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ASTM F136-13

(Specification)

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories in the measurement of chemical content. Tension test and bend test shall be performed to meet the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

General Information

Status
Historical
Publication Date
31-Oct-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 F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
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ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
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REDLINE ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
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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:F136 −13
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
ThisstandardisissuedunderthefixeddesignationF136;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* Based Test Methodology)
F981Practice for Assessment of Compatibility of Biomate-
1.1 This specification covers the chemical, mechanical, and
rials for Surgical Implants with Respect to Effect of
metallurgical requirements for wrought annealed titanium-
Materials on Muscle and Bone
6aluminum-4vanadium ELI (extra low interstitial) alloy
3
(R56401) to be used in the manufacture of surgical implants. 2.2 ISO Standards:
ISO 6892Metallic Materials Tensile Testing at Ambient
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
Temperature
as standard. The values given in parentheses are mathematical
ISO 9001Quality Management Systems Requirements
conversions to SI units that are provided for information only
2.3 ASQ Standard:
and are not considered standard.
ASQC1SpecificationsofGeneralRequirementsforaQual-
4
2. Referenced Documents
ity Control Program
2
5
2.1 ASTM Standards:
2.4 Aerospace Material Specifications:
E8/E8MTest Methods for Tension Testing of Metallic Ma-
AMS 2249Chemical Check Analysis Limits, Titanium and
terials
Titanium Alloys
E29Practice for Using Significant Digits in Test Data to
AMS 2631Ultrasonic Inspection—Titanium and Titanium
Determine Conformance with Specifications
Alloy Bar and Billet
E290Test Methods for Bend Testing of Material for Ductil-
AMS 2380Approval and Control of Premium Quality Tita-
ity
nium Alloys
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray
Fluorescence Spectrometry
3. Terminology
E1409TestMethodforDeterminationofOxygenandNitro-
3.1 Definitions of Terms Specific to This Standard:
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
3.1.1 beta transus, n—the minimum temperature at which
E1447Test Method for Determination of Hydrogen in Tita-
the alpha plus beta phase can transform to 100% beta phase.
nium and Titanium Alloys by Inert Gas Fusion Thermal
3.1.2 lot, n—the total number of mill products produced
Conductivity/Infrared Detection Method
fromoneheatunderthesameconditionsatessentiallythesame
E1941Test Method for Determination of Carbon in Refrac-
time.
toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
4. Product Classification
E2371Test Method for Analysis of Titanium and Titanium
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
Plasma Atomic Emission Spectrometry (Performance-
thickness and under 24 in. (610 mm) wide.
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
1 thickness and 24 in. (610 mm) or more in width.
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 Nov. 1, 2013. Published December 2013. Originally
3
published in 1984. Last previous edition approved in 2012 as F136–12a. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0136-13. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers (SAE), 400 Commonwealth
the ASTM website. 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 ----------------------
F136−13
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and forgings, it is permissible to remove minor surface imperfec-
over and 10 in. (254 mm) wide and over, with widths greater tions by grinding if the resultant area meets the dimensional
than five times thickness. Plate up to 4.00 in. (101.60 mm), and surface finish requirements of this specification.
thick inclusive is covered by this specification.
6.3 Condition—Material shall be furnished in the annealed
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to or cold-worked condition. Mechanical properties for condi-
4.00 in. (101.60 mm) in diameter or thickness (other sizes and tions other than those l
...

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: F136 − 12a F136 − 13
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
This standard is issued under the fixed designation F136; 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 ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
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
E539 Test Method for Analysis of Titanium Alloys by X-Ray Fluorescence Spectrometry
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)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
2.2 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems Requirements
2.3 ASQ Standard:
4
ASQ C1 Specifications of General Requirements for a Quality Control Program
5
2.4 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2631 Ultrasonic Inspection—Titanium and Titanium Alloy Bar and Billet
AMS 2380 Approval and Control of Premium Quality Titanium Alloys
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 beta transus, n—the minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase.
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 Dec. 1, 2012Nov. 1, 2013. Published December 2012December 2013. Originally published in 1984. Last previous edition approved in 2012 as
F136 – 12.F136 – 12a. DOI: 10.1520/F0136-12A.10.1520/F0136-13.
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
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
5
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 ----------------------
F136 − 13
3.1.2 lot, n—the total number of mill products produced from one heat under the same conditions at essentially the same time.
4. Product Classification
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in thickness and under 24 in. (610 mm) wide.
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in thickness and 24 in. (610 mm) or more in width.
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and over and 10 in. (254 mm) wide and over, with widths greater than five
times thickness. Plate up to 4.00 in. (101.60 mm), thick inclusive is covered b
...

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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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  • Guide
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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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  • Technical specification
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