ASTM F1713-08
(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).
1.2 The values stated in inch pound units are to be regarded as the standard. The SI equivalents in parentheses are provided for information only.
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Designation:F1713 −08
StandardSpecification for
Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical
1
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* 2.2 Aerospace Material Specification:
AMS 2249Chemical Check Analysis Limits, Titanium and
1.1 This specification covers the chemical, mechanical, and
4
Titanium Alloys
metallurgical requirements for wrought titanium-13niobium-
13zirconium alloy to be used in the manufacture of surgical
2.3 American Society for Quality (ASQ) Standard:
2
implants (1).
ASQC1SpecificationsofGeneralRequirementsforaQual-
5
ity Program
1.2 The values stated in inch pound units are to be regarded
asthestandard.TheSIequivalentsinparenthesesareprovided
2.4 ISO Standards:
for information only.
ISO5832-3ImplantsforSurgery—MetallicMaterials—Part
6
3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
2. Referenced Documents
ISO 6892Metallic Materials Tensile Testing at Ambient
6
3
Temperature
2.1 ASTM Standards:
6
ISO 9001Quality Management Systems—Requirements
E8Test Methods for Tension Testing of Metallic Materials
E29Practice for Using Significant Digits in Test Data to
3. Terminology
Determine Conformance with Specifications
E1409TestMethodforDeterminationofOxygenandNitro-
3.1 Definitions of Terms Specific to This Standard:
gen in Titanium and Titanium Alloys by the Inert Gas
3.1.1 beta transus, n—the minimum temperature at which
Fusion Technique
the alpha plus beta phase can transform to 100% beta phase.
E1447Test Method for Determination of Hydrogen in Tita-
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
ture.
F748PracticeforSelectingGenericBiologicalTestMethods
3.1.3 cold work, n—any mechanical deformation process
for Materials and Devices
performed below the recrystallization temperature which re-
F1472Specification for Wrought Titanium-6Aluminum-
sults in strain hardening of the material.
4VanadiumAlloyforSurgicalImplantApplications(UNS
R56400)
3.1.4 hot work, n—any mechanical deformation process
performed above the recrystallization temperature.
3.1.5 lot, n—the total number of mill products produced
1
This specification is under the jurisdiction of ASTM Committee F04 on
from the same melt heat under the same conditions at essen-
Medical and Surgical Materials and Devices and is the direct responsibility of
tially the same time.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Feb. 1, 2008. Published March 2008. Originally
approved in 1996. Last previous edition approved in 2003 as F1713–03. DOI:
10.1520/F1713-08.
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.
6
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 ----------------------
F1713−08
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,
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1713–03 Designation: F 1713 – 08
Standard Specification for
Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical
1
Implant Applications (UNS R58130)
This standard is issued under the fixed designation F 1713; 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 (e) 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 titanium-13niobium-
2
13zirconium alloy to be used in the manufacture of surgical implants (1).
1.2 The values stated in inch pound units are to be regarded as the standard. The SI equivalents in parentheses are provided for
information only.
2. Referenced Documents
3
2.1 ASTM Standards:
E 8Methods of Tension Testing of Metallic Materials Test Methods for Tension Testing of Metallic Materials
E120TestMethodsforChemicalAnalysisofTitaniumandTitaniumAlloys 29 PracticeforUsingSignificantDigitsinTestData
to Determine Conformance with Specifications
E 1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion
Technique
E 1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E 1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys
E 2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
2.2 Aerospace Material Specification:
4
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
2.3 American Society for Quality (ASQ) Standard:
ASQ C1 Specifications of General Requirements for a Quality Program
2.4 ISO Standard:
5
2.4 ISO Standards:
6
ISO 5832-3 Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
ISO 6892Metallic Materials Tensile Testing at Ambient Temperature Metallic Materials Tensile Testing at Ambient
6
Temperature
6
ISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1Definitions of Terms Specific to This Standard:
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 June 10, 2003. Published July 2003. Originally approved in 1996. Last previous edition approved in 1996 as F1713–96.
Current edition approved Feb. 1, 2008. Published March 2008. Originally approved in 1996. Last previous edition approved in 2003 as F 1713 – 03.
2
The boldface numbers in parentheses refer to the list of references at the end of the text.this standard.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 03.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
4
Annual Book of ASTM Standards, Vol 03.05.
4
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
5
Annual Book of ASTM Standards, Vol 13.01.
5
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
6
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001.
6
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 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 ----------------------
F1713–08
3.1.1capability aged, n—the condition of the material that is obtained if, following solution treatment, a sample of the mill
product is subjected to an aging treatment such as given below, for certification testing.
3.1.1.1Age for 6 6 0.25 h at 923 6 25°F (495 6 14°C).
3.1.1.2Remove from furnace and air cool to room temperature. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 beta transus, n—t
...
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