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Medical Electrical Equipment Part 1 2 General Requirements For Safety Collateral Standards Electromagnetic Compatibility Requirements And Tests Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Medical Electrical Equipment Part 1 2 General Requirements For Safety Collateral Standards Electromagnetic Compatibility Requirements And Tests book. This book definitely worth reading, it is an incredibly well-written.
Author : Canadian Standards Association,International Electrotechnical Commission,Standards Council of Canada
Publisher : Mississauga, Ont. : Canadian Standards Association
Page : 96 pages
File Size : 47,5 Mb
Release : 2003
Category : Electromagnetic compatibility
ISBN : 1553971760
Author : Norbert Leitgeb
Publisher : Springer Science & Business Media
Page : 235 pages
File Size : 45,6 Mb
Release : 2010-05-06
Category : Technology & Engineering
ISBN : 9783211996836
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,International Electrotechnical Commission. Technical Committee 62
Publisher : Unknown
Page : 103 pages
File Size : 49,6 Mb
Release : 2004
Category : Electromagnetic compatibility
ISBN : 2831876958
Author : Gennadi Saiko
Publisher : CRC Press
Page : 274 pages
File Size : 53,9 Mb
Release : 2022-09-29
Category : Medical
ISBN : 9781000632187
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 : CHETAN KATHALAY
Publisher : CHETAN KATHALAY
Page : 464 pages
File Size : 50,7 Mb
Release : 2020-06-03
Category : Technology & Engineering
ISBN : 8210379456XXX
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 : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
Page : 86 pages
File Size : 53,9 Mb
Release : 2018-01-01
Category : Technology & Engineering
ISBN : 8210379456XXX
This document provides the comprehensive list of Chinese Industry Standards - Category: YY; YY/T; YYT.
Author : Anonim
Publisher : Unknown
Page : 426 pages
File Size : 42,8 Mb
Release : 2014
Category : Delegated legislation
ISBN : UCR:31210024752576
Author : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
Page : 20 pages
File Size : 42,9 Mb
Release : 2017-01-17
Category : Medical
ISBN : 8210379456XXX
The clauses and subclauses of this section of the General Standard apply.
Author : Francis Hegarty,John Amoore,Paul Blackett,Justin McCarthy,Richard Scott
Publisher : CRC Press
Page : 595 pages
File Size : 50,5 Mb
Release : 2017-01-06
Category : Business & Economics
ISBN : 9781315354507
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 : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
Page : 272 pages
File Size : 54,9 Mb
Release : 2022-06-02
Category : Social Science
ISBN : 8210379456XXX
This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2021.
Author : Kim Fowler
Publisher : Newnes
Page : 592 pages
File Size : 55,6 Mb
Release : 2009-11-19
Category : Technology & Engineering
ISBN : 0080942555
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 : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
Page : 26 pages
File Size : 54,8 Mb
Release : 2016-07-29
Category : Medical
ISBN : 8210379456XXX
This Standard specifies the terms and conditions, system compositions, requirements and test methods of digital medical X-ray radiography system.
Author : Claudio Becchetti,Alessandro Neri
Publisher : John Wiley & Sons
Page : 612 pages
File Size : 50,9 Mb
Release : 2013-07-29
Category : Science
ISBN : 9781119952404
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.
Author : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
Page : 7291 pages
File Size : 55,9 Mb
Release : 2018-01-01
Category : Law
ISBN : 8210379456XXX
This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).
Author : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
Page : 16 pages
File Size : 48,5 Mb
Release : 2016-11-24
Category : Medical
ISBN : 8210379456XXX
This Standard specifies the definitions, classification and composition, requirements, test methods, inspection rules, marking, packaging, packaging and transportation. This Standard applies to the electroencephalographic biofeedback equipment.
