ASTM F1839-2008e2 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments《作为测试矫形设备标准材料和仪器使用的硬质聚氨酯泡沫塑料标准规范》.pdf

1、Designation: F1839 082Standard 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,

2、 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.1NOTEUnits information was editorially corrected in August 2009.2NOTEUnits in Table 6 were e

3、ditorially corrected from kPa to MPa in December 2011.1. 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

4、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 possess

5、es 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,physi

6、cal 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 propert

7、ies 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 followi

8、ng 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 healthpr

9、actices 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 Ri

10、gid 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

11、.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.3.1.1.2 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 duri

12、ng 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 be1This specification is under the jurisdiction of ASTM Committee F04 onMed

13、ical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Nov. 15, 2008. Published December 2008. Originallyapproved in 1997. Last previous edition approved in 2007 as F1839 01(2007).DOI: 10.1520/F1839-08E02.2For referen

14、ced 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West C

15、onshohocken, PA 19428-2959, United States.marked 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

16、 have been defined in thisspecification. Their nominal densities are: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

17、into one of these ten grades becauseit does not meet one or more of the physical requirements ofSection 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

18、DiscussionThe supplied form may be a solid or aliquid. The foam may be in a uniform solid form such as a slab,plate, or block or a liquid in which two liquid components(base and activator) can be mixed by the end user to producea rigid, unicellular foam slab.4. Physical and Mechanical Requirements4.

19、1 CompositionThe material shall be supplied either insolid or liquid form. The solid or combined liquid parts shallproduce a foam consisting of polyether polyurethane.4.2 Appearance:4.2.1 Solid Supplied FormThe solid foam slab shall befree of obvious extraneous matter, and appear to the unaidedeye t

20、o be uniform throughout the slab in color and porosity.4.2.2 Liquid Supplied FormThe two liquid componentsshall appear to the unaided eye throughout their volumes to beuniform and free from obvious extraneous matter or particulatedebris.4.2.3 Solid Final FormThe solid foam slab shall be freeof obvio

21、us extraneous matter, and appear to the unaided eye tobe uniform throughout the slab in color and porosity.4.3 Void ContentThe material in the solid final form shallmeet the requirements of Table 1 for voids, cracks andnonuniform areas, when examined using the procedures de-scribed in 8.1. All speci

22、mens shall meet this requirement.4.4 DensityThe material in the solid final form shall havea density within the ranges specified in Table 2, according tothe foams grade specification. The density shall be determinedusing the method described in 8.2. All specimens shall meetthis requirement.4.5 Dimen

23、sional StabilityThe material in the solid finalform shall have an average percentage thickness change lessthan 5.0 %, when tested according to the method described in8.3.4.6 Compressive StrengthThe material in the solid finalform shall meet the compressive strength requirements given inTable 3, when

24、 tested according to the method described in 8.4.All specimens shall meet this requirement.4.7 Compressive ModulusThe material in the solid finalform shall meet the compressive modulus requirements givenTABLE 1 Requirements for Voids, Cracks, and Nonuniform AreasDefects RequirementsVoidsVoid depth (

25、measured perpendicularto slabs transverse plane)Void depth shall be less than 50 % ofthe slab thickness, and less than6.35 mmVoid diameter (measured parallel toslabs transverse plane)Larger than 6.35 mm None allowed in any gradeBetween 3.18 mmand 6.35 mmNo more than 10 allowed per 230cm2surface area

26、 for Grades 5 and10. No more than 1 allowed forGrades 12, 15, 20, 25, 30, and 35.None allowed for Grades 40 and 50.Between 1.57 mmand 3.18 mmNo more than 20 allowed per 230cm2surface area for Grades 5 and10. No more than 6 allowed forGrades 12, 15, 20, 25, 30, and 35.No more than 3 allowed for Grade

27、s40 and 50.Cracks None allowedNon-uniform areas Concentrated areas of poorconstruction, irregular cells, and hardand soft spots shall not exceed 10 %of the visible surface areaTABLE 2 Grade Designation and DensityGradeMinimum Density,kg/m3Maximum Density,kg/m35 72.10 88.1010 144.0 176.012 173.0 211.

28、515 216.0 264.520 288.5 352.525 360.5 440.530 432.5 528.535 504.5 617.040 576.5 705.050 721.0 881.0TABLE 3 Requirements for Compressive StrengthGradeMinimumCompressiveStrength,MPaMaximumCompressiveStrength,MPa5 0.4495 0.780010 1.745 2.82012 2.485 3.97015 3.820 6.05020 6.630 10.4525 10.15 16.0030 14.

29、30 22.7035 19.15 30.5540 24.60 39.5550 37.35 61.05F1839 0822in Table 4, when tested according to the method described in8.4. All specimens shall meet this requirement.4.8 Shear StrengthThe material in the solid final formshall meet the shear strength requirements given in Table 5,when tested accordi

30、ng to the method described in 8.5. Allspecimens shall meet this requirement.4.9 Shear ModulusThe material in the solid final formshall meet the shear modulus requirements given in Table 6,when tested according to the method described in 8.5. Allspecimens shall meet this requirement.4.10 Screw Pullou

31、tThe material in the solid final formshall meet the screw pullout requirements given in Table 7,when tested according to the method described in 8.6. Allspecimens shall meet this requirement.5. Significance and Use5.1 This specification describes the compositional require-ments, physical requirement

32、s, mechanical requirements, andtest methods for rigid unicellular polyurethane foam for use intesting orthopaedic devices or instruments.5.2 This foam described in this specification is not intendedto replicate the mechanical properties of human or animalbone. The requirements of this specification

33、are intended toprovide a consistent and uniform material with properties onthe order of human cancellous bone to use as a test mediumwhen testing various orthopaedic devices, such as bone screws.6. Apparatus6.1 Analytical Balance or Scalecapable of weighing foamspecimens to the nearest mg.6.2 Microm

34、eter Dial Gage or Calipercapable of measur-ing dimensions of the foam specimens to 60.1 %.6.3 Conditioning OvenForced-air circulating oven ca-pable of maintaining 121 6 2.8C for 24 h.6.4 Desiccatorcontaining desiccant with high affinity forwater vapor (anhydrous calcium chloride or equivalent).6.5 V

35、acuum Apparatuscapable of applying a vacuumpressure of 508 mm (20 in.) of mercury to foam specimen fordimensional stability test.6.6 Testing Machine and Load Cellconforming to Prac-tices E4 and capable of applying tensile and compressive loadsat a constant displacement rate.7. Sampling and Test Spec

36、imens7.1 The number of test specimens and the specimen sizesrequired for physical characterization and mechanical testingare described in 8.1-8.6. Test specimens are required for eachgrade and formulation.7.2 Test specimens shall be solid foam blocks. The short-transverse direction of the specimens

37、shall coincide with thefoam rise direction of the original foam bun.8. Procedure8.1 Determination of Void Content:8.1.1 Use the foam block specimens described and specifiedin 8.2-8.6.8.1.2 Examine all of the surfaces and edges of test speci-mens for voids and nonuniform areas with the unaided eye.Me

38、asure the dimensions of the void or nonuniform areas usingan instrument capable of measuring 60.025 mm.TABLE 4 Requirements for Compressive ModulusGradeMinimumCompressiveModulus,MPaMaximumCompressiveModulus,MPa5 12.30 20.3510 45.75 71.7012 64.50 100.515 98.00 151.020 167.5 257.525 253.5 390.030 355.

39、5 548.535 472.0 732.040 603.0 941.050 907.5 1435TABLE 5 Requirements for Shear StrengthGradeMinimumShear Strength,MPaMaximumShear Strength,MPa5 0.420 0.80510 1.225 2.01012 1.610 2.58015 2.235 3.51020 3.395 5.27525 4.665 7.27530 6.025 9.49535 7.460 11.9540 8.960 14.5550 12.10 20.40TABLE 6 Requirement

40、s for Shear ModulusGradeMinimumShear Modulus,MPaMaximumShear Modulus,MPa5 5.460 9.00010 15.15 22.7512 19.70 29.2015 27.10 39.7020 40.75 59.2525 55.70 81.1530 71.70 105.035 88.65 131.040 106.5 159.050 144.0 220.0Editorially corrected.TABLE 7 Requirements for Screw PulloutGradeMinimumPullout,NMaximumP

41、ullout,N5 56.00 176.010 220.0 453.012 309.5 592.515 464.5 831.020 770.0 131025 1125 189030 1520 257035 1950 335540 2400 424550 3380 6350F1839 08238.2 Determination of Foam Density:8.2.1 Prepare three specimens, 25.4 by 25.4 by 25.4 mmfrom solid foam.8.2.2 Determine the apparent density of the three

42、foamspecimens, in kg/m3, in accordance with Test Method D1622.8.2.3 Calculate the average apparent density of the threefoam specimens.8.3 Determination of Dimensional Stability:8.3.1 Prepare three specimens, 25.4 by 25.4 by 12.7 mmfrom solid foam.8.3.2 Condition the specimen for 24 h at 21 6 2.8C an

43、d50 6 10 % relative humidity. Measure the specimen thicknessnear the center of the length to 60.025 mm and mark thelocation of the measurement.8.3.3 Place the specimen on a 6.35-mm thick aluminumplate and apply a minimum vacuum pressure of 508 mm ofmercury under a vacuum bag or diaphragm. Place this

44、 assem-bly in a circulating forced-air oven for not less than2hat1216 2.8C. Remove the assembly and allow to cool to 49C orless while maintaining the vacuum.8.3.4 Recondition and remeasure the thickness at themarked location in accordance with 8.3.2. Calculate the per-cent thickness change.8.3.5 Cal

45、culate the average percent thickness change of thethree specimens.8.4 Determination of Compressive Strength and Modulus:8.4.1 Prepare five specimens, 50.8 by 50.8 by 25.4 mm,from solid foam, with the thickness of the specimen parallel tothe foam rise direction. Measure the dimensions within60.025 mm

46、. The specimens shall be conditioned at 24 62.8C for 3 h prior to testing.8.4.2 Test in accordance with Test Method D1621 at 24 62.8C. The specimens shall be oriented such that the axis of thecompressive load is applied parallel to the foam rise direction.8.4.3 Determine the compressive strength usi

47、ng ProcedureA of Test Method D1621 and the maximum compressivemodulus for each specimen.8.4.4 Calculate the average compressive strength and modu-lus of the five specimens.8.5 Determination of Shear Strength and Modulus:8.5.1 Prepare five specimens, 76.2 by 25.4 by 6.35 mm,from solid foam, with the

48、thickness of the specimen parallel tothe foam rise direction. Measure the dimensions within60.025 mm. The specimens shall be conditioned at 24 62.8C for 3 h before testing.8.5.2 Bond the edges of the foam specimen directly to theshear plates with an appropriate adhesive, such as an epoxy, sothat the

49、 foam rise direction is perpendicular to the plane ofmaximum shear stress.8.5.3 Test in accordance with Test Method C273.8.5.4 Determine the shear strength and shear modulus foreach specimen.8.5.5 Calculate the average shear strength and modulus ofthe five specimens.8.6 Determination of Screw Pullout Strength8.6.1 Prepare five specimens, 50.8 by 50.8 by 25.4 mm,from solid foam, with the thickness of the specimen parallel tothe foam rise direction.8.6.2 Obtain five steel screws or threaded tools that meet thethread requirements given