Biocompatibility And Performance Of Medical Devices

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

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

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.

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

The scientific advances in life sciences and engineering are constantly challenging, expanding, and redefining concepts related to the biocompatibility and safety of medical devices. New biomaterials, new products, and new testing regimes are being introduced to scientific research practices. In order to provide clinically predictive results and to ensure a high benefit–risk ratio for patients, we need to optimize material and implant characteristics, and to adapt performance and safety evaluation practices for these innovative medical devices. Various characteristics related to materials and implant development such as raw materials composition, implant surface morphology, design, geometry, porosity, and mechanical properties need to be thoroughly characterized before evaluating the biological performance of implants. Furthermore, with the increase of regulatory demands, biological evaluation needs to ensure appropriate models and methods for each implant development stage. This book is a result of the Special Issue of Materials on "Biomaterials and Implant Biocompatibility”, which focused on the recent progress in development, material testing, and the biocompatibility and bioactivity evaluation of various materials including, but not limited to, bioceramics, biopolymers, biometals, composite materials, biomimetic materials, hybrid biomaterials, and drug/device combinations for implants and prostheses with medical applications spanning from soft to hard tissue regeneration. The book covers aspects ranging from investigations into material characterization to in vitro and in vivo testing for the assessment of biological performance of advanced, novel biomaterials and implants.

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.