ASTM F1295-05

Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6 aluminum-7 niobium alloy bar and wire to be used in the manufacture of surgical implants (1-4).
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.

General Information

• Status: Historical
• Publication Date: 31-Dec-2004
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F1295-01 - Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
• Effective Date: 01-Jan-2005
• Replaced By: ASTM F1295-11 - Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
• Effective Date: 15-Nov-2011
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Jan-2005
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Jan-2005
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Jan-2005
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 01-Jan-2005
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 01-Jan-2005

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: F1295 – 05
Standard Specification for
Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical
1
Implant Applications (UNS R56700)
This standard is issued under the fixed designation F1295; 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.
6
1. Scope* 2.3 Aerospace Material Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and
1.1 This specification covers the chemical, mechanical, and
Titanium Alloys
metallurgical requirements for wrought annealed, cold worked,
7
2.4 American Society for Quality Standard:
or hot rolled titanium-6aluminum-7niobium alloy bar and wire
2
ASQ C1 Specification of General Requirements for a Qual-
to be used in the manufacture of surgical implants (1-4).
ity Program
1.2 The values stated in inch-pound units are to be regarded
as the standard. The SI equivalents in parentheses are for
3. Product Classification
information only.
3.1 bar—roundsorflatsfrom0.1875to4in.(4.76to101.60
2. Referenced Documents mm) in diameter or thickness. Other sizes and shapes by
3 special order.
2.1 ASTM Standards:
3.2 forging bar—bar as described in 3.1, used for the
E8 Test Methods for Tension Testing of Metallic Materials
production of forgings, may be furnished in the hot rolled
E120 Test Methods for Chemical Analysis of Titanium and
4
condition.
Titanium Alloys
3.3 wire—rounds or flats less than 0.1875 in. (4.76 mm) in
E1409 Test Method for Determination of Oxygen and
diameter or thickness.
Nitrogen inTitanium andTitaniumAlloys by the Inert Gas
Fusion Technique
4. Ordering Information
E1447 Test Method for Determination of Hydrogen in
4.1 Include with inquiries and orders for material under this
Titanium and Titanium Alloys by Inert Gas Fusion Ther-
specification the following information:
mal Conductivity/Infrared Detection Method
4.1.1 Quantity (weight or number of pieces),
F981 Practice forAssessment of Compatibility of Biomate-
4.1.2 Applicable ASTM designation, date of issue.
rials for Surgical Implants with Respect to Effect of
4.1.3 Form (bar or wire),
Materials on Muscle and Bone
5 4.1.4 Condition (see 5.3),
2.2 ISO Standards:
4.1.5 Mechanical Properties (if applicable for special con-
ISO 5832–11 Implants for Surgery—Metallic Materials—
ditions),
Part 11: Wrought Titanium 6–Aluminum 7–Niobium Al-
4.1.6 Finish (see 5.2),
loy
4.1.7 Applicable dimensions including size, thickness,
ISO 6892 Metallic Materials—Tensile Testing
width, or drawing number,
4.1.8 Special tests, if any,
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.9 Other requirements.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
5. Materials and Manufacture
Current edition approved Jan. 1, 2005. Published January 2005. Originally
approved in 1992. Last previous edition approved in 2001 as F1295 – 01. DOI: 5.1 The various titanium mill products covered in this
10.1520/F1295-05.
specification normally are formed with the conventional forg-
2
The boldface numbers in parentheses refer to a list of references at the end of
ing and rolling equipment found in primary ferrous and
the text.
3
nonferrous plants. The alloy is usually multiple melted in arc
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
6
the ASTM website. Available from Society of Automotive Engineers (SAE), 400 Commonwealth
4
Withdrawn. Dr., Warrendale, PA 15096-0001.
5 7
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
4th Floor, New York, NY 10036. Milwaukee, WI 53203.
*A Summary of Changes section appears at the end of this standard.
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F1295 – 05
A
TABLE 2 Product Analysis Tolerances
furnaces (including furnaces such as plasma arc and electron
B
beam) of a type conventionally used for reactive metals. Tolerance Under the Minimum or Over the Maximum Limit
5.2 Finish—The mill product may be furnished to the
Aluminum 0.10
Niobium 0.10
implant manufacturer as descaled or pickled, sandblasted,
Tantalum 0.10
chemically milled, ground, machined, peeled, polished, cold
Iron 0.10
drawn, or as specified by the purchaser.
Oxygen 0.02
Carbon 0.02
5.3 Condition—Material shall be furnished in the annealed,
Ni
...