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3.1.1 bar—round bar and flats from 0.1875 in. [4.75 mm] to TABLE 1 Chemical Composition
4.00 in. [101.60 mm] in diameter or thickness (other sizes and Element
Composition,
shaped by special order). % (mass/mass)
Carbon 0.08 max
3.1.2 forging bar—as described in section 3.1.1 used for the Manganese 21.00 to 24.00
production of forgings, may be furnished in the hot rolled Phosphorus 0.03 max
condition. Sulfur 0.01 max
Silicon 0.75 max
3.1.3 lot—the total number of mill products produced from Chromium 19.00 to 23.00
Nickel 0.05 max
the same melt heat under the same conditions at essentially the Molybdenum 0.50 to 1.50
same time. Nitrogen 0.85 to 1.10
Copper 0.25 max
3.1.4 wire—rounds less than 0.1875 in. [4.75 mm] in Iron balanceA
diameter. 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
4. Ordering Information required.
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7.3 The surface of products supplied with a machined or NOTE 1—AMS 2630 specifies a minimum size limit of 0.50 in. [12.7
ground surface finish shall have no free ferrite when optically mm]. F04.12 subcommittee has intentionally specified the use of AMS
2630 below 0.50 in. [12.7 mm] based on the experience of users and
examined at a magnification of 100×. producers on the committee. There is disagreement in the industry as to
whether AMS 2632, which does apply to sizes under 0.50 in. [12.7 mm],
8. Mechanical Requirements applies to solid round bar.
8.1 Tensile Properties: 10. Dimensions and Permissible Variations
8.1.1 Tensile properties shall be determined in accordance
with Test Methods E8/E8M. 10.1 Units of Measure:
8.1.2 The mechanical properties of test specimens shall 10.1.1 Selection—This specification requires that the pur-
conform to the requirements specified in Table 3. chaser selects the units (SI or inch-pound) to be used for
product certification. In the absence of a stated selection of
8.2 Hardness: units on the purchase order, this selection may be expressed by
8.2.1 Hardness values shall be determined in accordance the purchaser in several alternate forms listed in order of
with Test Methods E10 or Test Methods E18. precedence.
8.2.2 When desired, hardness limits may be specified by the 10.1.1.1 If the purchaser and supplier have a history of
purchaser. Hardness determinations shall be made on a product 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.
the same lot, in the same manner, for each failed test piece. 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—If the supplier’s test equipment
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-
requirements specified. Refer to subsections 7.11.4 and 7.11.5 poses. Accurate arithmetic conversion and proper use of
of Test Methods E8/E8M. If either the elongation or reduction significant digits should be observed when performing this
of area is less than the minimum requirement, discard the test conversion. IEEE/ASTM SI 10 provides guidelines for the use
and retest. Retest one specimen for each specimen that did not of SI units. Annex A of that standard provides conversion
meet the minimum requirements. tables and Annex B provides rules for conversion and signifi-
cance.
9. Ultrasonic Inspection
11. Special Tests
9.1 All centerless ground or peeled and polished round bar
≥ 0.375 in. [9.5 mm] in nominal diameter shall be ultrasoni- 11.1 Bar and wire conforming to this specification shall be
cally inspected at final diameter according to AMS 2630, Class capable of passing the intergranular corrosion susceptibility
A1. Equivalent test methods may be substituted when agreed test in accordance with Practice E of Practices A262.
upon by the purchaser and supplier. 11.2 Bar and wire conforming to this specification shall
have a homogeneous microstructure with an average grain size
of ASTM No. 5 or finer when measured in accordance with
Test Methods E112.
TABLE 3 Mechanical Requirements 11.2.1 It is preferred that samples for grain size determina-
Reduction tion be selected after the hot working operation or after the
Ultimate Tensile Yield Strength
Condition Strength min, (0.2 % offset), Elongation
A in final annealing operation prior to the final cold working
min, % Area min,
psi [MPa] min, psi [MPa]
%
operation.
Annealed 120 000 75 000 30 50
11.2.2 If grain size samples are selected after a final cold
Condition A [827] [517] working, the specimens shall be tested according to Test
Cold Worked 150 000 120 000 20 50 Method E112 or as agreed upon between the supplier and
Condition B [1034] [827]
Cold Worked 200 000 180 000 12 40
purchaser.
Condition C [1379] [1241] 11.3 Any other special requirements shall be specified by
A
Elongation of material 0.063 in. [1.6 mm] or greater in diameter (D) or width (W) the purchaser.
shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length
shall 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.
12. Significance of Numerical Limits
Alternatively, a gauge length corresponding to ISO 6892 (5.65 × So1/2, where So is 12.1 The following applies to all specified numerical limits
the original cross sectional area of the gauge length) may be used when agreed
upon between the supplier and purchaser . in this specification. To determine conformance to these limits,
an observed or calculated value shall be rounded to the nearest
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unit in the last right hand digit used in expressing the 14. Quality Program Requirements
specification limit, in accordance with the rounding method of
14.1 The bar and wire producer and any processors shall
Practice E29.
maintain a quality program such as that which is defined in
13. Certification ISO 9001 or a similar quality program.
13.1 The supplier shall provide a certification that the
material was tested in accordance with this specification. A 15. Keywords
report of the test results shall be furnished to the purchaser at 15.1 low-nickel; manganese; metals (for surgical implants);
the time of shipment. nitrogen strengthened; stainless steel; surgical applications
APPENDIXES
(Nonmandatory Information)
X1. RATIONALE
X1.1 The purpose of this specification is to characterize the layer shall be removed from the finished product prior to its use
composition and properties of wrought low nickel, nitrogen as a medical or surgical device.
strengthened 21 chromium-23 manganese-1 molybdenum bar
and wire to ensure consistency in the starting material used, X1.8 This alloy has been tested in accordance with Test
directly or as modified by forging, in the manufacturing of Method F746 and exhibits pitting and crevice corrosion resis-
medical devices. tance greater than Specification F138 reference material and is
equivalent to Specifications F1314 and F1586 alloys (1).5
X1.2 ISO standards are listed for reference only. Use of an Cyclic anodic polarization testing in 37°C Ringer’s solution
ISO standard instead of a preferred ASTM standard may be indicated better corrosion resistance than Specification F138
negotiated between the purchaser and the supplier. reference material (1,2). Additional information on the corro-
sion resistance and the physical, mechanical, and metallurgical
X1.3 The metallurgical requirements include a fine-grained properties of this alloy has also been published (10-13).
austenitic structure free of ferrite, chi, and sigma phases with a
defined inclusion content and the capability of passing an X1.9 Units of Measure:
intergranular corrosion susceptibility test. X1.9.1 ASTM Policy—ASTM is promoting the use of ratio-
X1.4 This alloy can be supplied in either the annealed or nalized SI (metric) units in their standards. The F12.04
cold-worked condition. Committee has modified this specification to facilitate the
transition by the medical materials industry to SI between now
X1.5 This alloy is capable of being cold worked to ultimate and 2018. In the first phase of this transition, running to 2013,
tensile strengths exceeding 200 000 psi [1380 MPa] for high- the specifications will be structured to allow the use of either SI
strength surgical implant applications. There is an associated or inch-pound units. The choice of primary units in each
reduction in ductility with these higher strength levels. specification will be determined by the industry using the
specification. The change to SI units during this period may be
X1.6 The nitrogen used for strengthening this steel can initiated by the purchaser through his purchase documentation.
result in the formation of carbonitrides. Carbonitrides can be In the second phase of this transition, the specifications shall be
revealed by etching electrolytically in a solution of potassium written with SI as the primary units. Harmonization with
hydroxide (56 g of KOH in 100 mL of water for 3 s at 2 V]. corresponding ISO documents should be considered when
They may affect the finish of electropolished surfaces. assigning the SI values.
X1.7 Heat treating this alloy in oxidizing, reducing, or
hydrogen atmosphere can result in the formation of a magnetic 5
The boldface numbers in parentheses refer to the list of references at the end of
(ferritic) surface layer on the heat-treated product. This surface this standard.
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X2. BIOCOMPATIBILITY
X2.1 The suitability of this material from a human implant if the material is used in appropriate applications. Since the
perspective is dependent on the specific application. The time of the original approval of this specification, this stainless
biological tests appropriate for the specific site, such as steel alloy has been used clinically in humans in several
recommended in Practice F748 should be used as a guideline. different medical device applications.
A summary of the testing that has been performed to-date is
provided in X2.3 and the reference list. X2.3 An extensive series of testing has been performed to
document the biocompatibility of this material (3-9). In all
X2.2 No known surgical implant material has ever been cases, the biocompatibility test results for this material were
shown to be completely free of adverse reactions in the human favorable and met the requirements of the test standards used.
body. The material referred to in this specification has shown
that an acceptable level of biological response can be expected, X2.4 Refer to 510k number K003496.
REFERENCES
(1) Brown, R. S., and Gebeau, R. C., “Strength and Corrosion Resistance B. N., Mutation Research, 113: 173-215 ( 1993). Extraction proce-
of BioDur®108 Alloy,” Society for Biomaterials, Sixth World Bioma- dures were based upon ISO 10993-12, 1996. The test article was
terials Congress Transactions, Vol II (USA), May 2000, p. 828. concluded to be non-mutagenic based on the methods employed.
(2) Disegi, J. A., Zardiakas, L. D., and Mitchell, D. W., “Anodic (8) Toxikon Corporation implantation with histopathology testing based
Polarization Evaluation of Nickel-Free Implant Quality Stainless on ANSI/AAMI/ISO 10993-6: 1995; Biological Testing of Medical
Steel,” Society for Biomaterials, Sixth World Biomaterials Congress Devices—Part 6: Tests for Local Effects After Implantation; and
Transactions, Vol II (USA), May 2000, p. 816. ASTM Standards Section 13, Vol 13.01, Medical Devices, Designa-
(3) Toxikon Corporation (15 Wiggens Avenue, Bedford, MA 01730, tion: F981-93 (1996). No signs of toxicity were exhibited after 14 and
USA) cytotoxicity study based on the procedure described in ANSI/ 28 day implantation test periods and the test article was concluded to
AAMI/ISO 10993-5: 1993; Biological Evaluation of Medical be non-toxic.
Devices—Part 5: Test for Cytotoxicity. The test article was concluded (9) Toxikon Corporation hemocompatibility testing based on the follow-
to be non-cytotoxic and meeting the requirements of the Elution Test, ing references: DHEW publication # (NIH) 77-1294, 9.213, 1977:
ISO 10993. ISO Biological Evaluation of Medical Devices—Part 4, Selection of
(4) Toxikon Corporation irritation testing based upon ISO Biological Tests for Interactions with Blood, ISO 10993-4 (1992); Extraction
Testing of Medical Devices—Part 10: Irritation and Sensitization Procedures were based on ISO 10993-12, 1996; Autian Method
Tests; ISO 10993-10, 1995. Extraction procedures were based upon
described in ATTP-I, University of Tennessee Center for the Health
ISO 10993-12, 1996. The test sites did not exhibit any signs of
Sciences, Memphis TN, 18-Apr-77; Veterinary Hematology, Schalm
erythema, edema or necrosis and the test article was concluded to be
O. W., pp 51-53, 1965, Leas & Feviger, Philadelphia. The test article
a negligible irritant.
was concluded to be non-hemolytic based on the methods employed.
(5) Toxikon Corporation acute systemic toxicity testing based on ISO
(10) Gebeau, R. C., and Brown, R. S., “Corrosion Resistance and
Biological Evaluation of Medical Devices—Part 11: Tests for Sys-
temic Toxicity; ISO 10993-11, 1993. Extraction procedures were Strength of BioDur®108 Alloy, a Nickel-Free Austenitic Stainless
based upon ISO 10993-12, 1996. No signs of toxicity were observed Steel,” pp. 157-164, Structural Biomaterials for the 21st Century, a
and the test article was concluded to meet the requirements of ISO publication of TMS (The Minerals, Metals & Materials Society),
10993-11, Systemic Injection Test. published 2001.
(6) Toxikon Corporation pyrogenicity testing based on ISO Biological (11) Roach, M. D., Zardiackas, L. D., Brown, R. S., and Gebeau, R. C.,
Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity; “Physical, Metallurgical and Mechanical Comparison of a Low-
ISO 10993-11, 1993, and upon the standards set by the current version Nickel Stainless Steel,” Society for Biomaterials 27th Annual Meet-
of the United States Phamacopia. Extraction procedures were based ing Transactions (USA), April 24-29, 2001, p. 343 .
upon ISO 10993-12, 1996. The test article was concluded to meet the (12) Roach, M. D., Zardiackas, L. D., Brown, R. S., and Gebeau, R. C.,
requirements of ISO 10993-11 for the absence of pyrogens as “Stress Corrosion Cracking of a Low-Nickel Steel,” Society for
specified for the Pyrogen Test. Biomaterials 27th Annual Meeting Transactions (USA), April 24-29,
(7) Toxikon Corporation mutagenicity testing based on ISO Biological 2001, p. 469.
Evaluation of Medical Devices—Part 3: Tests Genotoxicity, Carcino- (13) Gebeau, R. C., and Brown, R. S., “Biomedical Implant Alloy,”
genicity and Reproductive Toxicity; ISO 10993-3, 1992, and revised Advanced Materials & Processes (USA), Vol 159, No. 9, September
methods for the Salmonella Mutagenicity test, Maron, D. M., Ames, 2001, pp. 46-48.
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SUMMARY OF CHANGES
Committee F04 has identified the location of selected changes to this standard since the last issue (F2229 – 07)
that may impact the use of this standard. (Approved Oct. 1, 2012.)
(1) Editorial changes have been made in order to meet the (2) Ultrasonic inspection language has been added.
terminology and formatting guidelines that have been estab- (3) Language has been added to address the selection of units
lished for implant specifications. of measurement for material certification.
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