Testing and introduction of new materials - Orthopaedic Biomaterials in Research and Practice - page 392

the International Standards Organization (ISO; Geneva, Switzerland)
similarly in the European Community.
Schedule for introduction of a new material
The entire process of introducing a new biomaterial has been suggested
to take as long as 8-11 years. The progression from concept to general
clinical use is shown, for a typical situation, in Table 15.4.
Serendipity and friendly fortune may slightly shorten this progression.
However, for chronic applications in which patients may be facing expo-
sures exceeding 25 years, prudence suggests the need for care and thor-
oughness in developing and introducing new orthopaedic biomaterials.
afterword
Adverse clinical experiences with some joint replacement components
should serve to further temper enthusiasm for the rapid clinical introduc-
tion of novel materials or even of long used biomaterials in novel designs.
Design and material properties are intimately related: new, improved
materials permit new designs; new design approaches produce the need
for new materials. The use of the careful stepwise process described in
this chapter, combined with patience on the part of all stakeholders in
that process, should permit the future evolution and clinical introduction
of new devices fabricated from safe and effective biomaterials.
annotated bibliography
1. Medical Device Amendments of 1976. Public Law 94-295, May 28, 1976.
One of the last official acts of the Ford Presidency; the basic law regu-
lating medical use of biomaterials in the United States.
2. ASTM F748-06 (2010): Standard Practice for Selecting Generic
Biological Test Methods for Materials and Devices. Volume 13.1, Annual
Book of Standards: Medical Devices . American Society for Testing and
Materials, West Conshohocken, PA.
A consensus guide for selection of appropriate biologic tests.
3. ASTM F981-04 (2010): Standard Practice for Assessment of Compatibility
of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone. Volume 13.1, Annual Book of Standards: Medical Devices .
American Society for Testing and Materials, West Conshohocken, PA.
Guide for experimental protocols for biological assays of tissue reaction
to nonabsorbable biomaterials for surgical implants.
4. Blue Book Guidance G95-1, Use of International Standard ISO-10993,
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,'
FDA, May 1, 1995.
5. Design control guidance for medical device manufacturers. FDA, 1997.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guid
ancedocuments/ucm070627.htm, U.S. Food and Drug Administration,
Center for Devices and Radiological Health, Silver Spring, MD.