ASTM F2582-20

Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components

SIGNIFICANCE AND USE
5.1 This test method should be used to evaluate and compare different femoral and acetabular prosthesis designs to assess the damage tolerance under controlled laboratory conditions.  
5.2 Although the methodology described attempts to identify physiologically relevant motions and loading conditions, the interpretation of results is limited to an in-vitro comparison between different femoral and acetabular prosthesis designs regarding their ability to resist impingement damage modes (defined in 8.2) under the stated test conditions.
SCOPE
1.1 This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary, quantitative assessment of changes in modular component attachment strength.  
1.2 This test method can be used to evaluate impingement between femoral components and the following: single-piece, modular, semi-constrained, bipolar, constrained, or dual mobility acetabular components, manufactured from polymeric, metallic, or ceramic materials.  
1.3 The values stated in SI units are regarded as the standard.  
1.4 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.  
1.5 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.

General Information

• Status: Published
• Publication Date: 14-Nov-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Standards Content (Sample)

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.
Designation: F2582 − 20
Standard Test Method for
Dynamic Impingement Between Femoral and Acetabular Hip
1
Components
This standard is issued under the fixed designation F2582; 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 F2003Practice for Accelerated Aging of Ultra-High Mo-
lecular Weight Polyethylene after Gamma Irradiation in
1.1 This test method covers a procedure to simulate dy-
Air
namic impingement between femoral and acetabular compo-
F2009Test Method for Determining the Axial Disassembly
nents in a hip replacement; the subsequent qualitative assess-
Force of Taper Connections of Modular Prostheses
ment of damage modes (as outlined in 8.2); and, if necessary,
F2033Specification for Total Hip Joint Prosthesis and Hip
quantitative assessment of changes in modular component
Endoprosthesis Bearing Surfaces Made of Metallic,
attachment strength.
Ceramic, and Polymeric Materials
1.2 This test method can be used to evaluate impingement
F2091Specification for Acetabular Prostheses
between femoral components and the following: single-piece,
3
2.2 ISO Standards:
modular, semi-constrained, bipolar, constrained, or dual mo-
ISO 7206-1Implants for Surgery – Partial and Total Hip
bility acetabular components, manufactured from polymeric,
Joint Prostheses – Part 1: Classification and Designation
metallic, or ceramic materials.
of Dimensions
1.3 The values stated in SI units are regarded as the
ISO 7206-6Implants for Surgery – Partial and Total Hip
standard.
Joint Prostheses – Part 6: Endurance Properties Testing
and Performance Requirements of Neck Region of
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the Stemmed Femoral Components
ISO14242-1ImplantsforSurgery–WearofTotalHip-Joint
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter- Prostheses – Part 1: Loading and Displacement Param-
eters for Wear-Testing Machines and Corresponding En-
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor- vironmental Conditions for Test
dance with internationally recognized principles on standard- ISO 21535Non-Active Surgical Implants – Joint Replace-
ization established in the Decision on Principles for the ment Implants – Specific Requirements for Hip-Joint
Development of International Standards, Guides and Recom- Replacement Implants
4
mendations issued by the World Trade Organization Technical
2.3 FDA Document:
Barriers to Trade (TBT) Committee.
21 CFR 888.6Degree of Constraint
2. Referenced Documents
3. Terminology
2
2.1 ASTM Standards:
3.1 Definitions:
E4Practices for Force Verification of Testing Machines
3.1.1 femoral head—convex spherical bearing member for
F1820Test Method for Determining the Forces for Disas-
articulation with the natural acetabulum or prosthetic acetabu-
sembly of Modular Acetabular Devices
lum.
3.1.2 impingement—the point at which two opposing com-
ponents collide to restrict motion.
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
3.1.3 locking mechanism—the pieces of various compo-
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
F04.22 on Arthroplasty. nentsthatcontributetothefixingofonecomponenttoanother.
Current edition approved Nov. 15, 2020. Published December 2020. Originally
approved in 2008. Last previous edition approved in 2014 as F2582 – 14. DOI:
10.1520/F2582-20.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Food and Drug Administration (FDA), 10903 New
the ASTM website. Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2582 − 20
3.1.4 range of motion—the effective pattern of motion regarding their ability to resist impingement damage modes
limited by impingement. In one plane this is measured from (defined in 8.2) under the stated test conditions.
one impingement poi
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F2582 − 14 F2582 − 20
Standard Test Method for
Impingement of Acetabular ProsthesesDynamic
Impingement Between Femoral and Acetabular Hip
1
Components
This standard is issued under the fixed designation F2582; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number 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 test method covers a procedure to evaluate acetabular component fatigue, deformation, and wear and femoral head
assembly dislocation under dynamic impingement conditions.simulate dynamic impingement between femoral and acetabular
components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary,
quantitative assessment of changes in modular component attachment strength.
1.2 This test method can be used to evaluate single-piece acetabular prostheses, modular prostheses, and constrained prostheses
impingement between femoral components and the following: single-piece, modular, semi-constrained, bipolar, constrained, or
dual mobility acetabular components, manufactured from polymeric, metallic, or ceramic materials.
1.3 The values stated in SI units are regarded as the standard.
1.4 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E467F1820 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing SystemTest Method for
Determining the Forces for Disassembly of Modular Acetabular Devices
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
F2009 Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
F2033 Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and
Polymeric Materials
F2091 Specification for Acetabular Prostheses
1
This test method 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.
Current edition approved April 1, 2014Nov. 15, 2020. Published April 2014December 2020. Originally approved in 2008. Last previous edition approved in 20082014
as F2582 – 08.14. DOI: 10.1520/F2582-14.10.1520/F2582-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2582 − 20
3
2.2 ISO Standards:
ISO 7206-1 Implants for Surgery – Partial and Total Hip Joint Prostheses – Part 1: Classification and Designation of Dimensions
ISO 7206-6 Implants for Surgery – Partial and Total Hip Joint Prostheses – Part 6: Endurance Properties Testing and
Performance Requirements of Neck Region of Stemmed Femoral Components
ISO 14242-1 Implants for Surgery – Wear of Total Hip-Joint Prostheses – Part 1: Loading and Displacement Parameters for
Wear-Testing Machines and Corresponding Environmental Conditions for Test
ISO 14242-2 Implants for Surgery – Wear of Total Hip-Joint Prostheses – Part 2: Methods of Measurement
ISO 21535 Non-Active Surgical Implants – Joint Replacement Implants – Specific Requirements for Hip-Joint Replacement
Implants
4
2.3 FDA Document:
21 CFR 888.6 Degree of Constraint
3. Terminology
3.1 Definitions:
3.1.1 component separation—the disruption of a connection between components. May be stable or unstable.
3.1.2 dislocation—the loss of normal physical con
...