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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
Significance and Use
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 predough or dough stage in accordance with the manufacturer's recommendations.
1.2 Units of premeasured 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).
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D638 Test Method for Tensile Properties of Plastics
D695 Test Method for Compressive Properties of Rigid Plastics
D1193 Specification for Reagent Water
D3835 Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756 Practice for Assessment of Hemolytic Properties of Materials
F763 Practice for Short-Term Screening of Implant Materials
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ANSI/ADA StandardNo.15 Specification for Acrylic Resin Teeth Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295466(Surgical bone cement)