ASTM F2581-12

Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum (UNS S29225) low-nickel stainless steel alloy bars and wires for surgical implants. The alloys shall be furnished in the annealed or cold-worked condition, and finished cold-drawn, pickled, ground, ground and polished, or as specified by the purchaser. Mechanical properties to which the alloys shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum low-nickel stainless steel alloy bar and wire for 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Sep-2012
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 77.140.20 - Stainless steels
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F2581-07 - Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
• Effective Date: 01-Oct-2012
• Referred By: ASTM F2181-20 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
• Effective Date: 01-Oct-2012
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-Oct-2012
• Referred By: ASTM F621-12(2021)e1 - Standard Specification for Stainless Steel Forgings for Surgical Implants
• Effective Date: 01-Oct-2012

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2581 −12
Standard Specification for
Wrought Nitrogen Strengthened 11Manganese-17Chromium-
3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire
1
for Surgical Implants (UNS S29225)
This standard is issued under the fixed designation F2581; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E18Test Methods for Rockwell Hardness of Metallic Ma-
terials
1.1 This specification covers the chemical, mechanical, and
E29Practice for Using Significant Digits in Test Data to
metallurgical requirements for wrought nitrogen strengthened
Determine Conformance with Specifications
11manganese-17chromium-3molybdenum low-nickel stainless
E45Test Methods for Determining the Inclusion Content of
steel alloy bar and wire for surgical implants.
Steel
1.2 The values stated in either SI units or inch-pound units
E112Test Methods for Determining Average Grain Size
are to be regarded separately as standard. The values stated in
E354 Test Methods for Chemical Analysis of High-
each system may not be exact equivalents; therefore, each
Temperature,Electrical,Magnetic,andOtherSimilarIron,
system shall be used independently of the other. Combining
Nickel, and Cobalt Alloys
values from the two systems may result in non-conformance
E407Practice for Microetching Metals and Alloys
with the standard.
F138 Specification for Wrought 18Chromium-14Nickel-
1.3 This standard does not purport to address all of the 2.5MolybdenumStainlessSteelBarandWireforSurgical
Implants (UNS S31673)
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- F746Test Method for Pitting or Crevice Corrosion of
Metallic Surgical Implant Materials
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. F748PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
2. Referenced Documents F1314Specification for Wrought Nitrogen Strengthened 22
2 Chromium–13Nickel–5Manganese–2.5Molybdenum
2.1 ASTM Standards:
Stainless Steel Alloy Bar and Wire for Surgical Implants
A262Practices for Detecting Susceptibility to Intergranular
(UNS S20910)
Attack in Austenitic Stainless Steels
F1586Specification for Wrought Nitrogen Strengthened
A484/A484MSpecification for General Requirements for
21Chromium—10Nickel—3Manganese—
Stainless Steel Bars, Billets, and Forgings
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
A555/A555MSpecification for General Requirements for
Implants (UNS S31675)
Stainless Steel Wire and Wire Rods
IEEE/ASTM SI 10American National Standard for Metric
A751Test Methods, Practices, and Terminology for Chemi-
Practice
cal Analysis of Steel Products
3
2.2 Aerospace Material Specification:
E8/E8MTest Methods for Tension Testing of Metallic Ma-
AMS 2248Chemical CheckAnalysis Limits, Corrosion and
terials
Heat Resistant Steels and Alloys, Maraging and Other
E10Test Method for Brinell Hardness of Metallic Materials
Highly-Alloyed Steels, and Iron Alloys
AMS 2630Inspection, Ultrasonic Product over 0.5 Inch
(12.7 mm) Thick
1
This specification is under the jurisdiction of ASTM Committee F04 on
4
2.3 ISO Standard:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. ISO 6892Metallic Materials Tensile Testing at Ambient
Current edition approved Oct. 1, 2012. Published October 2012. Originally
Temperature
approved in 2007. Last previous edition approved in 2007 as F2581–07. DOI:
10.1520/F2581-12.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001, http://www.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 ----------------------
F2581−12
TABLE 1 Chemical Composition
ISO 9001Quality Management Systems—Requirements
Element Composition, % (mass/mass)
Carbon 0.15 to 0.25
3. Terminology
Manganese 9.50 to 12.50
3.1 Definitions of Terms Specific to This Standard:
Phosphorus 0.020 max
Sulfur 0.010 max
3.1.1 bar—round, rectangular, or other complex shaped
Silicon
...

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: F2581 − 07 F2581 − 12
Standard Specification for
Wrought Nitrogen Strengthened 11Manganese-17Chromium-
3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire
1
for Surgical Implants (UNS S29225)
This standard is issued under the fixed designation F2581; 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 Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened
11manganese-17chromium-3molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.
1.2 As of the time of the original approval of this specification no product utilizing this alloy had been approved through a
510(k) submission.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as the standard. The values given in
parentheses are for information only. 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 and health practices and determine the applicability of regulatory
limitations prior to use.
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
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
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
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium – 13 Nickel – 5 Manganese – 2.5 Molybdenum Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless
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 Jan. 1, 2007Oct. 1, 2012. Published January 2007October 2012. Originally approved in 2007. Last previous edition approved in 2007 as
F2581 – 07. DOI: 10.1520/F2581-07.10.1520/F2581-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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 ----------------------
F2581 − 12
Steel Alloy Bar for Surgical Implants (UNS S31675)
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 Aerospace Material Specification:
AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
AMS 2630 Inspection, Ultrasonic Product over 0.5 Inch (12.7 mm) Thick
4
2.3 ISO Standard:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperatu
...