ASTM F899-2012a 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 12 F899 12aStandard 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 rev

2、ision. A 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 requ

3、irements for wrought stainless steels used for the manufacture of surgicalinstruments. The data contained in Tables 1-4 of this specification, including typical hardness values, common heat treating cycles,and examples of selected stainless steels that have been used for surgical instruments, is pro

4、vided for reference only. Mechanicalproperty requirements, heat treating requirements, hardness requirements and all other requirements except chemistry are governedby the appropriate material standards as referenced below or as agreed upon between the purchaser and supplier.1.2 The values stated in

5、 inch-pound units are to be regarded as standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information only and are not considered standard.2. Referenced Documents2.1 ASTM Standards:2A276 Specification for Stainless Steel Bars and ShapesA313/A313M

6、 Specification for Stainless Steel Spring WireA314 Specification for Stainless Steel Billets and Bars for ForgingA480/A480M Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and StripA484/A484M Specification for General Requirements for Stainless

7、 Steel Bars, Billets, and ForgingsA555/A555M Specification for General Requirements for Stainless 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 Stainless Steel BarsA751 Test M

8、ethods, Practices, and Terminology for Chemical 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 Requ

9、irements for a Quality Program3. Classification and Type3.1 ClassesStainless steel material requirements for surgical instruments shall conform to one of the following classes, asspecified:3.1.1 Class 3Austenitic Stainless Steel.3.1.2 Class 4Martensitic Stainless Steel.3.1.3 Class 5Precipitation Har

10、dening Stainless Steel.3.1.4 Class 6Ferritic Stainless Steel.3.2 TypeWhere applicable, the commercially recognized type of stainless steel is included in Tables 5 and 6.1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direc

11、t responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved June 1, 2012Nov. 1, 2012. Published July 2012 December 2012. Originally approved in 1984. Last previous edition approved in 20112012 asF899 11.F899 12. DOI: 10.1520/F0899-12.10.1520/F0899-12A.2 For referenced

12、ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from American National Standards Institute (ANSI), 25 W. 43rd S

13、t., 4th Floor, New York, NY 10036, http:/www.ansi.org.4 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes h

14、ave 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 current versionof the standard as published by ASTM is to be considered the official d

15、ocument.*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 States14. Ordering Information4.1 Inquiries and orders for material under this specification shall include the following

16、 information as agreed upon by thepurchaser 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

17、, width, and length (exact, random, or multiples) or drawing number.5. Manufacture5.1 ConditionStainless steels shall be furnished to the purchaser, as specified, in the hot-finished, cold-finished, annealed,solution-treated, solution-treated and aged, quench-hardened and tempered, or as specified b

18、y the purchaser. (Note that highlyhardenable martensitic stainless billets and bars such as Types 420A, 420B, 420C, 420 Mod, 420F, 420F Mod., 440A, 440B, and440C intended for forging are commonly annealed prior to shipment and so specified in order to avoid the possibility of thermalcracking. Other

19、hardenable martensitic grades such as Types 403, 410, 416, 416 Mod., and 431, which also may require annealing,depending on their composition and size, are furnished suitable for cold cutting when so specified on the purchase order.)5.2 ConditioningBillet and bar intended for forging may be conditio

20、ned by chipping, grinding, or other suitable means toremove injurious surface defects.5.3 FinishTypes of finish available for bar and wire products are cold drawn, pickled, ground, ground and polished, or asspecified in the purchase order.6. General Requirements for Delivery6.1 In addition to the ch

21、emistry requirements of this specification, all requirements of the current editions of SpecificationsA276, A313/A313M, A314, A480/A480M, A484/A484M, A555/A555M, A564/A564M, A582/A582M, and A751 shall applywhere applicable, as agreed upon between the purchaser and supplier.6.2 This specification com

22、pliments the applicable ISO document covering stainless steel for surgical instruments and, byreference, includes all of the stainless grades in ISO 7153/1.7. Chemical Requirements7.1 The heat analysis shall conform to the requirements as to chemical composition specified in Tables 5-8.TABLE 1 Typic

23、al Maximum Hardness for Selected Class 4Martensitic Stainless Steels in The Annealed ConditionAType Typical 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 S

24、42010 235A Excludes billets and bars for forging.B Or equivalent Rockwell hardness.F899 12a27.2 Unified Numbering System (UNS) designations have been added to Tables 5-8 to provide an easy cross reference to acommon numbering system. In order to ensure consistency in the materials used for the manuf

25、acture of surgical instruments,compositional limits tighter than typical UNS limits have been established for certain elements (as denoted by an asterisk). Forexample, more restrictive carbon and sulfur limits are specified in Table 7.TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Value

26、s for Selected Class 4 Martensitic Stainless SteelsType Typical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatureB Type Typical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatureBF C (HRC) F C (HRC)410 1850F (1010C) + 500 260 43 420C 1900F (1038C) + 300

27、 149 58Oil quench 700 371 43 Warm oil quench 400 204 55/56or air cool 900C 482 42 500 260 53/541000C 538 30 600 315 53/541100 593 24 700 371 54/55410X 1875F (1024C) + 500 260 46 800D 427 55Oil quench 700 371 46/47 420F 1900F (1038C) + 300 149 52or air cool 900C 482 48 Warm oil quench 400 204 521000C

28、 538 44 500 260 501100 593 31 600 315 50416 Mod 1800F (982C) + 300 149 38 700 371 49Oil quench 500 260 37 800D 427 49700 371 37 420F Mod 1900F (1038C) + 300 149 53900C 482 35 Warm oil quench 400 204 501000C 538 30 500 260 481100 593 22 600 315 48416 1800F (982C) + 300 149 41 700 371 48Oil quench 500

29、 260 39 800D 427 48700 371 41 UNSS420261920F(1050C)+400 204 56900C 482 36 oil quench or 500 260 54/551000C 538 31 pressure gas 600 315 53/541100 593 26 431 1900F (1038C) + 500 260 42Oil quench 700 371 42900C 482 451100C 593 34420A 1850F (1010C) + 300 149 53 440A 1900F (1038C) + 300 149 56/57Warm oil

30、 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 51800D 427 48 800D 427 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 50 500 260 53/54600 315 50 600 315 5

31、3700 371 49 700 371 54800D 427 49 800D 427 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 50 600 315 56700 371 49 700

32、371 56800D 427 49 800D 427 56S42010 1900F 400 204 50 440F 1900F (1038C) + 300 149 60(1038C) + Warm 500 260 47 Warm oil quench 400 204 59Oil Quench 600E 316 47 500 260 57700 371 48 600 315 56850 454 48 700 371 56800D 427 56S42027 1850F 300 149 58/59(1010C) + 400 204 57/58oil quench or 500 260 57/58pr

33、essure gas 600 315 56/57A Time at temperature depends on section size. Controlled heat treating atmosphere or alternate quench media may be used in accordance with good commercialpractice.B Temper at least one hour at the indicated temperature and air cool. Large section sizes require longer times a

34、t temperature.C Tempering in the range of 750/1050F (399/566C) results in decreased impact strength and reduced corrosion resistance.D Tempering over 800F (427C) results in reduced corrosion resistance.E Tempering above 600F (316C) results in reduced toughness.F899 12a37.3 The chemical composition r

35、equirements for Types 301, 303, 304, 316, 410, 420A, 420B, 420C, and 430F also meet thecomposition requirements in ISO 7153/1.7.4 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods,Practices, and Terminology A751.8. Mechanical

36、Requirements8.1 Material shall conform to the mechanical property requirements cited in the appropriate ASTM standards (see 2.1) or shallmeet the mechanical property requirements specified by the purchaser.8.2 When desired, Brinell hardness number (HB), Rockwell hardness, B scale (HRB) or Rockwell h

37、ardness, C scale (HRC),limits may be specified. Typical hardness values for selected Class 4 martensitic stainless steels in the annealed condition are listedin Table 1. These typical hardness values are provided for reference only.9. Heat Treatment9.1 Material shall be heat treated per the applicab

38、le referenced ASTM standard (see 2.1) for the selected stainless steel.TABLE 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

39、 tissue, forceps, dressing forceps, retractors,probes420A Bone rongeurs, conchotomes, bone cuttingforceps, chisels and gouges, bone curettes,scissors with carbide insertsforceps, retractors, probes, forceps with bowhandles, branch forceps420B bone rongeurs, scissors420C scissors, bone rongeurs, bone

40、 cutting forceps,conchotomes, scalpels, knives, bone curettes,chisels and gouges420 Mod bone rongeurs, conchotomes, bone cuttingforceps, chisels and gouges, bone curettes,scissors with carbide inserts, scissors, scalpels,knivestissue forceps, dressing forceps, retractors,probes, forceps, forceps wit

41、h bow handles,branch forcepsTABLE 4 Examples of Selected 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, ten

42、dorpassers, springs303A chisels, curettes, knives cannula, 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

43、vents, retractors, specula,spreaders, suction tubes, tendon passers316 specula410 chisels, curettes, dissectors, osteotomes, reamers,scissors with insertsclamps, clip applicators, elevators, forceps, hemostats, holders, needleholders, punches, retractors, skin hooks, sounds, spreaders, probes, dilat

44、ors410X curettes, dissectors, rongeurs clamps, forceps, hemostats, holders, punches, retractors416A chisels, curettes, dissectors clamps, punches, retractors, skin hooks, spreaders420B chisels, curettes, cutters, bone cutting forceps,knives, scissors, rongeurs, scalpels, skin punches,conchotomesclam

45、ps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles420FA cutters burrs431 cheek retractors, insertion wrenches, orthopeadic instruments440C chisels, knives, osteotomes, scalpels drills, retractors, spreaders, tongs420 Mod chisels, curettes, cutters, bone cutting forceps,knives

46、, scissors, rongeurs, scalpels, skin punches,conchotomes, ostoetomes, reamersclamps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles, cheek retractors, insertion wrenches, orthopaedic instruments, drills,spreaders, tongs, screwdrivers630 reamersXM-16 scissors drills, needlesXM

47、-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 driversA It is not recommended that free-machining grades be

48、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)B Types 420A, 420B, 420C, or UNS S42026

49、 may be used depending on instrument design and application.C Types 440A, 440B, or 440C may be used depending on instrument design and application.F899 12a49.2 Commonly used heat treating cycles guidelines and the resulting typical hardness values for selected Class 4 martensiticstainless steels are listed in Table 2 and are provided for reference only.9.3 Heat treating guidelines for Class 5 precipitation hardening stainless steels are included in Specification A564/A564M.9.4 Specifying a hardness requirement app