ASTM F899-2011 Standard Specification for Wrought Stainless Steels for Surgical Instruments《外科器械用不锈钢锻件的标准规范》.pdf

1、Designation:F89910 Designation: F899 11Standard 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 o

2、f last revision. 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 chem

3、istry requirements 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 instrumen

4、ts, is provided 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 purchaser and supplier.1.2 The values sta

5、ted in 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

6、/A313M 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 Sta

7、inless 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

8、Test Methods, 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 Genera

9、l Requirements 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 5Precipitati

10、on Hardening 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 6.1This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the

11、direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2010. Published December 2010. Originally approved in 1984. Last previous edition approved in 2009 as F899091. DOI:10.1520/F0899-10.Current edition approved March 1, 2011. Published May 2011. Orig

12、inally approved in 1984. Last previous edition approved in 2010 as F899 10. DOI: 10.1520/F0899-11.2For referenced 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 Doc

13、ument Summary page on the 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.1This document is

14、not an ASTM standard and is 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 appropri

15、ate. In all cases only the 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 standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States

16、.4. Ordering Information4.1 Inquiries and orders for material under this specification shall include the following information as agreed upon by purchaserand 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 Fini

17、sh (see 5.3),4.1.7 Mechanical properties or hardness, and4.1.8 Applicable dimensions including size, thickness, 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-f

18、inished, annealed,solution-treated, solution-treated and aged, quench-hardened and tempered, or as specified by 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 com

19、monly annealed prior to shipment and so specified in order to avoid the possibility of thermalcracking. Other 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 cuttin

20、g when so specified on the purchase order.)5.2 ConditioningBillet and bar intended for forging may be conditioned 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 an

21、d polished, or asspecified in the purchase order.6. General Requirements for Delivery6.1 In addition to the chemistry 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

22、A751 shall applywhere applicable, as agreed upon between purchaser and supplier.6.2 This specification compliments the ISO applicable 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 a

23、nalysis shall conform to the requirements as to chemical composition specified in Tables 5-8.7.2 UNS designations have been added to Tables 5-8 to provide an easy cross reference to a common numbering system. Inorder to ensure consistency in the materials used for the manufacture of surgical instrum

24、ents, compositional limits tighter thantypical UNS limits have been established for certain elements (as denoted by an asterisk). For example, more restrictive carbonand sulfur limits are specified in Table 7.7.3 The chemical composition requirements for Types 301, 303, 304, 316, 410, 420A, 420B, 42

25、0C, and 430F also meet thecomposition requirements in ISO 7153/1.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 Mo

26、d 262431 285440A 285440B 285440C 285440F 285UNS S42026 260UNS S42010 235AExcludes billets and bars for forging.BOr equivalent Rockwell hardness.F899 1127.4 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods,Practices, and Termi

27、nology A751.8. Mechanical 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

28、 scale (HRB) or Rockwell hardness, C scale (HRC),limits may be specified. Typical hardness values for selected Class 4 martensitic stainless steels in the annealed condition are listedTABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless Steels

29、TypeTypical HardeningAHeat TreatmentTypical Hardness atIndicated TemperingTemperatureB TypeTypical HardeningAHeat TreatmentTypical 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

30、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 (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 (982

31、C) + 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 22 600 315 48416 1800F (982C) + 300 149 41 700 371 48Oil quench 500 260 39 800D427 48700 371 41 UNSS420261920F(1050C)+400 204 56

32、900C482 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 (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 54

33、600 315 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 50 500 260 53/54600 315 50 600 315 53700 371 49 700 371 54800D427 49 800D427 54420 Mod 180F (1010C)+ oil

34、 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 49 700 371 56800D427 49 800D427 56S42010 1900F 400 204 50 440F 1900F (1038C)

35、+ 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 heat treating atmosphere or alternate quench media may be used in accordance with good commerci

36、alpractice.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 impact strength and reduced corrosion resistance.DTempering over 800F (427C) results in reduced corr

37、osion resistance.ETempering above 600F (316C) results in reduced toughness.F899 113in Table 1. These typical hardness values are provided for reference only.9. Heat Treatment9.1 Material shall be heat treated per the applicable referenced ASTM standard (see 2.1) for the selected stainless steel.9.2

38、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 Specifi

39、cation A564/A564M.9.4 Specifying a hardness requirement appropriate for the selected alloy and intended application is the responsibility of thepurchaser.10. Special Information10.1 Some examples of selected stainless steels that have been used for various surgical instrument applications are listed

40、 inTable 3 and Table 4 for information purposes.NOTE 1Re-sulphurized free-machining grades can exhibit lower general corrosion resistance, lower pitting corrosion resistance, and difficulty inpolishing or welding. It is suggested that these grades be utilized only for applications where the appropri

41、ate steps in manufacture can be taken in orderto avoid such issues thus resulting in satisfactory long-term performance of the device.TABLE 3 Examples of Selected Stainless Steels That Have Been Used for Surgical Instruments in Accordance with ISO 7153/1Type Cutting Instruments Non-Cutting Instrumen

42、ts303 Chisels and gouges, bone curettes probes304 retractors410 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 forcep

43、s420B 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 gouges, bone curettes,scissors with carbide inserts, scissors, scalpels,knivestissue for

44、ceps, 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 Cutting Instruments Non-Cutting Instruments302 knives, chisels, gouges, curettes cannula, for

45、ceps, guides, needle vents, retractors, specula, spreaders, tendorpassers, springs303Achisels, curettes, knives cannula, clamps, drills, forceps, handles, hammers, mallets, needle vents,punches, retractors, rulers, screws, skin hooks, specula, spreaders, suctiontubes, tendonstrips, tongs, tunnelers,

46、 probes304 cannula, clamps, forceps, holders, handles, needle vents, retractors, specula,spreaders, suction tubes, tendon passers316 specula410 chisels, curettes, dissectors, osteotomes, reamers,scissors with insertsclamps, clip applicators, elevators, forceps, hemostats, holders, needleholders, pun

47、ches, retractors, skin hooks, sounds, spreaders, probes, dilators410X curettes, dissectors, rongeurs clamps, forceps, hemostats, holders, punches, retractors416Achisels, curettes, dissectors clamps, punches, retractors, skin hooks, spreaders420Bchisels, curettes, cutters, bone cutting forceps,knives

48、, scissors, rongeurs, scalpels, skin punches,conchotomesclamps, elevators, punches, rounds, dissectors, retractors, skin hooks,needles420FAcutters burrs431 cheek retractors, insertion wrenches, orthopeadic instruments440Cchisels, knives, osteotomes, scalpels drills, retractors, spreaders, tongs420 M

49、od chisels, curettes, cutters, bone cutting forceps,knives, 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-13 reamers, raspsS11100 reamers, scissors, rasps, knives Clamps, punches, impactor guides, strike plates, screwdrivers, hex driversS46500 reamers, scissors, rasps,