Biomedical Material (E-book)
Workshop on Standards for Biomedical Materials and Devices
Published By :
U. S. DEPARTMENT OF COMMERCE
Technology Administration
National Institute of Standards
and Technology
Gaithersburg, MD 20899-8230
U.S. DEPARTMENT OF COMMERCE
Donald L. Evans, Secretary
NATIONAL INSTITUTE OF STANDARDS
AND TECHNOLOGY
Dr. Karen H. Brown, Acting Director
Introduction
The Workshop on Biomedical Materials and Devices, held June 13-14, 2001, is the latest in a series of workshops and topical meetings organized by NIST in the area of biomedical technology. The workshop complements other recent NIST efforts to make its leadership in standards and measurements more available to the health care industry, which accounts for about 13% of the U.S. Gross National Product and continues to grow rapidly.
The primary goal of the workshop was to identify and prioritize standards needs in selected biomedical materials and devices technologies as the basis for a NIST standards strategy in those areas.Thetechnical focus areas in this workshop,
_ Biomaterials
_ Tissue engineered medical devices
_ Therapeutic and drug delivery systems
_ Auditory diagnostic and prosthetic devices
_ Manufacturing and processing of prostheses
were chosen because they are areas in which NIST currently has active projects and is prepared to respond to the findings and recommendations of the workshop. The workshop also addressed three crosscutting topics that are common to all of the focus areas and many other biomedical areas as well:
_ Data exchange and integrity
_ Sterilization
_ Harmonization
A second goal of the workshop was to obtain recommendations for collaborations between NIST and other key stakeholders in the biomedical materials and devices industry to address national and international standards issues. NIST has a long history of effective partnerships with others in many technical and industrial fields and has found that such arrangements can facilitate the acceptance and use of new standards, measurement methods, and technology.
The participants for the workshop were chosen from among a core group of idea generators and decision makers from industrial companies; organizations that shape the standards, regulatory, and research and development environment in which those companies work; and the standards community. The findings and recommendations in this report represent the consensus that they reached on critical standards needs and the actions needed to address them. The workshop participants accomplished a great deal in a limited time. The ideas and plans that were developed already represent a significant result. However, the true success of the workshop will be measured by the actions that NIST and others subsequently take in response to the recommendations in this report.
The Workshop Planning Committee wishes to thank all those who organized, facilitated, and participated in the workshop.
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