Download or read book Comprehensive Clinical Plasma Medicine written by Hans-Robert Metelmann and published by Springer. This book was released on 2018-05-04 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the state of the art in clinical plasma medicine and outlines translational research strategies. Written by an international group of authors, it is divided into four parts. Part I is a detailed introduction and includes basic and recent research information on plasma sciences, plasma devices and mechanisms of biological plasma effects. Parts II and III provide valuable clinical insights f.e. into the treatment of superficial contaminations, ulcerations, wounds, treatment of cells in cancer, special indications like in heart surgery, dentistry, palliative treatment in head and neck cancer or the use of plasma in hygiene. Part IV offers information on how and where to qualify in plasma medicine and which companies produce and supply medical devices and is thus of particular interest to medical practitioners. This comprehensive book offers a sciences based practical to the clinical use of plasma and includes an extended selection of scientific medical data and translational literature.

Download or read book Reclamation Safety and Health Standards written by and published by . This book was released on 2009 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Medical Device Use Error written by Michael Wiklund and published by CRC Press. This book was released on 2016-01-06 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors

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 Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Download or read book Handbook of Electroporation written by Damijan Miklavčič and published by Springer. This book was released on 2017-09-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This major reference work is a one-shot knowledge base on electroporation and the use of pulsed electric fields of high intensity and their use in biology, medicine, biotechnology, and food and environmental technologies. The Handbook offers a widespread and well-structured compilation of 156 chapters ranging from the foundations to applications in industry and hospital. It is edited and written by most prominent researchers in the field. With regular updates and growing in its volume it is suitable for academic readers and researchers regardless of their disciplinary expertise, and will also be accessible to students and serious general readers. The Handbook's 276 authors have established scholarly credentials and come from a wide range of disciplines. This is crucially important in a highly interdisciplinary field of electroporation and the use of pulsed electric fields of high intensity and its applications in different fields from medicine, biology, food processing, agriculture, process engineering, energy and environment. An Editorial Board of distinguished scholars from across the world has selected and reviewed the various chapters to ensure the highest quality of this Handbook. The book was edited by an international team of Section Editors: P. Thomas Vernier, Boris Rubinsky, Juergen Kolb, Damijan Miklavcic, Marie-Pierre Rols, Javier Raso, Richard Heller, Gregor Serša, Dietrich Knorr, and Eugene Vorobiev.

Download or read book WHO List of Priority Medical Devices for Cancer Management written by World Health Organization and published by . This book was released on 2017-05-09 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the model list and clearing house of appropriate, basic, and priority medical devices based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring, and end of life care. This publication addresses medical devices that can be used for the management of cancer and specifically describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung, and prostate. This book is intended for ministries of health, public health planners, health technology managers, disease management, researchers, policy makers, funding, and procurement agencies and support and advocacy groups for cancer patients.

Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer. This book was released on 2017-10-26 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.

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.

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Download or read book Chinese Standard GB GB T GBT JB JB T YY HJ NB HG QC SL SN SH JJF JJG CJ TB YD YS NY FZ JG QB SJ SY DL AQ CB GY JC JR JT written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 7263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).

Download or read book GB T 2021 GB 2021 Chinese National Standard PDF English Catalog year 2021 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-06-02 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2021.

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 Electrical Safety Handbook 3E written by John Cadick and published by McGraw Hill Professional. This book was released on 2005-10-19 with total page 621 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an accident-avoiding prescription for electricians, safety managers, and inspectors, and engineers dealing with electricity any voltage level. Presenting crucial protective safety strategies for industrial and commercial systems, the Handbook references all major safety codes (OSHA, NEC, NESC, and NFPA) where appropriate, creating a unique, one-stop compliance manual for any company’s electrical safety training and reference needs.

Download or read book ANSI AAMI St79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities written by Aami and published by Association for the Advancement of Medical Instrumentation (AAMI). This book was released on 2013-10-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization.

Download or read book GB GB T GBT Product Catalog Translated English of Chinese Standard All national standards GB GB T GBT GBZ written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 2809 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB; GB/T, GBT.