ASTM F899-2009e1 Standard Specification for Wrought Stainless Steels for Surgical Instruments《外科器械用锻造不锈钢的标准规范》.pdf

1、Designation: F899 091Standard Specification forWrought Stainless Steels for Surgical Instruments1This standard is issued under the fixed designation F899; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A

2、 number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1NOTE“Other Elements” in Table 8 were corrected editorially in Ap

3、ril 2010.1. Scope*1.1 This specification covers the chemistry requirements forwrought stainless steels used for the manufacture of surgicalinstruments. The data contained in Tables 1-4 of this specifi-cation, including typical hardness values, common heat treat-ing cycles, and examples of selected s

4、tainless steels that havebeen used for surgical instruments, is provided for referenceonly. Mechanical property requirements, heat treating require-ments, hardness requirements and all other requirements ex-cept chemistry are governed by the appropriate materialstandards as referenced below or as ag

5、reed upon betweenpurchaser and supplier.1.2 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2A2

6、76 Specification for Stainless Steel Bars and ShapesA314 Specification for Stainless Steel Billets and Bars forForgingA480/A480M Specification for General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet, and StripA484/A484M Specification for General Requirements forStainle

7、ss Steel Bars, Billets, and ForgingsA555/A555M Specification for General Requirements forStainless Steel Wire and Wire RodsA564/A564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and ShapesA582/A582M Specification for Free-Machining StainlessSteel BarsA751 Test M

8、ethods, Practices, and Terminology for Chemi-cal Analysis of Steel Products2.2 ISO Standards:3ISO 7153/1 Instruments For SurgeryMetallic MaterialsPart 1: Stainless SteelISO 9001 Quality Management SystemsRequirements2.3 American Society for Quality (ASQ) Standard:4ASQ C1 Specification of General Req

9、uirements for a Qual-ity Program3. Classification and Type3.1 ClassesStainless steel material requirements for sur-gical instruments shall conform to one of the following classes,as specified:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Dev

10、ices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Feb. 1, 2009. Published February 2009. Originallyapproved in 1984. Last previous edition approved in 2007 as F899 07. DOI:10.1520/F0899-09E01.2For referenced ASTM standards, visit the ASTM

11、 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 American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036,

12、 http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.TABLE 1 Typical Maximum Hardness for Selected Class 4Martensitic Stainless Steels in The Annealed ConditionATypeTypical MaximumBrinell HardnessB410 210410X 220416 262

13、416 Mod 262420A 220420B 235420 Mod 255420X 262420C 262420F 262420F Mod 262431 285440A 285440B 285440C 285440F 285UNS S42026 260UNS S42010 235AExcludes billets and bars for forging.BOr equivalent Rockwell hardness.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM Inter

14、national, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.1 Class 3Austenitic Stainless Steel.3.1.2 Class 4Martensitic Stainless Steel.3.1.3 Class 5Precipitation Hardening Stainless Steel.3.1.4 Class 6Ferritic Stainless Steel.3.2 TypeWhere applicable, the comm

15、ercially recognizedtype of stainless steel is included in Tables 5 and 6.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information as agreed upon bypurchaser and supplier:4.1.1 Quantity (weight or number of pieces),4.1.2 Classificati

16、on, optional,TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless SteelsTypeTypical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatureB TypeTypical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatur

17、eBF C (HRC) F C (HRC)410 1850F (1010C) + 500 260 43 420C 1900F (1038C) + 300 149 58Oil quench 700 371 43 Warm oil quench 400 204 55/56or air cool 900C482 42 500 260 53/541000C538 30 600 315 53/541100 593 24 700 371 54/55410X 1875F (1024C) + 500 260 46 800D427 55Oil quench 700 371 46/47 420F 1900F (1

18、038C) + 300 149 52or air cool 900C482 48 Warm oil quench 400 204 521000C538 44 500 260 501100 593 31 600 315 50416 Mod 1800F (982C) + 300 149 38 700 371 49Oil quench 500 260 37 800D427 49700 371 37 420F Mod 1900F (1038C) + 300 149 53900C482 35 Warm oil quench 400 204 501000C538 30 500 260 481100 593

19、 22 600 315 48416 1800F (982C) + 300 149 41 700 371 48Oil quench 500 260 39 800D427 48700 371 41 UNSS420261920F(1050C)+400 204 56900C482 36 oil quench or 500 260 54/551000C538 31 pressure gas 600 315 53/541100 593 26 431 1900F (1038C) + 500 260 42Oil quench 700 371 42900C482 451100C593 34420A 1850F

20、(1010C) + 300 149 53 440A 1900F (1038C) + 300 149 56/57Warm oil quench 400 204 50 Warm oil quench 400 204 56500 260 48 500 260 54600 315 48 600 315 51/52700 371 48 700 371 51800D427 48 800D427 50420B 1900F (1038C) + 300 149 52 440B 1900F (1038C) + 300 149 58/59Warm oil quench 400 204 52 Warm oil que

21、nch 400 204 56/57500 260 50 500 260 53/54600 315 50 600 315 53700 371 49 700 371 54800D427 49 800D427 54420 Mod 180F (1010C)+ oil quench orpressure gas35040050060017720426031556/57555453420X 1900F (1038C) + 300 149 52 440C 1900F (1038C) + 300 149 60Warm oil quench 400 204 52 Warm oil quench 400 204

22、59500 260 50 500 260 57600 315 50 600 315 56700 371 49 700 371 56800D427 49 800D427 56S42010 1900F 400 204 50 440F 1900F (1038C) + 300 149 60(1038C) + Warm 500 260 47 Warm oil quench 400 204 59Oil Quench 600E316 47 500 260 57700 371 48 600 315 56850 454 48 700 371 56800D427 56ATime at temperature de

23、pends on section size. Controlled heat treating atmosphere or alternate quench media may be used in accordance with good commercialpractice.BTemper at least one hour at indicated temperature and air cool. Large section sizes require longer time at temperature.CTempering in the range of 750/1050F (39

24、9/566C) results in decreased impact strength and reduced corrosion resistance.DTempering over 800F (427C) results in reduced corrosion resistance.ETempering above 600F (316C) results in reduced toughness.F899 09124.1.3 Type,4.1.4 Form,4.1.5 Condition (see 5.1),4.1.6 Finish (see 5.3),4.1.7 Mechanical

25、 properties or hardness, and4.1.8 Applicable dimensions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber.5. Manufacture5.1 ConditionStainless steels shall be furnished to thepurchaser, as specified, in the hot-finished, cold-finished,annealed, solution-treat

26、ed, solution-treated and aged, quench-hardened and tempered, or as specified by the purchaser. (Notethat highly hardenable martensitic stainless billets and barssuch as Types 420A, 420B, 420C, 420 Mod, 420F, 420F Mod.,440A, 440B, and 440C intended for forging are commonlyannealed prior to shipment a

27、nd so specified in order to avoidthe possibility of thermal cracking. Other hardenable marten-sitic grades such as Types 403, 410, 416, 416 Mod., and 431,which also may require annealing, depending on their compo-sition and size, are furnished suitable for cold cutting when sospecified on the purcha

28、se order.)5.2 ConditioningBillet and bar intended for forging maybe conditioned by chipping, grinding, or other suitable meansto remove injurious surface defects.5.3 FinishTypes of finish available for bar and wireproducts are cold drawn, pickled, ground, ground and polished,or as specified in the p

29、urchase order.6. General Requirements for Delivery6.1 In addition to the chemistry requirements of this speci-fication, all requirements of the current editions of Specifica-tions A276, A314, A480/A480M, A484/A484M, A555/TABLE 3 Examples of Selected Stainless Steels That Have Been Used for Surgical

30、Instruments in Accordance with ISO 7153/1Type Cutting Instruments Non-Cutting Instruments303 Chisels and gouges, bone curettes probes304 retractors410 tissue, forceps, dressing forceps, retractors,probes420A Bone rongeurs, conchotomes, bone cuttingforceps, chisels and gouges, bone curettes,scissors

31、with carbide insertsforceps, retractors, probes, forceps with bowhandles, branch forceps420B bone rongeurs, scissors420C scissors, bone rongeurs, bone cutting forceps,conchotomes, scalpels, knives, bone curettes,chisels and gouges420 Mod bone rongeurs, conchotomes, bone cuttingforceps, chisels and g

32、ouges, bone curettes,scissors with carbide inserts, scissors, scalpels,knivestissue forceps, dressing forceps, retractors,probes, forceps, forceps with bow handles,branch forcepsTABLE 4 Examples of Selected Stainless Steels That Have Been Used For Surgical Instruments in the United StatesType Cuttin

33、g Instruments Non-Cutting Instruments302 knives, chisels, gouges, curettes cannula, forceps, guides, needle vents, retractors, specula, spreaders, tendorpassers, springs303Achisels, curettes, knives cannula, clamps, drills, forceps, handles, hammers, mallets, needle vents,punches, retractors, rulers

34、, screws, skin hooks, specula, spreaders, suctiontubes, tendonstrips, tongs, tunnelers, probes304 cannula, clamps, forceps, holders, handles, needle vents, retractors, specula,spreaders, suction tubes, tendon passers316 specula410 chisels, curettes, dissectors, osteotomes, reamers,scissors with inse

35、rtsclamps, clip applicators, elevators, forceps, hemostats, holders, needleholders, punches, retractors, skin hooks, sounds, spreaders, probes, dilators410X curettes, dissectors, rongeurs clamps, forceps, hemostats, holders, punches, retractors416Achisels, curettes, dissectors clamps, punches, retra

36、ctors, skin hooks, spreaders420Bchisels, curettes, cutters, bone cutting forceps,knives, scissors, rongeurs, scalpels, skin punches,conchotomesclamps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles420FAcutters burrs431 cheek retractors, insertion wrenches, orthopeadic instrum

37、ents440Cchisels, knives, osteotomes, scalpels drills, retractors, spreaders, tongs420 Mod chisels, curettes, cutters, bone cutting forceps,knives, scissors, rongeurs, scalpels, skin punches,conchotomes, ostoetomes, reamersclamps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles

38、, cheek retractors, insertion wrenches, orthopaedic instruments, drills,spreaders, tongs, screwdrivers630 reamersXM-16 scissors drills, needlesXM-13 reamers, raspsS46500 reamers, scissors, rasps, knives Clamps, punches, impactor guides, strike plates, screwdrivers, hex driversAIt is not recommended

39、that free-machining grades be used for critical portions of surgical instruments. Free machining grades should only be considered for instrumentapplications when appropriate steps can be taken during manufacture to minimize the inherent limitations of this class of alloys (see section 10.1)BTypes 42

40、0A, 420B, 420C, or UNS S42026 may be used depending on instrument design and application.CTypes 440A, 440B, or 440C may be used depending on instrument design and application.F899 0913A555M, A564/A564M, A582/A582M, and A751 shall applywhere applicable, as agreed upon between purchaser andsupplier.6.

41、2 This specification compliments the ISO applicabledocument covering stainless steel for surgical instruments and,by reference, includes all of the stainless grades in ISO 7153/1.7. Chemical Requirements7.1 The heat analysis shall conform to the requirements asto chemical composition specified in Ta

42、bles 5-8.7.2 UNS designations have been added to Tables 5-8 toprovide an easy cross reference to a common numberingsystem. In order to ensure consistency in the materials used forTABLE 5 Composition of Class 3, Austenitic Stainless Steels, %UNS TypeCarbon,maxManganesePhosphorus,maxSulfurSilicon,maxC

43、hromium NickelOtherElementsS30100 301 0.15 2.00 max 0.045 0.030 max 1.00 16.0018.00 6.008.00 S30200 302 0.15 2.00 max 0.045 0.030 max 1.00 17.0019.00 8.0010.00 N 0.10 maxAS30300 303 0.12A2.00 max 0.06A0.150.35A1.00 17.0019.00 8.0010.00 Mo 0.70 maxAS30400 304 0.07A2.00 max 0.045 0.030 max 1.00 17.001

44、9.00A8.0011.00AN0.10maxAS31600 316 0.07A2.00 max 0.045 0.030 max 1.00 16.5018.50A10.5013.50AMo 2.002.50AN0.10maxAS31700 317 0.08 2.00 max 0.045 0.030 max 1.00 18.0020.00 11.0015.00 Mo 3.004.00N0.10maxAS30430 XM-7 0.1 2.00 max 0.045 0.030 max 1.00 17.0019.00 8.0010.00 Cu 3.004.00S28200 0.15 17.0019.0

45、0 0.040 0.04 max 1.00 17.0019.00 Mo 0.751.25Cu 0.751.25N 0.400.60S20161 0.15 4.06.0 0.045 0.030 3.04.0 15.0018.00 4.06.0 N 0.080.20S20162 0.15 4.08.0 0.040 0.040 2.54.5 16.5021.00 6.010.0 N 0.050.25S21800 0.10 7.09.0 0.060 0.030 3.54.5 16.018.0 8.09.0 N 0.080.18ADenotes more restrictive limit than U

46、NS.TABLE 6 Composition of Class 6, Ferritic Stainless Steels, %UNS TypeCarbon,maxManganese,maxPhosphorus,maxSulfurSilicon,MaxChromiumOtherElementsS43020 430 F 0.08A1.25 0.06 0.150.35A1.00 16.0018.00 Mo 0.60 maxNi 1.00 maxAS18200 XM-34 0.08 1.252.5A0.04 0.280.41A1.00 17.5019.50 Mo 1.502.50ADenotes mo

47、re restrictive limit than UNS.TABLE 7 Composition of Class 4, Martensitic Stainless Steels, %UNS Type CarbonAManganeseMaxPhosphorusMaxSulfurASiliconMaxChromium OtherS41000 410 0.090.15A1.00 0.04 0.030 max 1.00 11.5013.50 Ni 1.00 maxAS41000 410X 0.160.21A1.00 0.04 0.030 max 1.00 11.5013.50 Ni 1.00 ma

48、xAS41600 416 0.090.15A1.25 0.06 0.150.27A1.00 12.0014.00 . . .S41600 416 Mod 0.090.15A1.25 0.06 0.280.41A1.00 12.0014.00 . . .S42000 420A 0.160.25A1.00 0.04 0.030 max 1.00 12.0014.00 Ni 1.00 maxAS42000 420B 0.260.35A1.00 0.04 0.030 max 1.00 12.0014.00 Ni 1.00 maxAS42000 420 Mod 0.370.45A0.60 0.02 0.

49、005 max 0.60 15.0016.50 Mo 1.501.90V 0.200.40N 0.160.25S42000 420X 0.360.41A1.00 0.04 0.030 max 1.00 12.0014.50 Ni 1.00 maxAS42000 420C 0.420.50A1.00 0.04 0.030 max 1.00 12.5014.50 Ni 1.00 maxAS42020 420F 0.300.40A1.25 0.06 0.200.34A1.00 12.5014.00 Cu 0.60 maxBNi 0.50 maxB420F Mod 0.200.26A2.00 0.04 0.150.27A1.00 12.5014.00 Mo 1.101.50Ni 0.751.50S42026 . 0.330.43 1.00 0.03 0.030 max 1.00 12.514.5 Ni 1.00 maxMo 0.81.2S43100 431 0.20 max 1