1、Designation: F1586 08F1586/F1586M 13Standard Specification forWrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar forSurgical Implants (UNS S31675)1This standard is issued under the fixed designation F1586;F1586/F1586M; the number immediately following t
2、he designation indicatesthe year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of lastreapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification cov
3、ers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened21chromium10nickel3manganese2.5molybdenum stainless steel alloy bar for surgical implants.1.2 The values stated in either inch-pound units or SI units are to be regarded separately as standard. The values g
4、iven inparentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in non-conform
5、ance with the standard.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless SteelsA484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and ForgingsA751 Test Methods, Practices, and Termi
6、nology for Chemical Analysis of Steel ProductsE8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance
7、 with SpecificationsE45 Test Methods for Determining the Inclusion Content of SteelE112 Test Methods for Determining Average Grain SizeF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F746 Test Method for Pitting or Crevic
8、e Corrosion of Metallic Surgical Implant Materials2.2 Aerospace Material Specifications:3AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron Alloys1 This specification is under the jurisdiction of ASTM Committee F
9、04 on Medical and Surgical Materials and Devicesis under the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved May 1, 2008June 1, 2013. Published May 2008August 2013. Originally approved in 1995. Last previous edition approved in 20022008 asF1586 02.F158
10、6 08. DOI: 10.1520/F1586-08.10.1520/F1586-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from
11、 Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.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. Becauseit may not be tec
12、hnically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of thi
13、s standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.3 ASQC Standard:4ASQ C1 Specification of General Requirements for a Quality Program2.3 ISO Standard:4ISO 6892 Metallic Materials Tensile Testing at Ambient TemperatureISO 900
14、1 Quality Management SystemRequirements2.4 Quality Standard:SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System2.5 Quality Standard:5ASQ C1 Specification of General Requirements for a Quality Program3. Terminology3.1 Definitions of Terms Speci
15、fic to This Standard:3.1.1 lot, nthe total number of mill products produced from the same melt heat under the same conditions at essentially thesame time.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, all requirements of the current edition of Specific
16、ation A484/A484Mshall apply.4.2 In cases in which a conflict exists between this specification and the standards listed in Section 2, this specification shalltake precedence.5. Ordering Information5.1 Inquiries and orders for material under this specification shall include the following information:
17、5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Mechanical properties (if applicable, for special conditions),5.1.4 Form,5.1.5 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number,5.1.6 TolerancesUnless otherwise specified b
18、y purchaser, tolerances must meet the requirements of Specification A484/A484M as applicable.5.1.7 Condition (see 6.1),5.1.8 Finish (see 6.2),5.1.9 Special tests (if any), and5.1.10 Other requirements.6. Materials and Manufacture6.1 ConditionBars shall be furnished in the annealed, medium hard, or h
19、ard condition, as specified.6.2 FinishTypes of bar finishes available are cold-drawn, pickled, ground, ground and polished, or as specified by thepurchaser.7. Chemical Requirements7.1 The suppliers heat analysis shall conform to the chemical requirements prescribed in Table 1. The supplier shall not
20、 shipmaterial that is outside the limits specified in Table 1.7.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
21、7.1.2 Methods and practices relating to chemical analysis required by this specification shall be in accordance with TestMethods, Practices, and Terminology A751.7.2 Product AnalysisThe product analysis is either for the purpose of verifying the composition of a heat or manufacturinglot or to determ
22、ine variations in the composition within the heat.7.2.1 Acceptance or rejection of a heat or lot of material may be made by the purchaser on the basis of this product analysis.7.2.2 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations betweenlabora
23、tories in the measurement of chemical content. Product analysis limits shall be as specified in Table 2.5 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.4 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Mil
24、waukee, WI 53203, http:/www.asq.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.F1586/F1586M 1328. Metallurgical Requirements8.1 The material shall exhibit no delta ferrite, chi, or sigma phases when it is examined
25、metallographically at 100magnification.8.2 The microcleanliness of the steel, as determined by Test Methods E45, Method A, except using Plate Ir, on representativebillet or bar samples from the heat shall not exceed the following:Inclusion A B C DType (Sulfide) (Alumina) (Silicate) (GlobularOxide)Th
26、in 1.5 2.0 2.0 2.5Heavy 1.5 1.5 1.5 1.59. Mechanical Requirements9.1 Tensile Properties:9.1.1 Tensile properties shall be determined in accordance with Test Methods E8.9.1.2 The mechanical properties of test specimens shall conform to the requirements specified in Table 3.9.2 Hardness:9.2.1 Hardness
27、 values shall be determined in accordance with Test Method E10 or Test Methods E18.9.2.2 When desired, hardness limits may be specified by the purchaser. Hardness determinations shall be made on a productcross section, midway between the center and surface, if the cross section is adequate.9.3 Numbe
28、r of Tests:9.3.1 Perform at least one tension and one bend tests from each lot. Should any of these test pieces not meet the specifiedrequirements, test two additional test pieces representative of the same lot, in the same manner, for each failed test piece. The lotshall be considered in compliance
29、 only if all additional test pieces meet the specified requirements.TABLE 1 Chemical RequirementsElement Composition, % (Mass/Mass)Carbon 0.08 maxManganese 2.00 to 4.25Phosphorus 0.025 maxSulfur 0.01 maxSilicon 0.75 maxChromium 19.5 to 22.0Nickel 9.0 to 11.0Molybdenum 2.0 to 3.0Nitrogen 0.25 to 0.50
30、Niobium 0.25 to 0.80Copper 0.25 maxIron balanceAA The percentage of iron is determined by difference and need not be determinedor certified.TABLE 2 Product Analysis TolerancesAElementTolerance Under theMinimum or Overthe Maximum LimitBCarbon 0.01Manganese 0.05Phosphorus 0.005Sulfur 0.005Silicon 0.05
31、Chromium 0.25Nickel 0.15Molybdenum 0.10NitrogenC 0.02 under minimum;0.04 over maximumNiobium 0.05Copper 0.03A Refer to AMS 2248 for chemical check analysis limits (except nitrogen).B For elements in which only a maximum percentage is indicated, the “underminimum limit” is not applicable.C The specif
32、ied range for this element is not covered byAMS 2248 and permissiblevariation has been established through industrial practice.F1586/F1586M 1339.3.2 Tensile test results for which any specimen fractures outside the gage length shall be considered acceptable if both theelongation and reduction of are
33、a meet the minimum requirements specified. Refer to sections 7.11.4 and 7.11.5 of Test Method E8.If either the elongation or reduction of area is less than the minimum requirement, discard the test and retest. Retest one specimenfor each specimen that did not meet the minimum requirements.10. Dimens
34、ions and Permissable Variations10.1 Units of Measure:10.1.1 SelectionThis specification requires that the purchaser selects the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on the purchase order, this selection may be expressed by the pu
35、rchaserin several alternate forms listed in order of precedence.(1) If the purchaser and supplier have a history of using specific units, these units shall continue to be certified until expresslychanged by the purchaser.(2) In the absence of historic precedence, if the units used to define the prod
36、uct on the purchasers PO, specification, andengineering drawing are consistent, these units shall be used by the supplier for product certification.(3) If the purchasers selection of units is unclear, the units of measure shall be agreed upon between the purchaser and supplier.10.1.2 Conversion of U
37、nitsIf the suppliers test equipment does not report in the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be observed when performing this conversion. ASTM SI 10 prov
38、ides guidelines for the use of SI units. Annex A of thatstandard provides conversion tables and Annex B provides rules for conversion and significance.11. Special Tests11.1 Material conforming to this specification shall be capable of passing the intergranular corrosion susceptibility test inaccorda
39、nce with Practice E of Practices A262.11.2 Material conforming to this specification shall have a homogeneous microstructure with an average grain size of ASTMNo. 5 or finer when measured in accordance with Test Methods E112.11.2.1 If grain size samples are selected after final cold working operatio
40、n, specimens shall be tested according to Test MethodsE112 or as agreed upon between supplier and purchaser.11.3 Any other special requirements shall be specified by the purchaser.12. Significance of Numerical Limits12.1 The following applies to all specified numerical limits in this specification.
41、To determine conformance to these limits, anobserved or calculated value shall be rounded to the nearest unit in the last right hand digit used in expressing the specificationlimit, in accordance with the rounding method of Practice E29.13. Certification13.1 The supplier shall provide a certificatio
42、n that the material was tested in accordance with this specification. A report of thetest results shall be furnished to the purchaser at the time of shipment.TABLE 3 Mechanical PropertiesConditionDiameter orThickness, in.(mm)Ultimate TensileStrength, min, psi(MPa)Yield Strength(0.2 % Offset),min, ps
43、i (MPa)Elonga-tionA in4D, min,%Annealed all 107 000 (740) 62 400 (430) 35MediumhardB116 to 34(1.59 to 19.1)C145 000 (1000) 102 000 (700) 20HardB 116 to 34(1.59 to 19.1)C160 000 (1100) 145 000 (1000) 10A Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or thicknessshall be measure
44、d using a gage length of 2 in. or 4D or 4W (W = width). The gagelength must be reported with the test results. The method for determiningelongation of material under 0.063 in. (1.6 mm) in diameter or width may benegotiated. Alternatively, a gage length corresponding to ISO 6892 may be usedwhen agree
45、d upon between supplier and purchaser. (5.65 times the square root ofSo, where So is the original cross sectional area.)B The word “hard” is used to express strength relative to annealed material and isnot intended to specify a hardness value.C Other sizes may be furnished by agreement between the s
46、upplier and thepurchaser.F1586/F1586M 13414. Quality Program Requirements14.1 The supplier shall maintain a quality program such as defined in ASQ C1, ISO 9001, or similar.14.2 The supplier shall maintain a quality program such as defined in ISO 9001, or similar quality program.15. Keywords15.1 mang
47、anese; metals (for surgical implants); nitrogen strengthened; stainless steel; surgical applicationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize the composition and properties of wrought nitrogen strengthened21chromium10nickel3manganese2.
48、5molybdenum stainless steel alloy bar for surgical implants.X1.2 Acceptable metal conditions supplied to the implant manufacturer include annealed, medium hard, and hard conditions, thechoice dependent upon the implant design and application.X1.3 This alloy is capable of being cold worked to tensile
49、 strengths exceeding 200 000 psi (1380 MPa) for high-strength surgicalimplant applications.X1.4 The nitrogen used for strengthening this steel can result in the formation of carbonitrides. Carbonitrides can be revealed byetching electrolytically in a solution of potassium hydroxide (56 g of K(OH) in 100 mL of water for 3 s at 2 V). These small,dispersed second-phase particles exert a strengthening effect but do not significantly alter the corrosion properties of the alloy.Theymay affect the finish of electropolished surfaces.X1.5 ISO standards
