ASTM F1839-08
(Specification)Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
ABSTRACT
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
SIGNIFICANCE AND USE
This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.
This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1 Rationale for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.
1.5 This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual material lots.
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.
1.7 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: 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: F 1839 – 08
Standard Specification for
Rigid Polyurethane Foam for Use as a Standard Material for
1
Testing Orthopaedic Devices and Instruments
This standard is issued under the fixed designation F 1839; 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 2. Referenced Documents
2
1.1 This specification covers rigid unicellular polyurethane 2.1 ASTM Standards:
foam for use as a standard material for performing mechanical C 273 Test Method for Shear Properties of Sandwich Core
tests utilizing orthopaedic devices or instruments. The specifi- Materials
cation is applicable to sheets or blocks of foam, or foam that is D 1621 Test Method for Compressive Properties Of Rigid
made by the user using a two-part liquid mixture. Cellular Plastics
1.2 This specification covers polyurethane foam material D 1622 Test Method forApparent Density of Rigid Cellular
that is used in the laboratory for mechanical testing, as Plastics
described in 1.1. These materials are not intended for implan- E4 Practices for Force Verification of Testing Machines
tation into the human body. F 543 Specification and Test Methods for Metallic Medical
1.3 The foam described herein possesses mechanical prop- Bone Screws
erties which are on the order of those reported for human
3. Terminology
cancellous bone. See Appendix X1 Rationale for further
information regarding the appropriateness of using the speci- 3.1 Definitions:
3.1.1 final form—the condition of the foam product when
fied foam as a model for human cancellous bone.
1.4 This specification covers compositional requirements, used by the end user to perform tests of orthopaedic devices or
instruments.
physical requirements, mechanical requirements, and test
methods for rigid polyurethane foam in the solid final form. 3.1.1.1 Discussion—This is the condition of the foam prod-
uct of which all physical and mechanical tests required by this
1.5 This specification provides qualification criteria for
specification are performed.
vendor or end-user processes and acceptance criteria for
individual material lots. 3.1.1.2 solid—the foam is in a uniform solid form, such as
a slab, plate, or block.
1.6 Thisspecificationprovidesmechanicalpropertiesoffive
different grades of foam in the solid final form. A foam that 3.1.2 foam rise direction—the nominal direction that the
foam rises during the polymerization (“foaming”) process,
does not meet the specified mechanical properties shall be
identified as an ungraded foam. either at the supplier’s production facilities for the solid
supplied foam, or at the end-user’s facilities for foam produced
1.7 Unless otherwise indicated, the values stated in SI units
are to be regarded as standard. The values in parentheses are from the liquid supplied form. The foam rise direction shall be
marked on the foam block or indicated in the shipping
mathematical conversions to inch-pound units that are pro-
vided for information only and are not considered standard. documentation for foam that is supplied in the solid form.
3.1.3 grades—The grade designation refers to the nominal
1.8 The following precautionary statement pertains to the
test method portion only, Section 8, of this specification: This density of the foam, in its solid final form, expressed in units
3 3
of kg/m (lbm/ft ). Ten grades of foam have been defined in
standard does not purport to address all of the safety concerns,
if any, associated with its use. It is the responsibility of the user this specification. Their nominal densities are:
3 3
of this standard to establish appropriate safety and health Grade 5: 80.1 kg/m (5.0 lbm/ft )
3 3
Grade 10: 160.2 kg/m (10.0 lbm/ft )
practices and determine the applicability of regulatory limita-
3 3
Grade 12: 192.2 kg/m (12.0 lbm/ft )
tions prior to use. 3 3
Grade 15: 240.3 kg/m (15.0 lbm/ft )
3 3
Grade 20: 320.4 kg/m (20.0 lbm/ft )
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This specification is under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.21 on Osteosynthesis. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Nov. 15, 2008. Published December 2008. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 1997. Last previous edition approved in 2007 as F 1839 – 01(2007). 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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This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1839–01 (Reapproved 2007) Designation: F 1839 – 08
Standard Specification for
Rigid Polyurethane Foam for Use as a Standard Material for
1
Testing Orthopaedic Devices and Instruments
This standard is issued under the fixed designation F 1839; 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 rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests
utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by
the user using a two-part liquid mixture.
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in
1.1. These materials are not intended for implantation into the human body.
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous
bone. SeeAppendix X1 Rationale for further information regarding the appropriateness of using the specified foam as a model for
human cancellous bone.
1.4 Thisspecificationcoverscompositionalrequirements,physicalrequirements,mechanicalrequirements,andtestmethodsfor
rigid polyurethane foam in the solid final form.
1.5 This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual
material lots.
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form.Afoam that does
not meet the specified mechanical properties shall be identified as an ungraded foam.
1.7Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given
for information only.
1.7 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are
mathematical conversions to inch-pound units that are provided for information only and are not considered standard.
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: 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
2
2.1 ASTM Standards:
C 273 Test Method for Shear Properties of Sandwich Core Materials
D 1621 Test Method for Compressive Properties Of Rigid Cellular Plastics
D 1622 Test Method for Apparent Density of Rigid Cellular Plastics
E 4 Practices for Force Verification of Testing Machines
F 543 Specification and Test Methods for Metallic Medical Bone Screws
3. Terminology
3.1 Definitions:
3.1.1 final form—the condition of the foam product when used by the end user to perform tests of orthopedic devices or
instruments. The condition of the foam product of which all physical and mechanical tests required by this specification are
performed. —the condition of the foam product when used by the end user to perform tests of orthopaedic devices or instruments.
3.1.1.1 Discussion—This is the condition of the foam product of which all physical and mechanical tests required by this
specification are performed.
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
F04.21 on Osteosynthesis.
Current edition approved Oct. 1, 2007. Published October 2007. Originally approved in 1997. Last previous edition approved in 2001 as F1839–01.
Current edition approved Nov. 15, 2008. Published December 2008. Originally approved in 1997. Last previous edition approved in 2007 as F 1839 – 01(2007).
2
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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F1839–08
3.1.1.2 solid—the foam is in a uniform solid form, such as a slab, plate
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