Biological Evaluation Of Medical Devices Part 13 Identification And Quantification Of Degradation Products From Polymeric Medical Devices

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Biocompatibility and Performance of Medical Devices

Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 592 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand

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

Biocompatibility Protocols for Medical Devices and Materials

Author : Prakash Srinivasan Timiri Shanmugam
Publisher : Elsevier
ISBN 13 : 0323984924
Total Pages : 264 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Biocompatibility Protocols for Medical Devices and Materials by : Prakash Srinivasan Timiri Shanmugam

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

Bio-Implant Interface

Author : J.E. Ellingsen
Publisher : CRC Press
ISBN 13 : 0203491432
Total Pages : 467 pages
Book Rating : 4.2/5 (34 download)

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Book Synopsis Bio-Implant Interface by : J.E. Ellingsen

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

Medical Devices and IVDs

Author : Wolfgang Ecker
Publisher : BoD – Books on Demand
ISBN 13 : 3754385399
Total Pages : 346 pages
Book Rating : 4.7/5 (543 download)

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Book Synopsis Medical Devices and IVDs by : Wolfgang Ecker

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

Medical Device

Author : Rommel Garcia
Publisher : Xlibris Corporation
ISBN 13 : 1524589209
Total Pages : 403 pages
Book Rating : 4.5/5 (245 download)

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Book Synopsis Medical Device by : Rommel Garcia

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.

Fundamentals of BioMEMS and Medical Microdevices

Author : Steven Saliterman
Publisher : SPIE Press
ISBN 13 : 9780819459770
Total Pages : 644 pages
Book Rating : 4.4/5 (597 download)

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Book Synopsis Fundamentals of BioMEMS and Medical Microdevices by : Steven Saliterman

Download or read book Fundamentals of BioMEMS and Medical Microdevices written by Steven Saliterman and published by SPIE Press. This book was released on 2006 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is on the threshold of a revolution that will change medicine and how patients are treated forever. Bringing together the creative talents of electrical, mechanical, optical and chemical engineers, materials specialists, clinical-laboratory scientists, and physicians, the science of biomedical microelectromechanical systems (bioMEMS) promises to deliver sensitive, selective, fast, low cost, less invasive, and more robust methods for diagnostics, individualized treatment, and novel drug delivery. This book is an introduction to this multidisciplinary technology and the current state of micromedical devices in use today. The first text of its kind dedicated to bioMEMS training. Fundamentals of BioMEMS and Medical Microdevices is Suitable for a single semester course for senior and graduate-level students, or as an introduction to others interested or already working in the field.

Toxicologic Pathology

Author : Pritam S. Sahota
Publisher : CRC Press
ISBN 13 : 0429997450
Total Pages : 1776 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Toxicologic Pathology by : Pritam S. Sahota

Download or read book Toxicologic Pathology written by Pritam S. Sahota and published by CRC Press. This book was released on 2018-08-14 with total page 1776 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.

Safety Evaluation of Pharmaceuticals and Medical Devices

Author : Shayne C. Gad
Publisher : Springer Science & Business Media
ISBN 13 : 1441974490
Total Pages : 135 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Safety Evaluation of Pharmaceuticals and Medical Devices by : Shayne C. Gad

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.

Medical Textiles from Natural Resources

Author : Md. Ibrahim H. Mondal
Publisher : Woodhead Publishing
ISBN 13 : 0323904807
Total Pages : 936 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Medical Textiles from Natural Resources by : Md. Ibrahim H. Mondal

Download or read book Medical Textiles from Natural Resources written by Md. Ibrahim H. Mondal and published by Woodhead Publishing. This book was released on 2022-06-15 with total page 936 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Textiles from Natural Resources provides systematic and comprehensive coverage of the fundamentals, production methods, processing techniques, characterization techniques, properties and applications of medical textile materials from natural resources. Medical textiles offer a variety of technical and functional properties valued in medical and healthcare sectors, often relating to hygiene. As medical textile products remain in close contact with the human body, the fibre must have characteristics such as biological compatibility, biological degradability, permeability and nontoxicity. Only materials from natural renewable sources have such characteristics. This book provides the latest information on a wide range of medical applications, from single suture and wound dressings, to implants and tissue scaffolds. It also offers a systematic review of the manufacture, properties and applications of technical textiles for medical use. - Explains the latest technologies related to fibre extraction from natural sources, chemical treatments, weave constructions, fabric finishes and coatings. - Describes innovative applications of nanomaterials in the treatment of textile fabric and the utilization of carbohydrate polymers in the preparation of nanoparticles deposited in nonwoven fabrics. - Helps product designers to find appropriate materials from natural resources with the characteristics of biodegradability, renewability, biocompatibility and nontoxicity.

GB, GB/T, GBT Chinese Standard(English-translated version) - Catalog002

Author : CODEOFCHINA - Dr. Meng Yongye
Publisher : Codeofchina Inc.
ISBN 13 :
Total Pages : 3871 pages
Book Rating : 4./5 ( download)

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Book Synopsis GB, GB/T, GBT Chinese Standard(English-translated version) - Catalog002 by : CODEOFCHINA - Dr. Meng Yongye

Download or read book GB, GB/T, GBT Chinese Standard(English-translated version) - Catalog002 written by CODEOFCHINA - Dr. Meng Yongye and published by Codeofchina Inc.. This book was released on 2018-05-04 with total page 3871 pages. Available in PDF, EPUB and Kindle. Book excerpt: All English-translated Chinese codes are available at: www.codeofchina.com

List of English-translated Chinese standards 2001

Author : https://www.codeofchina.com
Publisher : https://www.codeofchina.com
ISBN 13 :
Total Pages : 182 pages
Book Rating : 4./5 ( download)

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Book Synopsis List of English-translated Chinese standards 2001 by : https://www.codeofchina.com

Download or read book List of English-translated Chinese standards 2001 written by https://www.codeofchina.com and published by https://www.codeofchina.com. This book was released on with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: HTTPS://WWW.CODEOFCHINA.COM EMAIL:[email protected] "Codeofchina Inc., a part of TransForyou (Beijing) Translation Co., Ltd., is a professional Chinese code translator in China. Now, Codeofchina Inc. is running a professional Chinese code website, www.codeofchina.com. Through this website, Codeofchina Inc. provides English-translated Chinese codes to clients worldwide. About TransForyou TransForyou (Beijing) Translation Co., Ltd., established in 2003, is a reliable language service provider for clients at home and abroad. Since our establishment, TransForyou has been aiming to build up a translation brand with our professional dedicated service. Currently, TransForyou is the director of China Association of Engineering Construction Standardization (CECS); the committeeman of Localization Service Committee / Translators Association of China (TAC) and the member of Boya Translation Culture Salon (BTCS); and the field study center of the University of the University of International Business & Economics (UIBE) and Hebei University (HU). In 2016, TransForyou ranked 27th among Asian Language Service Providers by Common Sense Advisory. "

Federal Register

Author :
Publisher :
ISBN 13 :
Total Pages : 426 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Federal Register by :

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:

Applications of Polyurethanes in Medical Devices

Author : Ajay Padsalgikar
Publisher : William Andrew
ISBN 13 : 0128231688
Total Pages : 283 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Applications of Polyurethanes in Medical Devices by : Ajay Padsalgikar

Download or read book Applications of Polyurethanes in Medical Devices written by Ajay Padsalgikar and published by William Andrew. This book was released on 2022-05-19 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Applications of Polyurethanes in Medical Devices provides detailed coverage of polyurethane (PU) chemistry, processing and preparation for performant medical devices. Polyurethanes have found many uses in medical applications, due to their biocompatibility, biostability, physical properties, surface polarity, and the ability to suit the field of application. This book enables the reader to understand polyurethane and how this valuable material can be used in medical devices. Sections cover the chemistry, structure, and properties of polyurethane, with in-depth sections examining raw materials, reaction chemistry, synthesis techniques, reaction kinetics, material microstructure, and structure-property relationships. Subsequent chapters demonstrate how polyurethane can be utilized in medical device applications, examining biological properties, rheology and processing before methodical coverage explains how polyurethane may be used for each category of medical device. Finally, future directions, and safety and environmental aspects, are covered. - Bridges the gap between polyurethane chemistry, processing and preparation for cutting-edge medical device applications - Includes in-depth coverage of polyurethane, covering raw materials, chemistry, synthesis techniques, reaction kinetics, properties and microstructural analysis - Takes a valuable and practical approach, addressing manufacturing issues and using testing and modeling to solve problems encountered in processing

Handbook of Biomaterials Biocompatibility

Author : Masoud Mozafari
Publisher : Woodhead Publishing
ISBN 13 : 0081029683
Total Pages : 759 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Handbook of Biomaterials Biocompatibility by : Masoud Mozafari

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

Biodegradable Systems in Tissue Engineering and Regenerative Medicine

Author : Rui L. Reis
Publisher : CRC Press
ISBN 13 : 1135494428
Total Pages : 920 pages
Book Rating : 4.1/5 (354 download)

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Book Synopsis Biodegradable Systems in Tissue Engineering and Regenerative Medicine by : Rui L. Reis

Download or read book Biodegradable Systems in Tissue Engineering and Regenerative Medicine written by Rui L. Reis and published by CRC Press. This book was released on 2004-11-29 with total page 920 pages. Available in PDF, EPUB and Kindle. Book excerpt: Conventional materials technology has yielded clear improvements in regenerative medicine. Ideally, however, a replacement material should mimic the living tissue mechanically, chemically, biologically and functionally. The use of tissue-engineered products based on novel biodegradable polymeric systems will lead to dramatic improvements in health

Biomedical Devices

Author : Tugrul Özel
Publisher : John Wiley & Sons
ISBN 13 : 1119267048
Total Pages : 225 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Biomedical Devices by : Tugrul Özel

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

Plastics in Medical Devices

Author : Vinny R. Sastri
Publisher : Elsevier
ISBN 13 : 081552028X
Total Pages : 289 pages
Book Rating : 4.8/5 (155 download)

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Book Synopsis Plastics in Medical Devices by : Vinny R. Sastri

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.