ASTM F139-19

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
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
2.1 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
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
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.
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.
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
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 thickness and under 24 in. [610 mm]610 mm [24
in.] wide.
4. General Requirements for Delivery
4.1 In addition to the requirements of this specification, all requirements of the current edition of Specification A480/A480M
shall apply.
4.2 In the case where a conflict exists between this specification and those listed in 2.1 and 2.2, this specification shall take
precedence.
5. Ordering Information
5.1 Inquiries and orders for material under this specification shall include the following information:
5.1.1 Quantity (weight or number of pieces);
5.1.2 ASTM designation and date of issue;
5.1.3 Form (sheet or strip);
5.1.4 Condition (see 6.1);
5.1.5 Mechanical properties (if applicable, for special conditions);
5.1.6 Finish (see 6.2);
5.1.7 Applicable dimensions including size, thickness, width, and length (exact, random, multiples) or drawing number;
5.1.8 Special tests, if any; and
5.1.9 Other requirements.
6. Materials and Manufacture
6.1 Condition—Sheet and strip shall be furnished as specified, in the annealed or cold-worked condition (see Table 1).
6.2 Finish—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, mirror finish, or as specified by the purchaser.
7. Chemical Requirements
7.1 The supplier’s heat analysis shall conform to the requirements specified in Table 2. The supplier shall not ship material with
chemistry outside the requirements of Table 2.
7.1.1 The compositional requirement shall meet the following:
TABLE 1 Mechanical Requirements
B
Ultimate Tensile
Elongation in
A
Rockwell
Yield Strength
A
Strength ,
Condition (0.2 % Offset), Hardness,
in. [50 mm]
min,
min, psi [MPa]
max
min, %
psi [MPa]
Annealed 71 000 27 500 40 95 HRB
[490] [190]
Cold-worked 125 000 100 000 10 .
[860] [690]
TABLE 1 Mechanical Requirements
B
Ultimate Tensile
Elongation in
A
Rockwell
Yield Strength
A
50 mm
Strength ,
Condition (0.2 % Offset), Hardness,
[2 in.]
min,
min, MPa [psi]
max
min, %
MPa [psi]
Annealed 490 190 40 95 HRB
[71 000] [27 500]
Cold-worked 860 690 10 .
[125 000] [100 000]
A
Minimum limits apply to tests taken longitudinal to the direction of rolling.
B
The gage length shall be reported with the test results. The method for
determining elongation of material under 0.063 in. [1.6 mm]1.6 mm [0.063 in.] in
thickness may be negotiated. Alternately, a gage length corresponding to ISO
6892 (5.65 times the square root of So, where So is the original cross sectional
area) may be used when agreed upon between the supplier and purchaser.
F139 − 19
TABLE 2 Chemical Requirements, Heat Analysis
Composition, %
Element
(mass/mass)
Carbon 0.030 max
Carbon 0.030 max
Manganese 2.00 max
Manganese 2.00 max
Phosphorus 0.025 max
Phosphorus 0.025 max
Sulfur 0.010 max
Sulfur 0.010 max
Silicon 0.75 max
Silicon 0.75 max
A
Chromium 17.00 to 19.00
Chromium 17.00 to 19.00
Nickel 13.00 to 15.00
A
Molybdenum 2.25 to 3.00
Molybdenum 2.25 to 3.00
Cobalt <0.10
Nitrogen 0.10 max
Nitrogen 0.10 max
Copper 0.50 max
Copper 0.50 max
B
Iron balance
A
Iron balance
Composition Index = % Cr + 3.3 × % Mo 26.0 min
A
The compositional requirement shall meet the following:
% Cr + 3.3 × % Mo $ 26.0
A
The percentage of iron content by difference is not required to be determined or
certified.
%Cr13.3 3%Mo $ 26.0 (1)
7.1.1 Requirements for the major and minor elemental constituents are listed in Table 2. Also listed are important residual
elements. Analysis for elements not listed in Table 2 is not required to certifyverify compliance with this specification.
7.1.2 All commercial metals contain small amounts of elements other than those which are specified. It is neither practical nor
necessary to specify limits for unspecified elements, whether residual elements or trace elements, that can be present. The producer
is permitted to analyze for unspecified elements and is permitted to report such analyses. The presence of an unspecified element
and the reporting of an analysis for that element shall not be a basis for rejection.
7.1.3 Intentional elemental additions other than those specified in Table 3 are not permitted.
7.1.4 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods
A751.
7.2 Product Analysis—Product analysis tolerances do not broaden the specified heat analysis requirements, but cover variations
between laboratories in the measurement of chemical content. The supplier shall not ship material that is outside the limits specified
in Table 2. Product analysis limits shall be as specified in Table 3.
7.2.1 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or to determine
variations in the composition within the heat.
7.2.2 Acceptance or rejection of a heat or lot of material may be made by the purchaser on the basis of this product analysis.
A
TABLE 3 Product Analysis Tolerances
Tolerance Under the Minimum
Element or Over the Maximum Limit,
B
% (mass/mass)
Carbon 0.005
Manganese 0.04
Phosphorus 0.005
Sulfur 0.005
Silicon 0.05
Chromium 0.20
Nickel 0.15
Molybdenum 0.10
Nitrogen 0.01
Copper 0.03
Cobalt 0.01
A
Refer to Specification A480/A480M.
B
Under minimum limit not applicable for elements where only a maximum
percentage is indicated.
F139 − 19
7.2.3 Product analysis outside the tolerance limits allowed in Table 3 are cause for rejection of the product. A referee analysis
may be used if agreed upon by supplier and purchaser.
7.2.4 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods
E354.
8. Metallurgical Requirements
8.1 The material shall exhibit no delta ferrite, chi, or sigma phases when examined metallographically at 100× magnification
when etched in accordance with Practice E407.
8.2 The microcleanliness of the steel as determined by Test Methods E45, Method A, except using Plate I-r on representative
hot-rolled band from the heat shall not exceed the following:
Inclusion A B C D
Type (Sulfide) (Alumina) (Silicate) (Globular Oxide)
Thin 1.5 1.5 1.5 1.5
Heavy 1.5 1.0 1.5 1.0
9. Mechanical Requirements
9.1 Tensile Properties:
9.1.1 Tensile properties shall be determined in accordance with Test Methods E8/E8M.
9.1.2 Material shall conform to the appropriate requirements as to mechanical properties specified in Table 1.
9.1.3 The level of mechanical properties for material in conditions other than those included in Table 1 shall be specified in the
purchase order.
9.2 Hardness:
9.2.1 Hardness values shall be determined in accordance with Test MethodsMethod E10 or Test Methods E18.
9.2.2 When desired, hardness limits may be specified by the purchaser. Hardness determinations shall be made on the product
cross section, midway between the center and surface, if the cross section is adequate.
9.2.3 Hardness values are for information only and shall not be used as a basis for rejection.
9.3 Number of Tests:
9.3.1 Perform at least one tension test from each lot. Should any of the test pieces n
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