1、Designation: F1314 07F1314 13Standard Specification forWrought Nitrogen Strengthened 22 Chromium 13 Nickel 5 Manganese 2.5 Chromium13 Nickel5 Manganese2.5Molybdenum Stainless Steel Alloy Bar and Wire for SurgicalImplants (UNS S20910)1This standard is issued under the fixed designation F1314; the num
2、ber immediately following 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
3、*1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22chromium 13 nickel 5 manganese 2.5 molybdenum stainless steel alloy bar and wire for surgical implants.1.2 The values stated in either SI units or inch-pound units are to be re
4、garded separately as the standard. The SI equivalents ofthe inch-pound units may be approximate.standard. The values stated in each system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combining values from the two systems may result in non-conformance
5、 with thestandard.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 ForgingsA555/A555M Specification for General Require
6、ments for Stainless Steel Wire and Wire RodsA751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel ProductsE8E8/E8M Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic
7、 MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Content of SteelE112 Test Methods for Determining Average Grain SizeE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Mag
8、netic, and Other Similar Iron, Nickel, andCobalt AlloysE407 Practice for Microetching Metals and AlloysF138 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
9、 Implant MaterialsIEEE/ASTM SI 10 American National Standard for Metric Practice2.2 Aerospace Materials Specification:3AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron AlloysAMS 2630 Inspection, Ultrasonic Prod
10、uct Over 0.5 inch (12.7 mm) ThickAMS 2632 Ultrasonic Inspection of Thin Materials1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approv
11、ed Feb. 1, 2007April 1, 2013. Published March 2007 April 2013. Originally approved in 1990. Last previous edition approved in 20012007 asF1314 01.F1314 07. DOI: 10.1520/F1314-07.10.1520/F1314-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at s
12、erviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.This document is not an ASTM standard and i
13、s 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 technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the
14、 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 this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.3 ASQ Standard:4ASQ C1 S
15、pecification of General Requirements for a Quality Program2.3 ISO Standards:4ISO 6892 Metallic Materials Tensile Testing at Ambient TemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bar, nround bars and flats from 0.1875
16、in. (4.75 mm)4.75 mm to 4.00 in. (101.60 mm)101.60 mm in diameter orthickness (other sizes and shapes by special order).3.1.2 forging bar, nas described in 3.1.2 used for production of forgings, may be furnished in the hot rolled condition.3.1.3 lot, nthe total number mill products produced under th
17、e same melt heat under the same conditions at essentially the sametime.3.1.4 wire, nrounds less than 0.1875 in. (4.75 mm)4.75 mm in diameter.4. Ordering Information4.1 Inquiries and orders for material under this specification shall include the following information:4.1.1 Quantity,Quantity;4.1.2 AST
18、M designation and date of issue,issue;4.1.3 Mechanical properties (if applicable for special conditions),conditions);4.1.4 Form (bar or wire),wire);4.1.5 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number,number;4.1.6 Tolerancesunless o
19、therwise specified by purchaser, tolerances must meet the requirements of Specification A484/A484M, A555/A555M, or both, as applicable,applicable;4.1.7 Condition (see 5.1),);4.1.8 Finish (see 5.2),);4.1.9 Special tests (if any),any); and4.1.10 Other requirements.5. Materials and Manufacture5.1 Condi
20、tionBar and wire shall be furnished in the hot-worked, annealed, or cold-worked condition, as specified.5.2 FinishBar and wire shall be furnished bright annealed, cold drawn, pickled, ground, or ground and polished, as specifiedby the purchaser.6. Chemical Requirements6.1 The suppliers heat analysis
21、 shall conform to the chemical requirements prescribed in Table 1. The supplier shall not ship4 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor,
22、New York, NY 10036, http:/www.ansi.org.TABLE 1 Chemical CompositionElement Composition, %(Mass/Mass)Carbon 0.030 maxManganese 4.00 to 6.00Phosphorus 0.025 maxSulfur 0.010 maxSilicon 0.75 maxChromium 20.50 to 23.50Nickel 11.50 to 13.50Molybdenum 2.00 to 3.00Nitrogen 0.20 to 0.40Niobium 0.10 to 0.30Va
23、nadium 0.10 to 0.30Copper 0.50 maxIron balanceAA Approximately equal to the difference of 100 % and the sum percentage of theother specified elements. Reporting of the iron difference is not required.F1314 132material with chemistry outside the requirements specified in Table 1.6.1.1 Requirements fo
24、r 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.6.1.2 Methods and practices relating to chemical analysis required by this specific
25、ation shall be in accordance withTest MethodsA751.6.2 Product AnalysisThe product analysis is either for the purpose of verifying the composition of a heat or manufacturinglot or to determine variations in the composition within the heat.6.2.1 Acceptance or rejection of a heat or lot of material may
26、 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 betweenlaboratories in the measurement of chemical content. Product analysis limits shall be as specified in Table 2.6.2.3 Me
27、thods and practices relating to chemical analysis required by this specification shall be in accordance withTest MethodsE354.7. Metallurgical Requirements7.1 The material shall contain no delta ferrite, chi, or sigma phases when it is examined metallographically at 100magnification in accordance wit
28、h Practice E407.7.2 The microcleanliness of the material, as determined by Practice E45, Method A, except using Plate Ir, on representativebillet or bar samples from the heat shall not exceed the following:InclusionTypeA(Sulfide)B(Alumina)C(Silicate)D (GlobularOxide)ThinHeavy1.51.52.51.52.51.52.51.5
29、8. Mechanical Requirements8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordance with Test Methods E8E8/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 ac
30、cordance with Test Method 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 productcross section, midway between the center and surface, if the cross section is adequate.8.3 Number of TestsBar, Forging Bar, Shape
31、s and Wire:8.3.1 Perform tension testing per Test Methods E8E8/E8M. Should any of the test specimens 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 only if al
32、l additional test pieces meet the specified requirements.TABLE 2 Product Analysis TolerancesAElementPermissible VariationUnder theMinimum Limit or Overthe Maximum Limit,% (Mass/Mass)BCarbon 0.005ManganeseC 0.05Phosphorus 0.005Sulfur 0.005Silicon 0.05Chromium 0.25Nickel 0.15Molybdenum 0.10NitrogenC 0
33、.02 under min;0.04 over maxNiobium 0.05Vanadium 0.03Copper 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 specified range for this element is not covered byA
34、MS 2248 and permissiblevariation has been established through industrial practice.F1314 1338.3.2 Tensile test results for which any specimen fractures outside the gauge length shall be considered acceptable if both theelongation and reduction of area meet the minimum requirements specified. Refer to
35、 subsections 7.11.4 and 7.11.5 of Test MethodE8E8/E8M. If either the elongation or reduction of area is less than the minimum requirement, discard the test and retest. Retestone specimen for each specimen that did not meet the minimum requirements.9. Dimensions and Permissible Variations9.1 Units of
36、 Measure:9.1.1 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 purchaserin several alternate forms listed in o
37、rder of precedence.9.1.1.1 If the purchaser and supplier have a history of using specific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the absence of historic precedence, if the units used to define the product on the purchasers purchase order
38、(PO),specification, and engineering drawing are consistent, these units shall be used by the supplier for product certification.9.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between the purchaser andsupplier.9.1.2 Conversion of UnitsIf the supplie
39、rs 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. IEEE/ASTM SI 10 provides guidelin
40、es for the use of SI units. Annex Aof that standard provides conversion tables and Annex B provides rules for conversion and significance.10. Special Tests10.1 Bar and wire conforming to this specification shall be capable of passing the intergranular corrosion susceptibility test inaccordance with
41、Practice E of Practices A262.10.2 Bar and wire conforming to this specification shall have a homogeneous microstructure with an average grain size ofASTM No. 5 or finer when measured in accordance with Test Method E112.10.2.1 If samples are selected after a final cold working, specimens shall be tes
42、ted in accordance with Test Method E112 or asagreed between the supplier and purchaser.10.3 All centerless ground or peeled and polished round bar 0.375 in. 9.5 mm in nominal diameter shall be ultrasonicallyinspected at final diameter according to AMS 2630, Class A1. Equivalent test methods may be s
43、ubstituted when agreed upon bythe purchaser and supplier.NOTE 1AMS 2630 specifies a minimum size limit of 0.50 in. 12.7 mm. F04.12 committee has intentionally specified the use of AMS 2630 below0.50 in. 12.7 mm based on the experience of users and producers on the committee. There is disagreement in
44、 the industry as to whether AMS 2632,which does apply to sizes under 0.50 in. 12.7 mm, applies to solid round bar.10.4 Billet shall also be ultrasonically tested prior to being hot rolled and should be free of internal defects.Acceptance criteriashall be agreed to between the purchaser and supplier.
45、10.5 Any other special requirements shall be specified by the purchaser.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limits in this specification. To determine conformance to these limits, anobserved or calculated value shall be rounded to the nearest uni
46、t in the last right hand digit used in expressing the specificationlimit, in accordance with the rounding of Practice E29.12. Certification12.1 The supplier shall provide a certification that the material was tested in accordance with this specification. specificationand met all requirements. A repo
47、rt of the test results shall be furnished to the purchaser at the time of shipment.TABLE 3 Mechanical Requirements, Bar and WireCondition Diameter or Thickness,in. (mm)Ultimate TensileStrength, min,psi (MPa)Yield Strength(0.2 % Offset),min, psi (MPa)ElongationAmin, %BrinellB Hardness,max, HBHot-work
48、edC Up to 2 (50.8)D , incl . . . 325Annealed All 100 000 (690) 55 000 (380) 35 .Cold-worked 0.063 to 0.750 (1.59 to19.1)D , incl150 000 (1035) 125 000 (862) 12 .A Refer to AMS 2248 for chemical check analysis limits (except nitrogen).B For elements in which only a maximum percentage is indicated, th
49、e “under minimum limit” is not applicable.C The specified range for this element is not covered by AMS 2248 and permissible variation has been established through industrial practice.F1314 13413. Quality Program Requirements13.1 The bar and wire producer and any processors shall maintain a quality program, such as that which is defined in ASQ C1and ISO 9001ISO 9001., or similar.14. Keywords14.1 manganese; metals (for surgical implants); nitrogen strengthened; stainless steel; surgical applicationsAPPENDIXES(Nonmandatory Infor
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