ASTM F2581-2012(2017) Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implant.pdf

1、Designation: F2581 12 (Reapproved 2017)Standard Specification forWrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wirefor Surgical Implants (UNS S29225)1This standard is issued under the fixed designation F2581; the number immediately followin

2、g the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification

3、covers the chemical, mechanical, andmetallurgical requirements for wrought nitrogen strengthened11manganese-17chromium-3molybdenum low-nickel stainlesssteel alloy bar and wire for surgical implants.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.

4、 The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.1.3 This standard does not purport to address all of thesafety concerns, if any, associat

5、ed with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles

6、on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Susceptib

7、ility to IntergranularAttack in Austenitic Stainless SteelsA484/A484M Specification for General Requirements forStainless Steel Bars, Billets, and ForgingsA555/A555M Specification for General Requirements forStainless Steel Wire and Wire RodsA751 Test Methods, Practices, and Terminology for Chemi-ca

8、l Analysis of Steel ProductsE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with Specifi

9、cationsE45 Test Methods for Determining the Inclusion Content ofSteelE112 Test Methods for Determining Average Grain SizeE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE407 Practice for Microetching Metals and Alloys

10、F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1

11、314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImp

12、lants (UNS S31675)IEEE/ASTM SI 10 American National Standard for MetricPractice2.2 Aerospace Material Specification:3AMS 2248 Chemical Check Analysis Limits, Corrosion andHeat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron Alloys1This specification is under the jurisd

13、iction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Sept. 1, 2017. Published September 2017. Originallyapproved in 2007. Last previous edition approved in 2012 as F2581 12

14、. DOI:10.1520/F2581-12R17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from Society of Automoti

15、ve Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was deve

16、loped in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1AMS 2630 Inspectio

17、n, Ultrasonic Product over 0.5 Inch(12.7 mm) Thick2.3 ISO Standard:4ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 barround, rectangular, or other complex shapedpro

18、duct delivered straightened and cut to defined lengths, witha maximum cross-sectional area of 16 in.2103 cm2.3.1.2 fine wirewire with diameter or major dimension lessthan 0.063 in. 1.6 mm.3.1.3 forging barbar as described in 3.1.1 used for pro-duction of forgings, may be furnished in the hot-rolled

19、anddescaled condition.3.1.4 lotthe total number of mill products produced fromthe same melt heat under the same conditions at essentially thesame time.3.1.5 wirerounds, rectangular, or other complex shapedproduct produced and delivered in coils.4. Ordering Information4.1 Inquiries and orders for mat

20、erial under this specificationshall 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 drawingnumber;4.1.6 Tolerances

21、Unless otherwise specified by thepurchaser, tolerances must meet the requirements of Specifi-cations A484/A484M and A555/A555M, as applicable;4.1.7 Condition (see 5.1);4.1.8 Finish (see 5.2);4.1.9 Special tests, if any; and4.1.10 Other requirements.5. Materials and Manufacture5.1 ConditionBar and wi

22、re shall be furnished, asspecified, in the annealed or cold-worked condition. Bar usedfor the production of forgings may be furnished in the hotworked and descaled condition, as agreed upon between thepurchaser and supplier.5.2 FinishTypes of finish available in bar and wire arecold-drawn, pickled,

23、ground, ground and polished, shaved, oras specified by the purchaser.6. Chemical Requirements6.1 The suppliers heat analysis shall conform to the chemi-cal requirements prescribed in Table 1. The supplier shall notship material that is outside the limits specified in Table 1.6.1.1 Requirements for t

24、he major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements.Analysis for elements not listed in Table 1 isnot required to verify compliance with this specification.6.1.2 Methods and practices relating to chemical analysisrequired by this specification s

25、hall be in accordance with TestMethods A751.6.1.3 For reference purposes, Test Methods E354 shallapply.6.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within the heat.6.2.1 Acceptance or reje

26、ction of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.6.2.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Productanalysis limits shall

27、 be as specified in Table 2.7. Metallurgical Requirements7.1 The material shall contain no delta ferrite, chi, or sigmaphases when it is examined metallographically at 100 mag-nification in accordance with Practice E407.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th

28、 Floor, New York, NY 10036, http:/www.ansi.org.TABLE 1 Chemical CompositionElement Composition, % (mass/mass)Carbon 0.15 to 0.25Manganese 9.50 to 12.50Phosphorus 0.020 maxSulfur 0.010 maxSilicon 0.2 to 0.6Chromium 16.50 to 18.00Nickel 0.05 maxMolybdenum 2.70 to 3.70Nitrogen 0.45 to 0.55Copper 0.25 m

29、axIron balanceAAApproximately equal to the difference of 100 % and the sum percentage of theother specified elements. The percentage of iron difference is not required to bereported.TABLE 2 Product Analysis TolerancesAElementPermissible VariationUnder the MinimumLimit or Over theMaximum Limit, % (ma

30、ss/mass)BCarbon 0.01ManganeseC0.20Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.03Molybdenum 0.05NitrogenC0.05Copper 0.03ARefer to AMS 2248 for chemical check analysis limits (except nitrogen).BFor elements in which only a maximum percentage is indicated, the “underminimum limit” is

31、not applicable.CThe specified range for this element is not covered by AMS 2248 and has beenestablished through industrial practice.F2581 12 (2017)27.2 The microcleanliness of the steel, as determined by TestMethod E45, MethodA, on representative billet or bar samplesfrom the heat shall not exceed t

32、he following:InclusionTypeA (Sulphide) B (Alumina) C (Silicate)D (Globularoxide)Thin 1.5 1.5 1.5 1.5Heavy 1.0 1.0 1.0 1.08. Mechanical Properties8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordancewith Test Methods E8/E8M.8.1.2 The mechanical properties of test specimens

33、 shallconform to the requirements specified in Table 3.8.1.3 The level of mechanical properties for material inother conditions shall be specified in the purchase order.8.2 Hardness:8.2.1 Hardness values shall be determined in accordancewith Test Method E10 or Test Methods E18.8.2.2 When desired, ha

34、rdness limits may be specified by thepurchaser. Hardness determinations shall be made on a productcross section, midway between the center and surface, if thecross section is adequate.8.3 Number of Tests:8.3.1 Perform tension testing per Test Methods E8/E8M.Should any of the test specimens not meet

35、the specifiedrequirements, test two additional test pieces representative ofthe same lot, in the same manner, for each failed test piece. Thelot shall be considered in compliance only if all additional testpieces meet the specified requirements.8.3.2 Tensile test results for which any specimen fract

36、uresoutside the gauge length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to subsections 7.11.4 and 7.11.5of Test Methods E8/E8M. If either the elongation or reductionof area is less than the minimum requirement, discard th

37、e testand retest. Retest one specimen for each specimen that did notmeet the minimum requirements.9. Ultrasonic Inspection9.1 All centerless ground or peeled and polished round bar 0.375 in. 9.5 mm in nominal diameter shall be ultrasoni-cally inspected at final diameter according toAMS 2630, ClassA1

38、. Equivalent test methods may be substituted when agreedupon by the purchaser and supplier.NOTE 1AMS 2630 specifies a minimum size limit of 0.50 in. 12.7mm. F04.12 subcommittee has intentionally specified the use of AMS2630 below 0.50 in. 12.7 mm based on the experience of users andproducers on the

39、committee. There is disagreement in the industry as towhether AMS 2632, which does apply to sizes under 0.50 in. 12.7 mm,applies to solid round bar.10. Dimensions and Permissible Variations10.1 Units of Measure:10.1.1 SelectionThis specification requires that the pur-chaser selects the units (SI or

40、inch-pound) to be used forproduct certification. In the absence of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, t

41、hese units shall continue to be certifieduntil expressly changed by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers purchase order(PO), specification, and engineering drawing are consistent,these units shall be used by the suppli

42、er for product certifica-tion.10.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.10.1.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsmay be converted

43、to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. IEEE/ASTM SI 10 provides guidelines for the useof SI units. Annex A of that standard provides conversiontables and Annex B provides

44、 rules for conversion and signifi-cance.11. Special Tests11.1 Bar and wire conforming to this specification shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A262.11.2 Bar and wire conforming to this specification shallhave a homogen

45、eous microstructure with an average grain sizeof ASTM No. 5 or finer when measured in accordance withTest Methods E112.11.2.1 It is preferred that samples for grain size determina-tion be selected after the hot working operation or after thefinal annealing operation prior to the final cold workingop

46、eration.11.2.2 If grain size samples are selected after a final coldworking, specimens shall be tested according to Test MethodsE112 or as agreed upon between the supplier and purchaser.TABLE 3 Mechanical RequirementsConditionUltimateTensileStrengthmin, psi MPaYieldStrength(0.2 %offset),min, psiMPaE

47、longationAmin, %Reductionin Area min,%Annealed 120 00082770 00048240 50Cold Worked 160 0001103120 00082712 .AElongation of material 0.063 in. 1.6 mm or greater in diameter (D) or width (W)shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthshall be reported with the test res

48、ults. The method for determining elongation ofmaterial under 0.063 in. 1.6 mm in diameter or thickness may be negotiated.Alternatively, a gauge length corresponding to ISO 6892 may be used whenagreed upon between supplier and purchaser (5.65 So1/2, where Sois theoriginal cross sectional area of the

49、gauge length).F2581 12 (2017)311.3 Any other special requirements shall be specified bythe purchaser.12. Significance and Numerical Limits12.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with rounding method ofPractice E29.13. Certification13.1 Certification shall be provided by the supplier that the