Biological Evaluation Of Medical Devices Tests For Irritation And Skin Sensitization

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Biocompatibility and Performance of Medical Devices

Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
ISBN 13 : 0081026447
Total Pages : 592 pages
Book Rating : 4.0/5 (81 download)

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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

Medical Textile Materials

Author : Yimin Qin
Publisher : Woodhead Publishing
ISBN 13 : 0081006241
Total Pages : 266 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Medical Textile Materials by : Yimin Qin

Download or read book Medical Textile Materials written by Yimin Qin and published by Woodhead Publishing. This book was released on 2015-11-21 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Textile Materials provides the latest information on technical textiles and how they have found a wide range of medical applications, from wound dressings and sutures, to implants and tissue scaffolds. This book offers a systematic review of the manufacture, properties, and applications of these technical textiles. After a brief introduction to the human body, the book gives an overview of medical textile products and the processes used to manufacture them. Subsequent chapters cover superabsorbent textiles, functional wound dressings, bandages, sutures, implants, and other important medical textile technologies. Biocompatibility testing and regulatory control are then addressed, and the book finishes with a review of research and development strategy for medical textile products. - Provides systematic and comprehensive coverage of the manufacture, properties, and applications of medical textile materials - Covers recent developments in medical textiles, including antimicrobial dressings, drug-releasing materials, and superabsorbent textiles - Written by a highly knowledgeable author with extensive experience in industry and academia

Toxicity Testing in the 21st Century

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309109922
Total Pages : 217 pages
Book Rating : 4.3/5 (91 download)

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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.

Alternatives to Animal Testing

Author : Hajime Kojima
Publisher : Springer
ISBN 13 : 9811324476
Total Pages : 136 pages
Book Rating : 4.8/5 (113 download)

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Book Synopsis Alternatives to Animal Testing by : Hajime Kojima

Download or read book Alternatives to Animal Testing written by Hajime Kojima and published by Springer. This book was released on 2018-12-27 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.

Sensitive Skin Syndrome

Author : Golara Honari
Publisher : CRC Press
ISBN 13 : 1498737358
Total Pages : 222 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Sensitive Skin Syndrome by : Golara Honari

Download or read book Sensitive Skin Syndrome written by Golara Honari and published by CRC Press. This book was released on 2017-03-31 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sensitive skin is a widely reported condition where there is subjective cutaneous hyper-reactivity to environmental factors. Progress has been made in many aspects of the background science that will help clinicians in their management of patients presenting with the condition. This new text sums up the advances in thinking on pathophysiology, classification, methods of investigation, and the different susceptibilities of different types of skin.

Indoor Allergens

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309048311
Total Pages : 321 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Indoor Allergens by : National Research Council

Download or read book Indoor Allergens written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than 50 million Americans, one out of five, suffer from hay fever, asthma, and other allergic diseases. Many of these conditions are caused by exposure to allergens in indoor environments such as the house, work, and schoolâ€"where we spend as much as 98 percent of our time. Developed by medical, public health, and engineering professionals working together, this unique volume summarizes what is known about indoor allergens, how they affect human health, the magnitude of their effect on various populations, and how they can be controlled. The book addresses controversies, recommends research directions, and suggests how to assist and educate allergy patients, as well as professionals. Indoor Allergens presents a wealth of information about common indoor allergens and their varying effects, from significant hay fever to life-threatening asthma. The volume discusses sources of allergens, from fungi and dust mites to allergenic chemicals, plants, and animals, and examines practical measures for their control. Indoor Allergens discusses how the human airway and immune system respond to inhaled allergens and assesses patient testing methods, covering the importance of the patient's medical history and outlining procedures and approaches to interpretation for skin tests, in vitro diagnostic tests, and tests of patients' pulmonary function. This comprehensive and practical volume will be important to allergists and other health care providers; public health professionals; specialists in building design, construction, and maintenance; faculty and students in public health; and interested allergy patients.

Butadiene and Styrene

Author : Marja Sorsa
Publisher :
ISBN 13 :
Total Pages : 440 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Butadiene and Styrene by : Marja Sorsa

Download or read book Butadiene and Styrene written by Marja Sorsa and published by . This book was released on 1993 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Both butadiene and styrene are produced in high volumes; their combined annual production is 20 million tons. They occur together in many industrial and commercial products, including latexes, polymers, adhesives, and particularly in styrene-butadiene rubber tires. Styrene was classified in 1987 within IARC criteria as 2B (possibly carcinogenic to humans); 1,3-butadiene was placed in class 2A (probably carcinogenic to humans) at the meeting of a working group convened by IARC in 1991. This volume brings together the latest information about the toxic hazards of the two compounds. The focus of research on styrene seems to be its neurotoxicological effects and its potential carcinogenicity. Interest in 1,3-butadiene is much more recent and appears to be directed primarily towards species-specific differences in its carcinogenicity. Papers included in this volume were selected so that current data obtained by ambient and biological monitoring and on genetic toxicity and carcinogenicity are amply covered for both compounds. Seven main areas of research are covered: exposures to butadiene and styrene; estimation of internal doses received by exposed people; measurements of metabolites and of adducts with DNA and protein as markers of exposure; neurotoxicity and reproductive effects; genetic toxicity; carcinogenicity; and implications for public health. New results from epidemiological studies of subjects occupationally exposed to butadiene and to styrene are reported. Special consideration is given to the need for developing and validating biological markers of exposure to butadiene and to styrene in order to measure biological effects and susceptibility in human populations, so that adverse effects can be detected earlier and action taken to reduce public health risks. Information on the mechanisms of carcinogenic action is reviewed, since differences between species with respect to such mechanisms can have a major bearing on the extrapolation to human of findings of carcinogenicity in animals. These topics, representing the 'state of the art' with respect to scientific knowledge about the toxic manifestations and mechanisms of 1,3-butadiene and styrene are all covered in this volume.

pH of the Skin: Issues and Challenges

Author : C. Surber
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318063851
Total Pages : 214 pages
Book Rating : 4.3/5 (18 download)

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Book Synopsis pH of the Skin: Issues and Challenges by : C. Surber

Download or read book pH of the Skin: Issues and Challenges written by C. Surber and published by Karger Medical and Scientific Publishers. This book was released on 2018-08-21 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of expressing acidity as the negative logarithm of the hydrogen ion concentration was defined and termed pH in the beginning of the 20th century. The general usefulness of the pH concept for life science was recognized and later gained importance to analytical research. Reports on results of pH measurements from living skin established the term acid mantle - the skin's own protective shield that maintains a naturally acid pH. It is invisible to the eye but crucial to the overall wellbeing of skin. Chronic alkalization can throw this acid mantle out of balance, leading to inflammation, dermatitis, and atopic skin diseases. It is therefore no surprise, that skin pH shifts have been observed in various skin pathologies. It is also obvious that the pH in topically applied preparations may play an important role. Optimal pH and buffer capacity within topical preparations not only support stability of active ingredients and auxiliary materials, but may also increase absorption of the non-ionized species of an acidic or a basic active ingredient. They may even open up opportunities to modify and "correct" skin pH and hence accelerate barrier recovery and maintain or enhance barrier integrity. Further efforts are needed to standardize and improve pH measurements in biological media or pharmaceutical/cosmetic vehicles to increase and ensure quality, comparability, and relevance of research data. In this volume, we present a unique collection of papers that address past, present and future issues of the pH of healthy and diseased skin. It is hoped that this collection will foster future efforts in clinical and experimental skin research.

Password Book: Include Alphabetical Index with Cute Flowers Seamless

Author : Shamrock Logbook
Publisher : Independently Published
ISBN 13 : 9781796948394
Total Pages : 112 pages
Book Rating : 4.9/5 (483 download)

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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.

Biomedical Product and Materials Evaluation

Author : P.V. Mohanan
Publisher : Woodhead Publishing
ISBN 13 : 012824173X
Total Pages : 808 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Biomedical Product and Materials Evaluation by : P.V. Mohanan

Download or read book Biomedical Product and Materials Evaluation written by P.V. Mohanan and published by Woodhead Publishing. This book was released on 2022-01-22 with total page 808 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. - Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more - Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies - Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Biocompatibility Protocols for Medical Devices and Materials

Author : Prakash Srinivasan Timiri Shanmugam
Publisher : Elsevier
ISBN 13 : 0323984924
Total Pages : 264 pages
Book Rating : 4.3/5 (239 download)

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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

Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309451272
Total Pages : 77 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers by : National Academies of Sciences, Engineering, and Medicine

Download or read book Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-06 with total page 77 pages. Available in PDF, EPUB and Kindle. Book excerpt: Both the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices ("respirators") for health care workers. Respirators protect the user from respiratory hazards by either removing contaminants from the air (air-purifying respirators) or by supplying clean air from another source (air-supplying respirators). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation. Respirators used by health care workers are air-purifying respirators that generally fall into three types: (1) disposable particulate filtering facepiece respirators (also termed N95s); (2) elastomeric respirators, also known as reusable respirators because they use a replaceable filter; or (3) powered air-purifying air respirators. To provide input to NIOSH and FDA and to discuss potential next steps to integrate the two agencies' processes to certify and approve N95 respirators for use in health care settings, a workshop was held by the National Academies of Sciences, Engineering, and Medicine in August 2016. The workshop was focused on exploring the strengths and limitations of several current test methods for N95 respirators as well as identifying ongoing research and research needs. This publication summarizes the presentations and discussions from the workshop.

In Vitro Skin Toxicology

Author : Andre Rougier
Publisher : Mary Ann Liebert
ISBN 13 :
Total Pages : 498 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis In Vitro Skin Toxicology by : Andre Rougier

Download or read book In Vitro Skin Toxicology written by Andre Rougier and published by Mary Ann Liebert. This book was released on 1994 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt:

WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer

Download WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer PDF Online Free

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9240002634
Total Pages : 220 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer by : World Health Organization

Download or read book WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer written by World Health Organization and published by World Health Organization. This book was released on 2020-05-11 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biomedical Devices

Author : Tugrul Özel
Publisher : John Wiley & Sons
ISBN 13 : 1119267048
Total Pages : 225 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Biomedical Devices by : Tugrul Özel

Download or read book Biomedical Devices written by Tugrul Özel and published by John Wiley & Sons. This book was released on 2016-09-12 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Human Hacked

Author : Len Noe
Publisher : John Wiley & Sons
ISBN 13 : 139426917X
Total Pages : 231 pages
Book Rating : 4.3/5 (942 download)

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Book Synopsis Human Hacked by : Len Noe

Download or read book Human Hacked written by Len Noe and published by John Wiley & Sons. This book was released on 2024-10-08 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the future of cybersecurity through the eyes of the world's first augmented ethical hacker In Human Hacked: My Life and Lessons as the World's First Augmented Ethical Hacker by Len Noe, a pioneering cyborg with ten microchips implanted in his body, you'll find a startlingly insightful take on the fusion of biology and technology. The author provides a groundbreaking discussion of bio-implants, cybersecurity threats, and defenses. Human Hacked offers a comprehensive guide to understanding an existing threat that is virtually unknown. How to implement personal and enterprise cybersecurity measures in an age where technology transcends human limits and any person you meet might be augmented. The book provides: Exposure of a subculture of augmented humans hiding in plain sight Explorations of the frontier of bio-Implants, showing you the latest advancements in the tech and how it paves the way for access to highly restricted technology areas Discussions of cybersecurity tactics, allowing you to gain in-depth knowledge of phishing, social engineering, MDM restrictions, endpoint management, and more to shield yourself and your organization from unseen threats A deep understanding of the legal and ethical landscape of bio-implants as it dives into the complexities of protections for augmented humans and the ethics of employing such technologies in the corporate and government sectors Whether you're a security professional in the private or government sector, or simply fascinated by the intertwining of biology and technology, Human Hacked is an indispensable resource. This book stands alone in its category, providing not just a glimpse into the life of the world's first augmented ethical hacker, but also offering actionable insights and lessons on navigating the evolving landscape of cybersecurity. Don't miss this essential read on the cutting edge of technology and security.

Drug Discovery Toxicology

Author : Yvonne Will
Publisher : John Wiley & Sons
ISBN 13 : 1119053323
Total Pages : 602 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Discovery Toxicology by : Yvonne Will

Download or read book Drug Discovery Toxicology written by Yvonne Will and published by John Wiley & Sons. This book was released on 2016-03-16 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices