ASTM F451-16

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).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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F451 −16
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 D3835Test Method for Determination of Properties of
Polymeric Materials by Means of a Capillary Rheometer
1.1 This specification covers self-curing resins used primar-
F619Practice for Extraction of Medical Plastics
ily for the fixation of internal orthopedic prostheses. The
F748PracticeforSelectingGenericBiologicalTestMethods
mixture may be used in either the predough or dough stage in
for Materials and Devices
accordance with the manufacturer’s recommendations.
F749Practice for Evaluating Material Extracts by Intracuta-
1.2 Units of premeasured powder and liquid are supplied in
neous Injection in the Rabbit
a form suitable for mixing. The mixture then sets in place.
F756Practice for Assessment of Hemolytic Properties of
1.3 While a variety of copolymers and comonomers may be Materials
F763Practice for Short-Term Screening of Implant Materi-
incorporated, the composition of the set cement shall contain
poly(methacrylic acid esters) as its main ingredient. als
F813Practice for Direct Contact Cell Culture Evaluation of
1.4 This specification covers compositional, physical
Materials for Medical Devices
performance, and biocompatibility as well as packaging re-
F895TestMethodforAgarDiffusionCellCultureScreening
quirements. The biocompatibility of acrylic bone cement as it
for Cytotoxicity
hasbeentraditionallyformulatedandusedhasbeenreportedin
2 F981Practice for Assessment of Compatibility of Biomate-
the literature (1, 2).
rials for Surgical Implants with Respect to Effect of
1.5 The values stated in SI units are to be regarded as
Materials on Muscle and Insertion into Bone
standard. No other units of measurement are included in this
2.2 ANSI/ADA Standard:
standard.
4
No. 15Specification for Acrylic Resin Teeth
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3. Terminology
responsibility of the user of this standard to establish appro-
3.1 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
3.1.1 doughing time—thetimeaftercommencementofmix-
bility of regulatory limitations prior to use.
ing at which the mixture ceases to adhere to a standard probe
(see 7.5).
2. Referenced Documents
3.1.2 exothermic or maximum temperature—the maximum
3
2.1 ASTM Standards:
temperature of the mixture due to self-curing in a standard
D638Test Method for Tensile Properties of Plastics
mold (see 7.6).
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).
D1193Specification for Reagent Water
3.1.4 intrusion—the distance of flow of the mixture into a
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
Subcommittee F04.11 on Polymeric Materials.
of the maximum and ambient temperatures (see 7.7).
Current edition approved Oct. 1, 2016. Published December 2016. Originally
3.1.6 unit—one package or vial of premeasured powder
approved in 1976. Last previous edition approved in 2008 as F451–08. DOI:
10.1520/F0451-16.
component and one package or vial of premeasured liquid
2
The boldface numbers in parentheses refer to the list of references at the end of
component.
this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. 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 ----------------------
F451−16
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.
7. Test Methods and Sample Size
4.1.2 Stability—Afterbeingheatedfor48hat60 62°C,the
7.1 Maintain all equipment, mixing surfaces, and materi
...

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 − 08 F451 − 16
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 predough or dough stage in accordance with the manufacturer’smanufacturer’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
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 and health practices and determine the applicability of regulatory
limitations prior to use.
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
D1193 Specification for Reagent Water
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 Insertion into Bone
2.2 ANSI/ADA Standard:
4
No. 15 Specification for Acrylic Resin Teeth
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
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 Aug. 1, 2008Oct. 1, 2016. Published September 2008December 2016. Originally approved in 1976. Last previous edition approved in 20072008
ε1
as F451 – 99a (2007)F451 – 08. . DOI: 10.1520/F0451-08.10.1520/F0451-16.
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 [e-mail]. 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 − 16
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 exothermic or maximum temperature—the maximum temperature of the mixture due to self-curing in a standard mold (see
7.6).
3.1.3 extrusion—the rate of flow of the material through a standard orifice under load (see 7.8.1).
3.1.4 intrusion—the distance of flow of the mixture into a standard mold under load (see 7.8.3).
3.1.5 setting time—the time after commencement of mixing at which the temperature of the curing mass equals the average of
the maximum and ambient temperatures (see 7.7).
3.1.6 unit—one package or vial of preme
...