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ASTM F1472-20a

(Specification)

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

ABSTRACT
This specification covers the requirements for wrought titanium-6aluminum-4vanadium alloy for use in surgical implant applications. The material shall be manufactured by multiple melting in plasma arc and electron beam furnaces into strip, sheet, plate, bar, forging bar, or wire. The material shall be available in the annealed or cold-worked condition, with the surface mechanically descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or a combination of these. Heat and product analyses as well as tension and bend (for sheet, strip, and plate) tests shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of alpha and beta phases as a result of processing in the alpha plus beta field, with no continuous alpha network at prior beta grain boundaries and no coarse, elongated alpha platelets.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants.  
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily 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 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
Historical
Publication Date
31-Oct-2020
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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Standards Content (Sample)

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: F1472 − 20a
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical
1
Implant Applications (UNS R56400)
This standard is issued under the fixed designation F1472; 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* E1447 Test Method for Determination of Hydrogen in Tita-
nium and Titanium Alloys by Inert Gas Fusion Thermal
1.1 This specification covers the chemical, mechanical, and
Conductivity/Infrared Detection Method
metallurgical requirements for wrought annealed titanium-
E1941 Test Method for Determination of Carbon in Refrac-
6aluminum-4vanadium alloy (UNS R56400) to be used in the
tory and Reactive Metals and Their Alloys by Combustion
manufacture of surgical implants.
Analysis
1.2 Units—The values stated in either SI units or inch-
E2371 Test Method for Analysis of Titanium and Titanium
pound units are to be regarded separately as standard. The
Alloys by Direct Current Plasma and Inductively Coupled
values stated in each system are not necessarily exact equiva-
Plasma Atomic Emission Spectrometry (Performance-
lents; therefore, to ensure conformance with the standard, each
Based Test Methodology)
system shall be used independently of the other, and values
E2626 Guide for Spectrometric Analysis of Reactive and
3
from the two systems shall not be combined.
Refractory Metals (Withdrawn 2017)
1.3 This international standard was developed in accor- E2994 Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
Alloys by Spark Atomic Emission Spectrometry and Glow
ization established in the Decision on Principles for the Discharge Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Method)
mendations issued by the World Trade Organization Technical F136 Specification for Wrought Titanium-6Aluminum-
Barriers to Trade (TBT) Committee.
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
Implant Applications (UNS R56401)
2. Referenced Documents 4
2.2 Aerospace Material Specifications:
2
2.1 ASTM Standards: AMS 2249 Chemical Check Analysis Limits, Titanium and
E8/E8M Test Methods for Tension Testing of Metallic Ma- Titanium Alloys
terials AMS 2631 Ultrasonic Inspection Titanium, and Titanium
E29 Practice for Using Significant Digits in Test Data to Alloy Bar, Billet, and Plate
Determine Conformance with Specifications AMS 4911 Titanium Alloy Sheet, Strip, and Plate 6Al-4V
E290 Test Methods for Bend Testing of Material for Ductil- Annealed
ity AMS 4928 Titanium Alloy Bars, Wire, Forgings, Rings, and
E527 Practice for Numbering Metals and Alloys in the Drawn Shapes 6Al-4V Annealed
Unified Numbering System (UNS) AMS 4965 Titanium Alloy, Bars, Wire, Forgings, and Rings
E539 Test Method for Analysis of Titanium Alloys by 6.0 Al 4.0 V Solution Heat Treated and Aged
5
Wavelength Dispersive X-Ray Fluorescence Spectrometry
2.3 ISO Standards:
E1409 Test Method for Determination of Oxygen and Nitro-
ISO 5832–3 Implants for Surgery—Metallic Materials—
gen in Titanium and Titanium Alloys by Inert Gas Fusion
Part 3, Wrought Titanium-6Aluminum-4Vanadium Alloy
ISO 6892 Metallic Materials—Tensile Testing at Ambient
Temperature
1
This specification is under the jurisdiction of ASTM Committee F04 on
ISO 9001 Quality Management Systems—Requirements
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2020. Published November 2020. Originally
3
published in 1993. Last previous edition approved in 2020 as F1472 – 20. DOI: The last approved version of this historical standard is referenced on www.ast-
10.1520/F1472-20A. m.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 from American 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 ----------------------
F1472 − 20a
4,6
2.4 Society of Automotive Engineers Standard: 6. Materials and Manufacture
SAE J1086 Pr
...

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: F1472 − 20 F1472 − 20a
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical
1
Implant Applications (UNS R56400)
This standard is issued under the fixed designation F1472; 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 annealed titanium-
6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants.
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in
each system are not necessarily 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 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:
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E290 Test Methods for Bend Testing of Material for Ductility
E527 Practice for Numbering Metals and Alloys in the Unified Numbering System (UNS)
E539 Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
E527 Practice for Numbering Metals and Alloys in the Unified Numbering System (UNS)
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)
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 Aug. 1, 2020Nov. 1, 2020. Published November 2020. Originally published in 1993. Last previous edition approved in 20142020 as
F1472 – 14.F1472 – 20. DOI: 10.1520/F1472-20.10.1520/F1472-20A.
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 ----------------------
F1472 − 20a
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
4
2.2 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection Titanium, and Titanium Alloy Bar, Billet, and Plate
AMS 4911 Titanium Alloy Sheet, Strip, and Plate 6Al-4V Annealed
AMS 4928 Titanium Alloy Bars, Wire, Forgings, Rings, and Drawn Shapes 6Al-4V Annealed
AMS 4965 Titanium Alloy, Bars, Wire, Forgings, and Rings 6.0 Al 4.0 V Solution Heat Treated and Aged
5
2.3 ISO Standards:
ISO 5832–3 Implants for Surgery—Metallic Materials—Part 3, Wrought Titanium-6Aluminum-4Vanadium Alloy
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
ISO 9001 Qual
...

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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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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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