1. 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 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 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.

ASTM Standards

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 Standard

Keywords

acrylic bone cement; compression strength; doughing time; exothermic temperature; extrusion; intrusion; poly(methacrylic acid esters); setting time; Compression testing--surgical applications; Orthopaedic medical devices--specifications; Orthopaedic medical devices (bone)--specifications; Plastic surgical devices/applications--specifications; Polymers (surgical applications)--specifications; Testing methods--surgical implants; Viscosity--acrylic resins; Bone fixation; Doughing time; Hardness (indentation); Intrusion; Rockwell hardness; Setting time; Temperature tests; Water absorption;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0451-99AE01

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