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 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 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 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 The ASQ Certified Medical Device Auditor Handbook written by Scott A Laman and published by Quality Press. This book was released on 2021-02-05 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques
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 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 Guide to Microbiological Control in Pharmaceuticals and Medical Devices Second Edition written by Stephen P. Denyer and published by CRC Press. This book was released on 2006-12-26 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.
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 425 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 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 Decontamination in Hospitals and Healthcare written by James T. Walker and published by Woodhead Publishing. This book was released on 2014-02-13 with total page 719 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decontamination in Hospitals and Healthcare brings an understanding of decontamination practices and the development of technologies for cleaning and control of infection to a wide audience interested in public health, including healthcare specialists, scientists, students or patients. Part one highlights the importance and history of decontamination in hospitals and healthcare before exploring the role of standards in decontamination, infection control in Europe, and future trends in the area. Part two focuses on decontamination practices in hospitals and healthcare. It considers the role of the nurse in decontamination, the issues of microbial biofilm in waterlines, control of waterborne microorganisms, and the use of gaseous decontamination technologies. Further chapters explore decontamination of prions, the use of protective clothing, no-touch automated room disinfection systems, and controlling the presence of microorganisms in hospitals. Part three discusses practices for decontamination and sterilization of surgical instruments and endoscopes. These chapters examine a range of guidance documents, including the choice framework for local policy and procedures for decontamination of surgical instruments, as well as novel technologies for cleaning and detection of contamination. Decontamination in Hospitals and Healthcare provides a reference source on decontamination for public health professionals and students concerned with healthcare. It is particularly useful for scientists in microbiology and disinfection/decontamination laboratories, healthcare workers who use disinfectants, students in microbiology, clinicians, members of the Institute of Decontamination Sciences/Central Sterilising Club, and those employed in the Central Sterile Services departments of healthcare facilities. - Discusses decontamination processes in Europe - Provides an in-depth understanding into decontamination in healthcare settings, specifically hospitals and dental practices - Examines the decontamination of surgical equipment and endoscopes
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 Sterilization Validation and Routine Operation Handbook written by Anne F. Booth and published by CRC Press. This book was released on 1999-09-01 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.
Download or read book Encyclopaedia of Medical Physics written by Slavik Tabakov and published by CRC Press. This book was released on 2021-07-19 with total page 1083 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains over 3300 entries with accompanying diagrams, images, formulas, further reading, and examples Covers both the classical and newest elements in medical imaging, radiotherapy, and radiation protection Discusses material at a level accessible to graduate and postgraduate students in medical physics and related disciplines as well as medical specialists and researchers.
Download or read book Infection Control in Primary Dental Care written by Martin R. Fulford and published by Springer. This book was released on 2019-07-04 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is an easy-to-use guide to all aspects of infection control and decontamination that will support the implementation of effective measures for risk reduction in dental practice. Among the topics addressed are the principles and practicalities of cleaning and sterilizing dental instruments, the role of personal protective equipment, the design and use of decontamination rooms, choice of dental equipment, environmental disinfection, and considerations relating to dental unit water lines. In addition, readers will find an informative and helpful section on the background history and basic science of infection control within dentistry. Infection Control in Primary Dental Care will be very useful for all members of the dental team, including dentists, dental nurses or assistants, dental hygienists, and therapists. The book is illustrated with photographs, diagrams, and tables to aid understanding and encourage good practice. The authors have a background in microbiology and dental practice and have extensive experience of providing advice and guidance to professional colleagues on infection control procedures.
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
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?
