & Economics
Languages : en
Pages : 570
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Book Description
Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website.
Author: Val Theisz
Publisher: CRC Press
ISBN: 9814669113
Category : Medical
Languages : en
Pages : 578
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Book Description
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Author: Avi Parush
Publisher: Springer Nature
ISBN: 3031016025
Category : Science
Languages : en
Pages : 202
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Book Description
Have you ever experienced the burden of an adverse event or a near-miss in healthcare and wished there was a way to mitigate it? This book walks you through a classic adverse event as a case study and shows you how. It is a practical guide to continuously improving your healthcare environment, processes, tools, and ultimate outcomes, through the discipline of human factors. Using this book, you as a healthcare professional can improve patient safety and quality of care. Adverse events are a major concern in healthcare today. As the complexity of healthcare increases-with technological advances and information overload-the field of human factors offers practical approaches to understand the situation, mitigate risk, and improve outcomes. The first part of this book presents a human factors conceptual framework, and the second part offers a systematic, pragmatic approach. Both the framework and the approach are employed to analyze and understand healthcare situations, both proactively-for constant improvement-and reactively-learning from adverse events. This book guides healthcare professionals through the process of mapping the environmental and human factors; assessing them in relation to the tasks each person performs; recognizing how gaps in the fit between human capabilities and the demands of the task in the environment have a ripple effect that increases risk; and drawing conclusions about what types of changes facilitate improvement and mitigate risk, thereby contributing to improved healthcare outcomes.
Author: KIHT
Publisher: KALAM INSTITUTE OF HEALTH TECHNOLOGY
ISBN: 8193744691
Category : Technology & Engineering
Languages : en
Pages : 81
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Book Description
The main objective of this technical compendium is to cover the entire spectrum pertaining to a medical equipment called Hemodialysis machine. This report explains the clinical aspects, requirements, and principles to understand the working of the equipment. The detailed technical aspects shed light on the criticality of the product at a component level and provide the information about relevant standards and regulations. In addition, the report is also briefly touching upon the export & import analysis.
