ASTM_F_1839_-_08_2012.pdf

Designation:F183908(Reapproved 2012)Standard Specification forRigid Polyurethane Foam for Use as a Standard Material forTesting Orthopaedic Devices and Instruments1This standard is issued under the fixed designation F1839;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers rigid unicellular polyurethanefoam for use as a standard material for performing mechanicaltests utilizing orthopaedic devices or instruments.The specifi-cation is applicable to sheets or blocks of foam,or foam that ismade by the user using a two-part liquid mixture.1.2 This specification covers polyurethane foam materialthat is used in the laboratory for mechanical testing,asdescribed in 1.1.These materials are not intended for implan-tation into the human body.1.3 The foam described herein possesses mechanical prop-erties which are on the order of those reported for humancancellous bone.See Appendix X1,Rationale,for furtherinformation regarding the appropriateness of using the speci-fied foam as a model for human cancellous bone.1.4 This specification covers compositional requirements,physical requirements,mechanical requirements,and testmethods for rigid polyurethane foam in the solid final form.1.5 This specification provides qualification criteria forvendor or end-user processes and acceptance criteria forindividual material lots.1.6 This specification provides mechanical properties of fivedifferent grades of foam in the solid final form.A foam thatdoes not meet the specified mechanical properties shall beidentified as an ungraded foam.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.8 The following precautionary statement pertains to thetest method portion only,Section 8,of this specification:Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.Referenced Documents2.1 ASTM Standards:2C273 Test Method for Shear Properties of Sandwich CoreMaterialsD1621 Test Method for Compressive Properties of RigidCellular PlasticsD1622 Test Method for Apparent Density of Rigid CellularPlasticsE4 Practices for Force Verification of Testing MachinesF543 Specification and Test Methods for Metallic MedicalBone Screws3.Terminology3.1 Definitions:3.1.1 final formthe condition of the foam product whenused by the end user to perform tests of orthopaedic devices orinstruments.3.1.1.1 DiscussionThis is the condition of the foam prod-uct of which all physical and mechanical tests required by thisspecification are performed.3.1.1.1 solidthe foam is in a uniform solid form,such asa slab,plate,or block.3.1.2 foam rise directionthe nominal direction that thefoam rises during the polymerization(“foaming”)process,either at the suppliers production facilities for the solidsupplied foam,or at the end-users facilities for foam producedfrom the liquid supplied form.The foam rise direction shall bemarked on the foam block or indicated in the shippingdocumentation for foam that is supplied in the solid form.3.1.3 gradesThe grade designation refers to the nominaldensity of the foam,in its solid final form,expressed in unitsof kg/m3.Ten grades of foam have been defined in thisspecification.Their nominal densities are:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Oct.1,2012.Published October 2012.Originallyapproved in 1997.Last previous edition approved in 2008 as F1839 082.DOI:10.1520/F1839-08R12.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Grade 5:80.1 kg/m3Grade 10:160.2 kg/m3Grade 12:192.2 kg/m3Grade 15:240.3 kg/m3Grade 20:320.4 kg/m3Grade 25:400.5 kg/m3Grade 30:480.5 kg/m3Grade 35:560.6 kg/m3Grade 40:640.7 kg/m3Grade 50:800.9 kg/m3Foam that does not fit into one of these ten grades be-cause it does not meet one or more of the physical require-ments of Section 4 is termed ungraded.3.1.3.1 DiscussionGrade 5 designates the nominal valueof 5 lbm/ft3.3.1.4 supplied formthe condition of the foam productwhen received from the supplier by the end user.3.1.4.1 DiscussionThe supplied form may be a solid or aliquid.The foam may be in a uniform solid form su