ASTM F1713-08(2013)

Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy (UNS R58130) bars and wires to be used in the manufacture of surgical implants. The mill products may be supplied as specified by the purchaser with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish. Materials shall be furnished in the unannealed, solution-treated, or capability-aged condition. The mechanical properties to which the alloys shall conform are tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy to be used in the manufacture of surgical implants  (1).2  
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: 28-Feb-2013
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 77.120.50 - Titanium and titanium alloys
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1713 −08 (Reapproved 2013)
Standard Specification for
Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical
Implant Applications (UNS R58130)
This standard is issued under the fixed designation F1713; 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 F1472Specification for Wrought Titanium-6Aluminum-
4VanadiumAlloyforSurgicalImplantApplications(UNS
1.1 This specification covers the chemical, mechanical, and
R56400)
metallurgical requirements for wrought titanium-13niobium-
2.2 Aerospace Material Specification:
13zirconium alloy to be used in the manufacture of surgical
AMS 2249Chemical Check Analysis Limits, Titanium and
implants (1).
Titanium Alloys
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
2.3 American Society for Quality (ASQ) Standard:
as standard. The values given in parentheses are mathematical
ASQC1SpecificationsofGeneralRequirementsforaQual-
conversions to SI units that are provided for information only
ity Program
and are not considered standard.
2.4 ISO Standards:
ISO5832-3ImplantsforSurgery—MetallicMaterials—Part
2. Referenced Documents
3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
2.1 ASTM Standards:
ISO 6892Metallic Materials Tensile Testing at Ambient
E8Test Methods for Tension Testing of Metallic Materials
Temperature
E29Practice for Using Significant Digits in Test Data to 7
ISO 9001Quality Management Systems—Requirements
Determine Conformance with Specifications
E1409TestMethodforDeterminationofOxygenandNitro-
3. Terminology
gen in Titanium and Titanium Alloys by the Inert Gas
3.1 Definitions of Terms Specific to This Standard:
Fusion Technique
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 capability-aged, adj—the condition of the material
Conductivity/Infrared Detection Method
thatisobtainedif,followingsolutiontreatment,asampleofthe
E1941Test Method for Determination of Carbon in Refrac-
mill product is subjected to an aging treatment such as given
toryandReactiveMetalsandTheirAlloysbyCombustion
below, for certification testing.
Analysis
3.1.2.1 Age for 6 6 0.25 h at 923 6 25°F (495 6 14°C).
E2371Test Method for Analysis of Titanium and Titanium
3.1.2.2 Removefromfurnaceandaircooltoroomtempera-
Alloys by Atomic Emission Plasma Spectrometry (With-
ture.
drawn 2013)
3.1.3 cold work, n—any mechanical deformation process
F748PracticeforSelectingGenericBiologicalTestMethods
performed below the recrystallization temperature which re-
for Materials and Devices
sults in strain hardening of the material.
3.1.4 hot work, n—any mechanical deformation process
This specification is under the jurisdiction of ASTM Committee F04 on
performed above the recrystallization temperature.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
3.1.5 lot, n—the total number of mill products produced
Current edition approved March 1, 2013. Published March 2013. Originally
from the same melt heat under the same conditions at essen-
approved in 1996. Last previous edition approved in 2008 as F1713–08. DOI:
tially the same time.
10.1520/F1713-08R13.
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
this standard.
3 5
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 [e-mail]. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.org.
4 7
The last approved version of this historical standard is referenced on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.astm.org. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1713−08 (2013)
TABLE 1 Chemical Requirements
3.1.6 solution-treated, adj—the condition of the material
that is obtained if, following the final hot-working or cold- Element Composition
(% mass/mass)
working operation, the mill product is rapidly quenched, for
Nitrogen, max 0.05
example, by water quenching, from a temperature above
Carbon, max 0.08
1112°F (600°C). A
Hydrogen, max 0.012
Iron, max 0.25
3.1.7 unannealed, adj—the condition of the material that is
Oxygen, max 0.15
obtained after the normal hot-working or cold-working opera-
Niobium 12.5–14.0
Zirconium 12.5–14.0
tion used for fabrication of the mill product. There are no
B
Titanium balance
subsequent heat treatment requirements.
A
Material 0.032 in. (0.813 mm) and under may have hydrogen content up to
0.015 %.
4. Product Classification
B
The percentage of titanium is determined by difference and need not be
determined or certified.
4.1 Bar—Rounds or flats from 0.188 in. (4.76 mm) to 4 in.
(101.6 mm), inclusive, in diameter or thickness. (Other sizes
and shapes by special order.)
A
TABLE 2 Product Analysis Tolerance
4.2 Wire—Rounds or flats less than 0.188 in. (4.76 mm) in
Tolerance Under the Minimum
diameter or thickness. or
Element
Over the Maximum Limit
B
(% mass/mass)
5. Ordering Information
Nitrogen 0.02
5.1 Include with inquiries and orders for material under this Carbon 0.02
Hydrogen 0.0020
specification the following information:
Iron 0.10
5.1.1 Quantity (weight or number of pieces);
Oxygen 0.02
5.1.2 Applicable ASTM designation and year of issue; Niobium 0.30
Zirconium 0.40
5.1.3 Form (wire or bar, see Section 4);
A
Refer to AMS 2249.
5.1.4 Condition (see 6.2);
B
Under the minimum limit not applicable for elements where only a maximum
5.1.5 Mechanical properties (if applicable, for special con-
percentage is indicated.
ditions) (see 8.1);
5.1.6 Finish (see 6.1);
A,B
5.1.7 Applicabledimensionsincludingsize,diameter,thick-
TABLE 3 Mechanical Properties
ness (for rectangular wire), or print number; Yield
Tensile Strength
5.1.8 Special tests (if any); and
Elongation Reduction
Strength (0.2 %
Condition min, of Area min,
5.1.9 Other requirements.
min, offset),
C D
% %
psi (MPa) min psi
(MPa)
6. Materials and Manufacture
Capability aged 125 000 105 000 815
6.1 Finish—The mill product may be supplied as specified
(860) (725)
by the purchaser with a descaled or pickled, abrasive blasted, Solution treated 80 000 50 000 15 30
(550) (345)
chemically milled, ground, machined, peeled, or polished
Unannealed 80 000 50 000 815
finish. On bars, it is permissible to remove minor surface
(550) (345)
imperfections by grinding if the resultant area meets the
A
Up to 4 in. (101.60 mm) inclusive diameter.
B
dimensional and surface finish requirements of this specifica-
Solution treated or unannealed material is not intended for use as a final product
without subsequent hot working or heat treatment, or both.
tion.
C
Limits apply to tests taken both longitudinal and transverse to the direction of
rolling. Elongation of material 0.063 in. (1.575 mm) or greater in diameter (D) or
6.2 Condition—Material shall be furnished in the
thickness (T) shall be measured using a gage length of 2 in. or 4D or 4T. The gage
unannealed, solution-treated, or capability-aged condition, as
length shall be reported with the test results. The method for determining
specified in the purchase order. Conditions and mechanical
elongation of material under 0.063 in. (1.575 mm) in diameter or thickness may be
negotiated. Alternately, a gage length corresponding to ISO 6892 may be used
propertiesotherthanthoselistedinTable3maybeestablished
when agreed upon between the supplier and purchaser. (5.65 square root S ,
o
by agreement between the supplier and the purchaser.
where S is the original cross sectional area.)
o
D
Applies to bar only.
7. Chemical Requirements
7.1 The heat analysis shall conform to the chemical com-
positionofTable1.Ingotanalysismaybeusedforreportingall 7.2 Product Analysis:
chemical requirements, except hydrogen. Samples for hydro- 7.2.1 Product analysis tolerances do not broaden the speci-
gen shall be taken from the finished mill product.The supplier fied heat analysis requirements but cover variations in the
shallnotshipmaterialwithchemistryoutsidetherequirements measurement of chemical content between laboratories. The
specified in Table 1. product analysis tolerances shall conform to the product
7.1.1 Requirements for the major and minor elemental tolerances in Table 2.
constituents are listed in Table 1. Also listed are important 7.2.2 The product analysis is either for the purpose of
residualelements.AnalysisforelementsnotlistedinTable1is verifying the composition of a heat or manufacturing lot or to
not required to verify compliance with this specification. determine variations in the composition within the heat.
F1713−08 (2013)
7.2.3 Acceptanceorrejectionofaheatormanufacturinglot retest.Retestonespecimenforeachspecimenthatdidnotmeet
of material may be made by the purchaser on the basis of this the minimum requirements.
product analyses. Product analysis outside the tolerance limits
9. Special Requirements
allowed in Table 2 shall be cause for rejection of the product.
Areferee
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