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ASTM F2033-05

(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. 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 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
31-May-2005
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

Relations

Replaces
ASTM F2033-00a - 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 F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
01-Jun-2005
Referred By
ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Effective Date
01-Jun-2005
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
01-Jun-2005
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
01-Jun-2005
Referred By
ASTM F2582-20 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
Effective Date
01-Jun-2005

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ASTM F2033-05 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric MaterialsASTM F2033-05 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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ASTM F2033-05 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
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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 – 05
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
1.1 This specification covers the requirements for the mat- 2.1 ISO Documents:
ing bearing surfaces of total hip prostheses and hip endopros- ISO 468 Surface Roughness—Parameters, Their Values,
theses. More specifically, this specification covers hip joint and General Rules for Specifying Requirements
replacement of the ball-and-socket configuration. This specifi- ISO 4287/1 Surface Roughness—Terminology
cationdoesnotaddressthetolerancematchbetweenthemating ISO 4291 Methods for the Assessment of Departure from
bearing surfaces. Roundness, Measurement of Variations, and Radius
1.2 This specification covers the sphericity, surface finish ISO 5436 Surface Texture of Products—Calibration Speci-
requirements, and dimensional tolerances for the spherical mens for Stylus Instruments
articulatingmetallicorceramicfemoralheadsoftotalhipjoint ISO 6318-1985 Measurement of Roundness—Terms, Defi-
prostheses. nitions, and Parameters of Roundness (Equivalent to BS
1.3 This specification covers the sphericity, surface finish 3730 Part 1: 1987)
requirements, and dimensional tolerances for the spherical ISO 7206-1 Implants for Surgery—Partial and Total Hip
concave mating surface of metallic and ceramic acetabular Joint Prosthesis—Part I: Classification, Designation of
components, including the inner polymeric bearing surface of Dimensions, and Requirements
bipolar heads, and the surface finish requirements and dimen- ISO 7206-2 Implants for Surgery—Partial and Total Hip
sional tolerances for the spherical concave mating surface of Joint Prosthesis—Part II: Bearing Surfaces Made of Me-
polymeric acetabular components. tallic and Plastics Materials
2
1.4 This specification covers the sphericity and surface 2.2 ANSI/ASME Document:
finish requirements for the spherical metallic or ceramic ANSI/ASME B46.1-1995 Surface Texture
femoral heads of hip endoprostheses, and the outer bearing
3. Dimensions and Characteristics
surface of bipolar heads.
1.5 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.
1.6 The values stated in SI units are to be regarded as the spherical articulating surface.
3.1.3 Cutoff Length—The cutoff length defines the maximal
standard. The values given in parentheses are for information
only. value of the mean twist of profile irregularities that shall be
consideredintheroughnessmeasurement,thatis,withacutoff
length of 0.8 mm, the profile irregularities with a mean twist
1
This specification is under the jurisdiction of ASTM Committee F04 on
higher than 0.8 mm shall not be considered.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
Current edition approved June 1, 2005. Published June 2005. Originally
2
approved in 2000. Last previous edition approved in 2000 as F2033–00a. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2033-05. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2033 – 05
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, ISO5436, metal acetabular component shall have a departure from
ISO4291, and ISO 6318:1985. roundness of not greater than 5 µm (200 µin.). This shall be
measuredas DZ inaccordancewiththeMinimumZoneCenter
3.1.4 Stylus Tip—The stylus tip is
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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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.  
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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.  
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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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off