ASTM F1713-08(2021)e1
(Specification)Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
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.
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
Relations
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:F1713 −08 (Reapproved 2021)
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.
ε NOTE—X2.2 was updated editorially in December 2021.
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 titanium-13niobium-
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
13zirconium alloy to be used in the manufacture of surgical
2 Plasma Atomic Emission Spectrometry (Performance-
implants (1).
Based Test Methodology)
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
F748PracticeforSelectingGenericBiologicalTestMethods
as standard. The values given in parentheses are mathematical
for Materials and Devices
conversions to SI units that are provided for information only
F1472Specification for Wrought Titanium-6Aluminum-
and are not considered standard.
4VanadiumAlloyforSurgicalImplantApplications(UNS
1.3 This international standard was developed in accor-
R56400)
dance with internationally recognized principles on standard-
2.2 Aerospace Material Specification:
ization established in the Decision on Principles for the
AMS 2249Chemical Check Analysis Limits, Titanium and
Development of International Standards, Guides and Recom-
Titanium Alloys
mendations issued by the World Trade Organization Technical
2.3 American Society for Quality (ASQ) Standard:
Barriers to Trade (TBT) Committee.
ASQC1SpecificationsofGeneralRequirementsforaQual-
ity Program
2. Referenced Documents
2.4 ISO Standards:
2.1 ASTM Standards:
ISO5832-3ImplantsforSurgery—MetallicMaterials—Part
E8/E8MTest Methods for Tension Testing of Metallic Ma-
3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
terials
ISO 6892Metallic Materials Tensile Testing at Ambient
E29Practice for Using Significant Digits in Test Data to
Temperature
Determine Conformance with Specifications
ISO 9001Quality Management Systems—Requirements
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:
nium and Titanium Alloys by Inert Gas Fusion Thermal
3.1.1 beta transus, n—the minimum temperature at which
Conductivity/Infrared Detection Method
the alpha-plus-beta phase can transform to 100% beta phase.
E1941Test Method for Determination of Carbon in Refrac-
3.1.2 capability-aged, adj—the condition of the material
thatisobtainedif,followingsolutiontreatment,asampleofthe
mill product is subjected to an aging treatment such as given
This specification is under the jurisdiction of ASTM Committee F04 on
below, for certification testing.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
3.1.2.1 Age for 6 6 0.25 h at 923 6 25°F (495 6 14°C).
Current edition approved Dec. 1, 2021. Published December 2021. Originally
approved in 1996. Last previous edition approved in 2013 as F1713–08 (2013).
DOI: 10.1520/F1713-08R21E01.
2 4
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof Available from Society of Automotive Engineers (SAE), 400 Commonwealth
this standard. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
3 5
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 fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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
´1
F1713−08 (2021)
TABLE 1 Chemical Requirements
3.1.2.2 Removefromfurnaceandaircooltoroomtempera-
ture. Element Composition
(% mass/mass)
3.1.3 cold work, n—any mechanical deformation process
Nitrogen, max 0.05
performed below the recrystallization temperature which re-
Carbon, max 0.08
A
sults in strain hardening of the material.
Hydrogen, max 0.012
Iron, max 0.25
3.1.4 hot work, n—any mechanical deformation process
Oxygen, max 0.15
performed above the recrystallization temperature.
Niobium 12.5–14.0
Zirconium 12.5–14.0
3.1.5 lot, n—the total number of mill products produced
B
Titanium balance
from the same melt heat under the same conditions at essen-
A
Material 0.032 in. (0.813 mm) and under may have hydrogen content up to
tially the same time.
0.015 %.
B
The percentage of titanium is determined by difference and need not be
3.1.6 solution-treated, adj—the condition of the material
determined or certified.
that is obtained if, following the final hot-working or cold-
working operation, the mill product is rapidly quenched, for
A
example, by water quenching, from a temperature above
TABLE 2 Product Analysis Tolerance
1112°F (600°C).
Tolerance Under the Minimum
or
Element
3.1.7 unannealed, adj—the condition of the material that is
Over the Maximum Limit
B
obtained after the normal hot-working or cold-working opera-
(% mass/mass)
tion used for fabrication of the mill product. There are no Nitrogen 0.02
Carbon 0.02
subsequent heat treatment requirements.
Hydrogen 0.0020
Iron 0.10
Oxygen 0.02
4. Product Classification
Niobium 0.30
4.1 Bar—Rounds or flats from 0.188 in. (4.76 mm) to 4 in. Zirconium 0.40
A
(101.6 mm), inclusive, in diameter or thickness. (Other sizes
Refer to AMS 2249.
B
Under the minimum limit not applicable for elements where only a maximum
and shapes by special order.)
percentage is indicated.
4.2 Wire—Rounds or flats less than 0.188 in. (4.76 mm) in
diameter or thickness.
A,B
TABLE 3 Mechanical Properties
Yield
5. Ordering Information
Tensile Strength
Elongation Reduction
5.1 Include with inquiries and orders for material under this Strength (0.2 %
Condition min, of Area min,
min, offset),
C D
specification the following information:
% %
psi (MPa) min psi
5.1.1 Quantity (weight or number of pieces);
(MPa)
5.1.2 Applicable ASTM designation and year of issue;
Capability aged 125 000 105 000 815
(860) (725)
5.1.3 Form (wire or bar, see Section 4);
Solution treated 80 000 50 000 15 30
5.1.4 Condition (see 6.2);
(550) (345)
Unannealed 80 000 50 000 815
5.1.5 Mechanical properties (if applicable, for special con-
(550) (345)
ditions) (see 8.1);
A
Up to 4 in. (101.60 mm) inclusive diameter.
5.1.6 Finish (see 6.1);
B
Solution treated or unannealed material is not intended for use as a final product
5.1.7 Applicabledimensionsincludingsize,diameter,thick-
without subsequent hot working or heat treatment, or both.
C
Limits apply to tests taken both longitudinal and transverse to the direction of
ness (for rectangular wire), or print number;
rolling. Elongation of material 0.063 in. (1.575 mm) or greater in diameter (D) or
5.1.8 Special tests (if any); and
thickness (T) shall be measured using a gage length of 2 in. or 4D or 4T. The gage
5.1.9 Other requirements. length shall be reported with the test results. The method for determining
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
6. Materials and Manufacture
when agreed upon between the supplier and purchaser. (5.65 square root S ,
o
where S is the original cross sectional area.)
o
6.1 Finish—The mill product may be supplied as specified
D
Applies to bar only.
by the purchaser with a descaled or pickled, abrasive blasted,
chemically milled, ground, machined, peeled, or polished
finish. On bars, it is permissible to remove minor surface
imperfections by grinding if the resultant area meets the
dimensional and surface finish requirements of this specifica- 7. Chemical Requirements
tion.
7.1 The heat analysis shall conform to the chemical com-
6.2 Condition—Material shall be furnished in the positionofTable1.Ingotanalysismaybeusedforreportingall
unannealed, solution-treated, or capability-aged condition, as chemical requirements, except hydrogen. Samples for hydro-
specified in the purchase order. Conditions and mechanical gen shall be taken from the finished mill product.The supplier
propertiesotherthanthoselistedinTable3maybeestablished shallnotshipmaterialwithchemistryoutsidetherequirements
by agreement between the supplier and the purchaser. specified in Table 1.
´1
F1713−08 (2021)
7.1.1 Requirements for the major and minor elemental failedtestpiece.Thelotshallbeconsideredincomplianceonly
constituents are listed in Table 1. Also listed are important if all additional test pieces meet the specified requirements.
residualelements.AnalysisforelementsnotlistedinTable1is 8.3.2 Tensile tests results for which any specimen fractures
not required to verify compliance with this specification. outside the gage length shall be considered acceptable if both
the elongation and reduction of area meet the minimum
7.2 Product Analysis:
requirements specified. If either the elongation or reduction of
7.2.1 Product analysis tolerances do not broaden the speci-
areaislessthantheminimumrequirement,discardthetestand
fied heat an
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.