ASTM F899-2012b Standard Specification for Wrought Stainless Steels for Surgical Instruments《外科器械用锻制不锈钢的标准规范》.pdf

1、Designation: F899 12bStandard 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.1. Scope*1.1 This specification covers the chemistry requirements

3、 forwrought stainless steels used for the manufacture of surgicalinstruments. The data contained in Tables 1-4 of thisspecification, including typical hardness values, common heattreating cycles, and examples of selected stainless steels thathave been used for surgical instruments, is provided forre

4、ference only. Mechanical property requirements, heat treat-ing requirements, hardness requirements and all other require-ments except chemistry are governed by the appropriatematerial standards as referenced below or as agreed uponbetween the purchaser and supplier.1.2 The values stated in inch-poun

5、d 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:2A276 Specification for Stainless Steel Bars and ShapesA313/A313M Specificati

6、on for Stainless Steel Spring WireA314 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 forStainless Steel Bars, Bil

7、lets, 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 Methods, Practices,

8、 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 Requirements for a Qu

9、al-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.3.1.3 Class 5Precipitation Hardening Stainles

10、s Steel.3.1.4 Class 6Ferritic Stainless Steel.3.2 TypeWhere applicable, the commercially 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 by thep

11、urchaser and supplier:4.1.1 Quantity (weight or number of pieces),4.1.2 Classification, optional,4.1.3 Type,4.1.4 Form,4.1.5 Condition (see 5.1),4.1.6 Finish (see 5.3),4.1.7 Mechanical properties or hardness, and4.1.8 Applicable dimensions including size, thickness,width, and length (exact, random,

12、or multiples) or drawingnumber.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 approved Dec. 1, 2012. Published December 2012. Originally

13、approved in 1984. Last previous edition approved in 2012 as F899 12a. DOI:10.1520/F0899-12B.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 S

14、ummary 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.org.*A Summary of Changes sectio

15、n appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Manufacture5.1 ConditionStainless steels shall be furnished to thepurchaser, as specified, in the hot-finished, cold-finished,annealed, solution-t

16、reated, 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 shipme

17、nt and 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 pu

18、rchase 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 t

19、he purchase order.6. General Requirements for Delivery6.1 In addition to the chemistry requirements of thisspecification, all requirements of the current editions of Speci-fications A276, A313/A313M, A314, A480/A480M, A484/A484M, A555/A555M, A564/A564M, A582/A582M, andA751 shall apply where applicab

20、le, as agreed upon between thepurchaser and supplier.6.2 This specification compliments the applicable ISOdocument 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

21、 requirements asto chemical composition specified in Tables 5-8.7.2 Unified Numbering System (UNS) designations havebeen added to Tables 5-8 to provide an easy cross reference toa common numbering system. In order to ensure consistency inthe materials used for the manufacture of surgical instruments

22、,compositional limits tighter than typical UNS limits have beenestablished for certain elements (as denoted by an asterisk). Forexample, more restrictive carbon and sulfur limits are specifiedin Table 7.7.3 The chemical composition requirements for Types 301,303, 304, 316, 410, 420A, 420B, 420C, and

23、 430F also meet thecomposition requirements in ISO 7153/1.7.4 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods, Practices, and Terminology A751.8. Mechanical Requirements8.1 Material shall conform to the mechanical propertyrequ

24、irements cited in the appropriateASTM standards (see 2.1)or shall meet the mechanical property requirements specifiedby the purchaser.8.2 When desired, Brinell hardness number (HB), Rockwellhardness, B scale (HRB) or Rockwell hardness, C scale (HRC),limits may be specified. Typical hardness values f

25、or selectedClass 4 martensitic stainless steels in the annealed conditionare listed in Table 1. These typical hardness values areprovided for reference only.9. Heat Treatment9.1 Material shall be heat treated per the applicable refer-enced ASTM standard (see 2.1) for the selected stainless steel.9.2

26、 Commonly used heat treating cycles guidelines and theresulting typical hardness values for selected Class 4 marten-sitic stainless steels are listed in Table 2 and are provided forreference only.9.3 Heat treating guidelines for Class 5 precipitation hard-ening stainless steels are included in Speci

27、fication A564/A564M.9.4 Specifying a hardness requirement appropriate for theselected alloy and intended application is the responsibility ofthe purchaser.10. Special Information10.1 Some examples of selected stainless steels that havebeen used for various surgical instrument applications arelisted

28、in Table 3 and Table 4 for information purposes.NOTE 1Re-sulphurized free-machining grades can exhibit lowergeneral corrosion resistance, lower pitting corrosion resistance, anddifficulty in polishing or welding. It is suggested that these grades beutilized only for applications where the appropriat

29、e steps in manufacturecan be taken in order to avoid such issues thus resulting in satisfactorylong-term performance of the device.11. Quality Program Requirements11.1 The supplier shall maintain a quality program, such asdefined in ASQ C1 and ISO 9001ISO 9001.TABLE 1 Typical Maximum Hardness for Se

30、lected Class 4Martensitic Stainless Steels in The Annealed ConditionATypeTypical MaximumBrinell HardnessB410 210410X 220416 262416 Mod 262420A 220420B 235420 Mod 255420X 262420C 262420F 262420F Mod 262UNS S42027 255431 285440A 285440B 285440C 285440F 285UNS S42026 260UNS S42010 235AExcludes billets

31、and bars for forging.BOr equivalent Rockwell hardness.F899 12b2TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless SteelsTypeTypical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatureB TypeTypical HardeningAHeat Treatme

32、ntTypical 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 4

33、6 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 o

34、il 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 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

35、 quench 700 371 42900C482 451100C593 34420A 1850F (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) + 30

36、0 149 58/59Warm oil quench 400 204 52 Warm oil quench 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 60W

37、arm oil quench 400 204 52 Warm oil quench 400 204 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

38、454 48 700 371 56800D427 56S42027 1850F 300 149 58/59(1010C) + 400 204 57/58oil quench or 500 260 57/58pressure gas 600 315 56/57ATime at temperature depends on section size. Controlled heat treating atmosphere or alternate quench media may be used in accordance with good commercialpractice.BTemper

39、at least one hour at the indicated temperature and air cool. Large section sizes require longer times at temperature.CTempering in the range of 750/1050F (399/566C) results in decreased impact strength and reduced corrosion resistance.DTempering over 800F (427C) results in reduced corrosion resistan

40、ce.ETempering above 600F (316C) results in reduced toughness.F899 12b311.2 The purchaser may audit the suppliers quality programfor conformance to the intent of ASQ C1, or other recognizedprogram.12. Keywords12.1 austenitic; ferritic; instruments; martensitic; precipita-tion hardenable; stainless st

41、eel; surgicalTABLE 3 Examples of Selected Stainless Steels That Have Been 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

42、Bone rongeurs, conchotomes, bone cuttingforceps, chisels and gouges, bone curettes, scis-sors with carbide insertsforceps, retractors, probes, forceps with bowhandles, branch forceps420B bone rongeurs, scissors420C scissors, bone rongeurs, bone cutting forceps,conchotomes, scalpels, knives, bone cur

43、ettes,chisels and gouges420 Mod bone rongeurs, conchotomes, bone cuttingforceps, chisels and gouges, bone curettes, scis-sors with carbide inserts, scissors, scalpels,knivestissue forceps, dressing forceps, retractors,probes, forceps, forceps with bow handles,branch forcepsTABLE 4 Examples of Select

44、ed Stainless Steels That Have Been Used For Surgical Instruments in the United StatesType Cutting Instruments Non-Cutting Instruments302 knives, chisels, gouges, curettes cannula, forceps, guides, needle vents, retractors, specula, spreaders, tendorpassers, springs303Achisels, curettes, knives cannu

45、la, clamps, drills, forceps, handles, hammers, mallets, needle vents,punches, retractors, rulers, screws, skin hooks, specula, spreaders, suctiontubes, tendonstrips, tongs, tunnelers, probes304 cannula, clamps, forceps, holders, handles, needle vents, retractors, specula,spreaders, suction tubes, te

46、ndon passers316 specula410 chisels, curettes, dissectors, osteotomes, reamers,scissors with insertsclamps, clip applicators, elevators, forceps, hemostats, holders, needleholders, punches, retractors, skin hooks, sounds, spreaders, probes, dilators410X curettes, dissectors, rongeurs clamps, forceps,

47、 hemostats, holders, punches, retractors416Achisels, curettes, dissectors clamps, punches, retractors, skin hooks, spreaders420Bchisels, curettes, cutters, bone cutting forceps,knives, scissors, rongeurs, scalpels, skin punches,conchotomesclamps, elevators, punches, rounds, dissectors, retractors, s

48、kin hooks,needles420FAcutters burrs431 cheek retractors, insertion wrenches, orthopeadic instruments440Cchisels, knives, osteotomes, scalpels drills, retractors, spreaders, tongs420 Mod chisels, curettes, cutters, bone cutting forceps,knives, scissors, rongeurs, scalpels, skin punches,conchotomes, o

49、stoetomes, reamersclamps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles, cheek retractors, insertion wrenches, orthopaedic instruments, drills,spreaders, tongs, screwdrivers630 reamersXM-16 scissors drills, needlesXM-13 reamers, raspsS11100 reamers, scissors, rasps, knives Clamps, punches, impactor guides, strike plates, screwdrivers, hex driversS46500 reamers, scissors, rasps, knives Clamps, punches, impactor guides, strike plates, screwdrivers, hex driversAIt is not recommended that free-mac