ASTM F451-08
(Specification)Standard Specification for Acrylic Bone Cement
Standard Specification for Acrylic Bone Cement
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 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.
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Designation:F451 −08
Standard Specification for
1
Acrylic Bone Cement
ThisstandardisissuedunderthefixeddesignationF451;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D1193Specification for Reagent Water
F619Practice for Extraction of Medical Plastics
1.1 This specification covers self-curing resins used primar-
F748PracticeforSelectingGenericBiologicalTestMethods
ily for the fixation of internal orthopedic prostheses. The
for Materials and Devices
mixture may be used in either the predough or dough stage in
F749Practice for Evaluating Material Extracts by Intracuta-
accordance with the manufacturer’s recommendations.
neous Injection in the Rabbit
1.2 Units of premeasured powder and liquid are supplied in
F756Practice for Assessment of Hemolytic Properties of
a form suitable for mixing. The mixture then sets in place.
Materials
1.3 While a variety of copolymers and comonomers may be F763Practice for Short-Term Screening of Implant Materi-
als
incorporated, the composition of the set cement shall contain
poly(methacrylic acid esters) as its main ingredient. F813Practice for Direct Contact Cell Culture Evaluation of
Materials for Medical Devices
1.4 This specification covers compositional, physical
F895TestMethodforAgarDiffusionCellCultureScreening
performance, and biocompatibility as well as packaging re-
for Cytotoxicity
quirements. The biocompatibility of acrylic bone cement as it
F981Practice for Assessment of Compatibility of Biomate-
hasbeentraditionallyformulatedandusedhasbeenreportedin
2 rials for Surgical Implants with Respect to Effect of
the literature (1, 2).
Materials on Muscle and Bone
1.5 The values stated in SI units are to be regarded as
2.2 ANSI/ADA Standard:
standard. No other units of measurement are included in this
4
No. 15Specification for Acrylic Resin Teeth
standard.
1.6 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 Definitions of Terms Specific to This Standard:
responsibility of the user of this standard to establish appro-
3.1.1 doughing time—thetimeaftercommencementofmix-
priate safety and health practices and determine the applica-
ing at which the mixture ceases to adhere to a standard probe
bility of regulatory limitations prior to use.
(see 7.5).
2. Referenced Documents
3.1.2 exothermic or maximum temperature—the maximum
3
temperature of the mixture due to self-curing in a standard
2.1 ASTM Standards:
mold (see 7.6).
D638Test Method for Tensile Properties of Plastics
D695Test Method for Compressive Properties of Rigid
3.1.3 extrusion—the rate of flow of the material through a
Plastics
standard orifice under load (see 7.8.1).
D3835Test Method for Determination of Properties of
3.1.4 intrusion—the distance of flow of the mixture into a
Polymeric Materials by Means of a Capillary Rheometer
standard mold under load (see 7.8.3).
3.1.5 setting time—the time after commencement of mixing
1
This specification is under the jurisdiction of ASTM Committee F04 on
atwhichthetemperatureofthecuringmassequalstheaverage
Medical and Surgical Materials and Devices and is the direct responsibility of
of the maximum and ambient temperatures (see 7.7).
Subcommittee F04.11 on Polymeric Materials.
Current edition approved Aug. 1, 2008. Published September 2008. Originally
3.1.6 unit—one package or vial of premeasured powder
ε1
approved in 1976. Last previous edition approved in 2007 as F451–99a (2007) .
component and one package or vial of premeasured liquid
DOI: 10.1520/F0451-08.
component.
2
The boldface numbers in parentheses refer to the list of references at the end of
this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F451−08
TABLE 2 Requirements for Cured Polymer After Setting
4. Physical Requirements
Property Requirement
4.1 Liquid:
Compressive Strength, min., MPa 70
4.1.1 Appearance—The liquid shall be free of extraneous
particulate matter or obvious visual contaminants in its con-
tainer.
4.1.2 Stability—Afterbeingheatedfor48hat60 62°C,the
6.2 It will only be necessary to maintain sterility in tests
viscosity of the liquid shal
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:F451–99a (Reapproved 2007) Designation: F 451 – 08
Standard Specification for
1
Acrylic Bone Cement
This standard is issued under the fixed designation F 451; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Sections 7.9.2.1 and X1.1 were editorially corrected in December 2007.
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 Thisspecificationcoverscompositional,physicalperformance,andbiocompatibilityaswellaspackagingrequirements.The
2
biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature(1,2).
1.5This 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.
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
3
2.1 ASTM Standards:
D 638 Test Method for Tensile Properties of Plastics
D 695 Test Method for Compressive Properties of Rigid Plastics
D 3835 Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
E29Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E141Practice for Acceptance of Evidence Based on the Results of Probability Sampling
D 1193 Specification for Reagent Water
F 619 Practice for Extraction of Medical Plastics
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F 756 Practice for Assessment of Hemolytic Properties of Materials
F 763 Practice for Short-Term Screening of Implant Materials
F 813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F 895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
2.2 ANSI/ADA Standard:
4
No. 15 Specification for Acrylic Resin Teeth
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Dec.Aug. 1, 2007.2008. Published JanuarySeptember 2008. Originally approved in 1976. Last previous edition approved in 19992007 as
´1
F 451 – 99a(2007) .
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F451–08
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 doughing time—the time after commencement of mixing at which the mixture ceases to adhere to a standard probe (see
7.5).
3.1.2 exothermicormaximumtemperature—themaximumtemperatureofthemixtureduetoself-cur
...
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