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Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
A Book

by Sophie Lerouge,Anne Simmons

  • Publisher : Elsevier
  • Release : 2012-09-27
  • Pages : 352
  • ISBN : 0857096265
  • Language : En, Es, Fr & De
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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

Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices
A Book

by Stephen F. Amato,Robert M. Ezzell Jr

  • Publisher : Elsevier
  • Release : 2014-10-27
  • Pages : 202
  • ISBN : 0857099205
  • Language : En, Es, Fr & De
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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Biomaterials and Medical Device - Associated Infections

Biomaterials and Medical Device - Associated Infections
A Book

by L Barnes,Ian Cooper

  • Publisher : Elsevier
  • Release : 2014-11-21
  • Pages : 278
  • ISBN : 0857097229
  • Language : En, Es, Fr & De
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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.

Biomaterials in the Design and Reliability of Medical Devices

Biomaterials in the Design and Reliability of Medical Devices
A Book

by Michael N. Helmus

  • Publisher : Springer Science & Business Media
  • Release : 2003-01-31
  • Pages : 226
  • ISBN : 9780306476907
  • Language : En, Es, Fr & De
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This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
Biocompatibility Testing and Safety Assessment

by Shayne Cox Gad,Samantha Gad-McDonald

  • Publisher : CRC Press
  • Release : 2015-12-01
  • Pages : 606
  • ISBN : 1482248387
  • Language : En, Es, Fr & De
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Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Design Engineering of Biomaterials for Medical Devices

Design Engineering of Biomaterials for Medical Devices
A Book

by David Hill

  • Publisher : Wiley
  • Release : 1998-09-16
  • Pages : 480
  • ISBN : 9780471967088
  • Language : En, Es, Fr & De
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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.

Sterilization Validation and Routine Operation Handbook (2001)

Sterilization Validation and Routine Operation Handbook (2001)
Radiation

by Anne F Booth

  • Publisher : CRC Press
  • Release : 2017-11-22
  • Pages : 170
  • ISBN : 1351357565
  • Language : En, Es, Fr & De
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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.

Characterization of biomaterials

Characterization of biomaterials
9. Standards and methods for assessing the safety and biocompatibility of biomaterials

by S.C. Gad

  • Publisher : Elsevier Inc. Chapters
  • Release : 2012-12-19
  • Pages : 334
  • ISBN : 0128091754
  • Language : En, Es, Fr & De
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Evaluation of biocompatability of medical devices and biomaterials to meet regulatory requirement starts with consideration of the ISO-10993 guidance (as currently revised) and relevant local expectations such as the FDA G-95 Memorandum requirements. All of these require one to consider the type and duration of potential patient exposure, then to conduct required testing, and finally to do an integrated risk assessment based on the data collected. This chapter seeks to summarize that effort.

Metals for Biomedical Devices

Metals for Biomedical Devices
A Book

by Mitsuo Niinomi

  • Publisher : Woodhead Publishing
  • Release : 2019-05-17
  • Pages : 596
  • ISBN : 0081026676
  • Language : En, Es, Fr & De
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Metals for Biomedical Devices, Second Edition, has been fully updated and builds upon the success of its first edition, discussing the latest techniques in metal processing methods and the behavior of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Subsequent chapters cover mechanical behavior, degradation and testing, corrosion, wear testing and biocompatibility, the processing of metals for biomedical applications, including topics such as forging metals and alloys, surface treatment, coatings and sterilization. Chapters in the final section discuss the clinical applications of metals, such as cardiovascular, orthopedic and new generation biomaterials. With its distinguished editor and team of expert contributors, this book 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 sterilization Examines metal selection for biomedical devices, considering the biocompatibility of various metals Assesses mechanical behavior and the testing of metals, featuring the latest information on corrosion, fatigue and wear Discusses biodegradable alloys, including a new section on Mg alloys Includes a new section that discusses the use of additive manufacturing in the production of medical devices

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals

by Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans

  • Publisher : Academic Press
  • Release : 2019-06-15
  • Pages : 252
  • ISBN : 0128050829
  • Language : En, Es, Fr & De
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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

Joining and Assembly of Medical Materials and Devices

Joining and Assembly of Medical Materials and Devices
A Book

by Y N Zhou,M D Breyen

  • Publisher : Elsevier
  • Release : 2013-05-31
  • Pages : 574
  • ISBN : 0857096427
  • Language : En, Es, Fr & De
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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

Biomaterials

Biomaterials
Principles and Practices

by Joyce Y. Wong,Joseph D. Bronzino,Donald R. Peterson

  • Publisher : CRC Press
  • Release : 2012-12-06
  • Pages : 281
  • ISBN : 1439872511
  • Language : En, Es, Fr & De
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Most current applications of biomaterials involve structural functions, even in those organs and systems that are not primarily structural in their nature, or very simple chemical or electrical functions. Complex chemical functions, such as those of the liver, and complex electrical or electrochemical functions, such as those of the brain and sense organs, cannot be carried out by biomaterials at this time. With these basic concepts in mind, Biomaterials: Principles and Practices focuses on biomaterials consisting of different materials such as metallic, ceramic, polymeric, and composite. It highlights the impact of recent advances in the area of nano- and microtechnology on biomaterial design. Discusses the biocompatibility of metallic implants and corrosion in an in vivo environment Provides a general overview of the relatively bioinert, bioactive or surface-reactive ceramics, and biodegradable or resorbable bioceramics Reviews the basic chemical and physical properties of synthetic polymers, the sterilization of the polymeric biomaterials, the importance of the surface treatment for improving biocompatibility, and the application of the chemogradient surface for the study on cell-to-polymer interactions Covers the fundamentals of composite materials and their applications in biomaterials Highlights commercially significant and successful biomedical biodegradable polymers Examines failure modes of different types of implants based on material, location, and function in the body The book discusses the role of biomaterials as governed by the interaction between the material and the body, specifically, the effect of the body environment on the material and the effect of the material on the body.

Medical Devices

Medical Devices
Regulations, Standards and Practices

by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo

  • Publisher : Woodhead Publishing
  • Release : 2015-08-18
  • Pages : 256
  • ISBN : 0081002912
  • Language : En, Es, Fr & De
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Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Materials and Coatings for Medical Devices

Materials and Coatings for Medical Devices
Cardiovascular

by Anonim

  • Publisher : ASM International
  • Release : 2009-01-01
  • Pages : 444
  • ISBN : 1615031359
  • Language : En, Es, Fr & De
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"The Materials Information Society, MPMD-Materials and Processes for Medical Devices."

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
New Paradigms to Bring Innovative Healthcare Products to Patients

by Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans

  • Publisher : Academic Press
  • Release : 2019-12-12
  • Pages : 262
  • ISBN : 0128131799
  • Language : En, Es, Fr & De
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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

Plastics in Medical Devices for Cardiovascular Applications

Plastics in Medical Devices for Cardiovascular Applications
A Book

by Ajay Padsalgikar

  • Publisher : William Andrew
  • Release : 2017-02-01
  • Pages : 196
  • ISBN : 0323371221
  • Language : En, Es, Fr & De
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Plastics in Medical Devices for Cardiovascular Applications enables designers of new cardiovascular medical devices to make decisions about the kind of plastics that can go into the manufacture of their device by explaining the property requirements of various applications in this area, including artificial valves, lead insulation, balloons, vascular grafts, and more. Enables designers to improve device performance and remain compliant with regulations by selecting the best material for each application Presents a range of applications, including artificial valves, stents, and vascular grafts Explains which materials can be used for each application, and why each is appropriate, thus assisting in the design of better tools and processes

Polymers in Disposable Medical Devices

Polymers in Disposable Medical Devices
A European Perspective

by Colin R. Blass

  • Publisher : iSmithers Rapra Publishing
  • Release : 1999
  • Pages : 104
  • ISBN : 9781859571828
  • Language : En, Es, Fr & De
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Modelling Degradation of Bioresorbable Polymeric Medical Devices

Modelling Degradation of Bioresorbable Polymeric Medical Devices
A Book

by J Pan

  • Publisher : Elsevier
  • Release : 2014-10-24
  • Pages : 260
  • ISBN : 1782420258
  • Language : En, Es, Fr & De
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The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices. The final set of chapters look at advances in modelling biodegradation of bioresorbable polymers. This book is an essential guide to those concerned with replacing tests and experiments with modelling. Provides a comprehensive mathematical framework for computer modelling of polymers and polymeric medical devices that can significantly reduce the number of experiments needed. Reviews the fundamental methods of modelling degradation, and applies these to particular materials including amorphous bioresorbable polyesters, semicrystalline biodegradable polyesters, and composite materials made of biodegradable polyesters and triclcium phosphates

An Introduction To Biomaterials Science And Engineering

An Introduction To Biomaterials Science And Engineering
A Book

by A Sandeep Kranthi Kiran,Seeram Ramakrishna

  • Publisher : World Scientific
  • Release : 2021-04-22
  • Pages : 412
  • ISBN : 9811228191
  • Language : En, Es, Fr & De
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This book presents a broad scope of the field of biomaterials science and technology, focusing on theory, advances and applications. It is written for those who would like to develop their interest and knowledge towards biomaterials or materials science and engineering. All aspects of biomaterials science are thoroughly addressed, from basic principles of biomaterials, organs and medical devices to advanced topics such as tissue engineering, surface engineering, sterilization techniques, 3D printing and drug delivery systems. Readers are also introduced to major concepts of surface modification techniques, and potential applications of different classes of biomaterials. Multiple-choice questions at the end of every chapter will be helpful for students to test their understanding of each topic, with answers provided at the end of the book.Ultimately, this book offers a one-stop source of information on the essentials of biomaterials and engineering. It is useful both as an introduction and advanced reference on recent advances in the biomaterials field. Suitable readers include undergraduate and graduate students, especially those in Materials Science, Biomedical Engineering and Bioengineering.

Functional Marine Biomaterials

Functional Marine Biomaterials
Properties and Applications

by Se-Kwon Kim

  • Publisher : Elsevier
  • Release : 2015-06-29
  • Pages : 170
  • ISBN : 1782420940
  • Language : En, Es, Fr & De
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Functional Marine Biomaterials: Properties and Applications provides readers with the latest information on the diverse marine environment as a resource for many new substances, including biopolymers, bioceramics, and biominerals. As recent advances and funding has enabled scientists to begin harnessing many of these materials for biomedical applications from drug delivery to bone tissue engineering and biosensors, this important new text provides readers with a comprehensive review of these materials and their functional applications in the biomedical field. Chapters discuss the properties of the main classes of functional marine biomaterials, applications of marine products in tissue engineering, applications in drug delivery systems, and the role of marine derived materials in medical devices. Provides readers with the latest information on the diverse marine environment as a resource for many new substances, including biopolymers, bioceramics, and biominerals Presents a comprehensive review of these materials and their functional applications in the biomedical field Discusses the properties of the main classes of functional marine biomaterials, applications of marine products in tissue engineering, applications in drug delivery systems, and the role of marine derived materials in medical devices