ASTM F2033-2012 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic Ceramic and Polymeric Materials《金属陶瓷和聚合材料制全髋关节假体和髋部内用.pdf

1、Designation: F2033 12Standard Specification forTotal Hip Joint Prosthesis and Hip Endoprosthesis BearingSurfaces Made of Metallic, Ceramic, and PolymericMaterials1This standard is issued under the fixed designation F2033; the number immediately following the designation indicates the year oforiginal

2、 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 the requirements for the mat-ing bearing

3、surfaces of total hip prostheses and hip endopros-theses. More specifically, this specification covers hip jointreplacement of the ball-and-socket configuration.1.2 This specification covers the sphericity, surface finishrequirements, and dimensional tolerances for the sphericalarticulating metallic

4、 or ceramic femoral heads of total hip jointprostheses.1.3 This specification covers the sphericity, surface finishrequirements, and dimensional tolerances for the sphericalconcave mating surface of metallic and ceramic acetabularcomponents, including the inner polymeric bearing surface ofbipolar he

5、ads, and the surface finish requirements and dimen-sional tolerances for the spherical concave mating surface ofpolymeric acetabular components.1.4 This specification covers the sphericity and surfacefinish requirements for the spherical metallic or ceramicfemoral heads of hip endoprostheses, and th

6、e outer bearingsurface of bipolar heads.1.5 This specification is intended for standard practiceregarding the design of total hip joint bearing surfaces.Additionally, the tolerances imposed on the polymeric portionof the bearing surface are intentionally large due totemperature-induced size changes

7、and other manufacturingconcerns. Some manufacturing methods or designs may inten-tionally reduce the diameter of the polymeric bearing to moreclosely mate with the diameter of the head.1.6 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are for inform

8、ationonly.2. Referenced Documents2.1 ISO Documents:2ISO 4287/1 Surface RoughnessTerminologyISO 4291 Methods for the Assessment of Departure fromRoundness, Measurement of Variations, and RadiusISO 5436 Surface Texture of ProductsCalibration Speci-mens for Stylus InstrumentsISO 6318-1985 Measurement o

9、f RoundnessTerms, Defi-nitions, and Parameters of Roundness (Equivalent to BS3730 Part 1: 1987)ISO 7206-1 Implants for SurgeryPartial and Total HipJoint ProsthesisPart I: Classification, Designation ofDimensions, and RequirementsISO 7206-2 Implants for SurgeryPartial and Total HipJoint ProsthesisPar

10、t II: Bearing Surfaces Made of Me-tallic and Plastics Materials2.2 ANSI/ASME Document:2ANSI/ASME B46.1 -1995 Surface Texture3. Dimensions and Characteristics3.1 Definition:3.1.1 pole of the articulating surfaceThe pole of anarticulating surface is defined by a point at the intercept of therevolution

11、 axis of the component and the spherical articulationsurface.3.1.2 equator of the articulating surfaceThe equator ofthe articulating surface is the circle normal to the revolutionaxis of the component, the center of which is the center of thespherical articulating surface.3.1.3 cutoff lengthThe cuto

12、ff length defines the maximalvalue of the mean twist of profile irregularities that shall beconsidered in the roughness measurement, that is, with a cutofflength of 0.8 mm, the profile irregularities with a mean twisthigher than 0.8 mm shall not be considered.1This specification is under the jurisdi

13、ction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Feb. 15, 2012. Published March 2012. Originallyapproved in 2000. Last previous edition approved in 2005 as F2033 05. DOI:10.1520/F2

14、033-12.2Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.3.1 Precise definitions of roughness parameters

15、, cutofflength, and roundness are given in ISO 4287/1, ISO 5436,ISO 4291, and ISO 6318:1985.3.1.4 stylus tipThe stylus tip is the tip of the measuringdevice (diamond or Focodyn) which measures the surfaceroughness. A stylus has a pseudoconical shape with a hemi-spherical tip. Typical sizes for the t

16、ip are 2, 5, or 10 m. Theselection of the stylus tip is dependent on the range of theroughness measured.3.2 Total Hip Joint Prosthesis:3.2.1 Femoral Head:3.2.1.1 When inspected visually under 5-diopter magnifica-tion, the bearing surface shall be free from particles, scratches,and score marks other

17、than those arising from the finishingprocess.3.2.1.2 sphericityThe metal or ceramic spherical bearingsurface of a femoral hip component shall have a departure fromroundness of not greater than 10 m (390 in.) This shall bemeasured as DZzin accordance with the Minimum Zone CenterMethod in ISO 4291 mea

18、suring the roundness in more thantwo planes, or by the method in Appendix X2. For metallicfemoral heads used in conjunction with metallic acetabularcomponents and ceramic femoral heads used in conjunctionwith ceramic acetabular components, the departure fromroundness values shall not be greater than

19、 5 m (200 in.).3.2.1.3 surface finishWhen measured in accordance withANSI/ASME B46.1, the spherical bearing surface of a femoralcomponent shall have a Ravalue not greater than 0.05 m (2in.). The measurements shall be taken at the location of thepole and 30 from the pole.3.2.1.4 dimensional tolerance

20、sThe spherical bearing sur-face shall have a diameter equal to the nominal diameter witha tolerance of +0.0, 0.2 mm (+0.000, 0.008 in.)3.2.1.5 For metallic femoral heads used in conjunction withmetallic acetabular components, or ceramic femoral heads usedin conjunction with ceramic acetabular compon

21、ents, the manu-facturer should report the diameters and tolerances of theheads, if different from the tolerance values in 3.2.1.4.3.2.2 Polymeric Acetabular Components:3.2.2.1 When inspected visually under 5-diopter magnifica-tion, the bearing surface shall be free from particles, scratches,and scor

22、e marks other than those arising from the finishingprocess.3.2.2.2 surface finishWhen measured in accordance withANSI/ASME B46.1, the spherical bearing surface of theacetabular component shall have a Ravalue not greater than 2m (80 in.)3.2.2.3 dimensional tolerancesThe spherical socket shallhave a d

23、iameter equal to the nominal diameter within atolerance of +0.3, 0.0 mm (+0.012, 0.0 in) at a temperatureof 20 6 2C (68 6 4F). The socket should be oversized to thenominal within the given tolerance range.3.2.3 Metallic Acetabular Components:3.2.3.1 When inspected visually under 5-diopter magnifica-

24、tion, the bearing surface shall be free from particles, scratches,and score marks other than those arising from the finishingprocess.3.2.3.2 sphericityThe spherical bearing surface of themetal acetabular component shall have a departure fromroundness of not greater than 15 m (590 in.). This shall be

25、measured as DZzin accordance with the Minimum Zone CenterMethod in ISO 4291 measuring the roundness in more thantwo places, or as determined by the method in Appendix X2.3.2.3.3 surface finishWhen measured in accordance withANSI/ASME B46.1, the spherical bearing surface of theacetabular component sh

26、all have a Ravalue of not greater than0.05 m (2 in.).3.2.3.4 Diametral clearance values shall be as follows: forhead diameters of 28 to 36 mm, the clearance between thearticulating part of the socket and metallic head, when bothcomponents are at maximum material condition (MMC), shallnever be less 4

27、0 m. When both components are at leastmaterial condition (LMC) the clearance shall never be largerthan 190 m. For head diameters larger than 36 mm, the MMCclearances shall never be less than 70 m or the LMCclearances greater than 360 m.3.2.3.5 Metallic heads and sockets from different manufac-turers

28、 should not be mated because the combinations oftolerances within the family, surface finish, and configurationfor the different manufacturers may not have been validatedthrough appropriate testing.3.2.4 Ceramic Acetabular Components:3.2.4.1 When inspected visually under 5-diopter magnifica-tion, th

29、e bearing surface shall be free from particles, scratches,and score marks other than those arising from the finishingprocess.3.2.4.2 sphericityThe ceramic spherical bearing surfaceof a acetabular component shall have a departure from round-ness of not greater than 5 m (200 in.). This shall be measur

30、edas DZzin accordance with the Minimum Zone Center Methodin ISO 4291 measuring the roundness in more than two planes,or as determined by the method in Appendix X2.3.2.4.3 surface finishWhen measured in accordance withANSI/ASME B46.1, the spherical bearing surface of theacetabular component shall hav

31、e a Ravalue of not greater than0.05 m (2 in.).3.2.4.4 Under MMC, the articulating part of the socket andceramic head, there should be clearance and both componentsnever produce an interference fit.3.2.4.5 Ceramic heads and sockets from different manufac-turers should not be mated because the combina

32、tions oftolerances within the family, surface finish, and configurationfor the different manufacturers may not have been validatedthrough appropriate testing.3.3 Hip Endoprostheses:3.3.1 When inspected visually under 5-diopter magnifica-tion, the bearing surface shall be free from particles, scratch

33、es,and score marks other than those arising from the finishingprocess.3.3.2 sphericityThe metal or ceramic spherical bearingsurface of a femoral hip component shall have a departure fromroundness of not greater than 100 m (3940 in.). This shall bemeasured as DZzin accordance with the Minimum Zone Ce

34、nterMethod in ISO 4291 measuring the roundness in more thantwo planes, or as determined by the method in Appendix X2.F2033 1223.3.3 surface finishWhen measured in accordance withANSI/ASME B46.1, the spherical bearing surface of femoralendoprostheses components shall have a Ravalue not greaterthan 0.

35、5 m (20 in.).3.3.4 dimensional tolerancesThe spherical bearing sur-face shall have a diameter equal to the nominal diameter witha tolerance of +0.0, 0.2 mm (+0.000, 0.008 in.).3.4 Bipolar Heads:3.4.1 inner surfaceThe inner surface of bipolar headsshall comply with the specification in 3.1.2.3.4.2 ou

36、ter surfaceThe outer surface of bipolar headsshall comply with the specifications in 3.2.4. Report4.1 When reporting results of tests to evaluate total hip jointand hip endoprosthesis components for conformance to thisspecification, deviations from the specified stylus tip radius,cutoff length of th

37、e measuring instrument, and locations of themeasurements shall be included.5. Keywords5.1 acetabular cup; arthroplasty; femoral head; roundnessAPPENDIXES(Nonmandatory Information)X1. RATIONALENOTE X1.1Individual designs may vary from this if there is goodengineering rationale supporting the design m

38、odifications.X1.1 The primary reasons for this specification are:X1.1.1 To define common parameters for characterizationof the roundness and surface finish requirements, and establishdimensional relationships for articulating metallic and ceramicfemoral heads of total hip joint prosthesis.X1.1.2 To

39、characterize the surface finish requirements anddimensional relationships for the spherical concave matingsurfaces of articulating components, such that the concavesurfaces are always oversized compared to the mating femoralhead.X1.1.3 To characterize the roundness, diametrical tolerance,and surface

40、 finish requirements for the spherical femoral headsof hip endoprosthesis.X1.1.4 To provide for interchangeability of femoral headsand acetabular cups.X1.1.5 To provide for minimum dimensions based on ac-ceptable clinical usage.X1.2 This specification is based in ISO 7206-2.X1.3 Tolerance mismatches

41、 between mating articulatingsurfaces are part of the design of the device. These mismatchestend to vary with design concepts and manufacturing philoso-phies. Consequently, they are not addressed in this specifica-tion.X1.4 The specification of standardized nominal dimensionsfor femoral head diameter

42、s or acetabular cup inside diametersis beyond the scope of this specification.X1.5 Roundness measured in more than one plane providesa measure of sphericity. The MZC method of measuringroundness is much more precise than the appended method ofmeasuring sphericity. The MZC method of measuring round-n

43、ess takes a large number of points around a section of thesphere and determines the roundness of that circle. By check-ing two or more nonparallel sections, sphericity can beassumed to be the maximum out-of-roundness. Where theappended method only uses 25 points over the whole surfaceand is allowed

44、to ignore the pole as long as it is a negativefeature. The appended method is not a preferred method todetermine the sphericity of a femoral head and should only beused if no other method is available to measure roundness.X1.6 The diametral clearance tolerance values were deter-mined by surveying ma

45、nufacturers of metal-on-metal hiparticulations through the Orthopaedic Surgical ManufacturersAssociation (OSMA). Diametral clearance values were pro-vided for devices that had been used clinically for more thanfive years. The diametral clearance values chosen for thestandard are inclusive of all the

46、 diametral clearance valuesprovided by the manufacturers for the diameter ranges stated inthe standard. It is noted that diametral clearance tolerancevalues are understood to be a necessary but not sufficientassurance of function of the device.F2033 123X2. DETERMINATION OF THE GEOMETRIC PROPERTIES O

47、F THE FEMORAL HEAD AND ACETABULARCOMPONENTSX2.1 Femoral Head:X2.1.1 Using a three-dimensional measuring machine, witha measuring stylus in accordance with the device to be tested,25 points situated as shown in Fig. X2.1 shall be measured.The25 points shall consist of 8 points spaced equally about th

48、ecircumference of the planes AA, BB, and CC, and a measure-ment at the pole. If the articulating surface extends below theequator, then AA shall be coincident with the equator of thefemoral ball. Otherwise,AAshall be a diametral plane, locatedwithin 1 mm of the border or the articulating surface. Th

49、eangles a, b, and c are measured relative to the neck axis andshall be as follows:c = a/3b = 2a/3NOTE X2.1IfAAis coincident with the equator, a = 90, b = 60, andc = 30.X2.1.2 Determine the average diameter by the least squaresmethod as well as the coordinates of the center 0 of the sphereof average diameter.X2.1.3 Determine the departure from roundness as thedifference between the smaller and the larger measured dis-tances from this 0 center.X2.1.4 Determine the measured imprecision due to both themachine and the metho