ASTM F2033-2005 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.pdf

1、Designation: F 2033 05Standard Specification forTotal Hip Joint Prosthesis and Hip Endoprosthesis BearingSurfaces Made of Metallic, Ceramic, and PolymericMaterials1This standard is issued under the fixed designation F 2033; the number immediately following the designation indicates the year oforigin

2、al adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the requirements for the mat-ing beari

3、ng surfaces of total hip prostheses and hip endopros-theses. More specifically, this specification covers hip jointreplacement of the ball-and-socket configuration. This specifi-cation does not address the tolerance match between the matingbearing surfaces.1.2 This specification covers the sphericit

4、y, surface finishrequirements, and dimensional tolerances for the sphericalarticulating metallic 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 metal

5、lic and ceramic acetabularcomponents, including the inner polymeric bearing surface ofbipolar heads, 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 surfacefini

6、sh requirements for the spherical metallic or ceramicfemoral heads of hip endoprostheses, and the 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 polymer

7、ic portionof the bearing surface are intentionally large due totemperature-induced size changes 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 stat

8、ed in SI units are to be regarded as thestandard. The values given in parentheses are for informationonly.2. Referenced Documents2.1 ISO Documents:2ISO 468 Surface RoughnessParameters, Their Values,and General Rules for Specifying RequirementsISO 4287/1 Surface RoughnessTerminologyISO 4291 Methods f

9、or the Assessment of Departure fromRoundness, Measurement of Variations, and RadiusISO 5436 Surface Texture of ProductsCalibration Speci-mens for Stylus InstrumentsISO 6318-1985 Measurement of RoundnessTerms, Defi-nitions, and Parameters of Roundness (Equivalent to BS3730 Part 1: 1987)ISO 7206-1 Imp

10、lants for SurgeryPartial and Total HipJoint ProsthesisPart I: Classification, Designation ofDimensions, and RequirementsISO 7206-2 Implants for SurgeryPartial and Total HipJoint ProsthesisPart II: Bearing Surfaces Made of Me-tallic and Plastics Materials2.2 ANSI/ASME Document:2ANSI/ASME B46.1-1995 S

11、urface 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 axis of the component and the spherical articulationsurface.3.1.2 Equator of the Articulating SurfaceThe equa

12、tor 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 cutoff length defines the maximalvalue of the mean twist of profile irregularities that shall beconsidered in the

13、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 jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSu

14、bcommittee F04.22 on Arthroplasty.Current edition approved June 1, 2005. Published June 2005. Originallyapproved in 2000. Last previous edition approved in 2000 as F 2033 00a.2Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM In

15、ternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.3.1 Precise definitions of roughness parameters, 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 measuringde

16、vice (diamond or Focodyn) which measures the surfaceroughness. A stylus has a pseudoconical shape with a hemi-spherical tip. Typical sizes for the tip 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 Hea

17、d: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 than those arising from the finishingprocess.3.2.1.2 SphericityThe metal or ceramic spherical bearingsurface of a femoral hip component shall have a dep

18、arture fromroundness of not greater than 10 m (390 in.) This shall bemeasured as DZzin accordance with the Minimum Zone CenterMethod in ISO 4291 measuring the roundness in more thantwo planes, or by the method in Appendix X2. For metallicfemoral heads used in conjunction with metallic acetabularcomp

19、onents and ceramic femoral heads used in conjunctionwith ceramic acetabular components, the departure fromroundness values shall not be greater than 5 m (200 in.).3.2.1.3 Surface FinishWhen measured in accordance withISO 468 or ANSI/ASME B46.1, the spherical bearing surfaceof a femoral component sha

20、ll have a Ravalue not greater than0.05 m (2 in.). The measurements shall be taken at thelocation of the pole and 30 from the pole.3.2.1.4 Dimensional TolerancesThe spherical bearingsurface shall have a diameter equal to the nominal diameterwith a tolerance of +0.0, 0.2 mm (+0.000, 0.008 in.)3.2.1.5

21、For metallic femoral heads used in conjunction withmetallic acetabular components, or ceramic femoral heads usedin conjunction with ceramic acetabular components, 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 Polymer

22、ic Acetabular Components:3.2.2.1 When inspected visually under 5-diopter magnifica-tion, the bearing surface shall be free from particles, scratches,and score marks other than those arising from the finishingprocess.3.2.2.2 Surface FinishWhen measured in accordanceISO 468 or ANSI/ASME B46.1, the sph

23、erical bearing surfaceof the acetabular component shall have a Ravalue not greaterthan 2 m (80 in.)3.2.2.3 Dimensional TolerancesThe spherical socket shallhave a diameter 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

24、 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-tion, the bearing surface shall be free from particles, scratches,and score marks other than those arising from the finishingprocess.3.2.

25、3.2 SphericityThe spherical bearing surface of themetal acetabular component shall have a departure fromroundness of not greater than 5 m (200 in.). This shall bemeasured as DZzin accordance with the Minimum Zone CenterMethod in ISO 4291 measuring the roundness in more thantwo places, or as determin

26、ed by the method in Appendix X2.3.2.3.3 Surface FinishWhen measured in accordance withISO 468 or ANSI/ASME B46.1, the spherical bearing surfaceof the acetabular component shall have a Ravalue of notgreater than 0.05 m (2 in.).3.2.3.4 Under maximum material condition (MMC), thearticulating part of th

27、e socket and metallic head, there shouldbe clearance and both components never produce an interfer-ence fit.3.2.3.5 Metallic heads and sockets from different manufac-turers should not be mated because the combinations oftolerances within the family, surface finish, and configurationfor the different

28、 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, the bearing surface shall be free from particles, scratches,and score marks other than those arising from the finishingprocess.3.2

29、.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 measuredas DZzin accordance with the Minimum Zone Center Methodin ISO 4291 measuring the roundness in more than two planes,or as deter

30、mined by the method in Appendix X2.3.2.4.3 Surface FinishWhen measured in accordance withISO 468 or ANSI/ASME B46.1, the spherical bearing surfaceof the acetabular component shall have a Ravalue of notgreater than 0.05 m (2 in.).3.2.4.4 Under MMC, the articulating part of the socket andceramic head,

31、 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 combinations oftolerances within the family, surface finish, and configurationfor the different manufacturers may not have b

32、een 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, scratches,and score marks other than those arising from the finishingprocess.3.3.2 SphericityThe metal or ceramic spherical

33、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 CenterMethod in ISO 4291 measuring the roundness in more thantwo planes, or as determined by the method in Appendix X2.

34、3.3.3 Surface FinishWhen measured in accordance withISO 468 or ANSI/ASME B46.1, the spherical bearing surfaceof femoral endoprostheses components shall have a Ravaluenot greater than 0.5 m (20 in.).F20330523.3.4 Dimensional TolerancesThe spherical bearing sur-face shall have a diameter equal to the

35、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 Outer SurfaceThe outer surface of bipolar headsshall comply with the specifications in 3.2.4. Report4.1 When

36、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 the measuring instrument, and locations of themeasurements shall be included.5. Keywords5.1 acetabular cup; a

37、rthroplasty; femoral head; roundnessAPPENDIXES(Nonmandatory Information)X1. RATIONALENOTE X1.1Individual designs may vary from this if there is goodengineering rationale supporting the design modifications.X1.1 The primary reasons for this specification are:X1.1.1 To define common parameters for cha

38、racterizationof the roundness and surface finish requirements, and establishdimensional relationships for articulating metallic and ceramicfemoral heads of total hip joint prosthesis.X1.1.2 To characterize the surface finish requirements anddimensional relationships for the spherical concave matings

39、urfaces 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 finish requirements for the spherical femoral headsof hip endoprosthesis.X1.1.4 To provide for interchange

40、ability 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 between mating articulatingsurfaces are part of the design of the device. These mismatchestend to vary wit

41、h 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 diameters or acetabular cup inside diametersis beyond the scope of this specification.X1.5 Roundness measured in mo

42、re 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-ness takes a large number of points around a section of thesphere and determines the roundness of that circl

43、e. 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 to ignore the pole as long as it is a negativefeature. The appended method is not a preferred method todete

44、rmine the sphericity of a femoral head and should only beused if no other method is available to measure roundness.X1.6 The specification of standardized dimensions forfemoral head diameters or acetabular socket diameters isbeyond the scope of this specification.X2. DETERMINATION OF THE GEOMETRIC PR

45、OPERTIES OF 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 equall

46、y about thecircumference 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 s

47、urface. Theangles 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.F2033053X2.1.2 Determine the average diameter by the least squaresmethod as well as the coordinates of the center 0 of the

48、 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 method. Imprecision on the average diametershall include the fa

49、ctor departure from roundness.X2.1.5 The same measures may be repeated on 24 points,excluding the polar point, in order to determine whether thepolar point is in a depression (and thus does not significantlyaffect function) or is projecting.X2.2 Acetabular Component:X2.2.1 Using a three-dimensional measuring machine, witha measuring stylus in accordance with the device to be tested,25 points situated as shown in Fig. X2.2 shall be measured.The25 points shall consist of 8 points spaced equally about thecircumference of the pla