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Une En 147912017
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Download or read book Medical Devices written by and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: decisions on the use of a medical device in the context of any particular clinical procedure; or business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971-- Scope, page 1.
Book Synopsis Structural Glycobiology by : Elizabeth Yuriev
Download or read book Structural Glycobiology written by Elizabeth Yuriev and published by CRC Press. This book was released on 2012-09-27 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: Structural Glycobiology covers the experimental, theoretical, and alternative technologies used in the study of the structural basis for the diverse biological roles of carbohydrates. The book overviews the application of specialized technologies to the study of carbohydrates in biology, reviews relevant and current research in the field, and is illustrated throughout by specific examples of how research investigations have yielded key structural and associated biological data on carbohydrates and glycolipids. In particular, the book focuses on: X-ray crystallography and small-angle scattering, NMR, and cryo-electron microscopy techniques Theoretical (modeling-based) approaches, such as molecular mechanics, molecular dynamics, free energy calculations, and carbohydrate docking Alternative techniques for yielding structural information on carbohydrates from complex biological samples Carbohydrates in medicine, specifically in areas that have been directly impacted by our understanding of the structural role of carbohydrates in immune recognition: cancer, organ transplantation, and infection
Book Synopsis Carbohydrate-based Vaccines by : René Roy
Download or read book Carbohydrate-based Vaccines written by René Roy and published by ACS Symposium. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first of its kind entirely dedicated to carbohydrate vaccines written by renowned scientists with expertise in carbohydrate chemistry and immunochemistry. It covers the synthesis of carbohydrate antigens related to bacteria and parasites such as: Heamophilus influenza, Streptococcus pnemoniae, Shigella flexneri, Candida albicans, Mycobacterium tuberculosis, and Chlamydia. The first three chapters are of wide interest as they cover fundamental concerns in new vaccine developments. The first one presents the immune system and how carbohydrate antigens are processed before protective antibodies are produced. It also illustrates antigen presentation in the context of major histocompatibility complexes (MHCs). The second chapter describes regulatory issues when carbohydrate vaccines are involved while the third one discuss several techniques used in conjugation chemistry and the implication of certain chemical linkages that may induce unexpected anti-linker antibodies. This section will be particularly appealing for those involved in drug-conjugate design, pro-drug developments, and drug vectorization. The book concludes with one chapter that illustrates the principle through which peptide antigens can functionally mimic carbohydrate epitopes, thus, unraveling the potential for peptide surrogates as replacement for complex carbohydrate structures. This book is unique in that it covers all aspects related to carbohydrate vaccines including the success story with the first semi-synthetic bacterial polysaccharide vaccine against Heamophilus influenza type b responsible for pneumonia and meningitis, liable for more than 600,000 infant deaths worldwide in developing countries. The book also presents regulatory issues and will thus be vital for government agencies approving candidate vaccines. It widely covers synthetic methodologies for the attachment of carbohydrate antigens to peptides and immunogenic protein carriers. Vaccines against bacterial antigens, cancer, and parasites are also discussed by worldwide experts in this field in details. No other book contains such a wide panel of different expertise. It will also be useful to students and researchers involved with the immunology of forreings antigens and how the under appreciated carbohydrate antigens are processed by the immune system.
Download or read book Glycoimmunology written by Azita Alavi and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proceedings of the Third Jenner International Glycoimmunology meeting held in Il Ciocco, Tuscany, Italy, October 11-14, 1994
Book Synopsis Synthetic Oligosaccharides by : Pavol Kováč
Download or read book Synthetic Oligosaccharides written by Pavol Kováč and published by . This book was released on 1994 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews the use of synthetic oligosaccharides in biochemistry, immunology, pharmaceutical and medicinal chemistry. Presents strategies for synthesis of complex oligosaccharides. Discusses the mechanisms of interaction between carbohydrates and biologically important proteins, such as enzymes, immunoglobulins, and receptor proteins. Valuable reading for biochemists, immunologists, pharmaceutical chemists, organic synthetic chemists, pharmacologists, and researchers in the life sciences.
Book Synopsis Sustainable Organic Synthesis by : Dr Stefano Protti
Download or read book Sustainable Organic Synthesis written by Dr Stefano Protti and published by Royal Society of Chemistry. This book was released on 2021-10-29 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent years have seen huge growth in the area of sustainable chemistry. In order to meet the chemical needs of the global population whilst minimising impacts on health and the environment it is essential to keep reconsidering and improving synthetic processes. Sustainable Organic Synthesis is a comprehensive collection of contributions, provided by specialists in Green Chemistry, covering topics ranging from catalytic approaches to benign and alternative reaction media, and innovative and more efficient technologies.
Book Synopsis Structural Steel I and H Sections. Tolerances on Shape and Dimensions by : British Standards Institute Staff
Download or read book Structural Steel I and H Sections. Tolerances on Shape and Dimensions written by British Standards Institute Staff and published by . This book was released on 1993-12-15 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: Steels, Structural steels, Metal sections, Dimensions, Straightness measurement, Beams, H-beams, I-beams, Sections (structures), Structural members, Dimensional tolerances, Form tolerances
Book Synopsis Protein Glycosylation: Cellular, Biotechnological and Analytical Aspects by : Harald S. Conradt
Download or read book Protein Glycosylation: Cellular, Biotechnological and Analytical Aspects written by Harald S. Conradt and published by Wiley-Blackwell. This book was released on 1991-08-28 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recombinant DNA technology has enabled the efficient production of large quantities of many biologically important glycoproteins by expression in heterologuous mammalian cell lines. In such quantities these glycoproteins can be used not only in basic research but also - after manufacturing by biotechnological means - for commercial purposes. A recent GBF workshop (Braunschweig, Germany, June 1990) was devoted to this highly significant field. In 39 contributions world-leading experts give a state-of-the-art description ranging from basic research reports to perspectives of practical applications. Pharmaceutical companies involved in the production of clinically important glycoproteins (such as immune-modulators, differentiation factors, hormones and receptors) will find this book indispensable. Researchers from industrial laboratories with an emphasis on biotechnology will also find the book invaluable for their daily work.
Book Synopsis Definition and Classification of Grades of Steel by : British Standards Institution
Download or read book Definition and Classification of Grades of Steel written by British Standards Institution and published by . This book was released on 1991 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
