ASTM F1801-20

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

SIGNIFICANCE AND USE
4.1 Implants, particularly orthopedic devices, are usually exposed to dynamic forces. Thus, implant materials must have high fatigue resistance in the physiological environment.  
4.1.1 This practice provides a procedure for fatigue testing in a simulated physiological environment. Axial tension-tension fatigue tests in an environmental test chamber are recommended as a standard procedure. The axial fatigue loading shall comply with Practices E466 and E467.
4.1.1.1 Bending and rotating bending beam fatigue tests or torsion tests may be performed in a similar environmental cell.  
4.1.2 This practice is intended to assess the fatigue and corrosion fatigue properties of materials that are employed or projected to be employed for implants. This practice is suitable for studying the effects of different material treatments and surface conditions on the fatigue behavior of implant materials. The loading mode of the actual implants may be different from that of this practice. Determining the fatigue behavior of implants and implant components may require separate tests that consider the specific design and loading mode.  
4.1.3 As a substitute for body fluid, 0.9 % saline solution is recommended as a standard environment. One of the various Ringer's solutions or another substitute for body fluid may also be suitable for particular tests. However, these various solutions may not give equal fatigue endurance results. The chloride ions are the most critical constituent in these solutions for initiating corrosion fatigue.  
4.1.4 Because implants are manufactured from highly corrosion-resistant materials, no visible corrosion may be detectable when inspected by means of optical microscopy or scanning electron microscopy. Only a decrease of fatigue strength in the high cycle range may be noticeable. Therefore, S-N curves covering a broad fatigue loading range should be generated in the test solution and in air. Comparison of fatigue curves generated in air and saline sol...
SCOPE
1.1 This practice covers the procedure for performing corrosion fatigue tests to obtain S-N (3.2.1) fatigue curves or statistically derived fatigue strength values, or both, for metallic implant materials. This practice describes the testing of axially loaded fatigue specimens subjected to a constant amplitude, periodic forcing function in saline solution at 37°C and in air at room temperature. The environmental test method for implant materials may be adapted to other modes of fatigue loading such as bending or torsion. While this practice is not intended to apply to fatigue tests on implantable components or devices, it does provide guidelines for fatigue tests with standard specimens in an environment related to physiological conditions.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 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.  
1.4 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: 30-Sep-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

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: F1801 − 20
Standard Practice for
1
Corrosion Fatigue Testing of Metallic Implant Materials
This standard is issued under the fixed designation F1801; 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 practice covers the procedure for performing cor- 2.1 ASTM Standards:
rosion fatigue tests to obtain S-N (3.2.1) fatigue curves or E4Practices for Force Verification of Testing Machines
statistically derived fatigue strength values, or both, for metal- E466Practice for Conducting Force Controlled Constant
lic implant materials. This practice describes the testing of Amplitude Axial Fatigue Tests of Metallic Materials
E467Practice for Verification of Constant Amplitude Dy-
axially loaded fatigue specimens subjected to a constant
namic Forces in an Axial Fatigue Testing System
amplitude, periodic forcing function in saline solution at 37°C
E468Practice for Presentation of Constant Amplitude Fa-
and in air at room temperature.The environmental test method
tigue Test Results for Metallic Materials
forimplantmaterialsmaybeadaptedtoothermodesoffatigue
E739PracticeforStatisticalAnalysisofLinearorLinearized
loading such as bending or torsion. While this practice is not
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
intendedtoapplytofatiguetestsonimplantablecomponentsor
E1012Practice for Verification of Testing Frame and Speci-
devices, it does provide guidelines for fatigue tests with
men Alignment Under Tensile and Compressive Axial
standard specimens in an environment related to physiological
Force Application
conditions.
E1150Definitions of Terms Relating to Fatigue (Withdrawn
3
1.2 The values stated in either SI units or inch-pound units
1996)
are to be regarded separately as standard. The values stated in
F86Practice for Surface Preparation and Marking of Metal-
each system may not be exact equivalents; therefore, each
lic Surgical Implants
system shall be used independently of the other. Combining
F601Practice for Fluorescent Penetrant Inspection of Me-
values from the two systems may result in non-conformance
tallic Surgical Implants
with the standard.
G15Terminology Relating to Corrosion and CorrosionTest-
3
ing (Withdrawn 2010)
1.3 This standard does not purport to address all of the
4
safety concerns, if any, associated with its use. It is the
2.2 ANSI Standard:
responsibility of the user of this standard to establish appro-
ANSI B46.1Surface Texture
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3. Terminology
1.4 This international standard was developed in accor-
3.1 Definitions:
dance with internationally recognized principles on standard-
3.1.1 Theterminologyusedinconjunctionwiththispractice
ization established in the Decision on Principles for the
complies with E1150 and Terminology G15.
Development of International Standards, Guides and Recom-
3.2 Definitions of Terms Specific to This Standard:
mendations issued by the World Trade Organization Technical
3.2.1 S-N curves—S-N curves (also known as Wöhler-
Barriers to Trade (TBT) Committee.
curves)showthecorrelationbetweentheappliedstress(S)and
the counted number (N) of cycles to failure.
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
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland Standards volume information, refer to the standard’s Document Summary page on
Surgical Materials and Devices and is the direct responsibility of Subcommittee the ASTM website.
3
F04.15 on Material Test Methods. The last approved version of this historical standard is referenced on
Current edition approved Oct. 1, 2020. Published October 2020. Originally www.astm.org.
4
approved in 1997. Last previous edition approved in 2014 as F1801–97(2014). Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/F1801-20. 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 ----------------------
F1801 − 20
4. Significance and Use 5.2.1 Tension-tensionfatiguetestsmaybeperformedonone
of the following types of axial fatigue testing machines:
4.1 Implants, particularly orthopedic devices, are usually
5.2.
...

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: F1801 − 97 (Reapproved 2014) F1801 − 20
Standard Practice for
1
Corrosion Fatigue Testing of Metallic Implant Materials
This standard is issued under the fixed designation F1801; 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 practice covers the procedure for performing corrosion fatigue tests to obtain S-N (3.2.1) fatigue curves or statistically
derived fatigue strength values, or both, for metallic implant materials. This practice describes the testing of axially loaded fatigue
specimens subjected to a constant amplitude, periodic forcing function in saline solution at 37°C and in air at room temperature.
The environmental test method for implant materials may be adapted to other modes of fatigue loading such as bending or torsion.
While this practice is not intended to apply to fatigue tests on implantable components or devices, it does provide guidelines for
fatigue tests with standard specimens in an environment related to physiological conditions.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
1.3 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.
1.4 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
E466 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E468 Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials
E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
E1012 Practice for Verification of Testing Frame and Specimen Alignment Under Tensile and Compressive Axial Force
Application
3
E1150 Definitions of Terms Relating to Fatigue (Withdrawn 1996)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved Oct. 1, 2014Oct. 1, 2020. Published November 2014October 2020. Originally approved in 1997. Last previous edition approved in 20092014
ε1
as F1801 – 97 (2014).(2009) . DOI: 10.1520/F1801-97R14.10.1520/F1801-20.
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.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1801 − 20
3
G15 Terminology Relating to Corrosion and Corrosion Testing (Withdrawn 2010)
4
2.2 ANSI Standard:
ANSI B46.1 Surface Texture
3. Terminology
3.1 Definitions:
3.1.1 The terminology used in conjunction with this practice complies to Terminology with E1150 and Terminology G15.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 S-N curves—S-N curves (also known as Wöhler-curves) show the correlation between the applied stress (S) and the counted
number (N) of cycles to failure.
4. Significance and Use
4.1 Implants, parti
...