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Author : British Standards Institution
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.:/5 (132 download)
Download or read book Biological Evaluation of Medical Devices written by British Standards Institution and published by . This book was released on 2022 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580324987
Total Pages : 18 pages
Book Rating : 4.3/5 (249 download)
Download or read book Biological Evaluation of Medical Devices. Framework for Identification and Quantification of Potential Degradation Products written by British Standards Institute Staff and published by . This book was released on 1999-06 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Biological analysis and testing, Chemical analysis and testing, Biological hazards, Degradation, Biodegradability, Leaching, Deterioration, Migration (chemical), Design, Experimental design, Reports
Author : J.E. Ellingsen
Publisher : CRC Press
ISBN 13 : 0203491432
Total Pages : 467 pages
Book Rating : 4.2/5 (34 download)
Download or read book Bio-Implant Interface written by J.E. Ellingsen and published by CRC Press. This book was released on 2003-04-29 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: Achieving good clinical outcomes with implanted biomaterials depends upon achieving optimal function, both mechanical and biological, which in turn depends upon integrating advances realized in biological science, material science, and tissue engineering. As these advances push back the frontiers of biomaterial medicine , the control and patterning
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 592 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 592 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 :
Publisher :
ISBN 13 :
Total Pages : 426 pages
Book Rating : 4.3/5 (121 download)
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:
Author : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 221 pages
Book Rating : 4./5 ( download)
Download or read book GB/T-2022, GB-2022 -- Chinese National Standard PDF-English, Catalog (year 2022) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2022-06-02 with total page 221 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 2022.
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.
Author : Masoud Mozafari
Publisher : Woodhead Publishing
ISBN 13 : 0081029683
Total Pages : 759 pages
Book Rating : 4.0/5 (81 download)
Download or read book Handbook of Biomaterials Biocompatibility written by Masoud Mozafari and published by Woodhead Publishing. This book was released on 2020-06-17 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Biomaterials Biocompatibility is a systematic reference on host response to different biomaterials, taking into account their physical, mechanical and chemical properties. The book reviews recent progress in the design and study of biomaterials biocompatibility, along with current understanding on how to control immune system response. Sections provide the fundamental theories and challenges of biomaterials biocompatibility, the role of different biomaterials physicochemical surface properties on cell responses, cell responses to different physicochemical properties of polymers, ceramics, metals, carbons and nanomaterials, and biomaterials in different tissues, such as the cardiac, nervous system, cartilage and bone. This resource will be suitable for those working in the fields of materials science, regenerative engineering, medicine, medical devices and nanotechnology. - Reviews the fundamental theories and challenges of biomaterials biocompatibility, including an overview of the standards and regulations - Provides an overview on the cellular and molecular mechanisms involved in host responses to biomaterials - Systematically looks at cellular response and tissue response to a wide range of biomaterials, including polymers, metals, ceramics, alloys and nanomaterials
Author : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 2809 pages
Book Rating : 4./5 ( download)
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.
Author : Wolfgang Ecker
Publisher : BoD – Books on Demand
ISBN 13 : 3754385399
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! 344 pages; 47 col. figures; 26 tables
Author : Shayne C. Gad
Publisher : Springer Nature
ISBN 13 : 3030352412
Total Pages : 496 pages
Book Rating : 4.0/5 (33 download)
Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
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 : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 482 pages
Book Rating : 4./5 ( download)
Download or read book GB/T-2017, GB-2017 -- Chinese National Standard PDF-English, Catalog (year 2017) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2020-06-06 with total page 482 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 2017.
Author : https://www.chinesestandard.net
Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 92 pages
Book Rating : 4./5 ( download)
Download or read book GB/T-2001, GB-2001 -- Chinese National Standard PDF-English, Catalog (year 2001) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2020-06-06 with total page 92 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 2001.
Author : Theodore R. Kucklick
Publisher : CRC Press
ISBN 13 : 104007913X
Total Pages : 513 pages
Book Rating : 4.0/5 (4 download)
Download or read book The Medical Device R&D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer
Author : Vinny R. Sastri
Publisher : Elsevier
ISBN 13 : 081552028X
Total Pages : 289 pages
Book Rating : 4.8/5 (155 download)
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
