Download or read book Block s Disinfection Sterilization and Preservation written by Gerald McDonnell and published by Lippincott Williams & Wilkins. This book was released on 2020-06-26 with total page 2941 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by William Andrew. This book was released on 2021-11-24 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. - Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data - Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management - Supports the development, marketing and commercialization of medical devices and materials for use in medical devices
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sterility Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Download or read book Healthcare Sterilisation written by Wayne J Rogers and published by Smithers Rapra. This book was released on 2014-06-09 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: The collection of topics in the second volume of this book challenges the reader to think beyond standard methods and question why certain current procedures remain static while technological advances abound in other aspects of sterilisation technology. By small means, better practices may come to pass to help answer some of the residual healthcare sterilisation and nosocomial infection queries: What are some of the current challenges in healthcare sterilisation, and how can they be handled? What are some of the acceptable current non-traditional sterilisation methods, challenging alternatives, and novel modalities? What are some of the packaging, validation and statistical considerations of sterilisation practices? How does design-of-product and packaging interrelate with sterilisation processing? Are the current sterility media and practices optimal for recovery of more modified and more resistant viable organism entities and product? Are there increased sterility and product quality needs with new types of implantables and technological advances within the three dimensional combinations of diagnostics, drug release and challenging medical devices?
Download or read book Medical Devices and In Vitro Diagnostics written by Christian Baumgartner and published by Springer Nature. This book was released on 2023-08-26 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
Download or read book Advanced Technologies Systems and Applications III written by Samir Avdaković and published by Springer. This book was released on 2018-11-03 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces innovative and interdisciplinary applications of advanced technologies. Featuring the papers from the 10th DAYS OF BHAAAS (Bosnian-Herzegovinian American Academy of Arts and Sciences) held in Jahorina, Bosnia and Herzegovina on June 21–24, 2018, it discusses a wide variety of engineering and scientific applications of the different techniques. Researchers from academic and industry present their work and ideas, techniques and applications in the field of power systems, mechanical engineering, computer modelling and simulations, civil engineering, robotics and biomedical engineering, information and communication technologies, computer science and applied mathematics.
Download or read book Healthcare Associated Infections in Australia written by Ramon Z Shaban and published by Elsevier Health Sciences. This book was released on 2023-04 with total page 979 pages. Available in PDF, EPUB and Kindle. Book excerpt: Infection prevention and control (IPC) is everybody's responsibility. Healthcare-associated Infections in Australia is the first Australian text to address the challenges posed by infectious diseases and healthcareassociated infections (HAIs) for all members of the multidisciplinary healthcare team. Drawing on the expertise of a wide author team, and based on current research, this important and comprehensive text provides a clear pathway for the reader to increase their knowledge and understanding of IPC. The text is designed for both students and practising clinicians, and is presented in two sections - Principles and Practice - for ease of use. With IPC principles and guidelines now embedded into all health-related curricula, and mandated by standards and guidelines across all areas of healthcare, this is a book no health professional should miss. - Includes practice tips, case studies and video-based learning materials providing real-life examples across more than 20 health professions - Suitable for increasing IPC knowledge across all members of the multidisciplinary team. Content is pitched at different levels, with examples ranging from novice to expert - Aligned to the Australian National Infection Control Guidelines 2019 and the NSQHS Standard Preventing and Controlling Healthcare Associated Infections, as well as the nine hospital-acquired complication (HAC) HAIs addressed in specific chapters - Endorsed by the Australian College for Infection Prevention and Control (ACIPC) and the Australian Society for Infectious Diseases (ASID) - Supported by a companion text, Epidemiology of Healthcare-associated Infections in Australia, providing data on the epidemiology of healthcare-associated surveillance in Australia Instructor and Student resources on Evolve: Multiple Choice Questions Case Studies Abbreviations and Glossary Useful Websites / Resources Video-based learning materials
Download or read book Electrospinning for Tissue Regeneration written by L Bosworth and published by Elsevier. This book was released on 2011-06-21 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: Electrospinning is a simple and highly versatile method for generating ultrathin fibres with diameters ranging from a few micrometres to tens of nanometres. Although most commonly associated with textile manufacturing, recent research has proved that the electrospinning technology can be used to create organ components and repair damaged tissues. Electrospinning for tissue regeneration provides a comprehensive overview of this innovative approach to tissue repair and regeneration and examines how it is being employed within the biomaterials sector.The book opens with an introduction to the fundamentals of electrospinning. Chapters go on to discuss polymer chemistry, the electrospinning process, conditions, control and regulatory issues. Part two focuses specifically on electrospinning for tissue regeneration and investigates its uses in bone, cartilage, muscle, tendon, nerve, heart valve, bladder, tracheal, dental and skin tissue regeneration before concluding with a chapter on wound dressings. Part three explores electrospinning for in vitro applications. Chapters discuss cell culture systems for kidney, pancreatic and stem cell research.With its distinguished editors and international team of expert contributors, Electrospinning for tissue regeneration is a valuable reference tool for those in academia and industry concerned with research and development in the field of tissue repair and regeneration. - Provides a comprehensive overview of this innovative approach to tissue repair and regeneration covering issues from polymer chemistry to the regulatory process - Examines employment within the biomaterials sector, reviewing extensive applications in areas such as uses in bone, muscle tendon, heart valve and tissue regeneration - Explores electrospinning for in vitro applications and discusses cell culture systems for kidney, pancreatic and stem cell research
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 Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Download or read book YY T 0698 2 2009 Translated English of Chinese Standard YYT 0698 2 2009 YY T0698 2 2009 YYT0698 2 2009 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2016-06-28 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Part of YY/T 0698 provides test methods and values for materials for preformed sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Download or read book Encyclopedia of Polymer Applications 3 Volume Set written by Munmaya Mishra and published by CRC Press. This book was released on 2018-12-17 with total page 6410 pages. Available in PDF, EPUB and Kindle. Book excerpt: Undoubtedly the applications of polymers are rapidly evolving. Technology is continually changing and quickly advancing as polymers are needed to solve a variety of day-to-day challenges leading to improvements in quality of life. The Encyclopedia of Polymer Applications presents state-of-the-art research and development on the applications of polymers. This groundbreaking work provides important overviews to help stimulate further advancements in all areas of polymers. This comprehensive multi-volume reference includes articles contributed from a diverse and global team of renowned researchers. It offers a broad-based perspective on a multitude of topics in a variety of applications, as well as detailed research information, figures, tables, illustrations, and references. The encyclopedia provides introductions, classifications, properties, selection, types, technologies, shelf-life, recycling, testing and applications for each of the entries where applicable. It features critical content for both novices and experts including, engineers, scientists (polymer scientists, materials scientists, biomedical engineers, macromolecular chemists), researchers, and students, as well as interested readers in academia, industry, and research institutions.
Download or read book Biomedical Engineering and Design Handbook Volume 2 written by Myer Kutz and published by McGraw Hill Professional. This book was released on 2009-07-13 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: A State-of-the-Art Guide to Biomedical Engineering and Design Fundamentals and Applications The two-volume Biomedical Engineering and Design Handbook, Second Edition, offers unsurpassed coverage of the entire biomedical engineering field, including fundamental concepts, design and development processes, and applications. This landmark work contains contributions on a wide range of topics from nearly 80 leading experts at universities, medical centers, and commercial and law firms. Volume 2 provides timely information on breakthrough developments in medical device design, diagnostic equipment design, surgery, rehabilitation engineering, prosthetics design, and clinical engineering. Filled with more than 400 detailed illustrations, this definitive volume examines cutting-edge design and development methods for innovative devices, techniques, and treatments. Volume 2 covers: Medical Product Design FDA Medical Device Requirements Cardiovascular Devices Design of Respiratory Devices Design of Artificial Kidneys Design of Controlled-Release Drug Delivery Systems Sterile Medical Device Package Development Design of Magnetic Resonance Systems Instrumentation Design for Ultrasonic Imaging The Principles of X-Ray Computed Tomography Nuclear Medicine Imaging Instrumentation Breast Imaging Systems Surgical Simulation Technologies Computer-Integrated Surgery and Medical Robotics Technology and Disabilities Applied Universal Design Design of Artificial Arms and Hands for Prosthetic Applications Design of Artificial Limbs for Lower Extremity Amputees Wear of Total Knee and Hip Joint Replacements Home Modification Design Intelligent Assistive Technology Rehabilitators Risk Management in Healthcare Technology Planning for Healthcare Institutions Healthcare Facilities Planning Healthcare Systems Engineering Enclosed Habitat Life Support
Download or read book ISO Catalogue written by International Organization for Standardization and published by . This book was released on 2007 with total page 946 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Packaging for Terminally Sterilized Medical Devices written by and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: BS EN ISO 11607-2:2020 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
