ASTM F2229-21

Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought, nitrogen strengthened manganese-chromium-molybdenum low-nickel stainless steel alloy bars and wires used for surgical implants. All bars and wires should be furnished as specified in either annealed or cold-worked condition and in cold-drawn, pickled, ground and polished, ground, or any other specified finish. The products should conform to the required chemical composition, microcleanliness, purity, surface finish, tensile properties, and hardness and should pass the intergranular corrosion susceptibility test. Both wires and bars must have a homogenous microstructure and with grain sizes within the specified range.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 23manganese-21chromium-1molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.  
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

General Information

• Status: Published
• Publication Date: 31-Jan-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Refers: ASTM A484/A484M-20a - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 05-May-2020

Standards Content (Sample)

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:F2229 −21
Standard Specification for
Wrought, Nitrogen Strengthened 23Manganese-
21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy
1
Bar and Wire for Surgical Implants (UNS S29108)
This standard is issued under the fixed designation F2229; 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* A751Test Methods and Practices for Chemical Analysis of
Steel Products
1.1 This specification covers the chemical, mechanical, and
E8/E8MTest Methods for Tension Testing of Metallic Ma-
metallurgical requirements for wrought nitrogen strengthened
terials
23manganese-21chromium-1molybdenum low-nickel stainless
E10Test Method for Brinell Hardness of Metallic Materials
steel alloy bar and wire for surgical implants.
E18Test Methods for Rockwell Hardness of Metallic Ma-
1.2 Units—The values stated in either SI units or inch-
terials
pound units are to be regarded separately as standard. The
E29Practice for Using Significant Digits in Test Data to
values stated in each system are not necessarily exact equiva-
Determine Conformance with Specifications
lents;therefore,toensureconformancewiththestandard,each
E45Test Methods for Determining the Inclusion Content of
system shall be used independently of the other, and values
Steel
from the two systems shall not be combined.
E112Test Methods for Determining Average Grain Size
1.3 This standard does not purport to address all of the
E354 Test Methods for Chemical Analysis of High-
safety concerns, if any, associated with its use. It is the Temperature,Electrical,Magnetic,andOtherSimilarIron,
responsibility of the user of this standard to establish appro-
Nickel, and Cobalt Alloys
priate safety, health, and environmental practices and deter- E407Practice for Microetching Metals and Alloys
mine the applicability of regulatory limitations prior to use.
F138Specification for Wrought 18Chromium-14Nickel-
1.4 This international standard was developed in accor- 2.5MolybdenumStainlessSteelBarandWireforSurgical
dance with internationally recognized principles on standard-
Implants (UNS S31673)
ization established in the Decision on Principles for the F746Test Method for Pitting or Crevice Corrosion of
Development of International Standards, Guides and Recom-
Metallic Surgical Implant Materials
mendations issued by the World Trade Organization Technical
F748PracticeforSelectingGenericBiologicalTestMethods
Barriers to Trade (TBT) Committee.
for Materials and Devices
F1314Specification for Wrought Nitrogen Strengthened 22
2. Referenced Documents
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
2
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
Practice
3
1
2.2 Aerospace Material Specification:
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
AMS2248Chemical CheckAnalysis Limits, Corrosion and
Subcommittee F04.12 on Metallurgical Materials.
Heat Resistant Steels and Alloys, Maraging and Other
Current edition approved Feb. 1, 2021. Published February 2021. Originally
Highly-Alloyed Steels, and Iron Alloys
approved in 2002. Last previous edition approved in 2020 as F2229–20. DOI:
10.1520/F2229-21.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers (SAE), 400 Commonwealth
the ASTM website. Dr., Warrendale, PA 15096-0001, http://www.sae.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 ----------------------
F2229−21
AMS 2630Inspection, Ultrasonic Product over 0.5 Inch 6. Chemical Requirements
(12.7 mm) Thick
6.1
...

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: F2229 − 20 F2229 − 21
Standard Specification for
Wrought, Nitrogen Strengthened 23Manganese-
21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy
1
Bar and Wire for Surgical Implants (UNS S29108)
This standard is issued under the fixed designation F2229; 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 nitrogen strengthened
23manganese-21chromium-1molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.
1.2 Units—The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound
units are to be regarded separately as standard. The values stated in each system mayare not benecessarily exact equivalents;
therefore, to ensure conformance with the standard, each system shall be used independently of the other. Combiningother, and
values from the two systems may result in nonconformance with the standard.shall not be combined.
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
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 and Practices 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
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 Nov. 15, 2020Feb. 1, 2021. Published November 2020February 2021. Originally approved in 2002. Last previous edition approved in 20122020
as F2229 – 12.F2229 – 20. DOI: 10.1520/F2229-20.10.1520/F2229-21.
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 ----------------------
F2229 − 21
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
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
...