ASTM F451-21

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F451 −21
Standard Specification for
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Acrylic Bone Cement
ThisstandardisissuedunderthefixeddesignationF451;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
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1.1 This specification covers self-curing resins used primar- 2.1 ASTM Standards:
ily for the fixation of internal orthopedic prostheses. The D638 Test Method for Tensile Properties of Plastics
mixture may be used in either the pre-dough or dough stage in D695 Test Method for Compressive Properties of Rigid
accordance with the manufacturer’s recommendations. Plastics
D1193 Specification for Reagent Water
1.2 Unitsofpre-measuredpowderandliquidaresuppliedin
D3835 Test Method for Determination of Properties of
a form suitable for mixing. The mixture then sets in place.
Polymeric Materials by Means of a Capillary Rheometer
1.3 While a variety of copolymers and comonomers may be
D5296 Test Method for Molecular Weight Averages and
incorporated, the composition of the set cement shall contain
Molecular Weight Distribution of Polystyrene by High
poly(methacrylic acid esters) as its main ingredient.
Performance Size-Exclusion Chromatography
D5630 Test Method for Ash Content in Plastics
1.4 This specification covers compositional, physical
performance, and biocompatibility as well as packaging re- E169 PracticesforGeneralTechniquesofUltraviolet-Visible
Quantitative Analysis
quirements. The biocompatibility of acrylic bone cement as it
hasbeentraditionallyformulatedandusedhasbeenreportedin E275 Practice for Describing and Measuring Performance of
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Ultraviolet and Visible Spectrophotometers
the literature (1, 2).
F619 Practice for Extraction of Materials Used in Medical
1.5 The values stated in SI units are to be regarded as
Devices
standard. No other units of measurement are included in this
F748 PracticeforSelectingGenericBiologicalTestMethods
standard.
for Materials and Devices
1.6 This standard does not purport to address all of the
F749 Practice for Evaluating Material Extracts by Intracuta-
safety concerns, if any, associated with its use. It is the
neous Injection in the Rabbit
responsibility of the user of this standard to establish appro-
F756 Practice for Assessment of Hemolytic Properties of
priate safety, health, and environmental practices and deter-
Materials
mine the applicability of regulatory limitations prior to use.
F763 Practice for Short-Term Screening of Implant Materi-
1.7 This international standard was developed in accor-
als
dance with internationally recognized principles on standard-
F813 Practice for Direct Contact Cell Culture Evaluation of
ization established in the Decision on Principles for the
Materials for Medical Devices
Development of International Standards, Guides and Recom-
F895 TestMethodforAgarDiffusionCellCultureScreening
mendations issued by the World Trade Organization Technical
for Cytotoxicity
Barriers to Trade (TBT) Committee.
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
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This specification is under the jurisdiction of ASTM Committee F04 on Materials on Muscle and Insertion into Bone
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.11 on Polymeric Materials.
Current edition approved March 15, 2021. Published April 2021. Originally
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approved in 1976. Last previous edition approved in 2016 as F451 – 16. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/F0451-21. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
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The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F451−21
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2.2 ANSI/ADA Standard: 4.2.2 Sterility—The powder, as poured from its package,
No. 15 Specification for Acrylic Resin Teeth shall pass the tests described in “Sterility Tests—Solids” (7.5)
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(2).
2.3 ISO Standards:
ISO 5833 Implants for Surgery—Acrylic Resin Cements
4.3 Powder-Liquid Mixture—The material shall conform to
ISO 80000-9 Quantities and Units—Part 9: Physical Chem-
the properties given in Table 1.
istry and Molecular Physics
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2.4 NIST Document:
TABLE 1 Requirements f
...