Download or read book Packaging for Terminally Sterilized Medical Devices Requirements for Materials Sterile Barrier Systems and Packaging Systems written by British Standards Institute Staff and published by . This book was released on 2006-05 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: Packaging materials, Packaging, Medical equipment, Medical instruments, Sterilization (hygiene), Sterile equipment, Packages, Wrapping, Quality, Design, Performance, Compatibility, Seals, Test methods, Performance testing, Quality assurance systems

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 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.

Download or read book Medical Device Packaging Handbook Revised and Expanded written by Max Sherman and published by CRC Press. This book was released on 1998-08-25 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.

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 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: This standard specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

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 A Practical Guide to Decontamination in Healthcare written by Gerald E. McDonnell and published by John Wiley & Sons. This book was released on 2012-07-23 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.

Download or read book Handbook of Nonwovens written by S. J. Russell and published by Woodhead Publishing. This book was released on 2022-05-31 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Nonwovens, Second Edition updates and expands its popular interdisciplinary treatment of the properties, processing, and applications of nonwovens. Initial chapters review the development of the industry and the different classes of nonwoven material. The book then discusses methods of manufacture such as dry-laid, wet-laid, and polymer-laid web formation. Other techniques analyzed include mechanical, thermal, and chemical bonding, as well as chemical and mechanical finishing systems. The book concludes by assessing the characterization, testing, and modeling of nonwoven materials.Covering an unmatched range of materials with a variety of compositions and manufacturing routes, this remains the indispensable reference to nonwovens for designers, engineers, materials scientists, and researchers, particularly those interested in the manufacturing of automotive, aerospace, and medical products. Nonwovens are a unique class of textile material formed from fibers that are bonded together through various means to form a coherent structure. The range of properties they can embody make them an important part of a range of innovative products and solutions, which continues to attract interest from industry as well as academia. - Describes in detail the manufacturing processes of a range of nonwoven materials - Provides detailed coverage of the mechanical and thermal properties of non-woven fabrics - Includes extensive updates throughout on the characterization and testing of nonwovens - Explains how to model nonwoven structures

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 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 Packaging for Terminally Sterilized Medical Devices Validation Requirements for Forming Sealing and Assembly Processes written by British Standards Institute Staff and published by . This book was released on 1918-05-15 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sealing processes, Packaging, Packaging processes, Acceptance (approval), Sterile equipment, Performance testing, Seals, Verification, Packaging materials, Sterilization (hygiene), Packages, Medical equipment, Medical instruments, Wrapping, Performance, Quality assurance systems, Quality

Download or read book Sterilization of Medical Devices written by Anne Booth and published by Routledge. This book was released on 2018-12-12 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.

Download or read book The Wiley Encyclopedia of Packaging Technology written by Kit L. Yam and published by John Wiley & Sons. This book was released on 2010-01-05 with total page 1368 pages. Available in PDF, EPUB and Kindle. Book excerpt: The complete and authoritative guide to modern packaging technologies —updated and expanded From A to Z, The Wiley Encyclopedia of Packaging Technology, Third Edition covers all aspects of packaging technologies essential to the food and pharmaceutical industries, among others. This edition has been thoroughly updated and expanded to include important innovations and changes in materials, processes, and technologies that have occurred over the past decade. It is an invaluable resource for packaging technologists, scientists and engineers, students and educators, packaging material suppliers, packaging converters, packaging machinery manufacturers, processors, retailers, and regulatory agencies. In addition to updating and improving articles from the previous edition, new articles are also added to cover the recent advances and developments in packaging. Content new to this edition includes: Advanced packaging materials such as antimicrobial materials, biobased materials, nanocomposite materials, ceramic-coated films, and perforated films Advanced packaging technologies such as active and intelligent packaging, radio frequency identification (RFID), controlled release packaging, smart blending, nanotechnology, biosensor technology, and package integrity inspection Various aspects important to packaging such as sustainable packaging, migration, lipid oxidation, light protection, and intellectual property Contributions from experts in all-important aspects of packaging Extensive cross-referencing and easy-to-access information on all subjects Large, double-column format for easy reference

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 Validating Medical Packaging written by Ronald Pilchik and published by CRC Press. This book was released on 2002-09-27 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc

Download or read book YY T 0681 17 2019 Translated English of Chinese Standard YY T 0681 17 2019 YYT0681 17 2019 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2023-01-30 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Part of YY/T 0681 specifies the determination of the aerosol filtration performance using aerosol that generates particles with a diameter of 1.0 ?m, and the evaluation of the filtration efficiency of the material using two particle counters. This Part of YY/T 0681 is applicable to air permeable materials used for the packaging of terminally sterilized medical devices. This Part of YY/T 0681 does not apply to materials with Bendtsen air permeability1) over 4,000 mL/min.