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Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications Evaluation And Testing Within A Risk Management Process
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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 Inspection of Medical Devices by : Almir Badnjević
Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer. This book was released on 2017-10-26 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
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
Book Synopsis WHO compendium of innovative health technologies for low-resource settings 2022 by : World Health Organization
Download or read book WHO compendium of innovative health technologies for low-resource settings 2022 written by World Health Organization and published by World Health Organization. This book was released on 2022-06-06 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Anesthesia Workstation Technical Compendium by : KIHT
Download or read book Anesthesia Workstation Technical Compendium written by KIHT and published by KALAM INSTITUTE OF HEALTH TECHNOLOGY. This book was released on 2020-04-16 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: The main objective of this product dossier is to give global industry insights, trends, outlook, and opportunity analysis, with a focus on the Indian market. In addition, it explains the clinical aspects, requirements, and principles to understand the need and working of the equipment. The detailed technical aspects shed light on the criticality of the product at the component level and provide a glimpse of the relevant standards and patents. This report is also equipped with market figures and EXIM analysis information, which will provide a good insight into the commercial aspects and demand of the product in the Indian scenario.
Book Synopsis Biodegradable Polymers by : Joanna Rydz
Download or read book Biodegradable Polymers written by Joanna Rydz and published by CRC Press. This book was released on 2023-07-17 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studying (bio)degradable polymers value chain can help one understand the importance of these to the environment and human health. This book provides an overview of the biodegradable polymer along the value chain, identifies and analyses existing practices for biodegradable plastics and assess the relevant legal, regulatory, economic and practical reasons for the importance of proper use and proper recycling of biodegradable plastics. It covers related materials development, environmental impacts, their synthesis by traditional and biotechnological routes, policy and certification, manufacturing processes, (bio)degradable polymer properties and so forth. Features: Gives a clear idea of the present state of the art and future trends in the research of the biodegradable polymers in the context of circular economy Describes the entire value chain and life cycle of bioplastics are covered, considering different types of polymers Clarifies the life safety of (bio)degradable polymeric materials Presents novel opportunities and ideas for developing or improving technologies Determines the course of degradation during prediction study This book is aimed at researchers, graduate students and professionals in the polymer processing industry (petrochemical polymer industry, industry producing bio-based and (bio)degradable polymers), food packaging industry, industry involved in waste management, pharma industry, chemical engineering, product engineering and biotechnology.
Book Synopsis Health Technologies and Innovations to Effectively Respond to the COVID-19 Pandemic by : Björn Wolfgang Schuller
Download or read book Health Technologies and Innovations to Effectively Respond to the COVID-19 Pandemic written by Björn Wolfgang Schuller and published by Frontiers Media SA. This book was released on 2022-03-10 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Biological Evaluation of Medical Devices by :
Download or read book Biological Evaluation of Medical Devices written by and published by . This book was released on 2018 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Toxicity Testing in the 21st Century by : National Research Council
Download or read book Toxicity Testing in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2007-10-05 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.
Book Synopsis WHO Guidelines for Indoor Air Quality by :
Download or read book WHO Guidelines for Indoor Air Quality written by and published by World Health Organization. This book was released on 2010 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents WHO guidelines for the protection of public health from risks due to a number of chemicals commonly present in indoor air. The substances considered in this review, i.e. benzene, carbon monoxide, formaldehyde, naphthalene, nitrogen dioxide, polycyclic aromatic hydrocarbons (especially benzo[a]pyrene), radon, trichloroethylene and tetrachloroethylene, have indoor sources, are known in respect of their hazardousness to health and are often found indoors in concentrations of health concern. The guidelines are targeted at public health professionals involved in preventing health risks of environmental exposures, as well as specialists and authorities involved in the design and use of buildings, indoor materials and products. They provide a scientific basis for legally enforceable standards.
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Book Synopsis Piezoelectric Energy Harvesting by : Alper Erturk
Download or read book Piezoelectric Energy Harvesting written by Alper Erturk and published by John Wiley & Sons. This book was released on 2011-04-04 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The transformation of vibrations into electric energy through the use of piezoelectric devices is an exciting and rapidly developing area of research with a widening range of applications constantly materialising. With Piezoelectric Energy Harvesting, world-leading researchers provide a timely and comprehensive coverage of the electromechanical modelling and applications of piezoelectric energy harvesters. They present principal modelling approaches, synthesizing fundamental material related to mechanical, aerospace, civil, electrical and materials engineering disciplines for vibration-based energy harvesting using piezoelectric transduction. Piezoelectric Energy Harvesting provides the first comprehensive treatment of distributed-parameter electromechanical modelling for piezoelectric energy harvesting with extensive case studies including experimental validations, and is the first book to address modelling of various forms of excitation in piezoelectric energy harvesting, ranging from airflow excitation to moving loads, thus ensuring its relevance to engineers in fields as disparate as aerospace engineering and civil engineering. Coverage includes: Analytical and approximate analytical distributed-parameter electromechanical models with illustrative theoretical case studies as well as extensive experimental validations Several problems of piezoelectric energy harvesting ranging from simple harmonic excitation to random vibrations Details of introducing and modelling piezoelectric coupling for various problems Modelling and exploiting nonlinear dynamics for performance enhancement, supported with experimental verifications Applications ranging from moving load excitation of slender bridges to airflow excitation of aeroelastic sections A review of standard nonlinear energy harvesting circuits with modelling aspects.
Book Synopsis Respiratory Protective Equipment at Work by : Great Britain, Health and Safety Executive Staff
Download or read book Respiratory Protective Equipment at Work written by Great Britain, Health and Safety Executive Staff and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition provides guidance on why respiratory protective equipment (RPE) should be used, what the law says and how to select RPE that is adequate and suitable. It also includes a useful dos and don'ts list for the management and supervision of RPE use.The guidance is aimed principally at employers and the self-employed who wear, or are responsible for workers who wear, RPE. It will also be useful for health and safety specialists, manufacturers and suppliers of RPE.It has been prepared in consultation with industry and updates the 2005 edition
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 Password Book: Include Alphabetical Index with Cute Flowers Seamless by : Shamrock Logbook
Download or read book Password Book: Include Alphabetical Index with Cute Flowers Seamless written by Shamrock Logbook and published by Independently Published. This book was released on 2019-02-15 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organize all your website account logins and passwords. No need to use Post-it notes or scraps of paper. This notebook contains more 300 places to store your password. The notebook contains spaces for website address, user name, email, password.
Book Synopsis Measuring Oxidants and Oxidative Stress in Biological Systems by : Lawrence J. Berliner
Download or read book Measuring Oxidants and Oxidative Stress in Biological Systems written by Lawrence J. Berliner and published by Springer Nature. This book was released on 2020-08-08 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the methods of analysis and determination of oxidants and oxidative stress in biological systems. Reviews and protocols on select methods of analysis of ROS, RNS, oxygen, redox status, and oxidative stress in biological systems are described in detail. It is an essential resource for both novices and experts in the field of oxidant and oxidative stress biology.
Book Synopsis Toxicological Profile for Copper by :
Download or read book Toxicological Profile for Copper written by and published by . This book was released on 2004 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
