Download or read book Medical Electrical Equipment written by and published by . This book was released on 2020 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: "IEC 60601-1-6 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, e.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documentd in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, assoicated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specifiy general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366."--Techstreet.com.
Download or read book Medical Electrical Equipment Part 1 6 General Requirements for Basic Safety and Essential Performance Collateral Standard Usability written by Polska. Polski Komitet Normalizacyjny and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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.
Download or read book CE MARKING 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 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
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:
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.
Download or read book Medical Electrical Equipment written by SABS Standards Division and published by . This book was released on 2021 with total page 15 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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 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.
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.
Download or read book World Congress on Medical Physics and Biomedical Engineering 2018 written by Lenka Lhotska and published by Springer. This book was released on 2018-05-29 with total page 894 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book (vol. 1) presents the proceedings of the IUPESM World Congress on Biomedical Engineering and Medical Physics, a triennially organized joint meeting of medical physicists, biomedical engineers and adjoining health care professionals. Besides the purely scientific and technological topics, the 2018 Congress will also focus on other aspects of professional involvement in health care, such as education and training, accreditation and certification, health technology assessment and patient safety. The IUPESM meeting is an important forum for medical physicists and biomedical engineers in medicine and healthcare learn and share knowledge, and discuss the latest research outcomes and technological advancements as well as new ideas in both medical physics and biomedical engineering field.
Download or read book Coronary Stents Technical Compendium written by KIHT and published by KALAM INSTITUTE OF HEALTH TECHNOLOGY. This book was released on with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: The main objective of this product dossier is to cover the entire spectrum pertaining to coronary stents. This dossier explains the clinical need, requirements, working principle, detailed technical aspects to enlighten the criticality of the product at the component level and provide a glimpse on relevant standards and regulations to ensure the safety, integrity, and function. The report highlights the market figures and EXIM analysis information which will provide insight into the commercial aspects and demand of the product in the Indian scenario.
