ASTM F138-13
(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.
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Designation:F138 −13
StandardSpecification 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 Department of Defense.
1. Scope* E112Test Methods for Determining Average Grain Size
E354 Test Methods for Chemical Analysis of High-
1.1 This specification covers the chemical, mechanical, and
Temperature,Electrical,Magnetic,andOtherSimilarIron,
metallurgicalrequirementsforwrought18chromium-14nickel-
Nickel, and Cobalt Alloys
2.5molybdenum stainless steel bar and wire used for the
E407Practice for Microetching Metals and Alloys
manufacture of surgical implants.
F981Practice for Assessment of Compatibility of Biomate-
1.2 The values stated in either SI units or inch-pound units
rials for Surgical Implants with Respect to Effect of
are to be regarded separately as standard. The values stated in
Materials on Muscle and Bone
each system may not be exact equivalents; therefore, each
F1350Specification for Wrought 18Chromium-14Nickel-
system shall be used independently of the other. Combining
2.5Molybdenum Stainless Steel Surgical Fixation Wire
values from the two systems may result in non-conformance
(UNS S31673)
with the standard.
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
4
A484/A484MSpecification for General Requirements for
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
A751Test Methods, Practices, and Terminology for Chemi-
ISO 9001Quality Management Systems—Requirements
cal Analysis of Steel Products
3. Terminology
E8/E8MTest Methods for Tension Testing of Metallic Ma-
terials
3.1 Definitions of Terms Specific to This Standard:
E10Test Method for Brinell Hardness of Metallic Materials
3.1.1 bar, n—rounds, flats, or other shapes from 0.1875 in.
E18Test Methods for Rockwell Hardness of Metallic Ma-
[4.76 mm] to 4 in. [101.60 mm] in diameter or thickness.
terials
(Other sizes and shapes by special order.)
E29Practice for Using Significant Digits in Test Data to
3.1.2 finewire,n—wireasdescribedin3.1.5,lessthan0.063
Determine Conformance with Specifications
in. [1.60 mm] in diameter or thickness.
E45Test Methods for Determining the Inclusion Content of
3.1.3 forging bar, n—bar as described in 3.1.1, used for the
Steel
production of forgings, may be furnished in the hot worked
condition.
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1.4 lot, n—the total number of mill products produced
Medical and Surgical Materials and Devices and is the direct responsibility of
from the same melt heat under the same conditions at essen-
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved April 1, 2013. Published April 2013. Originally tially the same time.
approved in 1971. Last previous edition approved in 2008 as F138–08. DOI:
10.1520/F0138-13.
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 ----------------------
F138−13
3.1.5 wire, n—rounds, flats or other shapes less than 0.1875 7.1.1 The compositional requirement shall meet the follow-
in. [4.76 mm] in diameter or thickness. ing:
%Cr13.3 3%Mo$26.0 (1)
4. General Requirements for Delivery
7.1.2 Requirements for the major and minor elemental
4.1 In addition to the requirements of this specification, all
constituents are listed in Table 3. Also listed are important
requirements of
...
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 − 08 F138 − 13
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 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 given in
parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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.
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
E8E8/E8M Test Methods for Tension Testing of Metallic Materials
3
E8M Test Methods for Tension Testing of Metallic Materials [Metric] (Withdrawn 2008)
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 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 May 1, 2008April 1, 2013. Published May 2008 April 2013. Originally approved in 1971. Last previous edition approved in 20032008 as
F138 – 03.F138 – 08. DOI: 10.1520/F0138-08.10.1520/F0138-13.
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 − 13
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
5
2.3 ASQ Standard:
ASQ C1 Specification of General Requirements for a Quality Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bar, n—rounds, flats, or other shapes from 0.1875 in. (4.76 mm)[4.76 mm] to 4 in. (101.60 mm)[101.60 mm] in diameter
or thickness. (Other sizes and shapes by special order.)
3.1.2 fine wire, n—wire as described in 3.1.5, less than 0.063 in. (1.60 mm)[1.60 mm] in diameter or thickness.
3.1.3 forging bar, n—bar as described in 3.1.1, used for the production of forgings, may be furnished in the hot worked
condition.
3.1.4 lot, n—the total number of mill products p
...
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