ASTM F2066/F2066M-13

Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of each other. Combining values from the two systems may result in non-conformance with the standard.

General Information

• Status: Historical
• Publication Date: 30-Sep-2013
• ICS: 11.040.30 - Surgical instruments and materials
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F2066/F2066M −13
StandardSpecification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
1
Applications (UNS R58150)
ThisstandardisissuedunderthefixeddesignationF2066/F2066M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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* toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
1.1 This specification covers the chemical, mechanical, and
E2371Test Method for Analysis of Titanium and Titanium
metallurgical requirements for wrought titanium-15 molybde-
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
num alloy to be used in the manufacture of surgical implants
2 Plasma Atomic Emission Spectrometry (Performance-
(1).
Based Test Methodology)
1.2 The values stated in either SI units or inch-pound units
F67Specification for Unalloyed Titanium, for Surgical Im-
are to be regarded separately as standard. The values stated in
plant Applications (UNS R50250, UNS R50400, UNS
each system may not be exact equivalents; therefore, each
R50550, UNS R50700)
system shall be used independently of each other. Combining
F748PracticeforSelectingGenericBiologicalTestMethods
values from the two systems may result in non-conformance
for Materials and Devices
with the standard.
F981Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
2. Referenced Documents
Materials on Muscle and Bone
3
2.1 ASTM Standards: F1408Practice for Subcutaneous ScreeningTest for Implant
Materials
E8/E8MTest Methods for Tension Testing of Metallic Ma-
terials IEEE/ASTM SI 10American National Standard for Use of
theInternationalSystemofUnits(SI):TheModernMetric
E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications System
4
E112Test Methods for Determining Average Grain Size 2.2 Aerospace Material Specifications:
E290Test Methods for Bend Testing of Material for Ductil- AMS 2249Chemical Check Analysis Limits, Titanium and
ity
Titanium Alloys
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray AMS 2631Ultrasonic Inspection — Titanium and Titanium
Fluorescence Spectrometry
Alloy Bar and Billet
E1409TestMethodforDeterminationofOxygenandNitro- AMS 2380Approval and Control of Premium Quality Tita-
gen in Titanium and Titanium Alloys by the Inert Gas
nium Alloys
5
Fusion Technique
2.3 ISO Standards:
E1447Test Method for Determination of Hydrogen in Tita-
ISO 6892Metallic Materials — Tensile Testing at Ambient
nium and Titanium Alloys by Inert Gas Fusion Thermal
Temperature
Conductivity/Infrared Detection Method
ISO9001 Quality Management Systems Requirements
E1941Test Method for Determination of Carbon in Refrac-
2.4 American Society for Quality Standard:
ASQ C1Specification of General Requirements for a Qual-
6
ity Control Program
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of 3. Terminology
Subcommittee F04.12 on Metallurgical Materials.
3.1 Definitions of Terms Specific to This Standard:
Current edition approved Oct. 1, 2013. Published November 2013. Originally
approved in 2001. Last previous edition approved in 2011 as F2066–11. DOI:
10.1520/F2066_F2066M–13.
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 National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
6
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.
*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 ----------------------
F2066/F2066M−13
3.1.1 alpha + beta annealed, n—the condition of the mate- chemically milled, ground, machined, peeled, polished, com-
rial that is obtained if, following the final hot-working or binations of these operations, or as specified by the purchaser.
cold-working operation, the mill product may be rapidly On billets, bars, plates, and forgings, it is permissible to
quenched, for example, by water quenching or pressurized removeminorsurfaceimperfectionsbygri
...

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: F2066 − 11 F2066/F2066M − 13
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
1
Applications (UNS R58150)
This standard is issued under the fixed designation F2066;F2066/F2066M; 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 titanium-15 molybdenum
2
alloy to be used in the manufacture of surgical implants (1).
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given in
parentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in each
system may not be exact equivalents; therefore, each system shall be used independently of each other. Combining values from
the two systems may result in non-conformance with the standard.
2. Referenced Documents
3
2.1 ASTM Standards:
E8E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
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 the Inert Gas Fusion
Technique
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)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F1408 Practice for Subcutaneous Screening Test for Implant Materials
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
4
2.2 Aerospace Material Specification: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
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, 2011Oct. 1, 2013. Published December 2011November 2013. Originally approved in 2001. Last previous edition approved in 20082011
as F2066 – 08.F2066 – 11. DOI: 10.1520/F2066–11.10.1520/F2066_F2066M–13.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
4
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 ----------------------
F2066/F2066M − 13
5
2.3 ISO Standards:
ISO 6892 Metallic Materials — Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems Requirements
2.4 American Society for Quality Standard:
6
ASQ C1 Specification of General Requirements for a Quality Control Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 alpha + beta annealed, n—the condition of the material that is obtained if, following the final hot-working or
cold-w
...