ASTM F1295-97a

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

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: 09-Oct-2001
• 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

• Replaced By: ASTM F1295-01 - Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 10-Oct-2001
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-Oct-2001
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 10-Oct-2001
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-Oct-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1295 – 97a
Standard Specification for
Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical
Implant Applications [UNS R56700]
This standard is issued under the fixed designation F 1295; 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 3. Ordering Information
1.1 This specification covers the chemical, mechanical, and 3.1 Inquiries and orders for material under this specification
metallurgical requirements for wrought annealed titanium-6 shall include the following information:
aluminum-7 niobium alloy bar to be used in the manufacture of 3.1.1 Quantity (weight or number of pieces),
surgical implants (1-4). 3.1.2 ASTM designation,
1.2 The values stated in inch-pound units are to be regarded 3.1.3 Dimensions,
as the standard. The SI (metric) units given in parentheses are 3.1.4 Condition,
for information only. 3.1.5 Finish, and
3.1.6 Special requirements.
2. Referenced Documents
4. Materials and Manufacture
2.1 ASTM Standards:
E 8 Test Methods for Tension Testing of Metallic Materials 4.1 The titanium alloy shall be manufactured from multiple
E 120 Test Methods for Chemical Analysis of Titanium and vacuum melted material using conventional reactive metal
Titanium Alloys processing methods. The bar product covered in this specifi-
E 1409 Test Method for Determination of Oxygen in Tita- cation is normally formed with the conventional forging and
nium and Titanium Alloys by the Insert Gas Fusion rolling equipment found in ferrous and nonferrous plants.
Technique 4.2 Finish—Annealed bar may be furnished to the implant
E 1447 Test Method for Determination of Hydrogen in manufacturer as descaled or pickled, sandblasted, ground, or
Titanium and Titanium Alloys by the Insert Gas Fusion combinations of these operations.
Thermal Conductivity Method
5. Chemical Composition
F 981 Practice for Assessment of Compatibility of Biioma-
5.1 The heat analysis shall conform to the chemical com-
terials for Surgical Implants with Respect to Effect of
Materials in Muscle and Bone position of Table 1. Ingot analysis may be used for reporting all
chemical requirements, except hydrogen. Samples for hydro-
2.2 Aerospace Material Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and gen shall be taken from the finished mill product.
5.1.1 Requirements for the major and minor elemental
Titanium Alloys
constituents are listed in Table 1. Also listed are important
2.3 ASQC Standard:
C1 Specification of General Requirements for a Quality residual elements. Analysis for elements not listed in Table 1 is
not required to certify compliance with this specification.
Program
5.2 Product Analysis:
5.2.1 Product analysis tolerances do not broaden the speci-
fied heat analysis requirements but cover variations between
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee laboratories in the measurement of chemical content. The
F04.12 on Metallurgical Materials.
manufacturer shall not ship material that is outside the limits
Current edition approved June 10, 1997. Published September 1997. Originally
specified in Table 1. Product analysis limits shall be as
published as F 1295 – 92. Last previous edition F 1295 – 97.
specified in Table 2.
The boldface numbers in parentheses refer to a list of references at the end of
the text.
5.2.2 The product analysis is either for the purpose of
Annual Book of ASTM Standards, Vols 01.02, 02.01, 02.02, 02.03, and 03.01.
verifying the composition of a heat or lot or to determine
Annual Book of ASTM Standards, Vol 03.05.
5 variations in the composition within the heat.
Annual Book of ASTM Standards, Vol 03.06.
Annual Book of ASTM Standards, Vol 13.01. 5.3 For referee purposes, Test Methods E 120, E 1409, and
Available from Society of Automotive Engineers, 400 Commonwealth Drive,
E 1447 shall be used or other analytical methods agreed upon
Warrendale, PA 15096.
between purchaser and supplier shall be used.
Available from American Society for Quality Control, 161 West Wisconsin
5.4 Samples for chemical analysis shall be representative of
Ave., Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1295
TABLE 1 Chemical Requirements
speed shall be increased so as to produce fracture in approxi-
Element Composition, % mately one additional minute.
6.3 Number of Tests— A minimum of two tension tests shall
Aluminum 5.50 to 6.50
Niobium 6.50 to 7.50
be made from each lot. A lot is defined as the total number of
Tantalum 0.50 max
a specific mill product produced under the same conditions at
Iron 0.25 max
essentially the same time. Should either of the test specimens
Oxygen 0.20 max
Carbon 0.08 max
not meet the specific requirements or break outside the gage
Nitrogen 0.05 max
limits, two additional test pieces representative of the same lot
Hydrogen 0.009 max
A
shall be tested in the same manner. The lot shall be rejected if
Titanium Balance
A
either of the additional test pieces fail to meet the specified
The percentage of titanium is determined by difference and need not be
determined or certified. requirements.
7. Microstructure
A
TABLE 2 Product Analysis Tolerances
7.1 The microstructure shall be a fine dispersion of the alpha
B
Tolerance Under the Minimum or Over the Maximum Limit
and beta phases resulting from processing in the alpha plus beta
Aluminum 0.10
field. There shall be no continuous alpha network at prior beta
Niobium 0.10
grain boundaries. There shall be no coarse, elongated alpha
Tantalum 0.10
Iron 0.10
platelets. There shall be no alpha case.
Oxygen 0.02
7.2 Products supplied with a machined or ground surface
Carbon 0.02
finish shall have no alpha case. For other products, there shall
Nitrogen 0.02
Hydrogen 0.002
be no continuous layer of alpha case when examined at 1003.
A
Refer to AMS 2249. 7.3 A minimum of one sample per lot shall be examined.
B
Under minimum limit not applicable for elements where only a maximum
8. Certification
percentage is indicated.
8.1 A certificate of tests shall be provided with the following
information:
the material bei
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