Introduction

jack E. Lemons

A very dynamic situation continues to exist related to the development and introduction of new surgical implant devices. This, in part, relates to product and business competition. Significant amounts of proprietary research and development is conducted annually throughout the industrial sector, often first seen in product-related literature or within regulatory submissions that become public domain.

Surgical implant standards within the United States are based on consensus organizations with the American Society for Testing and Materials Committee F-4 (ASTM F-4) representing most implant devices. These standards are published annually in Volume 13.10 from the ASTM. Those interested in biomaterials and surgical implant devices should refer to the various national and international sources of product literature and standards as a key source of information. The section components of Chapter 10 will provide related references and sources for obtaining the industrial and standard related literature.

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