ASTM F451-99ae1 - 10.5.1999
 
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, which 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

F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

F895-11(2016)

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

No. 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.

F756-17

Standard Practice for Assessment of Hemolytic Properties of Materials

F749-20

Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

F813-20

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

D3835-16

Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer

D695-23

Standard Test Method for Compressive Properties of Rigid Plastics

D638-22

Standard Test Method for Tensile Properties of Plastics

D1193-06(2018)

Standard Specification for Reagent Water

F763-22

Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials