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Medical Electrical Equipment General Requirements For Basic Safety And Essential Performance Collateral Standard Usability
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Book Synopsis Safety of Electromedical Devices by : Norbert Leitgeb
Download or read book Safety of Electromedical Devices written by Norbert Leitgeb and published by Springer Science & Business Media. This book was released on 2010-05-06 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device written by Rommel Garcia and published by Xlibris Corporation. This book was released on 2017-06-06 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Technical Specifications for Oxygen Concentrators by : World Health Organization
Download or read book Technical Specifications for Oxygen Concentrators written by World Health Organization and published by World Health Organization. This book was released on 2016-10-25 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this guidance document is for the appropriate selection procurement utilization and maintenance of oxygen concentrators. This document also focuses on recommendations for the appropriate use and maintenance of oxygen concentrators in an effort to increase the availability management and quality of oxygen concentrators and ultimately to improve health outcomes in LRS. This document is intended to serve as a resource for the planning and provision of local and national oxygen concentrator systems for use by administrators clinicians and technicians who are interested in improving access to oxygen therapy and reducing global mortality associated with hypoxaemia.
Author : Publisher :IOS Press ISBN 13 : Total Pages :6097 pages Book Rating :4./5 ( download)
Download or read book written by and published by IOS Press. This book was released on with total page 6097 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis CE MARKING BOOK -OF ELECTRICAL AND ELECTRONIC PRODUCTS by : CHETAN KATHALAY
Download or read book CE MARKING BOOK -OF ELECTRICAL AND ELECTRONIC PRODUCTS written by CHETAN KATHALAY and published by CHETAN KATHALAY. This book was released on 2020-06-03 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Medical and Care Compunetics 4 by : Lodewijk Bos
Download or read book Medical and Care Compunetics 4 written by Lodewijk Bos and published by IOS Press. This book was released on 2007 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: The role of the International Council on Medical and Care Compunetics (ICMCC) with regards to patient-related ICT has become obvious with the start of the Record Access Portal. This work aims to come forward with a recommendation to the WHO on Record Access.
Book Synopsis Electrical Product Compliance and Safety Engineering by : Steli Loznen
Download or read book Electrical Product Compliance and Safety Engineering written by Steli Loznen and published by Artech House. This book was released on 2017-05-31 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive resource is designed to guide professionals in product compliance and safety in order to develop more profitable products, contribute to customer satisfaction, and reduce the risk of liability. This book analyzes the principles and methods of critical standards, highlighting how they should be applied in the field. It explores the philosophy of electrical product safety and analyzes the concepts of compliance and safety, perception of risk, failure, normal and abnormal conditions, and redundancy. Professionals find valuable information on power sources, product construction requirements, markings, compliance testing, and manufacturing of safe electrical products.
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Neurorehabilitation Technology by : David J. Reinkensmeyer
Download or read book Neurorehabilitation Technology written by David J. Reinkensmeyer and published by Springer. This book was released on 2016-08-03 with total page 647 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised, updated second edition provides an accessible, practical overview of major areas of technical development and clinical application in the field of neurorehabilitation movement therapy. The initial section provides a rationale for technology application in movement therapy by summarizing recent findings in neuroplasticity and motor learning. The following section then explains the state of the art in human-machine interaction requirements for clinical rehabilitation practice. Subsequent sections describe the ongoing revolution in robotic therapy for upper extremity movement and for walking, and then describe other emerging technologies including electrical stimulation, virtual reality, wearable sensors, and brain-computer interfaces. The promises and limitations of these technologies in neurorehabilitation are discussed. Throughout the book the chapters provide detailed practical information on state-of-the-art clinical applications of these devices following stroke, spinal cord injury, and other neurologic disorders. The text is illustrated throughout with photographs and schematic diagrams which serve to clarify the information for the reader. Neurorehabilitation Technology, Second Edition is a valuable resource for neurologists, biomedical engineers, roboticists, rehabilitation specialists, physiotherapists, occupational therapists and those training in these fields.
Book Synopsis Bringing a Medical Device to the Market by : Gennadi Saiko
Download or read book Bringing a Medical Device to the Market written by Gennadi Saiko and published by CRC Press. This book was released on 2022-09-29 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Introduction to Biomedical Engineering Technology by : Laurence J. Street
Download or read book Introduction to Biomedical Engineering Technology written by Laurence J. Street and published by CRC Press. This book was released on 2016-09-19 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition provides major revisions to a text that is suitable for the introduction to biomedical engineering technology course offered in a number of technical institutes and colleges in Canada and the US. Each chapter has been thoroughly updated with new photos and illustrations which depict the most modern equipment available in medical technology. This third edition includes new problem sets and examples, detailed block diagrams and schematics and new chapters on device technologies and information technology.
Book Synopsis Medical Instrument Design and Development by : Claudio Becchetti
Download or read book Medical Instrument Design and Development written by Claudio Becchetti and published by John Wiley & Sons. This book was released on 2013-07-29 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification Explains how to use theory to implement a market product (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book) Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.
Book Synopsis The ASQ Certified Medical Device Auditor Handbook by : Scott A Laman
Download or read book The ASQ Certified Medical Device Auditor Handbook written by Scott A Laman and published by Quality Press. This book was released on 2021-02-05 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques
Book Synopsis Human-Machine Interface by : Rishabha Malviya
Download or read book Human-Machine Interface written by Rishabha Malviya and published by John Wiley & Sons. This book was released on 2023-11-21 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: HUMAN-MACHINE INTERFACE The book contains the latest advances in healthcare and presents them in the frame of the Human-Machine Interface (HMI). The Human-Machine Interface (HMI) industry has witnessed the evolution from a simple push button to a modern touch-screen display. HMI is a user interface that allows humans to operate controllers for machines, systems, or instruments. Most medical procedures are improved by HMI systems, from calling an ambulance to ensuring that a patient receives adequate treatment on time. This book describes the scenario of biomedical technologies in the context of the advanced HMI, with a focus on direct brain-computer connection. The book describes several HMI tools and related techniques for analyzing, creating, controlling, and upgrading healthcare delivery systems, and provides details regarding how advancements in technology, particularly HMI, ensure ethical and fair use in patient care. Audience The target audience for this book is medical personnel and policymakers in healthcare and pharmaceutical professionals, as well as engineers and researchers in computer science and artificial intelligence.
Download or read book Medical Devices written by Carlo Boccato and published by Springer Nature. This book was released on 2022-02-24 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Book Synopsis Usability Testing of Medical Devices by : Michael E. Wiklund, P.E.
Download or read book Usability Testing of Medical Devices written by Michael E. Wiklund, P.E. and published by CRC Press. This book was released on 2015-12-23 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h
Book Synopsis Human Factors in Healthcare by : Avi Parush
Download or read book Human Factors in Healthcare written by Avi Parush and published by Springer Nature. This book was released on 2022-05-31 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
