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-24 - Standard Specification for General Requirements for Stainless Steel Bars, Billets, Shapes, and Forgings
• Effective Date: 01-Jan-2024
• Refers: ASTM E8/E8M-24 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jan-2024
• Refers: ASTM E407-23 - Standard Practice for Microetching Metals and Alloys
• Effective Date: 01-Nov-2023
• Refers: ASTM E45-18a(2023) - Standard Test Methods for Determining the Inclusion Content of Steel
• Effective Date: 01-Nov-2023
• Refers: ASTM A484/A484M-23a - Standard Specification for General Requirements for Stainless Steel Bars, Billets, Shapes, and Forgings
• Effective Date: 01-Sep-2023
• Refers: ASTM A484/A484M-23 - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 01-Mar-2023
• Refers: ASTM A484/A484M-20a - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 05-May-2020
• Refers: ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• Effective Date: 01-Dec-2019
• Refers: ASTM A484/A484M-19 - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 01-Sep-2019
• Refers: ASTM A484/A484M-18a - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 01-Nov-2018
• Refers: ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2018
• Refers: ASTM F1314-18 - Standard 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)
• Effective Date: 01-Feb-2018
• Refers: ASTM A484/A484M-18 - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 01-Jan-2018
• Refers: ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2017
• Refers: ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 15-Jul-2016

Overview

ASTM F2229-21 is the standard specification developed by ASTM International for wrought, nitrogen strengthened 23Manganese-21Chromium-1Molybdenum low-nickel stainless steel alloy bar and wire (UNS S29108) intended for use in surgical implants. This standard outlines the chemical, mechanical, and metallurgical requirements essential to ensure that the stainless steel bars and wires meet the stringent needs of surgical and medical device applications.

The specification helps manufacturers, suppliers, and medical device developers select materials that deliver high strength, corrosion resistance, and biocompatibility required for safe and effective human implantation.

Key Topics

ASTM F2229-21 covers critical aspects to ensure quality and performance for surgical implant use, including:

• Chemical Composition Requirements

  • Strict limits on levels of manganese, chromium, molybdenum, nitrogen, and minimal nickel.
  • Controls for carbon, phosphorus, sulfur, silicon, copper, and iron balance.

• Mechanical Properties

  • Specifications for tensile strength, yield strength, elongation, and reduction in area for material in annealed and cold-worked conditions.
  • Defined testing procedures in compliance with ASTM E8/E8M.

• Metallurgical Quality

  • Microstructure requirements: bars and wires must be free of ferrite, chi, and sigma phases.
  • Microcleanliness standards based on ASTM E45.
  • Consistent, homogeneous grain size according to ASTM E112.

• Corrosion Resistance

  • Products must pass intergranular corrosion testing, per ASTM A262.
  • Enhanced pitting and crevice corrosion resistance verified through additional testing.

• Finishing and Condition

  • Supplied in annealed or cold-worked conditions.
  • Finishes including cold-drawn, pickled, ground, polished, and customer-specific options.

• Certification and Quality Assurance

  • Mandatory certification of compliance and test results.
  • Adherence to ISO 9001 or equivalent quality management systems.
  • Tracking and documentation of purchase order requirements, test results, and product traceability.

Applications

This low-nickel, high-manganese stainless steel alloy is primarily used for surgical implants and medical devices due to its specialty properties:

• Orthopedic and trauma implants (bone plates, screws, pins)
• Spinal devices
• Dental implants and prosthetics
• Other permanent or temporary biomedical devices where high strength and corrosion resistance are essential

Key advantages include:

• High Strength: Capable of being cold worked to ultimate tensile strengths above 1380 MPa, making it suitable for demanding load-bearing implant applications.
• Corrosion Resistance: Superior to conventional implant-grade stainless steels, with proven performance against pitting and crevice corrosion.
• Biocompatibility: Favorable biological response documented in cytotoxicity, irritation, systemic toxicity, pyrogenicity, mutagenicity, and implantation testing.
• Low Nickel Content: Reduces the risk of nickel-induced allergic reactions, making it preferable for sensitive patients.

Related Standards

ASTM F2229-21 references and aligns with several other international and ASTM standards, ensuring compatibility and comprehensive quality control:

• ASTM A262: Test methods for detecting susceptibility to intergranular corrosion.
• ASTM A484/A555: General requirements for stainless steel bars and wires.
• ASTM E8/E10/E18/E45/E112: Mechanical testing, hardness, microstructure, and grain size.
• ASTM F138, F1314, F1586: Related surgical implant stainless steel standards.
• ISO 6892, ISO 9001, ISO 13485: Tensile testing, quality management systems, and medical device regulatory requirements.

By meeting the requirements of ASTM F2229-21, manufacturers and suppliers ensure that their stainless steel bar and wire products are optimized for critical medical applications, supporting patient safety and regulatory compliance.

Keywords: ASTM F2229-21, surgical implant stainless steel, low-nickel, nitrogen strengthened stainless steel, UNS S29108, medical device materials, corrosion resistant implant metal, biocompatible stainless steel bar, ASTM surgical materials.

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
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
2.1 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
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.
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 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
F2229−21
AMS 2630Inspection, Ultrasonic Product over 0.5 Inch 6. Chemical Requirements
(12.7 mm) Thick
6.1 Thesupplier’sheatanalysisshallconformtothechemi-
AMS2632UltrasonicInspectionOfThinMaterials0.5Inch
cal requirements prescribed in Table 1. The supplier shall not
(13 mm) and Thinner
ship material with a composition outside the requirements
2.3 ISO Standards: specified in Table 1.
ISO 6892 Metallic materials—Tensile testing—Part 1: 6.1.1 Requirements for the major and minor elemental
Method of test at room temperature constituents are listed in Table 1. Also listed are important
ISO9001Quality management systems—Requirements residualelements.AnalysisforelementsnotlistedinTable1is
ISO 13485 Medical devices—Quality management not required to verify compliance with this specification.
systems—Requirements for regulatory purposes 6.1.2 Methods and practices relating to chemical analysis
required by this specification shall be in accordance with Test
3. Terminology Methods A751.
3.1 Definitions of Terms Specific to This Standard: 6.2 Product Analysis—The product analysis is either for the
purpose of verifying the composition of a heat or manufactur-
3.1.1 bar, n—round, rectangular, or other complex-shaped
inglotortodeterminevariationsinthecompositionwithinthe
product delivered straightened and cut to a defined length.
heat.
3.1.2 forging bar, n—bar (see 3.1.1) used for the production
6.2.1 Acceptance or rejection of a heat or lot of material
of forgings. It may be furnished in the hot-rolled condition.
may be made by the purchaser on the basis of this product
3.1.3 lot, n—the total number of mill products produced
analysis.
from the same melt heat under the same conditions at essen-
6.2.2 Product analysis tolerances do not broaden the speci-
tially the same time.
fied heat analysis requirements but cover variations between
laboratories in the measurement of chemical content. Product
3.1.4 wire, n—round, rectangular, or other complex-shaped
analysis limits shall be as specified in Table 2.
product produced and delivered in coils, spools, or other
6.2.3 Methods and practices relating to chemical analysis
packaging as specified.
required by this specification shall be in accordance with Test
Methods E354.
4. Ordering Information
4.1 Inquiriesandordersformaterialunderthisspecification
7. Metallurgical Requirements
shall include the following information:
7.1 The material shall contain no delta ferrite, chi, or sigma
4.1.1 Quantity;
phases when it is examined metallographically at 100× mag-
4.1.2 ASTM designation and date of issue;
nification in accordance with Practice E407.
4.1.3 Mechanical properties;
7.2 The microcleanliness of the steel, as determined byTest
4.1.4 Form;
Methods E45, Method A, except using plate I-r, on represen-
4.1.5 Applicable dimensions including size, thickness,
tative billet or bar samples from the heat shall not exceed the
width, and length (exact, random, or multiples) or drawing
following:
number;
Inclusion A B C D
4.1.6 Tolerances—Unless otherwise specified by purchaser,
Type (Sulphide) (Alumina) (Silicate) (Globular oxide)
tolerances must meet the requirements of Specifications A484/
Thin 1.5 2.5 2.5 2.5
A484M and/or A555/A555M, as applicable;
Heavy 1.5 1.5 1.5 1.5
4.1.7 Condition (see 5.1);
7.3 The surface of products supplied with a machined or
4.1.8 Finish (see 5.2);
ground surface finish shall have no free ferrite when optically
4.1.9 Special tests, if any; and
examined at a magnification of 100×.
4.1.10 Other requirements.
TABLE 1 Chemical Composition
5. Materials and Manufacture
Composition,
Element
% (mass/mass)
5.1 Condition—Bar and wire shall be furnished, as
Carbon 0.08 max
specified, in the annealed or cold-worked condition. Bar used
Manganese 21.00 to 24.00
for the production of forgings may be furnished in the
Phosphorus 0.03 max
hot-worked condition, as agreed upon between the purchaser Sulfur 0.01 max
Silicon 0.75 max
and supplier.
Chromium 19.00 to 23.00
Nickel 0.05 max
5.2 Finish—Types of finish available in bar and wire are
Molybdenum 0.50 to 1.50
cold-drawn, pickled, ground, ground and polished, or as
Nitrogen 0.85 to 1.10
specified by the purchaser.
Copper 0.25 max
A
Iron balance
A
Approximately equal to the difference of 100 % and the sum percentage of the
other specified elements. Reporting the percentage of iron difference is not
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
required.
4th Floor, New York, NY 10036, http://www.ansi.org.
F2229−21
A
TABLE 2 Product Analysis Tolerances
requirements specified. Refer to subsections 7.11.4 and 7.12.5
Permissible Variation Under
of Test Methods E8/E8M. If either the elongation or reduction
the Minimum Limit or
Element of area is less than the minimum requirement, discard the test
Over the Maximum Limit, %
B
and retest. Retest one specimen for each specimen that did not
(mass/mass)
Carbon 0.01 meet the minimum requirements.
C
Manganese 0.20
Phosphorus 0.005
9. Ultrasonic Inspection
Sulfur 0.005
Silicon 0.05
9.1 All centerless ground or peeled and polished round bar
Chromium 0.25
Nickel 0.03 ≥9.5mm[0.375in.]innominaldiametershallbeultrasonically
Molybdenum 0.05
inspected at final diameter according toAMS 2630, ClassA1.
C
Nitrogen 0.05
Equivalent test methods may be substituted when agreed upon
Copper 0.03
A by the purchaser and supplier.
Refer to AMS 2248 for chemical check analysis limits (except nitrogen).
B
For elements in which only a maximum percentage is indicated, the “under
NOTE 1—AMS 2630 specifies a minimum size limit of 12.7 mm [0.50
minimum limit” is not applicable.
C in.]. Subcommittee F04.12 has intentionally specified the use of AMS
The specified range for this element is not covered byAMS 2248 and has been
2630 below 12.7 mm [0.50 in.] based on the experience of users and
established through industrial practice.
producers on the committee. There is disagreement in the industry as to
whetherAMS 2632, which does apply to sizes under 12.7 mm [0.50 in.],
should apply to solid round bar.
8. Mechanical Requirements
10. Dimensions and Permissible Variations
8.1 Tensile Properties:
8.1.1 Tensile properties shall be determined in accordance
10.1 Units of Measure:
with Test Methods E8/E8M.
10.1.1 Selection—This specification requires that the pur-
8.1.2 The mechanical properties of test specimens shall
chaser selects the units (SI or inch-pound) to be used for
conform to the requirements specified in Table 3.
product certification. In the absence of a stated selection of
8.2 Hardness:
unitsonthepurchaseorder,thisselectionmaybeexpressedby
8.2.1 Hardness values shall be determined in accordance
the purchaser in several alternate forms listed in order of
with Test Method E10 or Test Methods E18.
precedence.
8.2.2 Whendesired,hardnesslimitsmaybespecifiedbythe
10.1.1.1 If the purchaser and supplier have a history of
purchaser.Hardnessdeterminationsshallbemadeonaproduct
using specific units, these units shall continue to be certified
cross section, midway between the center and surface, if the
until expressly changed by the purchaser.
cross section is adequate.
10.1.1.2 In the absence of historic precedence, if the units
8.3 Number of Tests:
used to define the product on the purchaser’s purchase order
8.3.1 Perform tension testing per Test Methods E8/E8M.
(PO), specification, and engineering drawing are consistent,
Should any of the test specimens not meet the specified
these units shall be used by the supplier for product certifica-
requirements, test two additional test pieces representative of
tion.
thesamelot,inthesamemanner,foreachfailedtestpiece.The
10.1.1.3 If the purchaser’s selection of units is unclear, the
lot shall be considered in compliance only if all additional test
units of measure shall be agreed upon between the purchaser
pieces meet the specified requirements.
and supplier.
8.3.2 Tensile test results for which any specimen fractures
10.1.2 Conversion of Units—Ifthesupplier’stestequipment
outside the gauge length shall be considered acceptable if both
does not report in the selected units, the test equipment units
the elongation and reduction of area meet the minimum
may be converted to the selected units for certification pur-
poses. Accurate arithmetic conversion and proper use of
TABLE 3 Mechanical Requirements
significant digits should be observed w
...

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
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
2.1 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
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.
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
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
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 12.7 mm [0.5 in.]0.5 Inch (12.7 mm) Thick
AMS 2632 Ultrasonic Inspection Of Thin Materials 0.5 Inch (13 mm) and Thinner
2.3 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperaturematerials—Tensile testing—Part 1: Method of test at room
temperature
ISO 9001 Quality Management Systems—Requirementsmanagement systems—Requirements
ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bar—bar, n—round bar and flats from 4.75 mm [0.1875 in.] to 101.60 mm [4.00 in.] in diameter or thickness (other sizes
and shaped by special order).round, rectangular, or other complex-shaped product delivered straightened and cut to a defined
length.
3.1.2 forging bar—bar, n—as described in bar (see 3.1.1) used for the production of forgings, forgings. It may be furnished in the
hot rolled hot-rolled condition.
3.1.3 lot—lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the
same time.
3.1.4 wire—wire, n—rounds less than 4.75 mm [0.1875 in.] in diameter.round, rectangular, or other complex-shaped product
produced and delivered in coils, spools, or other packaging as specified.
4. Ordering Information
4.1 Inquiries and orders for material under this specification shall include the following information:
4.1.1 Quantity;
4.1.2 ASTM designation and date of issue;
4.1.3 Mechanical properties;
4.1.4 Form;
4.1.5 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number;
4.1.6 Tolerances—Unless otherwise specified by purchaser, tolerances must meet the requirements of Specifications A484/A484M
and/or A555/A555M, as applicable;
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.
F2229 − 21
4.1.7 Condition (see 5.1);
4.1.8 Finish (see 5.2);
4.1.9 Special tests, if any; and
4.1.10 Other requirements.
5. Materials and Manufacture
5.1 Condition—Bar and wire shall be furnished, as specified, in the annealed or cold-worked condition. Bar used for the
production of forgings may be furnished in the hot-worked condition, as agreed upon between the purchaser and supplier.
5.2 Finish—Types of finish available in bar and wire are cold-drawn, pickled, ground, ground and polished, or as specified by the
purchaser.
6. Chemical Requirements
6.1 The supplier’s heat analysis shall conform to the chemical requirements prescribed in Table 1. The supplier shall not ship
material with a composition outside the requirements specified in Table 1.
6.1.1 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.
6.1.2 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods
A751.
6.2 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.
TABLE 1 Chemical Composition
Composition,
Element
% (mass/mass)
Carbon 0.08 max
Manganese 21.00 to 24.00
Phosphorus 0.03 max
Sulfur 0.01 max
Silicon 0.75 max
Chromium 19.00 to 23.00
Nickel 0.05 max
Molybdenum 0.50 to 1.50
Nitrogen 0.85 to 1.10
Copper 0.25 max
A
Iron balance
TABLE 1 Chemical Composition
Composition,
Element
% (mass/mass)
Carbon 0.08 max
Manganese 21.00 to 24.00
Phosphorus 0.03 max
Sulfur 0.01 max
Silicon 0.75 max
Chromium 19.00 to 23.00
Nickel 0.05 max
Molybdenum 0.50 to 1.50
Nitrogen 0.85 to 1.10
Copper 0.25 max
A
Iron balance
A
Approximately equal to the difference of 100 % and the sum percentage of the
other specified elements. Reporting the percentage of iron difference is not
required.
F2229 − 21
6.2.1 Acceptance or rejection of a heat or lot of material may be made by the purchaser on the basis of this product analysis.
6.2.2 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.
6.2.3 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods
E354.
7. Metallurgical Requirements
7.1 The material shall contain no delta ferrite, chi, or sigma phases when it is examined metallographically at 100× magnification
in accordance with Practice E407.
7.2 The microcleanliness of the steel, as determined by Practice Test Methods E45, Method A, except using plate I-r, on
representative billet or bar samples from the heat shall not exceed the following:
Inclusion A B C D
Type (Sulphide) (Alumina) (Silicate) (Globular oxide)
Thin 1.5 2.5 2.5 2.5
Heavy 1.5 1.5 1.5 1.5
7.3 The surface of products supplied with a machined or ground surface finish shall have no free ferrite when optically examined
at a magnification of 100×.
8. Mechanical Requirements
8.1 Tensile Properties:
8.1.1 Tensile properties shall be determined in accordance with Test Methods E8/E8M.
8.1.2 The mechanical properties of test specimens shall conform to the requirements specified in Table 3.
8.2 Hardness:
8.2.1 Hardness values shall be determined in accordance with Test MethodsMethod E10 or Test Methods E18.
8.2.2 When desired, hardness limits may be specified by the purchaser. Hardness determinations shall be made on a product cross
section, midway between the center and surface, if the cross section is adequate.
A
TABLE 2 Product Analysis Tolerances
Permissible Variation Under
the Minimum Limit or
Element
Over the Maximum Limit, %
B
(mass/mass)
Carbon 0.01
C
Manganese 0.20
Phosphorus 0.005
Sulfur 0.005
Silicon 0.05
Chromium 0.25
Nickel 0.03
Molybdenum 0.05
C
Nitrogen 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 has been
established through industrial practice.
F2229 − 21
TABLE 3 Mechanical Requirements
Reduction
Ultimate Tensile Yield Strength
A
in
Elongation
Condition Strength min, (0.2 % offset),
min, %
Area min,
MPa [psi] min, MPa [psi]
%
Annealed 827 517 30 50
Condition A [120 000] [75 000]
Cold Worked 1034 827 20 50
Condition B [150 000] [120 000]
Cold Worked 1379 1241 12 40
Condition C [200 000] [180 000]
TABLE 3 Mechanical Requirements
Reduction
Ultimate Tensile Yield Strength
A
in
Elongation
Condition Strength min, (0.2 % offset),
min, %
Area min,
MPa [psi] min, MPa [psi]
%
Annealed 825 515 30 50
Condition A [120 000] [75 000]
Cold Worked 1030 825 20 50
Condition B [150 000] [120 000]
Cold Worked 1375 1240 12 40
Condition C [200 000] [180 000]
A
Elongation of material 1.6 mm [0.063 in.] or greater in diameter (D) or width (W)
shall be measured using a gauge length of 50 mm [2 in.] or 4D or 4W. The gauge
length shall be reported with the test results. The method for determining
elongation of material under 1.6 mm [0.063 in.] in diameter or thickness may be
1/2
negotiated. Alternatively, a gauge length corresponding to ISO 6892 (5.65 × S ,
o
where S is the original cross sectional cross-sectional area of the gauge length)
o
may be used when agreed upon between the supplier and purchaser.
8.3 Number of Tests:
8.3.1 Perform tension testing per Test Methods E8/E8M. Should any of the test specimens not meet the specified requirements,
test two additional test pieces representative of the same lot, in the same manner, for each failed test piece. The lot shall be
considered in compliance only if all additional test pieces meet the specified requirements.
8.3.2 Tensile test results for which any specimen fractures outside the gauge length shall be considered acceptable,acceptable if
both the elongation and reduction of area meet the minimum requirements specified. Refer to subsections 7.11.4 and 7.11.57.12.5
of Test Methods E8/E8M. If either the elongation or reduction of area is less than the minimum requirement, discard the test and
retest. Retest one specimen for each specimen that did not meet the minimum requirements.
9. Ultrasonic Inspection
9.1 All centerless ground or peeled and polished round bar ≥9.5 mm [0.375 in.] in nominal diameter shall be ultrasonically
inspected at final diameter according to AMS 2630, Class A1. Equivalent test methods may be substituted when agreed upon by
the purchaser and supplier.
NOTE 1—AMS 2630 specifies a minimum size limit of 12.7 mm [0.50 in.]. Subcommittee F04.12 has intentionally specified the use of AMS 2630 below
12.7 mm [0.50 in.] based on the experience of users and producers on the committee. There is disagreement in the industry as to whether AMS 2632,
which does apply to sizes under 12.7 mm [0.50 in.], applies should apply to solid
...