Sterilisation Of Biomaterials And Medical Devices

Author : Sophie Lerouge,Anne Simmons
Publisher : Elsevier
Page : 352 pages
File Size : 54,9 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 : Wayne J. Rogers
Publisher : iSmithers Rapra Publishing
Page : 344 pages
File Size : 47,9 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 : Anne Booth
Publisher : Routledge
Page : 380 pages
File Size : 55,7 Mb
Release : 2018-12-12
Category : Medical
ISBN : 9781351413800

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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 : L Barnes,Ian Cooper
Publisher : Elsevier
Page : 278 pages
File Size : 42,5 Mb
Release : 2014-11-21
Category : Technology & Engineering
ISBN : 9780857097224

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Biomaterials and Medical Device - Associated Infections by L Barnes,Ian Cooper Pdf

Despite advances in materials and sterilisation, patients who receive biomaterials of medical device implants are still at risk of developing an infection around the implantation site. This book reviews the fundamentals of biomaterials and medical device related infections and methods and materials for the treatment and prevention of infection. The first part of the book provides readers with an introduction to the topic including analyses of biofilms, diagnosis and treatment of infection, pathology and topography. The second part of the book discusses a range of established and novel technologies and materials which have been designed to prevent infection. Provides analysis of biofilms and their relevance to implant associated infections. Assesses technologies for controlling biofilms. Considers advantages and disadvantages of in vivo infection studies.

Author : Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publisher : Academic Press
Page : 266 pages
File Size : 40,8 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 : Michael Szycher,Technomic Publishing Company. Program Division,Spiro Apostolou,Michael G. Fogarty
Publisher : Unknown
Page : 196 pages
File Size : 43,7 Mb
Release : 1989
Category : Biomedical materials
ISBN : 0877626979

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Sterilization Methods for Medical Devices by Michael Szycher,Technomic Publishing Company. Program Division,Spiro Apostolou,Michael G. Fogarty Pdf

Author : Anne F Booth
Publisher : CRC Press
Page : 160 pages
File Size : 50,9 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 : Mitsuo Niinomi
Publisher : Elsevier
Page : 432 pages
File Size : 53,9 Mb
Release : 2010-03-31
Category : Technology & Engineering
ISBN : 9781845699246

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Metals for Biomedical Devices by Mitsuo Niinomi Pdf

Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials. With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. Reviews the latest techniques in metal processing methods including surface treatment and sterilisation Examines metal selection for biomedical devices considering biocompatibility of various metals Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear

Author : Marimargaret Reichert,Jack H. Young
Publisher : Jones & Bartlett Learning
Page : 328 pages
File Size : 47,5 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 : David Hill
Publisher : Wiley
Page : 0 pages
File Size : 51,6 Mb
Release : 1998-09-16
Category : Medical
ISBN : 0471967084

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Design Engineering of Biomaterials for Medical Devices by David Hill Pdf

Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 40,6 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 : Vinny R. Sastri
Publisher : Elsevier
Page : 289 pages
File Size : 41,8 Mb
Release : 2010-03-05
Category : Technology & Engineering
ISBN : 9780815520283

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Plastics in Medical Devices by Vinny R. Sastri Pdf

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Author : Steven M. Kurtz
Publisher : William Andrew
Page : 309 pages
File Size : 47,8 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 : EUCOMED. Sterilisation Work Group,European Confederation of Medical Suppliers Associations
Publisher : Unknown
Page : 27 pages
File Size : 55,8 Mb
Release : 1988
Category : Medical instruments and apparatus
ISBN : 0950992550

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Recommendations for the Sterilisation of Medical Devices and Surgical Products by EUCOMED. Sterilisation Work Group,European Confederation of Medical Suppliers Associations Pdf

Author : Mamata Mukhopadhayay,Anuradha Chatterjee
Publisher : Springer Nature
Page : 213 pages
File Size : 45,9 Mb
Release : 2023-07-04
Category : Technology & Engineering
ISBN : 9783031173707

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Sterilization and Preservation by Mamata Mukhopadhayay,Anuradha Chatterjee Pdf

This book is intended to be used as a graduate textbook for students pursuing courses in food safety and technology, and food process engineering. It is a useful supplementary resource in sterilization of biomaterials and biomedical devices, and management of biological and biomedical wastes. It covers the fundamentals of sterilization and preservation. It further discusses the classification of foods, biomaterials, and microorganisms. The contents also present the supercritical carbon dioxide (SC CO2) technology as one of the emerging technologies, which has great potential in the food and pharmaceutical industries. It discusses the SC CO2 technology, its advantages over the prevalent methods for sterilization and stabilization, the processing techniques and selection of process parameters, and the effectiveness of the use of this technology for the aforementioned objectives. It also contains a few case studies. It is a useful textbook for students aspiring for specialized courses in the disciplines of food processing and preservation.