Standard Specification for Acrylic Bone Cement
|Publication Date:||1 October 2016|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the predough or dough stage in accordance with the manufacturer's recommendations.
Units of premeasured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place.
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.
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
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 and health practices and determine the applicability of regulatory limitations prior to use
2 The boldface numbers in parentheses refer to the list of references at the end of this standard