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Author :
Publisher :
ISBN 13 : 9781570203961
Total Pages : 0 pages
Book Rating : 4.2/5 (39 download)
Download or read book Biological Evaluation of Medical Devices - Part 13 written by and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Association for the Advancement of Medical Instrumentation
Publisher :
ISBN 13 : 9781570201370
Total Pages : 18 pages
Book Rating : 4.2/5 (13 download)
Download or read book Biological Evaluation of Medical Devices written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 1999-03 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Polska. Polski Komitet Normalizacyjny
Publisher :
ISBN 13 : 9788371907296
Total Pages : 13 pages
Book Rating : 4.9/5 (72 download)
Download or read book Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices written by Polska. Polski Komitet Normalizacyjny and published by . This book was released on 2002 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
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ISBN 13 :
Total Pages : 14 pages
Book Rating : 4.:/5 (15 download)
Download or read book Biological Evaluation of Medical Devices written by and published by . This book was released on 2017 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Malaysia. Jabatan Standard
Publisher :
ISBN 13 :
Total Pages : 10 pages
Book Rating : 4.:/5 (848 download)
Download or read book Biological Evaluation of Medical Devices written by Malaysia. Jabatan Standard and published by . This book was released on 2005 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Association for the Advancement of Medical Instrumentation
Publisher :
ISBN 13 : 9781570201370
Total Pages : 0 pages
Book Rating : 4.2/5 (13 download)
Download or read book Biological Evaluation of Medical Devices written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 1999-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book DR 02209 CPBiological Evaluation of Medical Devices - Part 13 written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580577192
Total Pages : 28 pages
Book Rating : 4.5/5 (771 download)
Download or read book Biological Evaluation of Medical Devices. Identification and Quantification of Degradation Products from Polymeric Medical Devices written by British Standards Institute Staff and published by . This book was released on 1910-10-31 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Biological analysis and testing, Biology, Degradation, Accelerated testing, Deterioration, Decomposition reactions, Polymers, Chemical analysis and testing, Quantitative analysis, Identification methods, Testing conditions
Author : International Organization for Standardization
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)
Download or read book Biological Evaluation of Medical Devices written by International Organization for Standardization and published by . This book was released on 1998 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Prakash Srinivasan Timiri Shanmugam
Publisher : Elsevier
ISBN 13 : 0323984924
Total Pages : 264 pages
Book Rating : 4.3/5 (239 download)
Download or read book Biocompatibility Protocols for Medical Devices and Materials written by Prakash Srinivasan Timiri Shanmugam and published by Elsevier. This book was released on 2023-04-07 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility Protocols for Medical Devices and Materials provides comprehensive coverage of the basic science and toxicological testing protocols necessary for the risk assessment and safety analysis of medical devices and materials which are based on the ISO guidelines for body contact and duration of contact. The book begins with device/component selection for toxicological experiments and provides an introduction to topics such as sensitization, irritation tests, material-mediated pyrogenicity, and bacterial-mediated pyrogenicity. Toxicology-related chapters explain the protocols for cytotoxicity, acute systemic toxicity, repeated-exposure systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity testing. Biocompatibility Protocols for Medical Devices and Materials is a practical guide that provides step-by-step toxicological protocols ranging from materials selection to data interpretation for toxicologists, biomedical researchers, healthcare professionals, product developers, and others working in risk assessment and safety analysis of medical devices. Explains the biocompatibility test protocols for medical devices Provides an overview about chemical characterization Describes toxicokinetic, carcinogenicity, and reproductive toxicity studies Discusses the basic points needed to leverage the data from another device
Author : Wolfgang Ecker
Publisher : BoD – Books on Demand
ISBN 13 : 3754384848
Total Pages : 346 pages
Book Rating : 4.7/5 (543 download)
Download or read book Medical Devices and IVDs written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 2022-03-25 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges!
Author : International Organization for Standardization
Publisher :
ISBN 13 :
Total Pages : 9 pages
Book Rating : 4.:/5 (644 download)
Download or read book Biological Evaluation of Medical Devices written by International Organization for Standardization and published by . This book was released on 2009 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : International Organization for Standardization
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.3/5 (91 download)
Download or read book Biological Evaluation of Medical Devices written by International Organization for Standardization and published by . This book was released on 2001 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 586 pages
Book Rating : 4.0/5 (81 download)
Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Woodhead Publishing. This book was released on 2019-11-21 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Author : Rommel Garcia
Publisher : Xlibris Corporation
ISBN 13 : 1524589209
Total Pages : 403 pages
Book Rating : 4.5/5 (245 download)
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.
Author : Tugrul Özel
Publisher : John Wiley & Sons
ISBN 13 : 1119267048
Total Pages : 225 pages
Book Rating : 4.1/5 (192 download)
Download or read book Biomedical Devices written by Tugrul Özel and published by John Wiley & Sons. This book was released on 2016-09-12 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source
Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 1441974490
Total Pages : 135 pages
Book Rating : 4.4/5 (419 download)
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
