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ASTM F2989-21

(Specification)

Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants.  
1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independent of the other. Combining values from the two systems may result in nonconformance with the specification.  
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
31-Oct-2021
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

Relations

Refers
ASTM F629-20 - Standard Practice for Radiography of Cast Metallic Surgical Implants
Effective Date
01-Feb-2020

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ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant ApplicationsASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
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REDLINE ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant ApplicationsREDLINE ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
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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: F2989 −21
Standard Specification for
Metal Injection Molded Unalloyed Titanium Components for
1
Surgical Implant Applications
This standard is issued under the fixed designation F2989; 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* B923Test Method for Metal Powder Skeletal Density by
Helium or Nitrogen Pycnometry
1.1 This specification covers the chemical, mechanical, and
E3Guide for Preparation of Metallographic Specimens
metallurgical requirements for three grades of metal injection
E8/E8MTest Methods for Tension Testing of Metallic Ma-
molded (MIM) unalloyed titanium components in two types to
terials
be used in the manufacture of surgical implants.
E29Practice for Using Significant Digits in Test Data to
1.2 The Type 1 MIM components covered by this specifi-
Determine Conformance with Specifications
cation may have been densified beyond their as-sintered
E165Practice for Liquid Penetrant Testing for General
density by post-sinter processing.
Industry
E407Practice for Microetching Metals and Alloys
1.3 Values in either inch-pound or SI are to be regarded
separately as standard. The values stated in each system may E539Test Method for Analysis of Titanium Alloys by
WavelengthDispersiveX-RayFluorescenceSpectrometry
not be exact equivalents; therefore, each system shall be used
independent of the other. Combining values from the two E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
systems may result in nonconformance with the specification.
E1447Test Method for Determination of Hydrogen in Tita-
1.4 This standard does not purport to address all of the
nium and Titanium Alloys by Inert Gas Fusion Thermal
safety concerns, if any, associated with its use. It is the
Conductivity/Infrared Detection Method
responsibility of the user of this standard to establish appro-
E1941Test Method for Determination of Carbon in Refrac-
priate safety, health, and environmental practices and deter-
toryandReactiveMetalsandTheirAlloysbyCombustion
mine the applicability of regulatory limitations prior to use.
Analysis
1.5 This international standard was developed in accor-
E2371Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
ization established in the Decision on Principles for the
Plasma Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Test Methodology)
mendations issued by the World Trade Organization Technical
E2626Guide for Spectrometric Analysis of Reactive and
Barriers to Trade (TBT) Committee.
3
Refractory Metals (Withdrawn 2017)
E2994Test Method for Analysis of Titanium and Titanium
2. Referenced Documents
2 AlloysbySparkAtomicEmissionSpectrometryandGlow
2.1 ASTM Standards:
Discharge Atomic Emission Spectrometry (Performance-
B243Terminology of Powder Metallurgy
Based Method)
B311Test Method for Density of Powder Metallurgy (PM)
F67Specification for Unalloyed Titanium, for Surgical Im-
Materials Containing Less Than Two Percent Porosity
plant Applications (UNS R50250, UNS R50400, UNS
B367Specification for Titanium and Titanium Alloy Cast-
R50550, UNS R50700)
ings
F601Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
1
This specification is under the jurisdiction of ASTM Committee F04 on
F629Practice for Radiography of Cast Metallic Surgical
Medical and Surgical Materials and Devices and is the direct responsibility of
Implants
Subcommittee F04.12 on Metallurgical Materials.
IEEE/ASTM SI 10American National Standard for Metric
Current edition approved Nov. 1, 2021. Published November 2021. Originally
approved in 2012. Last previous edition approved in 2013 as F2989–13. DOI: Practice
10.1520/F2989-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2989 − 21
4
2.2 ISO Standards: 3.3
...

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: F2989 − 13 F2989 − 21
Standard Specification for
Metal Injection Molded Unalloyed Titanium Components for
1
Surgical Implant Applications
This standard is issued under the fixed designation F2989; 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 Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded
(MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants.
1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by
post-sinter processing.
1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact
equivalents; therefore, each system shall be used independent of the other. Combining values from the two systems may result in
non-conformancenonconformance with the specification.
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:
B243 Terminology of Powder Metallurgy
B311 Test Method for Density of Powder Metallurgy (PM) Materials Containing Less Than Two Percent Porosity
B367 Specification for Titanium and Titanium Alloy Castings
B923 Test Method for Metal Powder Skeletal Density by Helium or Nitrogen Pycnometry
E3 Guide for Preparation of Metallographic Specimens
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E165 Practice for Liquid Penetrant Testing for General Industry
E407 Practice for Microetching Metals and Alloys
E539 Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
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
F04.12 on Metallurgical Materials.
Current edition approved April 1, 2013Nov. 1, 2021. Published April 2013November 2021. Originally approved in 2012. Last previous edition approved in 20122013 as
F2989F2989 – 13.– 12. DOI: 10.1520/F2989-13.10.1520/F2989-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2989 − 21
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
3
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals (Withdrawn 2017)
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surg
...

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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 F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
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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