ASTM F138-03

Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

SCOPE
1.1 This specification covers the requirements for wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel bar and wire used for the manufacture of surgical implants.  
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI units given in parentheses are for information only.

General Information

• Status: Historical
• Publication Date: 09-Jun-2003
• 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 F138-00 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• Effective Date: 10-Jun-2003
• Replaced By: ASTM F138-08 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• Effective Date: 01-May-2008
• Referred By: ASTM F647-22 - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• Effective Date: 10-Jun-2003
• Referred By: ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 10-Jun-2003
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-Jun-2003
• Referred By: ASTM F2181-20 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
• Effective Date: 10-Jun-2003
• 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-Jun-2003
• Referred By: ASTM F621-12(2021)e1 - Standard Specification for Stainless Steel Forgings for Surgical Implants
• Effective Date: 10-Jun-2003
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Jun-2003
• Referred By: ASTM F2581-12(2017) - Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
• Effective Date: 10-Jun-2003
• 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-Jun-2003
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 10-Jun-2003
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 10-Jun-2003
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 10-Jun-2003
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 10-Jun-2003

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 138 – 03
Standard Specification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
Steel Bar and Wire for Surgical Implants (UNS S31673)
This standard is issued under the fixed designation F 138; 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.
This standard has been approved for use by agencies of the Department of Defense.
5
1. Scope* Part 1:Wrought Stainless Steel
5
ISO 6892 Metallic Materials—Tensile Testing
1.1 This specification covers the requirements for wrought
2.3 ASQ Standard:
18chromium-14nickel-2.5molybdenum stainless steel bar and
C1 Specification of General Requirements for a Quality
wire used for the manufacture of surgical implants.
6
Program
1.2 The values stated in inch-pound units are to be regarded
as the standard. The SI units given in parentheses are for
3. General Requirements for Delivery
information only.
3.1 In addition to the requirements of this specification, all
2. Referenced Documents requirements of the current editions of Specifications A 484/
A 484M and A 555/A 555M shall apply.
2.1 ASTM Standards:
3.2 In the case where a conflict exists between this specifi-
A 262 Practices for Detecting Susceptibility to Intergranu-
2
cation and those listed in 2.1 and 2.2, this specification shall
lar Attack in Austenitic Stainless Steels
take precedence.
A 484/A 484M Specification for General Requirements for
2
Stainless Steel Bars, Billets, and Forgings
4. Ordering Information
A 555/A 555M Specification for General Requirements for
2 4.1 Inquiries and orders for material under this specification
Stainless Steel Wire and Wire Rods
shall include the following information:
A 751 Test Methods, Practices, and Terminology for
2 4.1.1 Quantity (weight or number of pieces),
Chemical Analysis of Steel Products
3
4.1.2 ASTM designation,
E 8 Test Methods forTensionTesting of Metallic Materials
4.1.3 Form (bar, wire, fine wire),
E 8M Test Methods for Tension Testing of Metallic Mate-
3 4.1.4 Condition (see 5.1),
rials [Metric]
4.1.5 Mechanical properties (if applicable, for special con-
E 45 Test Methods for Determining the Inclusion Content
3 ditions),
of Steel
3 4.1.6 Finish (see 5.2),
E 112 Test Methods for Determining Average Grain Size
3 4.1.7 Applicable dimensions including size, thickness,
E 407 Practice for Microetching Metals and Alloys
width,andlength(exact,randomormultiples)orprintnumber,
F 981 Practice for Assessment of Compatibility of Bioma-
and
terials for Surgical Implants with Respect to Effect of
4 4.1.8 Special requirements.
Materials in Muscle and Bone
F 1350 Specification for Wrought 18Chromium-14Nickel-
5. Materials and Manufacture
2.5Molybdenum Stainless Steel Surgical Fixation Wire
4 5.1 Condition:
(UNS S31673)
5.1.1 Bar and wire shall be furnished, as specified, in the
2.2 ISO Standards:
hot-worked, annealed, cold -worked, or extra hard condition
ISO 5832-1 Implants for Surgery—Metallic Materials—
(see Table 1).
5.1.2 Fine wire shall be furnished, as specified, in the
cold-drawn condition (see Table 2).
1
This specification is under the jurisdiction of ASTM Committee F04 on
5.2 Finish:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved June 10, 2003. Published July 2003. Originally
5
approved in 1971. Last previous edition approved in 2000 as F 138 – 00. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
2
Annual Book of ASTM Standards, Vol 01.03. 4th Floor, New York, NY 10036.
3 6
Annual Book of ASTM Standards, Vol 03.01. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
4
Annual Book of ASTM Standards, Vol 13.01. Milwaukee, WI 53203.
*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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F138–03
TABLE 1 Mechanical Requirements, Wire and Bar
A B
Ultimate Tensile Elongation in Brinell
Yield Strength (0.2 %
Condition Diameter or Thickness, in. (mm) Strength, min, psi 4D or 4W, Hardness, max,
offset), min, psi (MPa)
(MPa) min, % HB
C
Hot-worked all . . . 250
Annealed 0.063 and over (1.60) 71 000 (490) 27 500 (190) 40 .
Cold-worked 0.063 to 1.500 (1.60 to 38.1) 125 000 (860) 100 000 (690) 12 .
Extra-hard 0.063 to 0.250 (1.60 to 6.35) 196 000 (1350) . . .
A
4D =4 3 diameter; 4W =4 3 width. Alternatively, a gage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser.
...