Chapter category: BioMaterials
Nonclinical Medical Device Testing
Biomaterials in the Design and Reliability of Medical Devices
Edited by: Michael N. HelmusISBN: 0-306-47690-8
» Get more information about this book at landesbioscience.com «
Chapter authors:
Sharon J. Northup
The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrument, apparatus, appliance material or other article intended by the manufacturer to be used for human beings solely or principally for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, injury, or handicap; investigation, replacement or modification of the anatomy or of a physiological process; or control of conception...” (ISO 10993-1, 1997). Additionally, the definition provides that a medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. Efficacy is embodied in the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap. Safety essentially implies that medical devices will not have an adverse effect on humans when used as intended by the manufacturer. This chapter will provide a review of the biological assays that are commonly used to evaluate the efficacy and safety of medical devices and integrate the information derived from these assays with contemporary recommendations for assessing the potential hazards and health risks for the patient from exposure to medical devices. This chapter contains a general overview of the requirements for safety evaluation and a detailed discussion of laboratory methodologies. Efficacy is reviewed from the dual perspectives of product design and the functional aspects of the medical device.
Additional chapters from this book:
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
Katherine S. Tweden
The majority of medical devices available today are manufactured of relatively inert materials to discourage aggressive biological responses. It has become clear in the last decade or more that the ...
Tissue Engineering Constructs and Commercialization
Kelvin G.M. Brockbank
Tissue engineering is an interdisciplinary field that applies the principles of engineering (materials science and biomedical engineering) and the life sciences (biochemistry, genetics, cell and mol...
Product Development in a Small Company Environment
Roger W. Snyder
A small company, particularly a start-up operation, is an exciting, and often stressful, environment. If the company has a limited number of products, all under development, there is always pressure...
Failure Analysis: Learning for the Future from the Past
Michael N. Helmus
One of the most important tasks a medical device manufacturer can make is to have a detailed methodology in place for explant analysis. The ability to examine the device for both adverse biological ...
Nonclinical Medical Device Testing
Sharon J. Northup
The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrument...
Regulation of Medical Devices
Barry Sall
The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufactur...
Standards and Guidelines for Biocompatibility of Medical Devices
Sharon J. Northup
Strategic management—the formulation, implementation and achievement of objec tives—is essential to establishing the biocompatibility of a new medical device. The harmonization of global requirement...
Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
Michael N. Helmus
Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be ...
