ASTM F136-02

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

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-Apr-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

• Replaced By: ASTM F136-02a - 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
• 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-Apr-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-Apr-2002
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1472-23 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 10-Apr-2002
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 10-Apr-2002
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 10-Apr-2002
• Referred By: ASTM F3001-14(2021) - Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 10-Apr-2002
• 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-Apr-2002
• Referred By: ASTM F2146-22 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
• Effective Date: 10-Apr-2002

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 136 – 02
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.
1. Scope * AMS 2249 Chemical Check Analysis Limits, Titanium and
Titanium Alloys
1.1 This specification covers the chemical, mechanical, and
AMS 4930 Titanium Alloy Bars, Forgings, and Rings
metallurgical requirements for wrought annealed titanium-
6AL-4V Extra Low Interstitial Annealed
6aluminum-4vanadium ELI (extra low interstitial) alloy
2.4 Society of Automotive Engineers Standard:
(R56401) to be used in the manufacture of surgical implants.
SAE J1086 Practice for Numbering Metals and Alloys
1.2 The values stated in inch-pound units are to be regarded
8
(UNS)
as the standard. The SI equivalents in parentheses are provided
for information only.
3. Product Classification
2. Referenced Documents 3.1 Strip—Any product under 0.1875 in. (4.75 mm) in
thickness and under 24 in. (610 mm) wide.
2.1 ASTM Standards:
2 3.2 Sheet—Any product under 0.1875 in. (4.75 mm) in
E 8 Test Methods of Tension Testing of Metallic Materials
thickness and 24 in. (610 mm) or more in width.
E 120 Test Methods for Chemical Analysis of Titanium and
3 3.3 Plate—Any product 0.1875 in. (4.75 mm) thick and
Titanium Alloys
over and 10 in. (254 mm) wide and over, with widths greater
E 290 Test Method for Bend Testing of Materials for
3 than five times thickness. Plate up to 4.00 in. (101.60 mm),
Ductility
4
thick inclusive is covered by this specification.
E 527 Practice for Numbering Metals and Alloys (UNS)
3.4 Bar—Round bars and flats from 0.1875 in. (4.75 mm) to
E 1409 Test Methods for Determination of Oxygen in
4.00 in. (101.60 mm) in diameter or thickness (other sizes and
Titanium and Titanium Alloys by the Inert Gas Fusion
3
shapes by special order).
Technique
3.5 Forging Bar—Bar as described in 3.4, used for produc-
E 1447 Test Method for Determination of Hydrogen in
tion of forgings, may be furnished in the hot rolled condition.
Titanium and Titanium Alloys by the Inert Gas Fusion
3
3.6 Wire—Rounds less than 0.1875 in. (4.75 mm) in diam-
Thermal Conductivity Method
eter.
F 981 Practice for Assessment of Compatibility of Bioma-
terials for Surgical Implants with Respect to Effect of
4. Ordering Information
5
Materials on Muscle and Bone
4.1 Include with inquiries and orders for material under this
2.2 ASQ Standard:
specification the following information:
ASQ C1 Specifications of General Requirements for a
6 4.1.1 Quantity,
Quality Control Program
7 4.1.2 ASTM designation and date of issue,
2.3 Aerospace Material Specifications:
4.1.3 Form (sheet, strip, plate, bar, or wire),
4.1.4 Condition (See 5.3),
1
This specification is under the jurisdiction of ASTM Committee F04 on 4.1.5 Mechanical properties (if applicable, for special con-
Medical and Surgical Materials and Devices and is the direct responsibility of
ditions),
Subcommittee F04.12 on Metallurgical Materials.
4.1.6 Finish (See 5.2),
Current edition approved Apr. 10, 2002. Published June 2002. Originally
e1
4.1.7 Applicable dimensions including size, thickness,
published as F 136 – 84. Last previous edition F 136 – 98 .
2
Annual Book of ASTM Standards, Vol 03.01.
width, or drawing number,
3
Annual Book of ASTM Standards, Vol 03.05.
4.1.8 Special tests, if any, and
4
Annual Book of ASTM Standards, Vol 01.01.
5 4.1.9 Other requirements.
Annual Book of ASTM Standards, Vol 13.01.
6
Available from American Society for Quality, 600 N. Plankinton Ave.,
Milwaukee, WI 53203.
7
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
8
Dr., Warrendale, PA 15096-0001. 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.
1

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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.
F 136
A
TABLE 2 Product Analysis Tolerance
5. Materials and Manufacture
Tolerance Under the Minimum or
5.1 The various titanium mill products covered in this
Element Over the Maximum Limit
specification normally are formed with the conventional forg- B
(Composition %)
ing and rolling equipment found in primary ferrous and
Nitrogen 0.02
nonferrous plants. The alloy
...