Biocompatibility and Performance of Medical Devices

Author: Jean-Pierre Boutrand
Publisher: Elsevier
ISBN: 0857096451
Format: PDF, Docs
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Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance

Biomaterials Medical Devices and Combination Products

Author: Shayne Cox Gad
Publisher: CRC Press
ISBN: 1482248387
Format: PDF, Kindle
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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 safety of the materials used in producing medical devices as well as the devices themselves. Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market-ready devices. Also incorporated are new case examples and citations with the means of access to Internet-based regulatory and scientific sites, reflecting the universal adoption of this technology into our world. The book takes into consideration the fact that device markets are global, the continual advancement of technology, and the increasing global harmonization of safety regulations. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives.

Surface Coating and Modification of Metallic Biomaterials

Author: Cuie Wen
Publisher: Woodhead Publishing
ISBN: 1782423168
Format: PDF, ePub, Docs
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Despite advances in alternative materials, metals are still the biomaterial of choice for a number of clinical applications such as dental, orthopedic and cardiac implants. However, there are a number of intrinsic problems associated with implanting metal in the biological environment, such as wear, corrosion, biocompatibility and toxicity, which must be addressed. Modern technology has enabled scientists to modify metal surfaces or apply special coatings to metals to improve their performance safety. Surface Coating and Modification of Metallic Biomaterials will discuss the most important modification techniques and coatings for metals, first covering the fundamentals of metals as a biomaterial and then exploring surface modification techniques and coatings. An expansive overview of surface modification techniques for biomedical use In-depth exploration of issues arising from metal biomaterial use Includes examples of applications in a clinical setting

Joining and Assembly of Medical Materials and Devices

Author: Y N Zhou
Publisher: Elsevier
ISBN: 0857096427
Format: PDF, Docs
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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 for Oral and Dental Tissue Engineering

Author: Lobat Tayebi
Publisher: Woodhead Publishing
ISBN: 0081009674
Format: PDF, Docs
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Biomaterials for Oral and Dental Tissue Engineering examines the combined impact of materials, advanced techniques and applications of engineered oral tissues. With a strong focus on hard and soft intraoral tissues, the book looks at how biomaterials can be manipulated and engineered to create functional oral tissue for use in restorative dentistry, periodontics, endodontics and prosthodontics. Covering the current knowledge of material production, evaluation, challenges, applications and future trends, this book is a valuable resource for materials scientists and researchers in academia and industry. The first set of chapters reviews a wide range of biomaterial classes for oral tissue engineering. Further topics include material characterization, modification, biocompatibility and biotoxicity. Part Two reviews strategies for biomaterial scaffold design, while chapters in parts three and four review soft and hard tissues. Connects materials science with restorative dentistry Focuses on the unique field of intraoral tissues Highlights long-term biocompatibility and toxicity of biomaterials for engineered oral tissues

Biomaterials in Plastic Surgery

Author: W Peters
Publisher: Elsevier
ISBN: 0857096419
Format: PDF, ePub
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Employed for both cosmetic and reconstructive purposes, breast implants are one of the most widely-used and controversial prostheses available. The development of safe, reliable products is vital to the future of this important field of surgery. Biomaterials in plastic surgery reviews the history, materials and safety issues associated with breast implants. Beginning with an introduction to the history of biomaterials used for breast augmentation, Biomaterials in plastic surgery goes on to discuss development issues. It then discusses the chemistry and physical properties of biomedical silicones before reviewing cohesive gel and polyurethane foam implants. The book concludes by analysing the epidemiological evidence on the safety issues relating to breast implants, followed by a review of retrieval and analysis of breast implants emphasizing strength, durability and failure mechanisms. With its distinguished editors and international team of expert contributors, Biomaterials in plastic surgery is an important guide for surgeons, manufacturers and all those researching this important field. Comprehensively examines the history, materials and safety issues associated with breast implants Provides an overview of the history of biomaterials used for breast augmentation and goes on to discuss the development and chemical and physical properties of biomedical silicones Reviews cohesive gel breast implants and polyurethane foam breast implants

Implantable Sensor Systems for Medical Applications

Author: Andreas Inmann
Publisher: Elsevier
ISBN: 0857096281
Format: PDF, ePub, Mobi
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Implantable sensor systems offer great potential for enhanced medical care and improved quality of life, consequently leading to major investment in this exciting field. Implantable sensor systems for medical applications provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of these devices in a diverse range of medical applications. Part one reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, microassembly, electrode array design and fabrication, and the use of biofuel cells as sustainable power sources. Part two goes on to consider the challenges associated with implantable systems. Biocompatibility, sterilization considerations and the development of active implantable medical devices in a regulated environment are discussed, along with issues regarding data protection and patient privacy in medical sensor networks. Applications of implantable systems are then discussed in part three, beginning with Microelectromechanical systems (MEMS) for in-vivo applications before further exploration of tripolar interfaces for neural recording, sensors for motor neuroprostheses, implantable wireless body area networks and retina implants. With its distinguished editors and international team of expert contributors, Implantable sensor systems for medical applications is a comprehensive guide for all those involved in the design, development and application of these life-changing technologies. Provides a wide-ranging overview of the core technologies, key challenges and main issues related to the development and use of implantable sensor systems in a range of medical applications Reviews the fundamentals of implantable systems, including materials and material-tissue interfaces, packaging and coatings, and microassembly Considers the challenges associated with implantable systems, including biocompatibility and sterilization

Biomaterials and Medical Device Associated Infections

Author: L Barnes
Publisher: Elsevier
ISBN: 0857097229
Format: PDF, Kindle
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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.

Regulatory Affairs for Biomaterials and Medical Devices

Author: Stephen F. Amato
Publisher: Elsevier
ISBN: 0857099205
Format: PDF, Mobi
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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

Biointegration of Medical Implant Materials

Author: Chandra P. Sharma
Publisher: Elsevier
ISBN: 1845699807
Format: PDF, ePub, Docs
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Biointegration is essential for the successful performance of implanted materials and devices within the human body. With an increasing number and wide range of implant procedures being performed, it is critical that materials scientists and engineers effectively design implant materials which will create a positive biological and mechanical response with the host tissue. Biointegration of medical implant materials provides a unique and comprehensive review of recent techniques and research into material and tissue interaction and integration. Part one discusses soft tissue biointegration with chapters on the biocompatibility of engineered stem cells, corneal tissue engineering and vascular grafts. Part two then reviews particular techniques in drug delivery including inorganic nanoparticles for targeted drug delivery and alginate based drug delivery devices. Part three covers design considerations with coverage of themes such as biocompatibility of materials and its relevance to drug delivery and tissue engineering, mechanisms of failure of medical implants during long term use and rapid prototyping in biomedical engineering. With its distinguished editor and team of international contributors, Biointegration of medical implant materials: science and design is a standard reference for medical materials scientists and engineers in industry and the academic sector. Provides a unique and comprehensive review of recent techniques and research into material and tissue interaction and integration Discusses soft tissue biointegration with chapters on the biocompatibility of engineered stem cells, corneal tissue engineering, vascular grafts and replacement materials for facial reconstruction Reviews particular techniques in drug delivery featuring inorganic nanoparticles and functionalized nanoparticles for targeted drug delivery