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ASTM F2146-22

(Specification)

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. The mill product shall be furnished as descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished. Conditions for annealing, cold-working and stress relieving, and surface cleanliness are specified. Heat analysis shall conform to the chemical composition requirements prescribed for: nitrogen, carbon, hydrogen, iron, oxygen, aluminum, vanadium, yttrium, and titanium. The material shall conform to the mechanical property requirements specified for: ultimate tensile strength, yield strength, and elongation. Requirements for tension testing, microstructure, ultrasonic testing, and longitudinal and transverse notch machining are specified as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. See Section 4 for size limitations.  
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, and values from the two systems shall not be combined.  
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
31-Dec-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

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REDLINE ASTM F2146-22 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)REDLINE ASTM F2146-22 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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REDLINE ASTM F2146-22 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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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:F2146 −22
Standard Specification for
Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless
1
Tubing for Surgical Implant Applications (UNS R56320)
This standard is issued under the fixed designation F2146; 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* E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
1.1 This specification covers the chemical, mechanical, and
E1447Test Method for Determination of Hydrogen in Tita-
metallurgical requirements for wrought and annealed or cold-
nium and Titanium Alloys by Inert Gas Fusion Thermal
worked and stress-relieved titanium-3aluminum-2.5vanadium
Conductivity/Infrared Detection Method
alloy (UNS R56320) seamless tubing to be used in the
E1941Test Method for Determination of Carbon in Refrac-
manufacture of surgical implants. See Section 4 for size
toryandReactiveMetalsandTheirAlloysbyCombustion
limitations.
Analysis
1.2 The values stated in either SI units or inch-pound units
E2371Test Method for Analysis of Titanium and Titanium
are to be regarded separately as standard. The values stated in
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
each system may not be exact equivalents; therefore, each
Plasma Atomic Emission Spectrometry (Performance-
system shall be used independently of the other, and values
Based Test Methodology)
from the two systems shall not be combined.
E2626Guide for Spectrometric Analysis of Reactive and
3
1.3 This standard does not purport to address all of the Refractory Metals (Withdrawn 2017)
safety concerns, if any, associated with its use. It is the
F136 Specification for Wrought Titanium-6Aluminum-
responsibility of the user of this standard to establish appro- 4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
priate safety, health, and environmental practices and deter-
Implant Applications (UNS R56401)
mine the applicability of regulatory limitations prior to use. F1472 Specification for Wrought Titanium-6Aluminum-
1.4 This international standard was developed in accor-
4VanadiumAlloyforSurgicalImplantApplications(UNS
dance with internationally recognized principles on standard- R56400)
ization established in the Decision on Principles for the
IEEE/ASTM SI 10American National Standard for Metric
Development of International Standards, Guides and Recom-
Practice
4
mendations issued by the World Trade Organization Technical
2.2 Aerospace Material Specifications:
Barriers to Trade (TBT) Committee.
AMS2244Tolerances,TitaniumandTitaniumAlloyTubing
AMS 2249Chemical Check Analysis Limits, Titanium and
2. Referenced Documents
Titanium Alloys
2
2.1 ASTM Standards: AMS 2634Ultrasonic Inspection, Thin Wall Metal Tubing
B367Specification for Titanium and Titanium Alloy Cast- AMS 4943Titanium Alloy, Seamless, Hydraulic Tubing,
ings 3.0A1-2.5VAnnealed
E8/E8MTest Methods for Tension Testing of Metallic Ma- AMS 4944Titanium Alloy, Seamless, Hydraulic Tubing,
terials 3.0A1-2.5V Cold-Worked, Stress-Relieved
E29Practice for Using Significant Digits in Test Data to AMS 6940Titanium Alloy Bars, Forgings, and Forging
Determine Conformance with Specifications Stock, 3.0Al-2.5VAnnealed-UNS R56320
5
2.3 ISO Standards:
ISO 6892Metallic Materials Tensile Testing at Ambient
1
This specification is under the jurisdiction of ASTM Committee F04 on
Temperature
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Jan. 1, 2022. Published January 2022. Originally
3
approved in 2001. Last previous edition approved in 2013 as F2146–13. DOI: The last approved version of this historical standard is referenced on
10.1520/F2146-22. www.astm.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001, http://www.sae.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.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 -----
...

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: F2146 − 13 F2146 − 22
Standard Specification for
Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless
1
Tubing for Surgical Implant Applications (UNS R56320)
This standard is issued under the fixed designation F2146; 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 specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked
and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of
surgical implants. See Section 4 for size limitations.
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 aremay not necessarilybe exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, and values from the two systems shall not be combined.
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 requirementslimitations 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:
B367 Specification for Titanium and Titanium Alloy Castings
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
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)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
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 March 1, 2013Jan. 1, 2022. Published April 2013January 2022. Originally approved in 2001. Last previous edition approved in 20072013 as
F2146 – 07.F2146 – 13. DOI: 10.1520/F2146-13.10.1520/F2146-22.
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.
3
The last approved version of this historical standard is referenced on 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 ----------------------
F2146 − 22
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
IEEE/ASTM SI 10 American National Standard for Metric Practice
4
2.2 Aerospace Material Specifications:
AMS 2244 Tolerances, Titanium and Titanium Alloy Tubing
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2634 Ultrasonic Inspection, Thin Wall Metal Tubing
AMS 4943 Titanium Alloy, Seamless, Hydraulic Tubing, 3.0A1-2.5V Annealed
AMS 4944 Titanium Alloy, Seamless, Hydraulic Tubing, 3.0A1-2.5V Cold-Worked, Stress-Relieved
AMS 6940 Titanium Alloy Bars, Forgings, and Forging Stock, 3.0Al-2.5V Annealed-UNS R56320
5
...

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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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ASTM
ASTM F3047M-23(Guide)
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 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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