ASTM F2229-20

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 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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance 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.

General Information

• Status: Historical
• Publication Date: 14-Nov-2020
• 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

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F2229 −20
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* 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
metallurgical requirements for wrought nitrogen strengthened
E18Test Methods for Rockwell Hardness of Metallic Ma-
23manganese-21chromium-1molybdenum low-nickel stainless
terials
steel alloy bar and wire for surgical implants.
E29Practice for Using Significant Digits in Test Data to
1.2 The SI units in this standard are the primary units. The
Determine Conformance with Specifications
values stated in either primary SI units or secondary inch-
E45Test Methods for Determining the Inclusion Content of
pound units are to be regarded separately as standard. The
Steel
values stated in each system may not be exact equivalents;
E112Test Methods for Determining Average Grain Size
therefore,eachsystemshallbeusedindependentlyoftheother.
E354 Test Methods for Chemical Analysis of High-
Combiningvaluesfromthetwosystemsmayresultinnoncon-
Temperature,Electrical,Magnetic,andOtherSimilarIron,
formance with the standard.
Nickel, and Cobalt Alloys
1.3 This international standard was developed in accor- E407Practice for Microetching Metals and Alloys
dance with internationally recognized principles on standard-
F138Specification for Wrought 18Chromium-14Nickel-
ization established in the Decision on Principles for the 2.5MolybdenumStainlessSteelBarandWireforSurgical
Development of International Standards, Guides and Recom-
Implants (UNS S31673)
mendations issued by the World Trade Organization Technical F746Test Method for Pitting or Crevice Corrosion of
Barriers to Trade (TBT) Committee. Metallic Surgical Implant Materials
F748PracticeforSelectingGenericBiologicalTestMethods
2. Referenced Documents
for Materials and Devices
2
F1314Specification for Wrought Nitrogen Strengthened 22
2.1 ASTM Standards:
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
A262Practices for Detecting Susceptibility to Intergranular
Stainless Steel Alloy Bar and Wire for Surgical Implants
Attack in Austenitic Stainless Steels
(UNS S20910)
A484/A484MSpecification for General Requirements for
F1586Specification for Wrought Nitrogen Strengthened
Stainless Steel Bars, Billets, and Forgings
21Chromium—10Nickel—3Manganese—
A555/A555MSpecification for General Requirements for
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
Stainless Steel Wire and Wire Rods
Implants (UNS S31675)
A751Test Methods, Practices, and Terminology for Chemi-
IEEE/ASTM SI 10American National Standard for Metric
cal Analysis of Steel Products
Practice
3
2.2 Aerospace Material Specification:
1 AMS2248Chemical CheckAnalysis Limits, Corrosion and
This specification is under the jurisdiction of ASTM Committee F04 on
Heat Resistant Steels and Alloys, Maraging and Other
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Highly-Alloyed Steels, and Iron Alloys
Current edition approved Nov. 15, 2020. Published November 2020. Originally
AMS 2630Inspection, Ultrasonic Product over 12.7 mm
approved in 2002. Last previous edition approved in 2012 as F2229–12. DOI:
[0.5 in.] Thick
10.1520/F2229-20.
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

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F2229−20
4
TABLE 1 Chemical Composition
2.3 ISO Standards:
ISO6892Metallic Materials Tensile Testing at Ambient Composition,
Element
% (mass/mass)
Temperature
Carbon 0.08 max
ISO9001Quality Management Systems—Requirements
Manganese 21.00 to 24.00
Phosphorus 0.03 max
3. Terminology Sulfur 0.01 max
Silicon 0.75 max
3.1 Definitions of Terms Specific to This Standard:
Chromium 19.00 to 23.00
Nickel 0.05 max
3.1.1 bar—roundbarandflatsfrom4.75mm[0.1875in
...

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 − 12 F2229 − 20
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 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 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 nonconformance 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
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
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
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2012Nov. 15, 2020. Published October 2012November 2020. Originally approved in 2002. Last previous edition approved in 20072012
as F2229 – 07.F2229 – 12. DOI: 10.1520/F2229-12.10.1520/F2229-20.
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 − 20
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 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)12.7 mm [0.5 in.] Thick
4
2.3 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing
...