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ASTM F2033-12

(Specification)

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

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

ABSTRACT
This specification covers the design and dimensional requirements for metallic, ceramic, and polymeric mating bearing surfaces used in total hip joint prostheses and hip endoprostheses, more specifically, hip joint replacements of the ball-and-socket configuration. This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the following: spherical articulating metallic or ceramic femoral heads of total hip joint prostheses; spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads; spherical concave mating surface of polymeric acetabular components; and spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads. This specification, however, does not address the tolerance match between the mating bearing surfaces.
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.
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 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.
1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

General Information

Status
Historical
Publication Date
14-Feb-2012
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

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ASTM F2033-12 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric MaterialsASTM F2033-12 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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ASTM F2033-12 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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REDLINE ASTM F2033-12 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric MaterialsREDLINE ASTM F2033-12 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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REDLINE ASTM F2033-12 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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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:F2033 −12
Standard Specification for
Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing
Surfaces Made of Metallic, Ceramic, and Polymeric
1
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ISO Documents:
1.1 This specification covers the requirements for the mat-
ing bearing surfaces of total hip prostheses and hip endopros- ISO 4287/1Surface Roughness—Terminology
ISO 4291Methods for the Assessment of Departure from
theses. More specifically, this specification covers hip joint
replacement of the ball-and-socket configuration. Roundness, Measurement of Variations, and Radius
ISO 5436Surface Texture of Products—Calibration Speci-
1.2 This specification covers the sphericity, surface finish
mens for Stylus Instruments
requirements, and dimensional tolerances for the spherical
ISO 6318-1985 Measurement of Roundness—Terms,
articulatingmetallicorceramicfemoralheadsoftotalhipjoint
Definitions, and Parameters of Roundness (Equivalent to
prostheses.
BS 3730 Part 1: 1987)
ISO 7206-1Implants for Surgery—Partial and Total Hip
1.3 This specification covers the sphericity, surface finish
Joint Prosthesis—Part I: Classification, Designation of
requirements, and dimensional tolerances for the spherical
Dimensions, and Requirements
concave mating surface of metallic and ceramic acetabular
ISO 7206-2Implants for Surgery—Partial and Total Hip
components, including the inner polymeric bearing surface of
Joint Prosthesis—Part II: Bearing Surfaces Made of Me-
bipolar heads, and the surface finish requirements and dimen-
tallic and Plastics Materials
sional tolerances for the spherical concave mating surface of
2
polymeric acetabular components. 2.2 ANSI/ASME Document:
ANSI/ASME B46.1-1995 Surface Texture
1.4 This specification covers the sphericity and surface
finish requirements for the spherical metallic or ceramic
3. Dimensions and Characteristics
femoral heads of hip endoprostheses, and the outer bearing
3.1 Definition:
surface of bipolar heads.
3.1.1 pole of the articulating surface—The pole of an
1.5 This specification is intended for standard practice
articulating surface is defined by a point at the intercept of the
regarding the design of total hip joint bearing surfaces.
revolution axis of the component and the spherical articulation
Additionally, the tolerances imposed on the polymeric portion
surface.
of the bearing surface are intentionally large due to
3.1.2 equator of the articulating surface—The equator of
temperature-induced size changes and other manufacturing
the articulating surface is the circle normal to the revolution
concerns. Some manufacturing methods or designs may inten-
axis of the component, the center of which is the center of the
tionally reduce the diameter of the polymeric bearing to more
spherical articulating surface.
closely mate with the diameter of the head.
3.1.3 cutoff length—The cutoff length defines the maximal
value of the mean twist of profile irregularities that shall be
1.6 The values stated in SI units are to be regarded as the
consideredintheroughnessmeasurement,thatis,withacutoff
standard. The values given in parentheses are for information
length of 0.8 mm, the profile irregularities with a mean twist
only.
higher than 0.8 mm shall not be considered.
3.1.3.1 Precise definitions of roughness parameters, cutoff
length, and roundness are given in ISO 4287/1, ISO 5436, ISO
1
This specification is under the jurisdiction of ASTM Committee F04 on
4291, and ISO 6318:1985.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
Current edition approved Feb. 15, 2012. Published March 2012. Originally
2
approved in 2000. Last previous edition approved in 2005 as F2033–05. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2033-12. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2033−12
3.1.4 stylus tip—The stylus tip is the tip of the measuring MethodinISO4291measuringtheroundnessinmorethantwo
device (diamond or Focodyn) which measures the surface places, or as determined by the method in Appendix X2.
roughness. A stylus has a pseudoconical shape with a hemi-
3.2.3.3 surface finish—When measured in accordance with
spherical tip. Typical sizes for the tip are 2, 5, or 10 µm. The ANSI/ASME B46.1, the spherica
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2033–05 Designation: F2033 – 12
Standard Specification for
Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing
Surfaces Made of Metallic, Ceramic, and Polymeric
1
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 (´) indicates an editorial change since the last revision or reapproval.
1. 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 Thisspecificationcoversthesphericity,surfacefinishrequirements,anddimensionaltolerancesforthesphericalarticulating
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
matingsurfaceofmetallicandceramicacetabularcomponents,includingtheinnerpolymericbearingsurfaceofbipolarheads,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 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces.Additionally, the
tolerancesimposedonthepolymericportionofthebearingsurfaceareintentionallylargeduetotemperature-inducedsizechanges
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.
1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
2. Referenced Documents
2
2.1 ISO Documents: ISO 468Surface Roughness—Parameters, Their Values, and General Rules for Specifying Requirements
ISO 4287/1 Surface Roughness—Terminology
ISO 4291 Methods for the Assessment of Departure from Roundness, Measurement of Variations, and Radius
ISO 5436 Surface Texture of Products—Calibration Specimens for Stylus Instruments
ISO6318-1985 MeasurementofRoundness—Terms,Definitions,andParametersofRoundness(EquivalenttoBS3730Part1:
1987)
ISO 7206-1 Implants for Surgery—Partial and Total Hip Joint Prosthesis—Part I: Classification, Designation of Dimensions,
and Requirements
ISO 7206-2 Implants for Surgery—Partial and Total Hip Joint Prosthesis—Part II: Bearing Surfaces Made of Metallic and
Plastics Materials
2
2.2 ANSI/ASME Document:
ANSI/ASME B46.1-1995Surface Texture ANSI/ASME B46.1 -1995 Surface Texture
3. Dimensions and Characteristics
3.1 Definition:
3.1.1 Pole of the Articulating Surfacepole of the articulating surface—The pole of an articulating surface is defined by a point
at the intercept of the revolution axis of the component and the spherical articulation surface.
3.1.2 Equatorequator of the Aarticulating S surface—The equator of the articulating surface is the circle normal to the
1
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.
CurrenteditionapprovedJune1,2005.PublishedJune2005.Originallyapprovedin2000.Lastpreviouseditionapprovedin2000asF2033–00a.DOI:10.1520/F2033-05.
Current edition approved Feb. 15, 2012. Published March 2012. Originally approved in 2000. Last previous edition approved in 2005 as F2033–05. DOI:
10.1520/F2033-12.
2
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2033 – 12
revolution axis of the component, the center of which is the center of the spherical articulating surface.
3.1.3 Cutoff Lengthcutoff length—The cutoff length defines the maximal value of the mean twist of profile irregularities that
shall be considered in the roughness measurement, that is, with a cutoff len
...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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