ASTM F2581-07
(Specification)Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
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 As of the time of the original approval of this specification no product utilizing this alloy had been approved through a 510(k) submission.
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.4 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.
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Designation:F2581 −07
StandardSpecification for
Wrought Nitrogen Strengthened 11Manganese-17Chromium-
3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire
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 Nickel, and Cobalt Alloys
E407Practice for Microetching Metals and Alloys
1.1 This specification covers the chemical, mechanical, and
F138 Specification for Wrought 18Chromium-14Nickel-
metallurgical requirements for wrought nitrogen strengthened
2.5MolybdenumStainlessSteelBarandWireforSurgical
11manganese-17chromium-3molybdenum low-nickel stainless
Implants (UNS S31673)
steel alloy bar and wire for surgical implants.
F746Test Method for Pitting or Crevice Corrosion of
1.2 As of the time of the original approval of this specifi-
Metallic Surgical Implant Materials
cation no product utilizing this alloy had been approved
F748PracticeforSelectingGenericBiologicalTestMethods
through a 510(k) submission.
for Materials and Devices
F1314Specification for Wrought Nitrogen Strengthened 22
1.3 The values stated in SI units are to be regarded as the
standard. The values given in parentheses are for information Chromium–13Nickel–5Manganese–2.5Molybdenum
Stainless Steel Alloy Bar and Wire for Surgical Implants
only.
(UNS S20910)
1.4 This standard does not purport to address all of the
F1586Specification for Wrought Nitrogen Strengthened
safety concerns, if any, associated with its use. It is the
21Chromium—10Nickel—3Manganese—
responsibility of the user of this standard to establish appro-
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
priate safety and health practices and determine the applica-
Implants (UNS S31675)
bility of regulatory limitations prior to use.
2.2 Aerospace Material Specification:
2. Referenced Documents
AMS 2248Chemical CheckAnalysis Limits, Corrosion and
Heat Resistant Steels and Alloys, Maraging and Other
2.1 ASTM Standards:
Highly-Alloyed Steels, and Iron Alloys
A262Practices for Detecting Susceptibility to Intergranular
Attack in Austenitic Stainless Steels
2.3 ISO Standard:
A751Test Methods, Practices, and Terminology for Chemi-
ISO 6892Metallic Materials Tensile Testing at Ambient
cal Analysis of Steel Products
Temperature
E8Test Methods for Tension Testing of Metallic Materials 5
2.4 American Society for Quality Standard:
E29Practice for Using Significant Digits in Test Data to
ASQ C1Specification of General Requirements for a Qual-
Determine Conformance with Specifications
ity Program
E45Test Methods for Determining the Inclusion Content of
Steel
3. Terminology
E112Test Methods for Determining Average Grain Size
3.1 Definitions of Terms Specific to This Standard:
E354 Test Methods for Chemical Analysis of High-
3.1.1 lot—A lot is defined as the total number of mill
Temperature,Electrical,Magnetic,andOtherSimilarIron,
products produced from the same melt heat under the same
conditions at essentially the same time.
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, 2007. Published January 2007. DOI: 10.1520/ Available from Society of Automotive Engineers (SAE), 400 Commonwealth
F2581-07. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2581−07
4. Product Classification 7.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important
4.1 Bar—Round, rectangular, or other complex shaped
residualelements.AnalysisforelementsnotlistedinTable1is
product delivered straightened and cut to defined lengths, with
2 2 not required to verify compliance with this specification.
a maximum cross-sectional area of 16 in. (103 cm ).
7.1.2 Methods and practices relating to chemical analysis
4.2 Forging bar—Bar as described in 4.1 used for produc-
required by this specification shall be in accordance with Test
tion of forgings, may be furnished in the hot-rolled and
Methods A751.
descaled condition.
7.1.3 For reference purposes, Test Methods E354 shall
apply.
4.3 Wire—Rounds, rectangular, or other complex shaped
product produced and delivered in coils.
7.2 Product Analysis—The product analysis is either for the
purpose of verifying the composition of a heat or lot or to
4.4 Fine Wire—Wire with diameter or major dimension less
than 0.063 in. (1.6 mm). determine variations in the composition within the heat.
7.2.1 Acceptance or rejection of a heat or lot of material
5. Ordering Information
maybe made by the purchaser on the basis of this product
analysis.
5.1 Inquiriesandordersformaterialunderthisspecification
7.2.2 Product analysis tolerances do not broaden the speci-
shall include the following information:
fied heat analysis requirements but cover variations between
5.1.1 Quantity,
laboratories in the measurement of chemical content. Product
5.1.2 ASTM designation and date of issue,
analysis limits shall be as specified in Table 2.
5.1.3 Mechanical properties,
5.1.4 Form,
8. Metallurgical Requirements
5.1.5 Applicable dimensions including size, thickness,
8.1 The material shall contain no delta ferrite, chi, or sigma
width, and length (exact, random, or multiples) or drawing
phases when it is examined metallographically at 100× mag-
number,
nification in accordance with Practice E407.
5.1.6 Condition,
5.1.7 Special tests, if any, and
8.2 The microcleanliness of the steel, as determined byTest
5.1.8 Other requirements.
MethodE45,MethodA,onrepresentativebilletorbarsamples
from the heat shall not exceed the following:
6. Materials and Manufacture
Inclusion D (Globular
6.1 Condition—Bar and wire shall be furnished, as
A (Sulphide) B (Alumina) C (Silicate)
Type oxide)
specified, in the annealed or cold-worked condition. Bar used
for the production of forgings may be furnished in the hot Thin 1.5 1.5 1.5 1.5
Heavy 1.0 1.0 1.0 1.0
worked and descaled condition, as agreed upon between
purchaser and supplier.
9. Mechanical Properties
6.2 Finish—Types of finish available in bar and wire are
9.1 Tensile Properties:
cold-drawn, pickled, ground, ground and polished, shaved, or
9.1.1 Tensile properties shall be determined in accordance
as specified by the purchaser.
with Test Methods E8. Perform at least two tension test from
each lot. Should any test piece not meet the specified
7. Chemical Requirements
requirements, test two additional test pieces representative of
7.1 Thesupplier’sheatanalysisshallconformtothechemi-
thesamelot,inthesamemanner,foreachfailedtestpiece.The
cal requirements prescribed in Table 1. The supplier shall not
ship material that is outside the limits specified in Table 1.
A
TABLE 2 Product Analysis Tolerances
Permissible Variation
Under the Minimum
Element
Limit or Over the
TABLE 1 Chemical Composition
B
Maximum Limit, % (mass/mass)
Element Composition, % (mass/mass) Carbon 0.01
C
Carbon 0.15 to 0.25
Manganese 0.20
Manganese 9.50 to 12.50 Phosphorus 0.005
Phosphorus 0.020 max
Sulfur 0.005
Sulfur 0.010 max Silicon 0.05
Silicon 0.2 to 0.6 Chromium 0.25
Chromium 16.50 to 18.00 Nickel 0.03
Nickel 0.05 max Molybdenum 0.05
C
Molybdenum 2.70 to 3.70 Nitrogen 0.05
Nitrogen 0.45 to 0.55 Copper 0.03
Copper 0.25 max
A
Refer to AMS 2248 for chemical check analysis limits (except nitrogen).
A
Iron balance
B
For elements in which only a maximum percentage is indicated, the “under
A
Approximately equal to the difference of 100 % and the sum percentage of the minimum limit” is not applicable.
C
other specified elements. The percentage of iron difference is not required to be The specified range for this element is not covered byAMS 2248 and has been
reported. established through industrial practice.
F2581−07
lot shall be considered in compliance only if all additional test 10.2 Bar and wire conforming to this specification shall
pieces meet the specified requirements. haveahomogeneousmicrostructurewithanaveragegrainsize
9.1.2 Tensile test results for which any specimen fractures of ASTM No. 5 or finer when measured in accordance with
outsidethegaugelengthshallbeconsideredacceptable,ifboth Test Methods E112.
the elongation and reduction of area meet the minimum 10.2.1 It is preferred that samples for grain size determina-
requirements specified. Refer to Test Method E8 sections tion be selected after the hot working operation or after the
7.11.4 and 7.11.5. If either the elongation or reduction of area final annealing operation prior to the final cold working
is less than the minimum requirement, discard the test and operation.
retest.Retestonespecimenforeachspecimenthatdidnotmeet 10.2.2 If grain size samples are selected after a final cold
the minimum requirements. working, specimens shall be tested according to Test Methods
E112 or as agreed upon between supplier and purchaser.
9.2 The mechanical properties of test specimens shall con-
form to the requirements specified in Table 3. 10.3 Any other special requirements shall be specified by
the purchaser.
9.3 The level of mechanical properties for material in other
conditions shall be specified in the purchase order
11. Significance and Numerical Limits
10. Special Tests
11.1 The following applies to all specified numerical limits
inthisspecification.Todetermineconformancetotheselimits,
10.1 Bar and wire conforming to this specification shall be
an observed or calculated value shall be rounded to the nearest
capable of passing the intergranular corrosion susceptibility
unit in the last right hand digit used in expressing the
test in accordance with Practice E of Practices A262.
specification limit, in accordance with rounding method of
Practice E29.
TABLE 3 Mechanical Requirements
Yield
12. Certification
Ultimate Strength
Reduction
A
Tensile (0.2 %
Elongation
12.1 Certification shall be provided by the supplier that the
Condition in Area min,
min, %
Strength offset),
%
material meets the requirements of this specification. A report
min, psi (MPa) min, psi
(MPa) of the test results shall be furnished at the time of shipment.
Annealed 120 000 70 000 40 50
(827) (482)
13. Quality Program Requirements
Cold Worked 160 000 120 000 12 .
(1103) (827)
13.1 The bar and wire producer and any processors shall
A
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) maintain a quality program such as that which is defined in
shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length
ASQ C1.
must be reported with the test results. The method for determining elongation of
material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.
14. Keywords
Alternatively, a gauge length corresponding to ISO 6892 may be used when
1/2
agreed upon between supplier and purchaser (5.65 × S , where S is the
o o
14.1 low-nickel; manganese; metals (for surgical implants);
original cross sectional area of the gauge length).
nitrogen strengthened; stainless steel; surgical applications
APPENDIXES
(Nonmandatory Information)
X1. RATIONALE
X1.1 The purpose of this specification is to characterize the X1.4 This alloy can be supplied in either the annealed or
composition and properties of wrought low nickel, nitrogen cold-worked condition.
strengthened 11manganese-17chromium-3molybdenum bar
X1.5 This alloy is capable of being cold worked to ultimate
and wire to ensure consistency in the starting material used,
tensile strengths exceeding 200 000 psi (1380 MPa) for
directly or as modified by forging, in the manufacturing of
high-strength surgical implant applications.
medical devices.
X1.6 Prolongedheattreatingthisalloyatsolution-annealing
X1.2 ISO standards are listed for reference only. Use of an
temperature (typically 1050°C) may result in the formation of
ISO standard instead of a preferred ASTM standard may be
a ferritic surface layer. This surface layer shall be removed
negotiated between the purchaser and the supplier.
from the finished product prior to its use as a medical or
X1.3 The metallurgical requirements include a fine-grained surgical device. Formation of ferrite is caused by de-
austeniticstructurefreeofdeltaferrite,withadefinedinclusion nitrogenization.Thiseffectistypicalforhigh-nitrogenstainless
contentandthecapabilityofpassinganintergranularcorrosion steels. Since the nitrogen content in the composition of the
susceptibility test. steeldescribedinthisstandardisatmediumlevelthetendency
F2581−07
of de-nitrogenization is minimized. To avoid this effect during of reduced autenitic corrosion resistance and possible em-
processing, heating cycles shall be kept as short as possible. brittlement effects.
X1.9 Deltaferriteisamagneticphasethatmustbeabsentin
X1.7 This alloy has been tested in accordance with Test
order to provide a completely nonmagnetic microstructure that
Method F746 and exhibits pitting and crevice corrosion resis-
will not cause torque, displacement, or heating in a Magnetic
tance much greater than Specification F138 reference material
Resonance Imaging (MRI) environment.
andexceedsvaluesofmaterialspecifiedinSpecificationF1314
and Specification F1586.Additional information on the corro-
X1.10 Chemical composition of this steel exposes a high
sion resistance and the physical, mechanical, and metallurgical
level of carbon which in conventional metallurgy of
properties of this alloy has been published (1-4).
chromium-nickel-stainless steels is deemed to be critical. In
high-nitrogen stainless steels it replaces nitrogen since it also
X1.8 Molybdenum-enriched chi and sigma intermetallic
has a strong effect on stabilizing the austenitic phase. Replac-
compounds must not be present in the microstructure because
ing nitrogen by carbon has advantageous effects on corrosion
resistance, widens the range of austenite stability towards
6 lower solution ann
...
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