ASTM F2066-08
(Specification)Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; bar; or wire. The heat analysis shall conform to the chemical composition prescribed. Material shall be furnished in the beta annealed condition. Bend tests and tension tests shall be performed to conform to the specified requirements.
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).
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
Relations
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 – 08
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
1
Applications (UNS R58150)
This standard is issued under the fixed designation F2066; 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* rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
1.1 This specification covers the chemical, mechanical, and
F1408 Practice for Subcutaneous Screening Test for Im-
metallurgical requirements for wrought titanium-15 molybde-
plant Materials
num alloy to be used in the manufacture of surgical implants
2
2.2 Aerospace Material Specification:
(1).
AMS 2249 Chemical Check Analysis Limits, Titanium and
1.2 The values stated in inch-pound units are to be regarded
4
Titanium Alloys
as standard. The values given in parentheses are mathematical
5
2.3 ISO Standards:
conversions to SI units that are provided for information only
ISO 6892 Metallic Materials — Tensile Testing
and are not considered standard.
ISO 9001 Quality Management Systems
2. Referenced Documents
2.4 American Society for Quality Standard:
3
ASQ C1 Specification of General Requirements for a Qual-
2.1 ASTM Standards:
6
ity Program
E8 Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to
3. Terminology
Determine Conformance with Specifications
3.1 Definitions of Terms Specific to This Standard:
E112 Test Methods for Determining Average Grain Size
3.1.1 beta annealed, n—the condition of the material that is
E290 Test Methods for Bend Testing of Material for Duc-
obtained if, following the final hot-working or cold-working
tility
operation, the mill product is rapidly quenched, for example,
E1409 Test Method for Determination of Oxygen and
by water quenching or pressurized helium gas quench, from a
Nitrogen inTitanium andTitaniumAlloys by the Inert Gas
temperature above the beta transus of approximately 1382°F
Fusion Technique
(750°C).
E1447 Test Method for Determination of Hydrogen in
3.1.2 beta transus, n—the minimum temperature at which
Titanium and Titanium Alloys by Inert Gas Fusion Ther-
the alpha plus beta phase can transform to 100 % beta phase.
mal Conductivity/Infrared Detection Method
E2371 Test Method for Analysis of Titanium and Titanium
4. Product Classification
Alloys by Atomic Emission Plasma Spectrometry
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in
F67 Specification for Unalloyed Titanium, for Surgical
thickness and under 24 in. (610 mm) wide.
Implant Applications (UNS R50250, UNS R50400, UNS
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in
R50550, UNS R50700)
thickness and 24 in. (610 mm) or more in width.
F748 Practice for Selecting Generic Biological Test Meth-
4.3 Plate—Any product 0.1875 in. (4.76 mm) thick and
ods for Materials and Devices
over and 10 in. (254 mm) wide and over, with widths greater
F981 Practice forAssessment of Compatibility of Biomate-
than five times the thickness. Any plate up to 4 in. (101.60
mm), thick inclusive, is covered by this specification.
1
4.4 Bar—Rounds, flats, or other shapes from 0.1875 in.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
(4.76 mm) to 4 in. (101.60 mm) in diameter or thickness.
Subcommittee F04.12 on Metallurgical Materials.
(Other sizes and shapes by special order.)
Current edition approved Oct. 1, 2008. Published October 2008. Originally
approved in 2001. Last previous edition approved in 2007 as F2066 – 07. DOI:
10.1520/F2066–08.
2 4
The boldface numbers in parentheses refer to the list of references at the end of 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 service@astm.org. 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 from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
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 – 08
3
4.5 Wire—Rounds, flats, or other shapes less than ⁄
...
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:F2066–07 Designation: F 2066 – 08
Standard Specification for
Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
1
Applications (UNS R58150)
This standard is issued under the fixed designation F 2066; 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) .
1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareforinformation
only.
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.
2. Referenced Documents
3
2.1 ASTM Standards:
E 8 Test Methods for Tension Testing of Metallic Materials
E 29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E 112 Test Methods for Determining Average Grain Size
E 290 Test Methods for Bend Testing of Material for Ductility
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 2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F 67 SpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNS
R50700)
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F 1408 Practice for Subcutaneous Screening Test for Implant Materials
2.2 Aerospace Material Specification:
4
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
5
2.3 ISO Standards:
ISO 6892 Metallic Materials — Tensile Testing
ISO 9001 Quality Management Systems
2.4 American Society for Quality Standard:
6
ASQ C1 Specification of General Requirements for a Quality Program
3. Terminology
3.1 Definitions 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 AprilOct. 1, 2007.2008. Published June 2007.October 2008. Originally approved in 2001. Last previous edition approved in 20012007 as
F 2066 – 017.
2
The boldface numbers in parentheses refer to the list of references at the end of 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
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.
5
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
6
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., 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 ----------------------
F2066–08
3.1.1 beta annealed, n—the condition of the material that is obtained if, following the final hot-working or cold-working
operation, the mill product is rapidly quenched, for example, by water quenching or pressurized helium gas quench, from a
temperature above the beta transus of approximately 1382°F (750°C).
3.1.2 beta transus, n—the minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase.
4. Product Classification
4.1 Strip—Any product under 0.1875 in. (4.76 mm) in thickness and under 24 in. (610 mm) wide.
4.2 Sheet—Any product under 0.1875 in. (4.76 mm) in thickness and 24 in. (610 mm) or more in width.
4.3 Plate—Any product 0.18
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.