1、Designation: F 899 07Standard Specification forWrought Stainless Steels for Surgical Instruments1This standard is issued under the fixed designation F 899; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision.
2、A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope*1.1 This specification covers the chemistry requiremen
3、ts 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 stainless steels that havebeen used for surgical instruments, is provided
4、 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 agreed upon betweenpurchaser and supplier.2. Referenced Documents2.1 ASTM
5、Standards:2A 276 Specification for Stainless Steel Bars and ShapesA 314 Specification for Stainless Steel Billets and Bars forForgingA 480/A 480M Specification for General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet, and StripA 484/A 484M Specification for General Requ
6、irements forStainless Steel Bars, Billets, and ForgingsA 555/A 555M Specification for General Requirements forStainless Steel Wire and Wire RodsA 564/A 564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and ShapesA 582/A 582M Specification for Free-Machining Stain
7、lessSteel BarsA 751 Test Methods, Practices, and Terminology forChemical 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 Spec
8、ification of General Requirements 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:3.1.1 Class 3Austenitic Stainless Steel.3.1.2 Class 4Martensitic Stainless Steel.3.1
9、.3 Class 5Precipitation Hardening Stainless Steel.3.1.4 Class 6Ferritic Stainless Steel.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition a
10、pproved Feb. 1, 2007. Published March 2007. Originallyapproved in 1984. Last previous edition approved in 2002 as F 899 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, re
11、fer 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, http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.o
12、rg.TABLE 1 Typical Maximum Hardness for Selected Class 4Martensitic Stainless Steels in The Annealed ConditionATypeTypical MaximumBrinell HardnessB410 210410X 220416 262416 Mod 262420A 220420B 235420 Mod 255420X 262420C 262420F 262420F Mod 262431 285440A 285440B 285440C 285440F 285UNS42010 235AExclu
13、des billets and bars for forging.BOr equivalent Rockwell hardness.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2 TypeWhere applicable, the commercially recognized
14、type 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 Classification, optional,4.1.3
15、Type,4.1.4 Form,4.1.5 Condition (see 5.1),4.1.6 Finish (see 5.3),TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless SteelsTypeTypical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatureB TypeTypical HardeningAHeat Treat
16、mentTypical Hardness atIndicated TemperingTemperatureBF 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
17、 46 800D427 55Oil quench 700 371 46/47 420F 1900F (1038C) + 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
18、 oil quench 400 204 501000C538 30 500 260 481100 593 22 600 315 48416 1800F (982C) + 300 149 41 700 371 48Oil quench 500 260 39 800D427 48700 371 41 431 1900F (1038C) + 500 260 42900C482 36 Oil quench 700 371 421000C538 31 900C482 451100 593 26 1100C593 34420A 1850F (1010C) + 300 149 53 440A 1900F (
19、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 quench 400 204 56/57500 260 50 500 2
20、60 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 59500 260 50 500 260 57600 315 50
21、 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 depends on section size. Controlled
22、 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 (399/566C) results in decreased impa
23、ct strength and reduced corrosion resistance.DTempering over 800F (427C) results in reduced corrosion resistance.ETempering above 600F (316C) results in reduced toughness.F8990724.1.7 Mechanical properties or hardness, and4.1.8 Applicable dimensions including size, thickness,width, and length (exact
24、, 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-treated, solution-treated and aged, quench-hardened and tempered, or as specified by the purchaser. (Notethat h
25、ighly 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 and so specified in order to avoidthe possibility of thermal cracking. Other hardenable marten-sitic grades
26、 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 purchase order.)5.2 ConditioningBillet and bar intended for forging maybe conditioned by chipping, grinding, or
27、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 purchase order.6. General Requirements for Delivery6.1 In addition to the chemistry requirements of this sp
28、eci-fication, all requirements of the current editions of Specifica-tions A 276, A 314, A 480/A 480M, A 484/A 484M, A 555/A 555M, A 564/A 564M, A 582/A 582M, and A 751 shallapply where applicable, as agreed upon between purchaser andsupplier.TABLE 3 Examples of Selected Stainless Steels That Have Be
29、en Used for Surgical 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, bo
30、ne curettes,scissors 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 cuttingf
31、orceps, chisels and gouges, 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 Uni
32、ted StatesType Cutting 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,punche
33、s, retractors, rulers, 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, reame
34、rs,scissors with insertsclamps, 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 c
35、lamps, punches, retractors, skin hooks, spreaders420Bchisels, curettes, cutters, bone cutting forceps,knives, scissors, rongeurs, scalpels, skin punches,conchotomesclamps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles420FAcutters burrs431 cheak retractors, insertion wrenches
36、, orthopeadic instruments440Cchisels, 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, retractor
37、s, skin hooks,needles, 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 driversAI
38、t is not recommended 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 s
39、ection 10.1)BTypes 420A, 420B, or 420C may be used depending on instrument design and application.CTypes 440A, 440B, or 440C may be used depending on instrument design and application.F8990736.2 This specification compliments the ISO applicabledocument covering stainless steel for surgical instrumen
40、ts 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 Tables 5-8.7.2 UNS designations have been added to Tables 5-8 toprovide an easy cross reference to a common n
41、umberingsystem. In order to ensure consistency in the materials used forthe manufacture of surgical instruments, compositional limitstighter than typical UNS limits have been established forcertain elements (as denoted by an asterisk). For example,more restrictive carbon and sulfur limits are specif
42、ied in Table7.7.3 The chemical composition requirements for Types 301,303, 304, 316, 410, 420A, 420B, 420C, and 430F also meet thecomposition requirements in ISO 7153/1.TABLE 5 Composition of Class 3, Austenitic Stainless Steels, %UNS TypeCarbon,maxManganesePhosphorus,maxSulfurSilicon,maxChromium Ni
43、ckelOtherElementsS30100 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 17.0019.00A8.001
44、1.00AN0.10maxAS31600 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 17.0019.00 0.040 0.
45、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 UNS.TABLE 6
46、 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 more restric
47、tive 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 maxAS41600 4
48、16 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 0.005 max 0.
49、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 0.751.50S43100 431 0.20 max 1.00 0.04 0.030 max 1.00 15.0017.00 Ni 1.252.50S44002 440A 0.600.75 1.00 0.04 0.030 max 1.00
