ASTM F2033-00a

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

SCOPE
1.1 This specification covers the requirements for the mating bearing surfaces of total hip prostheses and hip endoprostheses. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration. This specification does not address the tolerance match between the mating bearing surfaces.
1.2 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical articulating metallic or ceramic femoral heads of total hip joint prostheses.
1.3 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads, and the surface finish requirements and dimensional tolerances for the spherical concave mating surface of polymeric acetabular components.
1.4 This specification covers the sphericity and surface finish requirements for the spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads.
1.5 The values stated in SI units are to be regarded as the standard.
1.6 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces. Additionally, the tolerances imposed on the polymeric portion of the bearing surface are intentionally large due to temperature-induced size changes and other manufacturing concerns. Some manufacturing methods or designs may intentionally reduce the diameter of the polymeric bearing to more closely mate with the diameter of the head.

General Information

• Status: Historical
• Publication Date: 09-Nov-2000
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Replaced By: ASTM F2033-05 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
• Effective Date: 01-Jun-2005
• Referred By: ASTM F2582-20 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
• Effective Date: 10-Nov-2000
• Referred By: ASTM F2979-20 - Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
• Effective Date: 10-Nov-2000
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• Effective Date: 10-Nov-2000
• Referred By: ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• Effective Date: 10-Nov-2000
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 10-Nov-2000

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2033 – 00a
Standard Specification for
Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing
Surfaces Made of Metallic, Ceramic, and Polymeric
Materials
This standard is issued under the fixed designation F2033; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
1.1 This specification covers the requirements for the mat- 2.1 ASTM Standards:
ing bearing surfaces of total hip prostheses and hip endopros- F370 Specification for Proximal Femoral Endoprostheses
theses. More specifically, this specification covers hip joint 2.2 ISO Documents:
replacement of the ball-and-socket configuration. This specifi- ISO 468 Surface Roughness-Parameters, Their Values, and
cationdoesnotaddressthetolerancematchbetweenthemating General Rules for Specifying Requirements
bearing surfaces. ISO 4287/1 Surface Roughness - Terminology
1.2 This specification covers the sphericity, surface finish ISO 4291 Methods for the Assessment of Departure from
requirements, and dimensional tolerances for the spherical Roundness, Measurement of Variations, and Radius
articulatingmetallicorceramicfemoralheadsoftotalhipjoint ISO 5436 Surface Texture of Products – Calibration Speci-
prostheses. mens for Stylus Instruments
1.3 This specification covers the sphericity, surface finish ISO 6318-1985 Measurement of Roundness—Terms, Defi-
requirements, and dimensional tolerances for the spherical nitions, and Parameters of Roundness (Equivalent to BS
concave mating surface of metallic and ceramic acetabular 3730 Part 1: 1987)
components, including the inner polymeric bearing surface of ISO 7206-1 Implants for Surgery—Partial and Total Hip
bipolar heads, and the surface finish requirements and dimen- Joint Prosthesis—Part I: Classification, Designation of
sional tolerances for the spherical concave mating surface of Dimensions, and Requirements
polymeric acetabular components. ISO 7206-2 Implants for Surgery—Partial and Total Hip
1.4 This specification covers the sphericity and surface Joint Prosthesis—Part II: Bearing Surfaces Made of Me-
finish requirements for the spherical metallic or ceramic tallic and Plastics Materials
femoral heads of hip endoprostheses, and the outer bearing 2.3 ANSI/ASME Document:
surface of bipolar heads. ANSI/ASME B46.1-1995 Surface Texture
1.5 The values stated in SI units are to be regarded as the
3. Dimensions and Characteristics
standard.
1.6 This specification is intended for standard practice 3.1 Definition:
3.1.1 Pole of the Articulating Surface—The pole of an
regarding the design of total hip joint bearing surfaces.
Additionally, the tolerances imposed on the polymeric portion articulating surface is defined by a point at the intercept of the
revolution axis of the component and the spherical articulation
of the bearing surface are intentionally large due to
temperature-induced size changes and other manufacturing surface.
3.1.2 Equator of the Articulating Surface—The equator of
concerns. Some manufacturing methods or designs may inten-
tionally reduce the diameter of the polymeric bearing to more the articulating surface is the circle normal to the revolution
axis of the component, the center of which is the center of the
closely mate with the diameter of the head.
spherical articulating surface.
3.1.3 Cutoff Length—The cutoff length defines the maximal
value of the mean twist of profile irregularities that shall be
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty. Annual Book of ASTM Standards, Vol 13.01.
Current edition approved Nov. 10, 2000. Published January 2001. Available from American National Standards Institute, 11 W. 42nd St., 13th
Originally published as F2033-00. Last previous edition F2033–00. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 2033
consideredintheroughnessmeasurement,thatis,withacutoff 3.2.3.1 When inspected visually under 5-diopter magnifica-
length of 0.8 mm, the profile irregularities with a mean twist tion, the bearing surface shall be free from particles, scratches,
higher than 0.8 mm shall not be considered. and score marks other than those arising from the finishing
process.
3.1.3.1 Precise definitions of roughness parameters, cutoff
3.2.3.2 Sphericity—The spherical bearing surface of the
length, and roundness are given in ISO 4287/1, ISO 5436, ISO
metal acetabular component shall have a departure from
4291, and ISO 6318:1985.
roundness of not greater than 5 µm (200 µin.). This shall be
3.1.4 Stylus Tip—The stylus tip is the tip of the measuring
measuredas DZ inaccordancewiththeMinimumZoneCenter
z
device (diamond or Focodyn) which measures the surface
MethodinISO4291measuringtheroundnessinmorethantwo
roughness. A stylus has a pseudoconical shape with a hemi-
places, or as determined by the method in Appendix X2.
spherical tip. Typical sizes for the tip are 2, 5, or 10 µm. The
3.2.3.3 Surface Finish—Whenmeasuredinaccordancewith
selection of the stylus tip is dependent on the range of the
ISO 468 or ANSI/ASME B46.1, the spherical bearing surface
roughness measured.
of the acetabular component shall have a R value of not
a
3.2 Total Hip Joint Prosthesis:
greater than 0.05 µm (2 µin.).
3.2.1 Femoral Head:
3.2.3.4 Under maximum material condition (MMC), the
3.2.1.1 When inspected visually under 5-diopter magnifica-
articulating part of the socket and metallic head, there should
tion, the bearing surface shall be free from particles, scratches,
be clearance and both components never produce an interfer-
and score marks other than those arising from the finishing
ence fit.
process.
3.2.3.5 Metallic heads and sockets from different manufac-
3.2.1.2 Sphericity—The metal or ceramic spherical bearing
turers should not be mated because the combinations of
surfaceofafemoralhipcomponentshallhaveadeparturefrom
tolerances within the family, surface finish, and configuration
roundness of not greater than 10 µm (390 µin.) This shall be for the different manufacturers may not have been validated
measuredas DZ inaccordancewiththeMinimumZoneCenter
through appropriate testing.
z
MethodinISO4291measuringtheroundnessinmorethantwo
3.2.4 Ceramic Acetabular Components:
planes,orbythemethodinAppendixX2.Formetallicfemoral
3.2.4.1 When inspected visually under 5-diopter magnifica-
headsusedinconjunctionwithmetallicacetabularcomponents
tion, the bearing surface shall be free from particles, scratches,
and ceramic femoral heads used in conjunction with ceramic
and score marks other than those arising from the finishing
acetabular components, the departure from roundness values
process.
shall not be greater than 5 µm (200 µin.).
3.2.4.2 Sphericity—The ceramic spherical bearing surface
3.2.1.3 Surface Finish—Whenmeasuredinaccordancewith of a acetabular component shall have a departure from round-
ISO 468 or ANSI/ASME B46.1, the spherical bearing surface nessofnotgreaterthan5µm(200µin.).Thisshallbemeasured
of a femoral component shall have a R value not greater than as DZ in accordance with the Minimum Zone Center Method
a z
inISO4291measuringtheroundnessinmorethantwoplanes,
0.05 µm (2 µin.). The measurements shall be taken at the
location of the pole and 30° from the pole. or as determined by the method in Appendix X2.
3.2.4.3 Surface Finish—Whenmeasuredinaccordancewith
3.2.1.4 Dimensional Tolerances—The spherical bearing
ISO 468 or ANSI/ASME B46.1, the spherical bearing surface
surface shall have a diameter equal to the nominal diameter
of the acetabular component shall have a R value of not
with a tolerance of +0.0, −0.2 mm (+0.000, −0.008 in.) a
greater than 0.05 µm (2 µin.).
3.2.1.5 For metallic femoral heads used in conjunction with
3.2.4.4 Under MMC, the articulating part of the socket and
metallicacetabularcomponents,orceramicfemoralheadsused
ceramic head, there should be clearance and both components
inconjunctionwithceramicacetabularcomponents,themanu-
never produce an interference fit.
facturer should report the diameters and tolerances of the
3.2.4.5 Ceramic heads and sockets from different manufac-
heads, if different from the tolerance values in 3.2.1.4.
turers should not be mated because the combinations of
3.2.2 Polymeric Acetabular Components:
tolerances within the family, surface finish, and configuration
3.2.2.1 When inspected visually under 5-diopter magnifica-
for the different manufacturers may not have been validated
tion, the bearing surface shall be free from particles, scratches,
through appropriate testing.
and score marks other tha
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