Applications Of Polymers And Plastics In Medical Devices

Author : Vinny R. Sastri
Publisher : Elsevier
Page : 289 pages
File Size : 40,6 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 : Syed Ali Ashter
Publisher : William Andrew
Page : 306 pages
File Size : 50,7 Mb
Release : 2022-03-09
Category : Technology & Engineering
ISBN : 9780128217382

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Applications of Polymers and Plastics in Medical Devices by Syed Ali Ashter Pdf

Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundamentals, materials, applications and regulatory requirements. Sections cover the role of plastics in medical devices, socioeconomic factors, the classification of medical devices. The performance of, medical grades and suppliers of polymer materials, which are categorized by performance level are also explored, along with manufacturing processes for device components, including extrusion, casting, injection molding and assembly processes. The book then covers applications in detail, examining each device and the role that polymers and plastics play in its construction and function. This is an essential resource for engineers, R&D, and other professionals working on plastics for medical devices and those in the plastics industry, medical device manufacturing, pharmaceuticals, packaging and biotechnology. In an academic setting, this book is of interest to researchers and advanced students in medical plastics, plastics engineering, polymer science, mechanical engineering, chemical engineering, biomedical engineering and materials science. Offers systematic coverage of the major classes of polymers used in medical devices, including properties, characteristics, performance, medical grades and suppliers Reviews regulatory requirements of the FDA and other global agencies, as well as considering quality control and socioeconomic factors Includes the latest advances in plastics for medical devices, such as novel applications, use of bio-based polymers, and processing of reusable medical devices

Author : Ajay Padsalgikar
Publisher : William Andrew
Page : 196 pages
File Size : 48,7 Mb
Release : 2017-02-01
Category : Technology & Engineering
ISBN : 9780323371223

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Plastics in Medical Devices for Cardiovascular Applications by Ajay Padsalgikar Pdf

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

Author : Sina Ebnesajjad
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 47,6 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076682

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Handbook of Polymer Applications in Medicine and Medical Devices by Sina Ebnesajjad Pdf

This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.

Author : Vinny R. Sastri
Publisher : William Andrew
Page : 324 pages
File Size : 50,5 Mb
Release : 2013-11-27
Category : Technology & Engineering
ISBN : 9780323265638

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Plastics in Medical Devices by Vinny R. Sastri Pdf

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices Unique coverage of medical device regulatory aspects, supplier control and process validation Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices

Author : Zheng Zhang,Ophir Ortiz,Ritu Goyal,Joachim Kohn
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 44,9 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076750

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Handbook of Polymer Applications in Medicine and Medical Devices by Zheng Zhang,Ophir Ortiz,Ritu Goyal,Joachim Kohn Pdf

The design and development of tissue-engineered products has benefited from many years of clinical utilization of a wide range of biodegradable polymers. Newly developed biodegradable polymers and modifications of previously developed biodegradable polymers have enhanced the tools available for creating clinically important tissue-engineering applications. Insights gained from studies of cell-matrix interactions, cell-cell signaling, and organization of cellular components, are placing increased demands on medical implants to interact with the patient’s tissue in a more biologically appropriate fashion. Whereas in the twentieth century biocompatibility was largely equated with eliciting no harmful response, the biomaterials of the twenty first century will have to elicit tissue responses that support healing or regeneration of the patient’s own tissue. This chapter surveys the universe of those biodegradable polymers that may be useful in the development of medical implants and tissue-engineered products. Here, we distinguish between biologically derived polymers and synthetic polymers. The materials are described in terms of their chemical composition, breakdown products, mechanism of breakdown, mechanical properties, and clinical limitations. Also discussed are product design considerations in processing of biomaterials into a final form (e.g., gel, membrane, matrix) that will effect the desired tissue response.

Author : Len Czuba
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 49,7 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076644

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Handbook of Polymer Applications in Medicine and Medical Devices by Len Czuba Pdf

This chapter will present a look at the medical device market with a particular focus on the materials of construction of devices and what we can expect in new products looking ahead. A deeper look at some other trends that have an effect on the direction of the medical device industry will be done. Finally, consideration will be given to a number of global factors that can have dramatic effects on our industry.

Author : Kayvon Modjarrad,Sina Ebnesajjad
Publisher : Elsevier
Page : 368 pages
File Size : 42,5 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780323221696

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Handbook of Polymer Applications in Medicine and Medical Devices by Kayvon Modjarrad,Sina Ebnesajjad Pdf

While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they’re creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. Gathers discussions of a large number of applications of polymers in medicine in one place Provides an insight into both the legal and clinical implications of device design Relevant to industry, academic and medical professionals Presents the latest developments in the field, including medical devices on a nano-scale

Author : André Colas,Jim Curtis
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 45,5 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076699

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Handbook of Polymer Applications in Medicine and Medical Devices by André Colas,Jim Curtis Pdf

Silicone materials have been widely used in medicine for over 60 years. Available in a variety of material types, they have unique chemical and physical properties that manifest in excellent biocompatibility and biodurability for many applications. Silicone elastomers have remarkably low glass-transition temperatures and maintain their flexibility over a wide temperature range, enabling them to withstand conditions from cold storage to steam autoclaving. They have high permeability to gases and many drugs, advantageous respectively in wound care or in transdermal drug delivery. They have low surface tension and remarkable chemical stability, enabling biocompatibility and biodurability in many long-term implant applications.

Author : Laurence W. McKeen
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 48,9 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076651

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Handbook of Polymer Applications in Medicine and Medical Devices by Laurence W. McKeen Pdf

Medical devices range from simple devices, to test equipment, to implants. Plastics are used more and more in these devices, for weight, cost, and performance purposes. Examples of medical devices include surgical instruments, catheters, coronary stents, pacemakers, magnetic resonance imaging (MRI) machines, X-ray machines, prosthetic limbs, artificial hips/knees, surgical gloves, and bandages.

Author : Wei He,Roberto Benson
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 48,5 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076668

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Handbook of Polymer Applications in Medicine and Medical Devices by Wei He,Roberto Benson Pdf

Biomaterials are an indispensable element in improving human health and quality of life. Applications of biomaterials include diagnostics (gene arrays and biosensors), medical supplies (blood bags and surgical tools), therapeutic treatments (medical implants and devices), and emerging regenerative medicine (tissue-engineered skin and cartilage). Polymers, being organic, offer a versatility that is unmatched by metals and ceramics. The wide spectrum of physical, mechanical, and chemical properties provided by polymers has fueled the extensive research, development, and applications of polymeric biomaterials. The significance of polymers as biomaterials is reflected in the market size of medical polymers, estimated to be approximately $1 billion. Many of these polymers were initially developed as plastics, elastomers, and fibers for nonmedical industrial applications, but were later developed as biomedical-specific materials. With rapid growth in modern biology and interdisciplinary collaborative efforts, polymeric biomaterials are being fashioned into bioactive and biomimetic materials, with excellent biocompatibility.

Author : Vinny R. Sastri
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 41,5 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076767

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Handbook of Polymer Applications in Medicine and Medical Devices by Vinny R. Sastri Pdf

Over the past 2000 years, many devices have been developed and used in the mitigation and diagnosis of diseases. The materials used in these devices have ranged from stone, wood, metal, ceramics, and most recently plastics. Medical devices have also evolved in sophistication and complexity over time. With the formalization of the scientific method in the seventeenth century such devices became more prevalent [1]. Many medical devices were manufactured by doctors or small companies and sold directly to the public with no government standards or oversight. With the explosion of medical technology in the early twentieth century, several intermediaries had evolved between the medical device industry and the public. In 1879, Dr E.R. Squibb, in an address to the Medical Society of the State of New York, proposed the enactment of a national statute to regulate food and drugs [2]. It was not until 27 years later that the Food and Drug Act of 1906 was introduced into the Congress and signed into law by President Theodore Roosevelt [3]. At that time, devices that were harmful to human safety and health proliferated the market but regulation of medical devices by the Bureau of Chemistry (the precursor to the Food and Drug Administration—FDA) was limited to challenging commercial products only after they had been released into the market. Devices in the marketplace that were defective, adulterated, or misbranded were seized and the device manufacturers were prosecuted in a court of law, but only after the products were sold in the market and caused harm to the end users. Thus, there was a strong need for regulating the devices before they entered the marketplace. An FDA report [4], issued in September 1970, detailed as many as 10,000 injuries and 731 deaths from ineffective medical devices. The report recommended the formation of a regulatory system and body that would enforce the production and sale of safe and effective devices to the public. All medical devices already on the market would be inventoried and classified into a three-tiered system based on their criticality of end use. It also detailed requirements for records and reports, registration and inspection of establishments, and uniform quality assurance programs called good manufacturing practices (GMP). After much lobbying by the FDA, Senate bill SR 510, “The Medical Device Amendments of 1973” was introduced by Senator Edward M. Kennedy and was passed by the Senate in 1975. House bill HR 11124, introduced by Representative Paul Rogers, was passed by the House in 1976. These bills eventually became the Medical Device Amendments of 1976, and were signed into law by President Nixon. The Medical Device Amendments of 1976 became the basis for the medical device regulation in the United States to control and regulate the production of finished devices and thus the device manufacturers themselves.

Author : Markus Schönberger,Marc Hoffstetter
Publisher : William Andrew
Page : 302 pages
File Size : 44,6 Mb
Release : 2016-01-06
Category : Technology & Engineering
ISBN : 9780323374651

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Emerging Trends in Medical Plastic Engineering and Manufacturing by Markus Schönberger,Marc Hoffstetter Pdf

Emerging Trends in Medical Plastic Engineering and Manufacturing gives engineers and materials scientists working in the field detailed insights into upcoming technologies in medical polymers. While plastic manufacturing combines the possibility of mass production and wide design variability, there are still opportunities within the plastic engineering field which have not been fully adopted in the medical industry. In addition, there are numerous additional challenges related to the development of products for this industry, such as ensuring tolerance to disinfection, biocompatibility, selecting compliant additives for processing, and more. This book enables product designers, polymer processing engineers, and manufacturing engineers to take advantage of the numerous upcoming developments in medical plastics, such as autoregulated volume-correction to achieve zero defect production or the development of ‘intelligent’ single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes. Finally, as medical devices get smaller, the book discusses the challenges posed by miniaturization for injection molders, how to respond to these challenges, and the rapidly advancing prototyping technologies. Provides a roadmap to the emerging technologies for polymers in the medical device industry, including coverage of ‘intelligent’ single use products, personalized medical devices, and the integration of manufacturing steps to improve workflows Helps engineers in the biomedical and medical devices industries to navigate and anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, and government regulations Presents tactics readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce defects in production and develop products that enable entirely new treatment possibilities

Author : Colin R. Blass
Publisher : iSmithers Rapra Publishing
Page : 112 pages
File Size : 50,8 Mb
Release : 1999
Category : Technology & Engineering
ISBN : 1859571824

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Polymers in Disposable Medical Devices by Colin R. Blass Pdf

Author : Vinny R. Sastri
Publisher : Unknown
Page : 271 pages
File Size : 44,8 Mb
Release : 2010
Category : Medical instruments and apparatus
ISBN : OCLC:703208394

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Plastics in Medical Devices by Vinny R. Sastri Pdf