Sterilization Of Medical Devices

Author : Anne Booth
Publisher : Routledge
Page : 425 pages
File Size : 51,5 Mb
Release : 2018-12-12
Category : Medical
ISBN : 9781351413817

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Sterilization of Medical Devices by Anne Booth Pdf

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.

Author : Sophie Lerouge,Anne Simmons
Publisher : Elsevier
Page : 352 pages
File Size : 53,9 Mb
Release : 2012-09-27
Category : Technology & Engineering
ISBN : 9780857096265

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Sterilisation of Biomaterials and Medical Devices by Sophie Lerouge,Anne Simmons Pdf

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

Author : Jan Huys
Publisher : Unknown
Page : 298 pages
File Size : 48,9 Mb
Release : 2010
Category : Electronic
ISBN : 3886811026

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Sterilization of Medical Supplies by Steam by Jan Huys Pdf

Author : Wayne J. Rogers
Publisher : iSmithers Rapra Publishing
Page : 344 pages
File Size : 48,7 Mb
Release : 2005
Category : Medical instruments and apparatus
ISBN : 1859574904

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Sterilisation of Polymer Healthcare Products by Wayne J. Rogers Pdf

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.

Author : Marimargaret Reichert,Jack H. Young
Publisher : Jones & Bartlett Learning
Page : 328 pages
File Size : 46,5 Mb
Release : 1997
Category : Medical instruments and apparatus
ISBN : 0834208385

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Sterilization Technology for the Health Care Facility by Marimargaret Reichert,Jack H. Young Pdf

This Second Edition is a comprehensive resource on sterilization and disinfection of reusable instruments and medical devices

Author : British Standards Institute Staff,British Standards Institution
Publisher : Unknown
Page : 32 pages
File Size : 48,7 Mb
Release : 1994-10
Category : Standards
ISBN : 0580232018

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Sterilization of Medical Devices. Validation and Routine Control of Ethylene Oxide Sterilization by British Standards Institute Staff,British Standards Institution Pdf

Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Specimen preparation, Test equipment

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 53,5 Mb
Release : 1994
Category : Medical equipment
ISBN : OCLC:758011123

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Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization by Anonim Pdf

Author : Nagaraja Prem Anand
Publisher : JAYPEE BROTHERS PUBLISHERS
Page : 278 pages
File Size : 46,6 Mb
Release : 2011
Category : Hospitals
ISBN : 9789350256619

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Hospital Sterilization by Nagaraja Prem Anand Pdf

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.

Author : Anne F Booth
Publisher : CRC Press
Page : 160 pages
File Size : 52,7 Mb
Release : 2017-11-22
Category : Medical
ISBN : 9781351357562

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Sterilization Validation and Routine Operation Handbook (2001) by Anne F Booth Pdf

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.

Author : Association for the Advancement of Medical Instrumentation
Publisher : Unknown
Page : 12 pages
File Size : 47,8 Mb
Release : 1981
Category : Sterilization
ISBN : OCLC:11490344

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Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices by Association for the Advancement of Medical Instrumentation Pdf

Author : Datapharm Information Services
Publisher : Unknown
Page : 67 pages
File Size : 53,6 Mb
Release : 1983*
Category : Medical instruments and apparatus
ISBN : OCLC:150903844

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Sterilization of Medical Devices by Datapharm Information Services Pdf

Author : Steven M. Kurtz
Publisher : William Andrew
Page : 309 pages
File Size : 53,6 Mb
Release : 2011-11-09
Category : Medical
ISBN : 9781437744637

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PEEK Biomaterials Handbook by Steven M. Kurtz Pdf

PEEK biomaterials are currently used in thousands of spinal fusion patients around the world every year. Durability, biocompatibility and excellent resistance to aggressive sterilization procedures make PEEK a polymer of choice, replacing metal in orthopedic implants, from spinal implants and hip replacements to finger joints and dental implants. This Handbook brings together experts in many different facets related to PEEK clinical performance as well as in the areas of materials science, tribology, and biology to provide a complete reference for specialists in the field of plastics, biomaterials, medical device design and surgical applications. Steven Kurtz, author of the well respected UHMWPE Biomaterials Handbook and Director of the Implant Research Center at Drexel University, has developed a one-stop reference covering the processing and blending of PEEK, its properties and biotribology, and the expanding range of medical implants using PEEK: spinal implants, hip and knee replacement, etc. Covering materials science, tribology and applications Provides a complete reference for specialists in the field of plastics, biomaterials, biomedical engineering and medical device design and surgical applications

Author : Laurence W. McKeen
Publisher : William Andrew
Page : 468 pages
File Size : 52,6 Mb
Release : 2018-02-22
Category : Technology & Engineering
ISBN : 9780128145128

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The Effect of Sterilization on Plastics and Elastomers by Laurence W. McKeen Pdf

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

Author : Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publisher : Academic Press
Page : 266 pages
File Size : 40,9 Mb
Release : 2019-06-15
Category : Technology & Engineering
ISBN : 9780128050828

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Assurance of Sterility for Sensitive Combination Products and Materials by Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans Pdf

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. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Author : Robert F. Morrissey,G. Briggs Phillips
Publisher : Springer
Page : 536 pages
File Size : 42,5 Mb
Release : 1993-02-28
Category : Medical
ISBN : UOM:39015057696620

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Sterilization Technology by Robert F. Morrissey,G. Briggs Phillips Pdf

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