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Biological Evaluation Of Medical Devices Part 12 Sample Preparation And Reference Materials
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Book Synopsis Biological evaluation of medical devices. Part 12, Sample preparation and reference materials. Amendment 1 (ISO 10993-12:2021/DAM 1:2024) by :
Download or read book Biological evaluation of medical devices. Part 12, Sample preparation and reference materials. Amendment 1 (ISO 10993-12:2021/DAM 1:2024) written by and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Book Synopsis GB, GB/T, GBT - Product Catalog. Translated English of Chinese Standard (All national standards GB, GB/T, GBT, GBZ) by : https://www.chinesestandard.net
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.
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
Book Synopsis 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 by : https://www.chinesestandard.net
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).
Book Synopsis YY/T 1465.6-2019 Translated English of Chinese Standard (YY/T 1465.6-2019, YYT1465.6-2019) by : https://www.chinesestandard.net
Download or read book YY/T 1465.6-2019 Translated English of Chinese Standard (YY/T 1465.6-2019, YYT1465.6-2019) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2024-03-20 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Part of YY/T 1465 specifies the method for the determination of animal spleen lymphocyte subsets by flow cytometry. This Part is applicable to the evaluation of immune responses induced by medical devices / materials.
Book Synopsis YY 0719.7-2011 Translated English of Chinese Standard. YY0719.7-2011 by : https://www.chinesestandard.net
Download or read book YY 0719.7-2011 Translated English of Chinese Standard. YY0719.7-2011 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2021-01-10 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: This part of YY 0719 specifies the biological test methods for contact lens care products. This part applies to contact lens care products.
Book Synopsis The Minipig in Biomedical Research by : Peter A. McAnulty
Download or read book The Minipig in Biomedical Research written by Peter A. McAnulty and published by CRC Press. This book was released on 2011-12-19 with total page 713 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors’ global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig’s origins, anatomy, genetics, immunology, and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. Regulatory aspects of its use are considered. The reader will find an extensive amount of theoretical and practical information in the pharmacology; ADME and toxicology chapters which will help scientists and managers when deciding which species to use in basic research; drug discovery and pharmacology; and toxicology studies of chemicals, biotechnology products and devices. The book discusses regulatory uses of minipigs in the evaluation of human and veterinary pharmaceuticals, medical devices, and other classes of xenobiotics. It describes features of normal health, normal laboratory values, and common diseases. It also carefully elucidates ethical and legal considerations in their supply, housing, and transport. The result is an all-inclusive and up to date manual about the experimental uses of the minipig that describes ‘How to’ and ‘Why’ and ’What to expect in the normal’, combining enthusiasm and experience with critical assessment of its values and potential problems.
Book Synopsis Biological Performance of Materials by : Jonathan Black
Download or read book Biological Performance of Materials written by Jonathan Black and published by CRC Press. This book was released on 1999-07-21 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: A balanced approach to understanding the response of living tissues and systems to manufactured biomaterials and the effect of life processes on the properties and behaviour of successful and unsuccessful biomaterials. This third edition contains a glossary of specialized terms; discussion of the emerging area of tissue engineering; more sources; and more tables to additional generic biomaterials properties.
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
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 1224 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.
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.
Book Synopsis Bio and Nano Packaging Techniques for Electron Devices by : Gerald Gerlach
Download or read book Bio and Nano Packaging Techniques for Electron Devices written by Gerald Gerlach and published by Springer Science & Business Media. This book was released on 2012-07-16 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses future trends and developments in electron device packaging and the opportunities of nano and bio techniques as future solutions. It describes the effect of nano-sized particles and cell-based approaches for packaging solutions with their diverse requirements. It offers a comprehensive overview of nano particles and nano composites and their application as packaging functions in electron devices. The importance and challenges of three-dimensional design and computer modeling in nano packaging is discussed; also ways for implementation are described. Solutions for unconventional packaging solutions for metallizations and functionalized surfaces as well as new packaging technologies with high potential for industrial applications are discussed. The book brings together a comprehensive overview of nano scale components and systems comprising electronic, mechanical and optical structures and serves as important reference for industrial and academic researchers.
Book Synopsis Integrated Safety and Risk Assessment for Medical Devices and Combination Products by : Shayne C. Gad
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.
Book Synopsis Bio-Nanotechnology by : Manashi Bagchi
Download or read book Bio-Nanotechnology written by Manashi Bagchi and published by John Wiley & Sons. This book was released on 2012-11-26 with total page 1118 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bio-nanotechnology is the key functional technology of the 21st century. It is a fusion of biology and nanotechnology based on the principles and chemical pathways of living organisms, and refers to the functional applications of biomolecules in nanotechnology. It encompasses the study, creation, and illumination of the connections between structural molecular biology, nutrition and nanotechnology, since the development of techniques of nanotechnology might be guided by studying the structure and function of the natural nano-molecules found in living cells. Biology offers a window into the most sophisticated collection of functional nanostructures that exists. This book is a comprehensive review of the state of the art in bio-nanotechnology with an emphasis on the diverse applications in food and nutrition sciences, biomedicine, agriculture and other fields. It describes in detail the currently available methods and contains numerous references to the primary literature, making this the perfect “field guide” for scientists who want to explore the fascinating world of bio-nanotechnology. Safety issues regarding these new technologies are examined in detail. The book is divided into nine sections – an introductory section, plus: Nanotechnology in nutrition and medicine Nanotechnology, health and food technology applications Nanotechnology and other versatile applications Nanomaterial manufacturing Applications of microscopy and magnetic resonance in nanotechnology Applications in enhancing bioavailability and controlling pathogens Safety, toxicology and regulatory aspects Future directions of bio-nanotechnology The book will be of interest to a diverse range of readers in industry, research and academia, including biologists, biochemists, food scientists, nutritionists and health professionals.
Book Synopsis YY/T 0811-2021 Translated English of Chinese Standard (YY/T 0811-2021, YYT0811-2021) by : https://www.chinesestandard.net
Download or read book YY/T 0811-2021 Translated English of Chinese Standard (YY/T 0811-2021, YYT0811-2021) written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2023-09-10 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Standard specifies relevant requirements and test methods for irradiation-crosslinked (extensively crosslinked) ultra-high molecular weight polyethylene fabricated (UHMWPE) forms for surgical implant applications. This Standard is applicable to pure resin powder required by GB/T 19701.1 or extensively irradiation-crosslinked UHMWPE products produced by molding compounds required by GB/T 19701.2. This Standard is only applicable to UHMWPE products that have been extensively irradiated by ?? rays and electron beam ionizing radiation sources. This Standard does not apply to UHMWPE that has only been treated with gas plasma, ethylene oxide or ionizing radiation with a dose of less than 40kGy, that is, materials that have undergone routine sterilization only. NOTE 1: The exact relationship between the mechanical properties of the above articles and the in vivo performance has not been established. Although scientists are devoted to the study of the relationship between polymer structure, polymer properties and polymer design, the above relationship has not been satisfactorily explained.
Book Synopsis Testing Tribocorrosion of Passivating Materials Supporting Research and Industrial Innovation by : Jean-Pierre Celis
Download or read book Testing Tribocorrosion of Passivating Materials Supporting Research and Industrial Innovation written by Jean-Pierre Celis and published by Routledge. This book was released on 2017-07-05 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first edition of Testing Tribocorrosion of Passivating Materials Supporting Research and Industrial Innovation: A Handbook treats in a clear, concise, and practical manner an important material degradation and protection matter. It is designed as a handbook and provides a well structured approach of the basics needed to investigate the tribocorrosion behavior of passivating materials, and to conduct in a correct way a laboratory investigation on it. It provides answers on practical and theoretical approaches of tribocorrosion phenomena to engineers and medical persons involved with material assemblies subjected to aggressive environmental and mechanical conditions. For academic researchers it is a pertinent tool assisting them in how they can perform a tribocorrosion investigation and obtain results that are correctly interpreted and can be exchanged. Different parts of the book are illustrated with practical examples. This handbook is truly an indispensable guide for every professional who comes into contact with the complex material degradation and protection processes that take place under combined corrosion and wear conditions. Fields of interest include: transportation (aeronautics, maritime, rail, automotive), medical implants (orthopaedics, dentistry), biochemistry, food production, energy production, and machining. The coordination of this handbook writing was done by Professor Jean-Pierre Celis (Katholieke Universiteit Leuven, Belgium) and Professor Pierre Ponthiaux (Ecole Centrale Paris, France) assisted by twelve European experts who contributed jointly to the nine chapters of this handbook. Main topics dealt with are tribocorrosion phenomena in medical and industrial sectors, depassivation and repassivation phenomena, impact on synergism in tribocorrosion, specific testing techniques, coupling tribology-to-corrosion, design of a testing protocol, and normalisation.
