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.  
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
Published
Publication Date
31-Oct-2013

Relations

Effective Date
01-Jan-2024
Effective Date
01-Mar-2019
Effective Date
15-Jul-2016
Effective Date
01-Feb-2015
Effective Date
01-Jun-2013
Effective Date
01-Apr-2013
Effective Date
01-Dec-2011
Effective Date
01-May-2011
Effective Date
01-Dec-2010
Effective Date
01-Jun-2010
Effective Date
01-Mar-2009
Effective Date
01-Oct-2008
Effective Date
15-Jun-2008
Effective Date
01-Jun-2007
Effective Date
01-Dec-2006

Overview

ASTM F136-13(2021)e1 is an internationally recognized standard specification developed by ASTM for wrought annealed Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401), designed specifically for the manufacture of surgical implants. This document outlines comprehensive chemical, mechanical, and metallurgical requirements to ensure high quality and reliability of titanium alloy materials used in medical applications. The specification applies to a range of product forms including strip, sheet, plate, bar, forging bar, and wire, setting strict performance criteria for each.

Key Topics

  • Material Requirements:
    The specification defines chemical composition limits for key elements such as aluminum, vanadium, oxygen, iron, and others to guarantee material consistency and biocompatibility. Extra low interstitial (ELI) levels further enhance implant suitability.

  • Mechanical Properties:
    Requirements include tensile and yield strength, elongation, and reduction of area. Both tension and bend tests are specified to ensure desirable mechanical characteristics such as strength and ductility, crucial for surgical implants subjected to stress and strain during use.

  • Product Classification:
    The standard details dimensional and form classifications (strip, sheet, plate, bar, forging bar, wire, and other forms by agreement) along with specific finishing requirements like descaling, pickling, abrasive blasting, grinding, machining, peeling, or polishing.

  • Testing & Analysis:
    Specifies test methods (including ASTM E8/E8M and E290) for mechanical properties and detailed procedures for chemical analysis, ensuring materials meet required tolerances and quality. Ultrasonic inspection is mandated for certain bar sizes to detect internal flaws.

  • Lot Traceability & Certification:
    The standard requires traceable lot production and certified reporting of test results to assure transparency and traceability throughout the manufacturing and supply chain.

Applications

  • Surgical Implants:
    This standard is vital for manufacturers of orthopedic, dental, and other surgical implants, offering guidelines for using Titanium-6Aluminum-4Vanadium ELI alloy, which is highly regarded for its biocompatibility, high strength-to-weight ratio, and corrosion resistance.

  • Medical Device Manufacturing:
    Used by producers of biomedical components that require reliable, high-quality titanium alloy in forms such as rods, plates, and wires for critical implantable devices.

  • Material Procurement:
    Enables purchasing departments and quality managers to specify exact requirements for titanium raw materials, ensuring that supplied products conform to internationally accepted medical-grade specifications.

Related Standards

Several documents are referenced or related to ASTM F136-13(2021)e1:

  • ASTM Standards:

    • ASTM E8/E8M: Tension Testing of Metallic Materials
    • ASTM E290: Bend Testing of Material for Ductility
    • ASTM E539/E1409/E1447/E1941/E2371: Methods for chemical analysis of titanium alloys
  • ISO Standards:

    • ISO 6892: Metallic Materials - Tensile Testing at Ambient Temperature
    • ISO 9001: Quality Management Systems Requirements
  • Other Standards:

    • AMS 2631: Ultrasonic Inspection - Titanium and Titanium Alloy Bar and Billet
    • ASQ C1: Specification for Quality Control Programs

These standards collectively help ensure quality control, material integrity, and compliance for suppliers and manufacturers operating in the surgical implant market.


By adhering to ASTM F136-13(2021)e1, stakeholders in the medical device industry enhance patient safety, accelerate regulatory approval, and support best practices in the use of titanium alloys for surgical implants. This specification is crucial for ensuring consistent, high-grade materials in biomedical engineering and device manufacturing worldwide.

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Technical specification

ASTM F136-13(2021)e1 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

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Frequently Asked Questions

ASTM F136-13(2021)e1 is a technical specification published by ASTM International. Its full title is "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)". This standard covers: 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. 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.

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. 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.

ASTM F136-13(2021)e1 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.

ASTM F136-13(2021)e1 has the following relationships with other standards: It is inter standard links to ASTM E8/E8M-24, ASTM E539-19, ASTM E8/E8M-16, ASTM E8/E8M-15, ASTM E8/E8M-13, ASTM E290-13, ASTM E8/E8M-11, ASTM E539-11, ASTM E1941-10, ASTM F981-04(2010), ASTM E1447-09, ASTM E29-08, ASTM E1409-08, ASTM E539-07, ASTM E539-06. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ASTM F136-13(2021)e1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

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.
´1
Designation:F136 −13 (Reapproved 2021)
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
R56401)
ThisstandardisissuedunderthefixeddesignationF136;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—X2.2 was updated editorially in August 2021.
1. Scope nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
1.1 This specification covers the chemical, mechanical, and
E1941Test Method for Determination of Carbon in Refrac-
metallurgical requirements for wrought annealed titanium-
toryandReactiveMetalsandTheirAlloysbyCombustion
6aluminum-4vanadium ELI (extra low interstitial) alloy
Analysis
(R56401) to be used in the manufacture of surgical implants.
E2371Test Method for Analysis of Titanium and Titanium
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
as standard. The values given in parentheses are mathematical
Plasma Atomic Emission Spectrometry (Performance-
conversions to SI units that are provided for information only
Based Test Methodology)
and are not considered standard.
F981Practice for Assessment of Compatibility of Biomate-
1.3 This international standard was developed in accor-
rials for Surgical Implants with Respect to Effect of
dance with internationally recognized principles on standard- Materials on Muscle and Insertion into Bone
ization established in the Decision on Principles for the 3
2.2 ISO Standards:
Development of International Standards, Guides and Recom-
ISO 6892Metallic Materials Tensile Testing at Ambient
mendations issued by the World Trade Organization Technical
Temperature
Barriers to Trade (TBT) Committee.
ISO 9001Quality Management Systems Requirements
2.3 ASQ Standard:
2. Referenced Documents
2 ASQC1SpecificationsofGeneralRequirementsforaQual-
2.1 ASTM Standards:
ity Control Program
E8/E8MTest Methods for Tension Testing of Metallic Ma-
2.4 Aerospace Material Specifications:
terials
AMS 2249Chemical Check Analysis Limits, Titanium and
E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications Titanium Alloys
AMS 2631Ultrasonic Inspection—Titanium and Titanium
E290Test Methods for Bend Testing of Material for Ductil-
ity Alloy Bar and Billet
AMS 2380Approval and Control of Premium Quality Tita-
E539Test Method for Analysis of Titanium Alloys by
WavelengthDispersiveX-RayFluorescenceSpectrometry nium Alloys
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion 3. Terminology
E1447Test Method for Determination of Hydrogen in Tita-
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.
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. 15, 2021. Published August 2021. Originally
published in 1984. Last previous edition approved in 2013 as F136–13. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0136-13R21E01. 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.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F136−13 (2021)
3.1.2 lot, n—the total number of mill products produced nonferrous plants. The alloy is usually multiple melted in arc
fromoneheatunderthesameconditionsatessentiallythesame furnaces (including furnaces such as plasma arc and electron
time. beam) of a type conventionally used for reactive metals.
6.2 Finish—The mill product may be furnished to the
4. Product Classification
implant manufacturer as mechanically descaled or pickled,
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
abrasively blasted, chemically milled, ground, machined,
thickness and under 24 in. (610 mm) wide.
peeled, polished, combinations of these operations, or as
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in specified by the purchaser. On billets, bars, plates, and
forgings, it is permissible to remove minor surface imperfec-
thickness and 24 in. (610 mm) or more in width.
tions by grinding if the resultant area meets the dimensional
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
and surface finish requirements of this specification.
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), 6.3 Condition—Material shall be furnished in the annealed
or cold-worked condition. Mechanical properties for condi-
thick inclusive is covered by this specification.
tions other than those listed in Tables 1 and 2 may be
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.76mm)to
established by agreement between the supplier and the pur-
4.00 in. (101.60 mm) in diameter or thickness (other sizes and
chaser.
shapes by special order).
4.5 Forging Bar—Bar as described in 4.4, used for produc-
7. Chemical Requirements
tionofforgings,maybefurnishedinthehotworkedcondition.
7.1 The heat analysis shall conform to the chemical com-
4.6 Wire—Rounds,flats,orothershapeslessthan0.1875in.
position specified in Table 3. Ingot analysis may be used for
(4.76 mm) in diameter.
reportingallchemicalrequirements,excepthydrogen.Samples
forhydrogenshallbetakenfromthefinishedmillproduct.The
4.7 Other—Other forms and shapes, including tubing, may
supplier shall not ship material with chemistry outside the
be provided by agreement between purchaser and supplier.
requirements specified in Table 3.
5. Ordering Information 7.1.1 Requirements for the major and minor elemental
constituents are listed in Table 3. Also listed are important
5.1 Include with inquiries and orders for material under this
residualelements.AnalysisforelementsnotlistedinTable3is
specification the following information:
not required to verify compliance with this specification.
5.1.1 Quantity,
5.1.2 ASTM designation and date of issue,
7.2 Product Analysis:
5.1.3 Form (sheet, strip, plate, bar, forging bar, or wire),
7.2.1 Product analysis tolerances do not broaden the speci-
5.1.4 Condition (see Section 3 and 6.3),
fied heat analysis requirements but cover variations between
5.1.5 Mechanical properties (if applicable, for special
laboratories in the measurement of chemical content. The
conditions),
product analysis tolerances shall conform to the product
5.1.6 Finish (see 6.2),
tolerances in Table 4.
5.1.7 Applicable dimensions including size, thickness,
7.2.2 The product analysis is either for the purpose of
width, length, or drawing number,
verifying the composition of a heat or manufacturing lot or
5.1.8 Special tests, if any, and
determining variations in the composition within the heat.
5.1.9 Other requirements. 7.2.3 Acceptanceorrejectionofaheatormanufacturinglot
of material may be made by the purchaser on the basis of this
6. Materials and Manufacture
product analysis. Product analysis outside the tolerance limits
6.1 The various titanium mill products covered in this allowed in Table 4 is cause for rejection of the product. A
specification normally are formed with the conventional forg- refereeanalysismaybeusedifagreeduponbythesupplierand
ing and rolling equipment found in primary ferrous and purchaser.
TABLE 1 Annealed Mechanical Properties of Bar, Wire, and Forgings
A B
Elongation in 4D or 4W min, % Reduction of Area min, %
Yield Strength
Nominal Diameter or Distance Tensile Strength min,
(0.2 % offset) min,
L LT ST L LT ST
Between Parallel Sides, in. (mm) psi (MPa)
psi (MPa)
— — — — — —
Under 0.187 (4.75) thickness or diameter 125 000 (860) 115 000 (795) 10 . . . . .
0.187 (4.75) to under 1.75 (44.45), incl 125 000 (860) 115 000 (795) 10 . . 25 . .
1.75 (44.45) to under 2.50 (63.50), incl 120 000 (825) 110 000 (760) 8 . . 20 . .
C C C C
2.50 (63.50) to 4.00 (101.60), incl 120 000 (825) 110 000 (760) 8 8 8 15 15 15
A
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gage length of 2 in. or4Dor4W. The gage length must
be reported with the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternatively,
a gage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original
cross-sectional area.) Gage length shall be reported with the elongation value. L = longitudinal; LT = long transverse; ST = short transverse.
B
Applies to bar and forgings only. L = longitudinal; LT = long transverse; ST = short transverse. For round bar, the long and short transverse are identical tests, therefore
only one transverse is required.
C
Transverse requirements in Table 1 apply only to product from which a tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.
´1
F136−13 (2021)
TABLE 2 Annealed Mechanical Properties of Sheet, Strip, and Plate
A
Bend Test
Elongation in 2 in. (50 mm), B
Reduction of Area min, %
C,D
min, % Mandrel Diameter
0.070 to
Nomi
...

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