ASTM F451-21
(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 pre-dough or dough stage in accordance with the manufacturer’s recommendations.
1.2 Units of pre-measured 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).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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 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.
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Standards Content (Sample)
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
1
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
3
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
2
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
1
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
3
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
2
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
1
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F451−21
4
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)
5
(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
6
2.4 NIST Document:
TABLE 1 Requirements f
...
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.
Designation: F451 − 16 F451 − 21
Standard Specification for
1
Acrylic Bone Cement
This standard is issued under the fixed designation F451; 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. 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 predoughpre-dough or dough stage in accordance with the manufacturer’s recommendations.
1.2 Units of premeasuredpre-measured 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
2
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
3
2.1 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
D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance
Size-Exclusion Chromatography
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 Oct. 1, 2016March 15, 2021. Published December 2016April 2021. Originally approved in 1976. Last previous edition approved in 20082016
as F451 – 08.F451 – 16. DOI: 10.1520/F0451-16.10.1520/F0451-21.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F451 − 21
D5630 Test Method for Ash Content in Plastics
E169 Practices for General Techniques of Ultraviolet-Visible Quantitative Analysis
E275 Practice for Describing and Measuring Performance of Ultraviolet and Visible Spectrophotometers
F619 Practice for Extraction of Materials Used in Medical Devices
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 Insertion into Bone
4
2.2 ANSI/ADA Standard:
No. 15 Specification for Acrylic Resin Teeth
5
2.3 ISO Standards:
ISO 5833 Implants for Surgery—Acrylic Resin Cements
ISO 80000-9 Quantities and Units—Part 9: Physical Chemistry and Molecular Physic
...
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