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Author : British Standards Institute Staff
Publisher : Unknown
Page : 26 pages
File Size : 40,7 Mb
Release : 1913-09-30
Category : Electronic
ISBN : 0580938778
Medical instruments, Medical equipment, Ophthalmic test equipment, Ophthalmic equipment, Contact lenses, Ophthalmology, Implants (surgical), Surgical equipment
Author : Joyce Tombran-Tink,Colin J. Barnstable,Joseph F. Rizzo
Publisher : Springer Science & Business Media
Page : 276 pages
File Size : 40,8 Mb
Release : 2007-12-08
Category : Medical
ISBN : 9781597454490
This volume details the latest technology in treating eye injuries and infections. It provides insight into the most up-to-date and established treatment options. The volume focuses on what can currently be achieved with a variety of ocular prostheses as well as what the future holds. Coverage reviews issues such as intraocular lens implants, biocompatibility of materials, retinal implants, testing models, and software designs.
Author : Seshadri Neervannan,Uday B. Kompella
Publisher : Springer Nature
Page : 650 pages
File Size : 50,6 Mb
Release : 2022-03-11
Category : Medical
ISBN : 9783030763671
This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:"Calibri",sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}
Author : British Standards Institute Staff
Publisher : Unknown
Page : 10 pages
File Size : 53,7 Mb
Release : 2000-07
Category : Electronic
ISBN : 0580343278
Lenses, Ophthalmic equipment, Ophthalmology, Eyes, Implants (surgical)
Author : Shayne C. Gad
Publisher : Springer Nature
Page : 490 pages
File Size : 46,8 Mb
Release : 2020-02-24
Category : Medical
ISBN : 9783030352417
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 : J.W. Kuo
Publisher : CRC Press
Page : 240 pages
File Size : 43,7 Mb
Release : 2005-09-23
Category : Medical
ISBN : 9781420037647
The ballooning body of research devoted to hyaluronan (HA) reflects its enormous potential for various medical applications. There have been many successes of varying degrees in the development of medical products based on HA, but also some setbacks. While there is obviously ample information available on the chemistry and various properties of this macromolecule, Practical Aspects of Hyaluronan Based Medical Products is the first book devoted to systematically applying this knowledge to product development. Based on the author's extensive experience working with HA, this book explores in detail the chemistry, composition, formulation, testing, safety, effectiveness, quality control, and regulatory approval of HA medical products. It begins with a survey of the historical development and recent products based on hyaluronan. Subsequent chapters detail the rheological properties of the molecule and explore the chemical principles and methods forming the technical basis of product development, illustrated by more than 50 figures of chemical structures, reaction schemes, and rheological properties. Individual chapters then consider standards, tests, and analytical methods; safety of HA-based products for their indicated applications; and clinical performance, mechanism of action, and product characteristics. Practical Aspects of Hyaluronan Based Medical Products surveys FDA review documents as well as peer-reviewed journal articles to identify the elements essential to successful product development, namely, understanding the critical issues in the regulatory path and linking clinical performance of the products to their original design.
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Page : 586 pages
File Size : 44,8 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9780081026441
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 : Thomas Kohnen,Douglas D. Koch
Publisher : Springer Science & Business Media
Page : 332 pages
File Size : 54,9 Mb
Release : 2006-01-14
Category : Medical
ISBN : 9783540266785
-Cataract surgery is the most frequently performed surgical intervention worldwide, and the number of refractive surgery procedures, such as LASIK, is growing rapidly -All editors are internationally known experts in the field -Well structured text and design, quick and easy to read -Bridges the gap between primary literature and daily practice, indispensable for continuous education and advanced training -Every 2nd year each volume is updated to include timely information about new developments
Author : British Standards Institute Staff
Publisher : Unknown
Page : 42 pages
File Size : 44,7 Mb
Release : 1912-12-31
Category : Electronic
ISBN : 0580708802
Lenses, Ophthalmic equipment, Ophthalmology, Eyes, Implants (surgical), Mechanical properties of materials, Performance, Mechanical testing
Author : British Standards Institute Staff
Publisher : Unknown
Page : 32 pages
File Size : 42,6 Mb
Release : 2002-03
Category : Electronic
ISBN : 0580392090
Lenses, Ophthalmic equipment, Ophthalmology, Eyes, Implants (surgical), Diagnosis (medical), Clinical medicine, Medical inspection
Author : British Standards Institute Staff
Publisher : Unknown
Page : 28 pages
File Size : 47,8 Mb
Release : 1917-09-21
Category : Electronic
ISBN : 0580853438
Diagnosis (medical), Mechanical properties of materials, Modification, Implants (surgical), Design, Ophthalmology, Lenses, Clinical testing, Ophthalmic equipment
Author : British Standards Institute Staff
Publisher : Unknown
Page : 28 pages
File Size : 47,5 Mb
Release : 2006-09-29
Category : Electronic
ISBN : 0580825388
Ophthalmology, Lenses, Eyes, Optics, Ophthalmic equipment, Implants (surgical), Optical properties of materials, Diagnosis (medical), Clinical testing
Author : British Standards Institute Staff
Publisher : Unknown
Page : 26 pages
File Size : 41,8 Mb
Release : 2006-10-31
Category : Electronic
ISBN : 058082537X
Ophthalmology, Lenses, Eyes, Optics, Ophthalmic equipment, Implants (surgical), Performance, Optical properties of materials, Handbooks, Instructions for use, Clinical testing, Optical measurement
Author : British Standards Institute Staff
Publisher : Unknown
Page : 36 pages
File Size : 54,8 Mb
Release : 2006-06-30
Category : Electronic
ISBN : 058048582X
Ophthalmology, Lenses, Eyes, Optics, Ophthalmic equipment, Biocompatibility, Biological analysis and testing, Physical testing, Chemical analysis and testing
Author : Gerald McDonnell
Publisher : Lippincott Williams & Wilkins
Page : 2941 pages
File Size : 49,8 Mb
Release : 2020-06-26
Category : Medical
ISBN : 9781496381507
With more international contributors than ever before, Block’s Disinfection, Sterilization, and Preservation, 6th Edition, is the first new edition in nearly 20 years of the definitive technical manual for anyone involved in physical and chemical disinfection and sterilization methods. The book focuses on disease prevention—rather than eradication—and has been thoroughly updated with new information based on recent advances in the field and understanding of the risks, the technologies available, and the regulatory environments.