Biocompatibility and Performance of Medical Devices

• Author : Jean-Pierre Boutrand
• Publisher : Woodhead Publishing
• Release : 21 November 2019

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

• Author : Jean-Pierre Boutrand
• Publisher : Elsevier
• Release : 26 October 2012

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

• Author : Nancy J. Stark
• Publisher : Unknown
• Release : 01 March 1996

• Author : Jonathan Black
• Publisher : CRC Press
• Release : 20 December 2005

Bioengineers need a thorough grounding in biocompatibility - the biological performance of materials. Until now, there were no publications suitable for a neophyte in the field; prior publications were either not comprehensive or focused on rather narrow interests. Drawing on the author's 35 years of experience as a teacher, researcher, and consult

• Author : Jonathan Black
• Publisher : CRC Press
• Release : 21 July 1999

A balanced approach to understanding the response of living tissues and systems to manufactured biomaterials and the effect of life processes on the properties and behaviour of successful and unsuccessful biomaterials. This third edition contains a glossary of specialized terms; discussion of the emerging area of tissue engineering; more sources; and more tables to additional generic biomaterials properties.

• Author : Jonathan Black
• Publisher : Marcel Dekker
• Release : 30 May 1992

• Author : Ajay Padsalgikar
• Publisher : William Andrew
• Release : 01 February 2017

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,

• Author : Mike Jenkins,Artemis Stamboulis
• Publisher : Elsevier
• Release : 13 August 2012

Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers. Part one provides a review of the types and properties of bioresorbable medical polymers. The effect of molecular structure on properties is discussed, along with the processing of bioresorbable and other polymers for medical applications. Transport phenomena and the degradation

• Author : Ajay Padsalgikar
• Publisher : William Andrew
• Release : 01 June 2022

Applications of Polyurethanes in Medical Devices provides detailed coverage of polyurethane (PU) chemistry, processing and preparation for performant medical devices. Polyurethanes have found many uses in medical applications, due to their biocompatibility, biostability, physical properties, surface polarity, and the ability to suit the field of application. This book enables the reader to understand polyurethane and how this valuable material can be used in medical devices. Sections cover the chemistry, structure, and properties of polyurethane, with in-depth sections examining raw materials,

• Author : Felipe Avalos Belmontes,Francisco J. González,Miguel Ángel López-Manchado
• Publisher : Springer Nature
• Release : 01 January 2023

This book presents a review of preparation methods for environmentally friendly nanocomposite materials. It describes the combination of biodegradable and biocompatible polymer matrices with nanoparticles, leading to finished products preferably prepared by sustainable methods. The chapters also describe how the addition of synthetic or non-biodegradable particles can influence the properties of the final products. This book presents a general overview of the process from the preparation to the final applications of green nanocomposites. In addition, the book also details the

• Author : Beth Ann Fiedler
• Publisher : Elsevier
• Release : 10 September 2016

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare,

• Author : W Peters,H Brandon,K L Jerina,C Wolf,V L Young
• Publisher : Elsevier
• Release : 02 July 2012

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

• Author : Marie B. Teixeira,Richard Bradley
• Publisher : CRC Press
• Release : 20 September 2002

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA

• Author : David Glocker,Shrirang Ranade
• Publisher : John Wiley & Sons
• Release : 11 July 2016

Medical Coatings and Deposition Technologies is an important new addition to the libraries of medical device designers and manufacturers. Coatings enable the properties of the surface of a device to be controlled independently from the underlying bulk properties; they are often critical to the performance of the device and their use is rapidly growing. This book provides an introduction to many of the most important types of coatings used on modern medical devices as well as descriptions of the techniques

• Author : Julian H. Braybrook
• Publisher : Wiley-Blackwell
• Release : 04 August 1997

This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it.