ASTM F138-19
(Specification)Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
ABSTRACT
This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants. Bar and wire shall be furnished, as specified, in the hot-worked, annealed, cold -worked, or extra hard condition. Fine wire shall be furnished, as specified, in the cold-drawn condition. Types of finish available for bar and wire products are cold-drawn, pickled, ground, and ground and polished. On the other hand, types of finish available for fine wire products are cold-drawn, ground, and ground and polished. The heat analysis shall conform to the requirements as to chemical composition specified and the material shall contain no delta ferrite, chi, or sigma phases when it is examined by metallography. Different tests shall be performed in order to determine the following mechanical properties of the wire and bar: ultimate tensile strength, yield strength, elongation, and Brinell hardness.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F138 −19
Standard Specification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
Steel Bar and Wire for Surgical Implants (UNS S31673)
ThisstandardisissuedunderthefixeddesignationF138;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the U.S. Department of Defense.
1. Scope* A751Test Methods, Practices, and Terminology for Chemi-
cal Analysis of Steel Products
1.1 This specification covers the chemical, mechanical, and
E8/E8MTest Methods for Tension Testing of Metallic Ma-
metallurgicalrequirementsforwrought18chromium-14nickel-
terials
2.5molybdenum stainless steel bar and wire used for the
E10Test Method for Brinell Hardness of Metallic Materials
manufacture of surgical implants.
E18Test Methods for Rockwell Hardness of Metallic Ma-
1.2 The values stated in either SI units or inch-pound units
terials
are to be regarded separately as standard. The values stated in
E29Practice for Using Significant Digits in Test Data to
each system may not be exact equivalents; therefore, each
Determine Conformance with Specifications
system shall be used independently of the other. Combining
E45Test Methods for Determining the Inclusion Content of
values from the two systems may result in non-conformance
Steel
with the standard.
E112Test Methods for Determining Average Grain Size
1.3 This standard does not purport to address all of the
E354 Test Methods for Chemical Analysis of High-
safety concerns, if any, associated with its use. It is the
Temperature,Electrical,Magnetic,andOtherSimilarIron,
responsibility of the user of this standard to establish appro-
Nickel, and Cobalt Alloys
priate safety, health, and environmental practices and deter-
E407Practice for Microetching Metals and Alloys
mine the applicability of regulatory limitations prior to use.
F981Practice for Assessment of Compatibility of Biomate-
1.4 This international standard was developed in accor-
rials for Surgical Implants with Respect to Effect of
dance with internationally recognized principles on standard-
Materials on Muscle and Insertion into Bone
ization established in the Decision on Principles for the
F1350Specification for Wrought 18Chromium-14Nickel-
Development of International Standards, Guides and Recom-
2.5Molybdenum Stainless Steel Surgical Fixation Wire
mendations issued by the World Trade Organization Technical
(UNS S31673)
Barriers to Trade (TBT) Committee.
IEEE/ASTM SI 10American National Standard for Metric
Practice
2. Referenced Documents
3
2.2 Aerospace Material Standard:
2
2.1 ASTM Standards:
AMS 2630Inspection, Ultrasonic Product Over 0.5 inch
A262Practices for Detecting Susceptibility to Intergranular
(12.7 mm) Thick
Attack in Austenitic Stainless Steels
AMS 2632Ultrasonic Inspection of Thin Materials
A484/A484MSpecification for General Requirements for
4
2.3 ISO Standards:
Stainless Steel Bars, Billets, and Forgings
ISO 5832–1Implants for Surgery—Metallic Materials—
A555/A555MSpecification for General Requirements for
Part 1:Wrought Stainless Steel
Stainless Steel Wire and Wire Rods
ISO 6892Metallic Materials—Tensile Testing
ISO 9001Quality Management Systems—Requirements
1
This specification is under the jurisdiction of ASTM Committee F04 on
ISO 13485 Medical Devices—Quality Management
Medical and Surgical Materials and Devices and is the direct responsibility of
Systems—Requirements For Regulatory Purposes
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2019. Published February 2020. Originally
approved in 1971. Last previous edition approved in 2013 as F138–13a. DOI:
10.1520/F0138-19.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromSAEInternational(SAE),400CommonwealthDr.,Warrendale,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM PA 15096-0001, http://aerospace.sae.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
*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
---------------------- Page: 1 ----------------------
F138−19
3. Terminology 6.1.1 Barandwireshallbefurnished,asspecified,inthehot
worked, annealed, cold work
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F138 − 13a F138 − 19
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 F138; 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.
This standard has been approved for use by agencies of the U.S. Department of Defense.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-
2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system aremay not necessarilybe exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, andother. Combining values from the two systems shall not be combined.may result in
non-conformance with the standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
E8/E8M Test Methods for Tension Testing of Metallic Materials
E10 Test Method for Brinell Hardness of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E45 Test Methods for Determining the Inclusion Content of Steel
E112 Test Methods for Determining Average Grain Size
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
E407 Practice for Microetching Metals and Alloys
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1350 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
IEEE/ASTM SI 10 American National Standard for Metric Practice
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2013Dec. 1, 2019. Published November 2013February 2020. Originally approved in 1971. Last previous edition approved in 2013 as
F138 – 13.F138 – 13a. DOI: 10.1520/F0138-13A.10.1520/F0138-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*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
---------------------- Page: 1 ----------------------
F138 − 19
3
2.2 Aerospace Material Standard:
AMS 2630 Inspection, Ultrasonic Product Over 0.5 inch (12.7 mm) Thick
AMS 2632 Ultrasonic Inspection of Thin Materials
4
2.3 ISO Standards:
ISO 5832–1 Implants for Surgery—Metallic Materials—Part 1:Wrought Stainless Steel
ISO 6892 Metallic Materials—Tensile Testing
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements For Regulatory Purposes
3. Te
...
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