Evaluation of acrylic bone cements and their performance standards

Abstract

Eight acrylic bone cement products were examined according to the methods set out in three published performance standards, viz., Australian Standard 2265 Part 1, 1979, ASTM specification F451-76, and the ISO specification 5833/1, 1979. In addition, chemical analyses were carried out by GC, NMR, and IR spectroscopy as well as refractive index measurement, all to establish the main constituent of the products. All the products compiled to the physical, compositional, and sterility requirements of AS 2265. However, all but one sample failed to comply with the solubility requirements of ASTM F451-76. Also, none of the samples compiled with the doughing time requirements of ISO 5833/1. On further analysis, the results suggest that the water solubility and sorption requirements of ASTM F451-76 are restrictive and that the ISO doughing time test methodology requires modification. Various degrees of noncompliance to the requirement of all three specifications were noted on the labeling and in the information content of product inserts. Two additional clauses on mixing tools and radiopacity have been suggested for incorporation into the above standards.