Ophthalmic Implants Intraocular Lenses Fundamental Requirements

Lenses, Ophthalmic equipment, Ophthalmology, Eyes, Implants (surgical)

This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).

This document provides the comprehensive list of Chinese Industry Standards - Category: YY; YY/T; YYT.

Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for ‘X’, and incorporating standards and design controls Discusses topics that prepare students for careers in medical device design or other related medical fields

This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2008.

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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;}

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.