ASTM F136-02a

Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories in the measurement of chemical content. Tension test and bend test shall be performed to meet the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.
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.

General Information

• Status: Historical
• Publication Date: 09-Nov-2002
• 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 F136-02 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
• Effective Date: 10-Nov-2002
• Replaced By: ASTM F136-08 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
• Effective Date: 01-Nov-2008
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 10-Nov-2002
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Nov-2002
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 10-Nov-2002
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 10-Nov-2002
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• Effective Date: 10-Nov-2002
• Referred By: ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
• Effective Date: 10-Nov-2002
• Referred By: ASTM F1472-23 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
• Effective Date: 10-Nov-2002
• Referred By: ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 10-Nov-2002

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: F 136 – 02a
Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS
1
R56401)
This standard is issued under the fixed designation F 136; 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.
8
1. Scope * 2.3 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and
1.1 This specification covers the chemical, mechanical, and
Titanium Alloys
metallurgical requirements for wrought annealed titanium-
AMS 4930 Titanium Alloy Bars, Forgings, and Rings
6aluminum-4vanadium ELI (extra low interstitial) alloy
6AL-4V Extra Low Interstitial Annealed
(R56401) to be used in the manufacture of surgical implants.
2.4 Society of Automotive Engineers Standard:
1.2 The values stated in inch-pound units are to be regarded
SAE J1086 Practice for Numbering Metals and Alloys
as the standard. The SI equivalents in parentheses are provided
9
(UNS)
for information only.
3. Terminology
2. Referenced Documents
3.1 Definitions of Terms Specific to This Standard:
2.1 ASTM Standards:
2
3.1.1 lot, n—the total number of mill products produced
E 8 Test Methods of Tension Testing of Metallic Materials
fromoneheatunderthesameconditionsatessentiallythesame
E 120 Test Methods for ChemicalAnalysis of Titanium and
3
time.
Titanium Alloys
E 290 Test Method for Bend Testing of Materials for
4. Product Classification
3
Ductility
4
4.1 Strip—Any product under 0.1875 in. (4.75 mm) in
E 527 Practice for Numbering Metals and Alloys (UNS)
thickness and under 24 in. (610 mm) wide.
E 1409 Test Method for Determination of Oxygen in Tita-
4.2 Sheet—Any product under 0.1875 in. (4.75 mm) in
nium and Titanium Alloys by the Inert Gas Fusion Tech-
5 thickness and 24 in. (610 mm) or more in width.
nique
4.3 Plate—Any product 0.1875 in. (4.75 mm) thick and
E 1447 Test Method for Determination of Hydrogen in
over and 10 in. (254 mm) wide and over, with widths greater
Titanium and Titanium Alloys by the Inert Gas Fusion
3 than five times thickness. Plate up to 4.00 in. (101.60 mm),
Thermal Conductivity Method
thick inclusive is covered by this specification.
F 981 Practice for Assessment of Compatibility of Bioma-
4.4 Bar—Roundbarsandflatsfrom0.1875in.(4.75mm)to
terials for Surgical Implants with Respect to Effect of
6 4.00 in. (101.60 mm) in diameter or thickness (other sizes and
Materials on Muscle and Bone
shapes by special order).
2.2 ASQ Standard:
4.5 Forging Bar—Bar as described in 4.4, used for produc-
ASQ C1 Specifications of General Requirements for a
7 tion of forgings, may be furnished in the hot rolled condition.
Quality Control Program
4.6 Wire—Rounds less than 0.1875 in. (4.75 mm) in diam-
eter.
1
This specification is under the jurisdiction of ASTM Committee F04 on
5. Ordering Information
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
5.1 Include with inquiries and orders for material under this
Current edition approved Nov. 10, 2002. Published December 2002. Originally
specification the following information:
published in 1984. Last previous edition approved in 2002 as F 136 – 02.
2
5.1.1 Quantity,
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 03.05.
5.1.2 ASTM designation and date of issue,
4
Annual Book of ASTM Standards, Vol 01.01.
5
Annual Book of ASTM Standards, Vol 03.06.
6 8
Annual Book of ASTM Standards, Vol 13.01. Available from Society of Automotive Engineers (SAE), 400 Commonwealth
7
Available from American Society for Quality, 600 N. Plankinton Ave., Dr., Warrendale, PA 15096-0001.
9
Milwaukee, WI 53203. New designation established in accordance with E 527 and SAE J1086.
*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.
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F 136 – 02a
A
TABLE 2 Product Analysis Tolerance
5.1.3 Form (sheet, strip, plate, bar, or wire),
5.1.4 Condition (See 6.3), Tolerance Under the Minimum or
Element Over the Maximum Limit
5.1.5 Mechanical properties (if applicable, for special con-
B
(Composition %)
ditions),
Nitrogen 0.02
5.1.6 Finish (See 6.2),
Carbon 0.02
5.1.7 Applicable dimensions including size, thickness,
Hydrogen 0.0020
Iron 0.10
width, or drawing number,
Oxygen 0.02
5.1.8 Special tests, if any, and
Aluminum 0.40
5.1.9 Other requirements.
Vanadium 0.15
A
See AMS 2249.
B
6. Materials and Manufacture Under minimum limit not applicable f
...