Download or read book Radiation Sterilization for Health Care Products written by Barry P. Fairand and published by CRC Press. This book was released on 2001-09-26 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency. It offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Bringing all the information into one source, Radiation Sterilization for Health Care Products is a uniquely comprehensive resource.

Download or read book Assurance of Sterility for Sensitive Combination Products and Materials written by Byron J. Lambert and published by Academic Press. This book was released on 2019-11-30 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design.

Download or read book Biotextiles as Medical Implants written by M W King and published by Elsevier. This book was released on 2013-10-31 with total page 739 pages. Available in PDF, EPUB and Kindle. Book excerpt: Textiles play a vital role in the manufacture of various medical devices, including the replacement of diseased, injured or non-functioning organs within the body. Biotextiles as medical implants provides an invaluable single source of information on the main types of textile materials and products used for medical implants. The first part of the book focuses on polymers, fibers and textile technologies, and these chapters discuss the manufacture, sterilization, properties and types of biotextiles used for medical applications, including nanofibers, resorbable polymers and shaped biotextiles. The chapters in part two provide a comprehensive discussion of a range of different clinical applications of biotextiles, including surgical sutures, arterial prostheses, stent grafts, percutaneous heart valves and drug delivery systems.This book provides a concise review of the technologies, properties and types of biotextiles used as medical devices. In addition, it addresses the biological dimension of how to design devices for different clinical applications, providing an invaluable reference for biomedical engineers of medical textiles, quality control and risk assessment specialists, as well as managers of regulatory affairs. The subject matter will also be of interest to professionals within the healthcare system including surgeons, nurses, therapists, sourcing and purchasing agents, researchers and students in different disciplines. - Provides an invaluable single source of information on the main types of textile materials and products used for medical implants - Addresses the technologies used and discusses the manufacture, properties and types of biotextiles - Examines applications of biotextiles as medical implants, including drug delivery systems and stent grafts and percutaneous heart valves

Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou

Download or read book Journal of Medical Engineering Technology written by and published by . This book was released on 1994 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Tattooed Skin and Health written by J. Serup and published by Karger Medical and Scientific Publishers. This book was released on 2015-03-26 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: With about 10–20% of the adult population in Europe being tattooed, there is a strong demand for publications discussing the various issues related to tattooed skin and health. Until now, only a few scientific studies on tattooing have been published. This book discusses different aspects of the various medical risks associated with tattoos, such as allergic reactions from red tattoos, papulo-nodular reactions from black tattoos as well as technical and psycho-social complications, in addition to bacterial and viral infections. Further sections are dedicated to the composition of tattoo inks, and a case is made for the urgent introduction of national and international regulations. Distinguished authors, all specialists in their particular fields, have contributed to this publication which provides a comprehensive view of the health implications associated with tattooing. The book covers a broad range of topics that will be of interest to clinicians and nursing staff, toxicologists and regulators as well as laser surgeons who often face the challenge of having to remove tattoos, professional tattooists and producers of tattoo ink.

Download or read book ANSI AAMI St79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities written by Aami and published by Association for the Advancement of Medical Instrumentation (AAMI). This book was released on 2013-10-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization.

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Download or read book Sterilization of Health Care Products written by Standards Australia (Organization) and published by . This book was released on 2006-01-01 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Surface Engineered Surgical Tools and Medical Devices written by Mark J. Jackson and published by Springer Science & Business Media. This book was released on 2007-08-03 with total page 595 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the interaction between nano tools and nano materials. It explains the use of appropriate tools in surgery for a variety of applications and provides a complete description of clinical procedures accompanied by photographs. Coverage also presents the latest developments in surface coatings technology such as chemical vapor deposition for use on complex cutting tools for biomedical applications.

Download or read book Decontamination in Hospitals and Healthcare written by James T. Walker and published by Woodhead Publishing. This book was released on 2019-11-26 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decontamination in Hospitals and Healthcare, Second Edition, enables users to obtain detailed knowledge of decontamination practices in healthcare settings, including surfaces, devices, clothing and people, with a specific focus on hospitals and dental clinics. - Offers in-depth coverage of all aspects of decontamination in healthcare - Examines the decontamination of surgical equipment and endoscopes - Expanded to include new information on behavioral principles in decontamination, control of microbiological problems, waterborne microorganisms, pseudomonas and the decontamination of laundry

Download or read book Aulton s Pharmaceutics written by Michael E. Aulton and published by Elsevier Health Sciences. This book was released on 2013 with total page 909 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Pharmaceutics is the art of pharmaceutical preparations. It encompasses design of drugs, their manufacture and the elimination of micro-organisms from the products. This book encompasses all of these areas."--Provided by publisher.

Download or read book Pharmaceutical Dosage Forms written by Kenneth E. Avis and published by Routledge. This book was released on 2018-05-04 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

Download or read book Guide to the Quality and Safety of Tissues and Cells for Human Application written by European Directorate for the Quality of Medicines & Healthcare and published by . This book was released on 2013-10-11 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types

Download or read book Characterization of Minerals Metals and Materials 2018 written by Bowen Li and published by Springer. This book was released on 2018-01-17 with total page 708 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection gives broad and up-to-date results in the research and development of materials characterization and processing. Coverage is well-rounded from minerals, metals, and materials characterization and developments in extraction to the fabrication and performance of materials. In addition, topics as varied as structural steels to electronic materials to plant-based composites are explored. The latest research presented in this wide area make this book both timely and relevant to the materials science field as a whole. The book explores scientific processes to characterize materials using modern technologies, and focuses on the interrelationships and interdependence among processing, structure, properties, and performance of materials. Topics covered include ferrous materials, non-ferrous materials, minerals, ceramics, clays, soft materials, method development, processing, corrosion, welding, solidification, composites, extraction, powders, nanomaterials, advanced materials, and several others.

Download or read book Applications of Radiation Chemistry in the Fields of Industry Biotechnology and Environment written by Margherita Venturi and published by Springer. This book was released on 2017-03-06 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: The series Topics in Current Chemistry Collections presents critical reviews from the journal Topics in Current Chemistry organized in topical volumes. The scope of coverage is all areas of chemical science including the interfaces with related disciplines such as biology, medicine and materials science. The goal of each thematic volume is to give the non-specialist reader, whether in academia or industry, a comprehensive insight into an area where new research is emerging which is of interest to a larger scientific audience. Each review within the volume critically surveys one aspect of that topic and places it within the context of the volume as a whole. The most significant developments of the last 5 to 10 years are presented using selected examples to illustrate the principles discussed. The coverage is not intended to be an exhaustive summary of the field or include large quantities of data, but should rather be conceptual, concentrating on the methodological thinking that will allow the non-specialist reader to understand the information presented. Contributions also offer an outlook on potential future developments in the field.