ASTM F2229-12

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 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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2012
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 −12
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* E112Test Methods for Determining Average Grain Size
E354 Test Methods for Chemical Analysis of High-
1.1 This specification covers the chemical, mechanical, and
Temperature,Electrical,Magnetic,andOtherSimilarIron,
metallurgical requirements for wrought nitrogen strengthened
Nickel, and Cobalt Alloys
23manganese-21chromium-1molybdenum low-nickel stainless
E407Practice for Microetching Metals and Alloys
steel alloy bar and wire for surgical implants.
F138Specification for Wrought 18Chromium-14Nickel-
1.2 The values stated in either SI units or inch-pound units
2.5MolybdenumStainlessSteelBarandWireforSurgical
are to be regarded separately as standard. The values stated in
Implants (UNS S31673)
each system may not be exact equivalents; therefore, each
F746Test Method for Pitting or Crevice Corrosion of
system shall be used independently of the other. Combining
Metallic Surgical Implant Materials
values from the two systems may result in non-conformance
F748PracticeforSelectingGenericBiologicalTestMethods
with the standard.
for Materials and Devices
F1314Specification for Wrought Nitrogen Strengthened 22
2. Referenced Documents
Chromium–13Nickel–5Manganese–2.5Molybdenum
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
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-
AMS2248Chemical 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
E18Test Methods for Rockwell Hardness of Metallic Ma-
AMS 2630Inspection, Ultrasonic Product over 0.5 Inch
terials
(12.7 mm) Thick
E29Practice for Using Significant Digits in Test Data to
4
2.3 ISO Standards:
Determine Conformance with Specifications
ISO6892Metallic Materials Tensile Testing at Ambient
E45Test Methods for Determining the Inclusion Content of
Temperature
Steel
ISO9001Quality Management Systems—Requirements
1
This specification is under the jurisdiction of ASTM Committee F04 on
3. Terminology
Medical and Surgical Materials and Devicesand is the direct responsibility of
3.1 Definitions of Terms Specific to This Standard:
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2012. Published October 2012. Originally
approved in 2002. Last previous edition approved in 2007 as F2229–07. DOI:
10.1520/F2229-12.
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 ----------------------
F2229−12
TABLE 1 Chemical Composition
3.1.1 bar—roundbarandflatsfrom0.1875in.[4.75mm]to
4.00 in. [101.60 mm] in diameter or thickness (other sizes and Composition,
Element
% (mass/mass)
shaped by special order).
Carbon 0.08 max
3.1.2 forging bar—asdescribedinsection3.1.1usedforthe
Manganese 21.00 to 24.00
production of forgings, may be furnished in the hot rolled Phosphorus 0.03 max
Sulfur 0.01 max
condition.
Silicon 0.75 max
3.1.3 lot—the total number of mill products produced from Chromium 19.00 to 23.0
...

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 − 07 F2229 − 12
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 values stated in either SI units or inch-pound units are to be regarded separately as the standard. The SI equivalents of
the inch-pound units may be approximate.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.
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
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
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 Aug. 1, 2007Oct. 1, 2012. Published August 2007October 2012. Originally approved in 2002. Last previous edition approved in 20022007 as
F2229 – 02.F2229 – 07. DOI: 10.1520/F2229-07.10.1520/F2229-12.
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.
3
Available from Society of Automotive Engineers (SAE), 400 Commonwealth 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 − 12
AMS 2630 Inspection, Ultrasonic Product over 0.5 Inch (12.7 mm) Thick
4
2.3 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
5
2.4 American Society for 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 bar—round bar and flats from 0.1875 in
...