Plastics in Medical Devices
Plastics in Medical Devices

Author: Vinny R. Sastri

Publisher: William Andrew

Published: 2013-11-27

Total Pages: 324

ISBN-13: 0323265634

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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

Biocompatibility and Performance of Medical Devices
Biocompatibility and Performance of Medical Devices

Author: Jean-Pierre Boutrand

Publisher: Woodhead Publishing

Published: 2019-11-21

Total Pages: 592

ISBN-13: 0081026447

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Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

The Combination Products Handbook
The Combination Products Handbook

Author: Susan Neadle

Publisher: CRC Press

Published: 2023-05-16

Total Pages: 439

ISBN-13: 1000874583

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Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

Hydroxyapatite
Hydroxyapatite

Author: Yoshiki Oshida

Publisher: Momentum Press

Published: 2014-12-01

Total Pages: 426

ISBN-13: 1606506749

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Evidence-based literature reviews can provide foundation skills in research-oriented bibliographic inquiry, with an emphasis on such review and synthesis of applicable literature. Information is gathered by surveying a broad array of multidisciplinary research publications written by scholars and researchers. This book is based on a review of about 2,000 carefully selected articles about hydroxyapatite (HA) materials from about 150 peer-review journals in both engineering and medical areas and presents itself as a typical example of evidence-based learning (EBL). HA is very unique material which has been employed equally in both engineering and medical and dental fields. In addition, the name “apatite” comes from the Greek word απατw, which means to deceive. What is actually happening inside the apatite crystal structure is based on the unique characteristics of ion exchangeability. Because of this, versatility of HA has been recognized in wide ranges, including bone-grafting substitutes, various ways to fabricate HAs, HA-based coating materials, HA-based biocomposites, scaffold materials, and drug-delivery systems. This book covers all these interesting areas involved in HA materials science and technology.

Plastics in Medical Devices
Plastics in Medical Devices

Author: Vinny R. Sastri

Publisher: Elsevier

Published: 2010-03-05

Total Pages: 289

ISBN-13: 081552028X

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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.

Medical Device Regulations
Medical Device Regulations

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.