ASTM F1586-21

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.
´1
Designation: F1586 − 13 F1586 − 21
Standard Specification for
Wrought Nitrogen Strengthened 21Chromium—10Nickel—
3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for
Surgical Implants (UNS S31675)
This standard is issued under the fixed designation F1586; 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.
ε NOTE—The designation was editorially corrected in August 2013.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened
21chromium—10nickel—3manganese—2.5molybdenum stainless steel alloy bar for surgical implants.
1.2 The values stated in either inch-pound units or SI 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-conformancenonconformance with the standard.
1.3 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
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A751 Test Methods and Practices for Chemical Analysis of Steel Products
E8E8/E8M Test Methods for Tension Testing of Metallic Materials [Metric] E0008_E0008M
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
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is under the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved June 1, 2013Sept. 15, 2021. Published August 2013September 2021. Originally approved in 1995. Last previous edition approved in 20082013
as F1586 – 08.F1586 – 13. DOI: 10.1520/F1586-13E01.10.1520/F1586-21.
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
F1586 − 21
2.2 Aerospace Material Specifications:
AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
2.3 ISO Standard:Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management System—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
2.4 Quality Standard:
IEEE/ASTM SI 10™10 American National Standard for Use of the International System of Units (SI): The Modern Metric
SystemMetric Practice
2.5 Quality 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 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the same
time.
4. General Requirements for Delivery
4.1 In addition to the requirements of this specification, all requirements of the current edition of Specification A484/A484M shall
apply.
4.2 In cases in which a conflict exists between this specification and the standards listed in Section 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,
5.1.2 ASTM designation and date of issue,
5.1.3 Mechanical properties (if applicable, for special conditions),
5.1.4 Form,
5.1.5 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number,
5.1.6 Tolerances—Unless otherwise specified by purchaser, tolerances must meet the requirements of Specification A484/A484M
as applicable.
5.1.7 Condition (see 6.1),
5.1.8 Finish (see 6.2),
5.1.9 Special tests (if any), and
5.1.10 Other requirements.
6. Materials and Manufacture
6.1 Condition—Bars shall be furnished in the annealed, medium hard, or hard condition, as specified.
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
F1586 − 21
6.2 Finish—Types of bar finishes available are cold-drawn, pickled, ground, ground and polished, or as specified by the purchaser.
7. Chemical Requirements
7.1 The supplier’s heat analysis shall conform to the chemical requirements prescribed in Table 1. The supplier shall not ship
material that is outside the limits specified in Table 1.
7.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residual
elements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
7.1.2 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods,
Practices, and Terminology A751.
7.2 Product Analysis—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.
7.2.1 Acceptance or rejection of a heat or lot of material may be made by the purchaser on the basis of this product analysis.
7.2.2 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories
in the measurement of chemical content. Product analysis limits shall be as specified in Table 2.
8. Metallurgical Requirements
8.1 The material shall exhibit no delta ferrite, chi, or sigma phases when it is examined metallographically at 100× magnification.
8.2 The microcleanliness of the steel, as determined by Test Methods E45, Method A, except using Plate Ir, on representative billet
or bar samples from the heat shall not exceed the following:
Inclusion A B C D
Type (Sulfide) (Alumina) (Silicate) (Globular
Oxide)
Thin 1.5 2.0 2.0 2.5
Heavy 1.5 1.5 1.5 1.5
9. Mechanical Requirements
9.1 Tensile Properties:
9.1.1 Tensile properties shall be determined in accordance with Test Methods E8E8/E8M.
9.1.2 The mechanical properties of test specimens shall conform to the requirements specified in Table 3.
TABLE 1 Chemical Requirements
Element Composition, % (Mass/Mass)
Carbon 0.08 max
Manganese 2.00 to 4.25
Phosphorus 0.025 max
Sulfur 0.01 max
Silicon 0.75 max
Chromium 19.5 to 22.0
Nickel 9.0 to 11.0
Molybdenum 2.0 to 3.0
Nitrogen 0.25 to 0.50
Niobium 0.25 to 0.80
Copper 0.25 max
A
Iron balance
A
The percentage of iron is determined by difference and need not be determined
or certified.
F1586 − 21
A
TABLE 2 Product Analysis Tolerances
Tolerance Under the
Element Minimum or Over
B
the Maximum Limit
Carbon 0.01
Manganese 0.05
Phosphorus 0.005
Sulfur 0.005
Silicon 0.05
Chromium 0.25
Nickel 0.15
Molybdenum 0.10
C
Nitrogen 0.02 under minimum;
0.04 over maximum
Niobium 0.05
Copper 0.03
A
Refer to AMS 2248 for chemical check analysis limits (except nitrogen).
B
For elements in which only a maximum percentage is indicated, the “under
minimum limit” is not applicable.
C
The specified range for this element is not covered by AMS 2248 and permissible
variation has been established through industrial practice.
TABLE 3 Mechanical Properties
Elonga-
Diameter or Ultimate Tensile Yield Strength
A
tion in
Condition Thickness, in. Strength, min, psi (0.2 % Offset),
4D, min,
(mm) (MPa) min, psi (MPa)
%
Annealed all 107 000 (740) 62 400 (430) 35
1 3
Medium ⁄16 to ⁄4 145 000 (1000) 102 000 (700) 20
B C
hard (1.59 to 19.1)
B
1 3
Hard ⁄16 to ⁄4 160 000 (1100) 145 000 (1000) 10
C
(1.59 to 19.1)
TABLE 3 Mechanical Properties
Elonga-
Diameter or Ultimate Tensile Yield Strength
A
tion in
Condition Thickness, in. Strength, min, psi (0.2 % Offset),
4D, min,
[mm] [MPa] min, psi [MPa]
%
Annealed all 107 000 [740] 62 400 [430] 35
1 3
Medium ⁄16 to ⁄4 145 000 [1000] 102 000 [700] 20
B C
hard [1.59 to 19.1]
B
1 3
Hard ⁄16 to ⁄4 160 000 [1100] 145 000 [1000] 10
C
[1.59 to 19.1]
A
Elongation of material 0.063 in. (1.6 mm)[1.6 mm] or greater in diameter (D) or
thickness shall be measured using a gage length of 2 in. or 4D or 4W (W = width).
The gage length must be reported with the test results. The method for determining
elongation of material under 0.063 in. (1.6 mm)[1.6 mm] in diameter or width may
be negotiated. Alternatively, a gage length corresponding to ISO 6892 may be
used when agreed upon between supplier and purchaser. (5.65 times the square
root of So, where So is the original cross sectional cross-sectional area.)
B
The word “hard” is used to express strength relative to annealed material and is
not intended to specif
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