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04-27-1995, 01:40 AM
Call for Papers
ASTM Committee F04 Workshop On
SPINAL IMPLANTS -- What Have We Learned from Testing, Failure
Analysis, and Device Retrieval


A work shop entitled "Spinal Implant -- What Have We Learned from
Testing, Failure Analysis, and Device Retrieval" is being sponsored
by ASTM Committee F04 on Medical and Surgical Materials and Devices
and the AAOS/Committee on Biomedical Engineering. It is scheduled
for Tuesday afternoon and Wednesday morning, May 21-22, 1996, in
conjunction with the meetings of ASTM Committee F04 on Medical and
Surgical Materials and Devices in Orlando, Florida. Abstracts from
interested parties in any of the following areas are solicited:

*Individual Device Testing
*Comparative Device Testing
*Comparisons of Spine Model Used in Testing
*Failure Analyses from Device Testing
*Device Retrieval Analyses
*Comparisons of in Vitro Device Failures and Retrieved Devices
*Clinical Information relating to Device Performance and
Integrity

The members of Division III are developing standardized test
methods to evaluate the numerous mechanical characteristics of the
spinal implants and spinal systems. One such standard is a
provisional standard PS-5-94, "Guide for Static and Dynamic Test
Method for Spinal Implant Assembly in a Corpectomy Model." Another
recently approved standard is F1582-95, "Definitions of Terms
Relating to Spinal Implants."

The next obvious step is to relate the results of standardized
testing to the clinical experience, estimate the critical clinical
loading parameters, and determine the most relevant mechanical
testing characteristics. It is hoped that this ASTM workshop will
act as a means of assessment of our current knowledge base,
published standards, and draft standards and will encourage new
standards activities.

Please submit copies abstracts and/or papers by August 31, 1995 to
Mark N. Melkerson, RE: ASTM Workshop 1996, FDA - Office of Device
Evaluation, Mail Stop: HFZ-410, Room 330Q, 9200 Corporate Blvd.,
Rockville, MD, 20850. If you have any questions, you may contact
any of the co-chairpersons: Mark N. Melkerson, FDA/Office of
Device Evaluation, at (301) 594-2036; John S. Kirkpatrick, M.D.,
University of Alabama at Birmingham, (205) 934-5018; Jack M.
Geiger, Ph.D., Electro-Biology, Inc., at (201) 299-9022 or James C.
Bayley, M.D., (AAOS/BME Committee) University of Massachusetts
(508) 856-2360.