ASTM F139-19
(Specification)Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip used for the manufacture of surgical implants. Sheet and strip shall be furnished as specified, in the annealed or cold-worked condition. Types of finish available in sheet and strip are dull cold rolled, bright cold rolled, intermediate polished, general-purpose polished, dull satin-finished, high luster finish, and mirror finish. Tensile test, hardness test, and intergranular corrosion susceptibility test shall be performed in accordance with specified requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip 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:F139 −19
Standard Specification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
Steel Sheet and Strip for Surgical Implants (UNS S31673)
ThisstandardisissuedunderthefixeddesignationF139;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E8/E8MTest Methods for Tension Testing of Metallic Ma-
terials
1.1 This specification covers the chemical, mechanical, and
E10Test Method for Brinell Hardness of Metallic Materials
metallurgicalrequirementsforwrought18chromium-14nickel-
E18Test Methods for Rockwell Hardness of Metallic Ma-
2.5molybdenum stainless steel sheet and strip used for the
terials
manufacture of surgical implants.
E29Practice for Using Significant Digits in Test Data to
1.2 The values stated in either SI units or inch-pound units
Determine Conformance with Specifications
are to be regarded separately as standard. The values stated in
E45Test Methods for Determining the Inclusion Content of
each system may not be exact equivalents; therefore, each
Steel
system shall be used independently of the other. Combining
E112Test Methods for Determining Average Grain Size
values from the two systems may result in non-conformance
E354 Test Methods for Chemical Analysis of High-
with the standard.
Temperature,Electrical,Magnetic,andOtherSimilarIron,
1.3 This standard does not purport to address all of the
Nickel, and Cobalt Alloys
safety concerns, if any, associated with its use. It is the E407Practice for Microetching Metals and Alloys
responsibility of the user of this standard to establish appro-
IEEE/ASTM SI 10American National Standard for Metric
priate safety, health, and environmental practices and deter- Practice
3
mine the applicability of regulatory limitations prior to use.
2.2 ISO Standards:
1.4 This international standard was developed in accor- ISO 5832-1Implants for Surgery-Metallic Materials—Part
dance with internationally recognized principles on standard-
1: Wrought Stainless Steel
ization established in the Decision on Principles for the ISO 6892Metallic Materials—Tensile Testing at Ambient
Development of International Standards, Guides and Recom-
Temperature
mendations issued by the World Trade Organization Technical
ISO 9001Quality Management Systems—Requirements
Barriers to Trade (TBT) Committee.
ISO 13485 Medical Devices—Quality Management
Systems—Requirements for Regulatory Purposes
2. Referenced Documents
2 3. Terminology
2.1 ASTM Standards:
3.1 Definitions of Terms Specific to This Standard:
A262Practices for Detecting Susceptibility to Intergranular
Attack in Austenitic Stainless Steels 3.1.1 lot, n—the total number of mill products produced
from the same melt heat under the same conditions at essen-
A480/A480MSpecification for General Requirements for
Flat-Rolled Stainless and Heat-Resisting Steel Plate, tially the same time.
Sheet, and Strip
3.1.2 sheet—any product under 4.76 mm [0.1875 in.] in
A751Test Methods, Practices, and Terminology for Chemi-
thickness and 610 mm [24 in.] or more in width.
cal Analysis of Steel Products
3.1.3 strip—any product under 4.76 mm [0.1875 in.] in
thickness and under 610 mm [24 in.] wide.
1
This specification is under the jurisdiction of ASTM Committee F04 on
4. General Requirements for Delivery
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
4.1 In addition to the requirements of this specification, all
Current edition approved Dec. 1, 2019. Published February 2020. Originally
requirements of the current edition of Specification A480/
approved in 1976. Last previous edition approved in 2012 as F139–12. DOI:
A480M shall apply.
10.1520/F0139-19.
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
3
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 ----------------------
F139−19
TABLE 2 Chemical Requirements, Heat Analysis
4.2 In the case where a conflict exists between this specifi-
cation and those listed in 2.1 and 2.2, this specification shall C
...
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: F139 − 12 F139 − 19
Standard Specification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
Steel Sheet and Strip for Surgical Implants (UNS S31673)
This standard is issued under the fixed designation F139; 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.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-
2.5molybdenum stainless steel sheet and strip 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
A480/A480M Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip
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
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 ISO Standards:
ISO 5832-1 Implants for Surgery-Metallic Materials—Part 1: Wrought Stainless Steel
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
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, 2012Dec. 1, 2019. Published October 2012February 2020. Originally approved in 1976. Last previous edition approved in 20082012 as
F139 – 08.F139 – 12. DOI: 10.1520/F0139-12.10.1520/F0139-19.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 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 ----------------------
F139 − 19
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the
same time.
3.1.2 sheet—any product under 0.1875 in. [4.76 mm]4.76 mm [0.1875 in.] in thickness and 24 in. [610 mm]610 mm [24 in.]
or more in width.
3.1.3 strip—any product under 0.1875 in. [4.76 mm]4.76 mm [0.1875 in.] in thick
...
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