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Sterilization Of Medical Devices
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Book Synopsis Sterilization of Medical Devices by : Anne Booth
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.
Book Synopsis Sterilisation of Biomaterials and Medical Devices by : Sophie Lerouge
Download or read book Sterilisation of Biomaterials and Medical Devices written by Sophie Lerouge and published by Elsevier. This book was released on 2012-09-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices
Book Synopsis Sterilization of Medical Supplies by Steam by : Jan Huys
Download or read book Sterilization of Medical Supplies by Steam written by Jan Huys and published by . This book was released on 2010 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sterilization Technology for the Health Care Facility by : Marimargaret Reichert
Download or read book Sterilization Technology for the Health Care Facility written by Marimargaret Reichert and published by Jones & Bartlett Learning. This book was released on 1997 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is a comprehensive resource on sterilization and disinfection of reusable instruments and medical devices
Book Synopsis Sterilization of Medical Devices. Validation and Routine Control of Ethylene Oxide Sterilization by : British Standards Institute Staff
Download or read book Sterilization of Medical Devices. Validation and Routine Control of Ethylene Oxide Sterilization written by British Standards Institute Staff and published by . This book was released on 1994-10 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Specimen preparation, Test equipment
Book Synopsis Sterilisation of Polymer Healthcare Products by : Wayne J. Rogers
Download or read book Sterilisation of Polymer Healthcare Products written by Wayne J. Rogers and published by iSmithers Rapra Publishing. This book was released on 2005 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.
Book Synopsis Radiation Sterilization for Health Care Products by : Barry P. Fairand
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.
Book Synopsis Sterilization Validation and Routine Operation Handbook by : Anne F. Booth
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.
Book Synopsis Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization by :
Download or read book Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization written by and published by . This book was released on 1994 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Aami Publisher :Association for the Advancement of Medical Instrumentation (AAMI) ISBN 13 :9780010671384 Total Pages : pages Book Rating :4.6/5 (713 download)
Book Synopsis ANSI/AAMI St79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities by : Aami
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.
Book Synopsis Joining and Assembly of Medical Materials and Devices by : Y N Zhou
Download or read book Joining and Assembly of Medical Materials and Devices written by Y N Zhou and published by Elsevier. This book was released on 2013-05-31 with total page 583 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications.Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications.Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives
Book Synopsis Sterilization Validation and Routine Operation Handbook (2001) by : Anne F Booth
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Book Synopsis Sterilization and Disinfection by Plasma by : Akikazu Sakud
Download or read book Sterilization and Disinfection by Plasma written by Akikazu Sakud and published by Nova Biomedical Books. This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the increased importance of hospital administration and continuous emergence of new infectious pathogens, particular attention should be paid to avoid iatrogenic diseases by minimising the contamination of medical instruments with infectious pathogens and toxins. It is well known that one of the most effective ways to prevent hospital-acquired infection is to implement a sterilisation and disinfection system that includes physical and chemical inactivation methods. This book presents information on the current status and future perspectives of a state-of-art physical technique, gas plasma sterilisation.
Book Synopsis Sterilization Technology by : Robert F. Morrissey
Download or read book Sterilization Technology written by Robert F. Morrissey and published by Springer. This book was released on 1993 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Includes as many case studies as the contributors could identify, with the goal of answering questions that arise as a result of conducting day-to-day sterilization activities. Discussion of the theory of microbial inactivation and the philosophy of sterilization validation is followed by practical information on methods of interest to a broad audience. Chapters on special considerations for ethylene oxide, packaging of sterile products, contract sterilization, and regulations complete the coverage. Annotation copyright by Book News, Inc., Portland, OR
Book Synopsis Hospital Sterilization by : Nagaraja Prem Anand
Download or read book Hospital Sterilization written by Nagaraja Prem Anand and published by JAYPEE BROTHERS PUBLISHERS. This book was released on 2011 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hospital infection is one of the major causes of morbidity and mortality following any procedure on the human body in the hospital. Infection arises primarily because of lack of knowledge by the hospital staff about sterilization. Today, majority of super-specialty hospitals import very expensive sterilizing equipment. However, very little effort is made to train the people who run these machines. We must understand that the machine is as clever or as dumb as the person behind it. Unfortunately, in spite of so many advances in health care and so many advances in medical education, many countries do not have a single recognized training program to train sterilization technicians. This is our effort in that direction to come up with a formal training program to train technicians in this vital area of health care delivery system. This book shall benefit technologists and Central Sterile Supplies Department (CSSD) staff as well as medical students and hospital administrators to understand the intricacies and workings of a successful CSSD unit and contribute to hospital infection control in a large way.
Book Synopsis Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by : Tim Sandle
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
Book Synopsis The Effect of Sterilization on Plastics and Elastomers by : Laurence W. McKeen
Download or read book The Effect of Sterilization on Plastics and Elastomers written by Laurence W. McKeen and published by William Andrew. This book was released on 2018-02-22 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Effect of Sterilization Methods on Plastics and Elastomers, Fourth Edition brings together a wide range of essential data on the sterilization of plastics and elastomers, thus enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials and sterilization method for a given product or application. The book is a unique and essential reference for anybody working with plastic materials that are likely to be exposed to sterilization methods, be it in medical device or packaging development, food packaging or other applications. Presents essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment Updated edition removes obsolete data, updates manufacturers, verifies data accuracy, and adds new plastics materials for comparison Provides essential information and guidance for FDA submissions required for new medical devices
