Abstract
This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient. The mixture may be used in either the predough or dough stage. This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. Materials shall be tested and shall conform to specified values of appearance, stability, sterility, viscosity, intrusion and compressive strength. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used is also detailed.
Scope
1.1 This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the pre-dough or dough stage in accordance with the manufacturer’s recommendations.
1.2 Units of pre-measured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place.
1.3 While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient.
1.4 This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature (1, 2).2
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
