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ASTM F2146-13

(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)

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. 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 and health practices and determine the applicability of regulatory requirements prior to use.

General Information

Status
Historical
Publication Date
28-Feb-2013
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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ASTM F2146-13 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)ASTM F2146-13 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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REDLINE ASTM F2146-13 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)REDLINE ASTM F2146-13 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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REDLINE ASTM F2146-13 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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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:F2146 −13
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* toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
1.1 This specification covers the chemical, mechanical, and
E2371Test Method for Analysis of Titanium and Titanium
metallurgical requirements for wrought and annealed or cold-
Alloys by Atomic Emission Plasma Spectrometry (With-
worked and stress-relieved titanium-3aluminum-2.5vanadium
3
drawn 2013)
alloy (UNS R56320) seamless tubing to be used in the
E2626Guide for Spectrometric Analysis of Reactive and
manufacture of surgical implants. See Section 4 for size
Refractory Metals
limitations.
F136 Specification for Wrought Titanium-6Aluminum-
1.2 The values stated in either SI units or inch-pound units
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
are to be regarded separately as standard. The values stated in
Implant Applications (UNS R56401)
each system may not be exact equivalents; therefore, each
F1472 Specification for Wrought Titanium-6Aluminum-
system shall be used independently of the other. Combining
4VanadiumAlloyforSurgicalImplantApplications(UNS
values from the two systems may result in non-conformance
R56400)
with the standard.
IEEE/ASTM SI 10 American National Standard for Metric
1.3 This standard does not purport to address all of the
Practice
4
safety concerns, if any, associated with its use. It is the 2.2 Aerospace Material Specifications:
responsibility of the user of this standard to establish appro-
AMS2244Tolerances,TitaniumandTitaniumAlloyTubing
priate safety and health practices and determine the applica- AMS 2249Chemical Check Analysis Limits, Titanium and
bility of regulatory requirements prior to use.
Titanium Alloys
AMS 2634Ultrasonic Inspection, Thin Wall Metal Tubing
2. Referenced Documents
AMS 4943Titanium Alloy, Seamless, Hydraulic Tubing,
2
3.0A1-2.5V Annealed
2.1 ASTM Standards:
AMS 4944Titanium Alloy, Seamless, Hydraulic Tubing,
E8/E8MTest Methods for Tension Testing of Metallic Ma-
3.0A1-2.5V Cold-Worked, Stress-Relieved
terials
AMS 6940Titanium Alloy Bars, Forgings, and Forging
E29Practice for Using Significant Digits in Test Data to
Stock, 3.0Al-2.5V Annealed-UNS R56320
Determine Conformance with Specifications
5
2.3 ISO Standards:
E1409TestMethodforDeterminationofOxygenandNitro-
ISO 6892Metallic Materials Tensile Testing at Ambient
gen in Titanium and Titanium Alloys by the Inert Gas
Temperature
Fusion Technique
ISO 9001Quality Management Systems Requirements
E1447Test Method for Determination of Hydrogen in Tita-
nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941Test Method for Determination of Carbon in Refrac-
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, 2013. Published April 2013. Originally
3
approved in 2001. Last previous edition approved in 2007 as F2146–07. DOI: The last approved version of this historical standard is referenced on
10.1520/F2146-13. 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 ----------------------
F2146−13
3. Terminology 7. Chemical Composition
3.1 Definitions of Terms Specific to This Standard: 7.1 The heat analysis shall conform to the chemical com-
positionofTable1.Ingotanalysismaybeusedforreportingall
3.1.1 beta transus, n—the minimum temperature at which
thealphaplusbetaphasecantransformto100%betaphaseon chemical requirements, except hydrogen. Samples for hydro-
gen shall be taken from each lot of finished mill product. The
heating.
number of samples per lot shall be as agreed upon between the
3.1.2 cold w
...

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 − 07 F2146 − 13
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 inch pound units either SI units or inch-pound units are to be regarded separately as the standard. The
SI equivalents in parentheses are for information only.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 and health practices and determine the applicability of regulatory
requirements prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E8E8/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 the Inert Gas Fusion
Technique
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
3
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry (Withdrawn 2013)
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
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
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 Feb. 1, 2007March 1, 2013. Published February 2007April 2013. Originally approved in 2001. Last previous edition approved in 20012007 as
F2146 – 01.F2146 – 07. DOI: 10.1520/F2146-07.10.1520/F2146-13.
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.
4
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.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 − 13
5
2.3 American Society for Quality Standard:
ASQ C1 Specifications of General Requirements for a Quality Program
5
2.3 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems Requirements
5
Available from American Society for Quality (ASQ), 600 N. Pla
...

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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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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 F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
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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