ASTM F899-12

    Historical Standard: ASTM F899-12 Standard Specification for Wrought Stainless Steels for Surgical Instruments

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    ASTM F899

    1. Scope

    1.1 This specification covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments. 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 provided for reference only. Mechanical property requirements, heat treating requirements, hardness requirements and all other requirements except chemistry are governed by the appropriate material standards as referenced below or as agreed upon between the purchaser and supplier.

    1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

    TABLE 1 Typical Maximum Hardness for Selected Class 4 Martensitic Stainless Steels in The Annealed ConditionA

    TypeTypical Maximum
    Brinell HardnessB
    410210
    410X220
    416262
    416 Mod262
    420A220
    420B235
    420 Mod255
    420X262
    420C262
    420F262
    420F Mod262
    UNS S42027255
    431285
    440A285
    440B285
    440C285
    440F285
    UNS S42026260
    UNS S42010235

    A Excludes billets and bars for forging.

    B Or equivalent Rockwell hardness.

    TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless Steels

    TypeTypical HardeningA
    Heat Treatment
    Typical Hardness at
    Indicated Tempering
    TemperatureB
    TypeTypical HardeningA
    Heat Treatment
    Typical Hardness at
    Indicated Tempering
    TemperatureB
    °F°C(HRC)°F°C(HRC)
    4101850°F (1010°C) + 50026043420C1900°F (1038°C) + 30014958
    Oil quench 700 371 43 Warm oil quench40020455/56
    or air cool 900C48242 50026053/54
    1000C53830 60031553/54
    110059324 70037154/55
    410X1875°F (1024°C) + 50026046800D42755
    Oil quench 700 371 46/47 420F1900°F (1038°C) + 30014952
    or air cool 900C48248 Warm oil quench40020452
    1000C53844 50026050
    110059331 60031550
    416 Mod1800°F (982°C) + 3001493870037149
    Oil quench 500 260 37 800D42749
    70037137 420F Mod1900°F (1038°C) + 30014953
    900C48235 Warm oil quench40020450
    1000C53830 50026048
    110059322 60031548
    4161800°F (982°C) + 3001494170037148
    Oil quench 500 260 39 800D42748
    70037141UNS
    S42026
    1920°F
    (1050°C)+
    40020456
    900C48236oil quench or50026054/55
    1000C53831pressure gas60031553/54
    110059326 4311900°F (1038°C) + 50026042
    Oil quench70037142
    900C48245
    1100C59334
    420A1850°F (1010°C) + 30014953440A1900°F (1038°C) + 30014956/57
    Warm oil quench 400 204 50 Warm oil quench40020456
    50026048 50026054
    60031548 60031551/52
    70037148 70037151
    800D42748 800D42750
    420B1900°F (1038°C) + 30014952440B1900°F (1038°C) + 30014958/59
    Warm oil quench 400 204 52 Warm oil quench40020456/57
    50026050 50026053/54
    60031550 60031553
    70037149 70037154
    800D42749 800D42754
    420 Mod180°F (1010°C)
    + oil quench or
    pressure gas
    350
    400
    500
    600
    177
    204
    260
    315
    56/57
    55
    54
    53
    420X1900°F (1038°C) + 30014952440C1900°F (1038°C) + 30014960
    Warm oil quench 400 204 52 Warm oil quench40020459
    5002605050026057
    60031550 60031556
    70037149 70037156
    800D42749800D42756
    S420101900°F 40020450 440F1900°F (1038°C) + 30014960
    (1038°C) + Warm 500 260 47 Warm oil quench40020459
    Oil Quench600E31647 50026057
    70037148 60031556
    85045448 70037156
    800D42756
    S420271850°F 30014958/59
    (1010°C) +40020457/58
    oil quench or50026057/58
    pressure gas60031556/57

    A Time at temperature depends on section size. Controlled heat treating atmosphere or alternate quench media may be used in accordance with good commercial practice.

    B Temper at least one hour at the indicated temperature and air cool. Large section sizes require longer times at temperature.

    C Tempering in the range of 750/1050°F (399/566°C) results in decreased impact strength and reduced corrosion resistance.

    D Tempering over 800°F (427°C) results in reduced corrosion resistance.

    E Tempering above 600°F (316°C) results in reduced toughness.

    TABLE 3 Examples of Selected Stainless Steels That Have Been Used for Surgical Instruments in Accordance with ISO 7153/1

    TypeCutting InstrumentsNon-Cutting Instruments
    303Chisels and gouges, bone curettesprobes
    304retractors
    410tissue, forceps, dressing forceps, retractors, probes
    420ABone rongeurs, conchotomes, bone cutting forceps, chisels and gouges, bone curettes, scissors with carbide insertsforceps, retractors, probes, forceps with bow handles, branch forceps
    420Bbone rongeurs, scissors
    420Cscissors, bone rongeurs, bone cutting forceps, conchotomes, scalpels, knives, bone curettes, chisels and gouges
    420 Modbone rongeurs, conchotomes, bone cutting forceps, chisels and gouges, bone curettes, scissors with carbide inserts, scissors, scalpels, knivestissue forceps, dressing forceps, retractors, probes, forceps, forceps with bow handles, branch forceps

    TABLE 4 Examples of Selected Stainless Steels That Have Been Used For Surgical Instruments in the United States

    TypeCutting InstrumentsNon-Cutting Instruments
    302knives, chisels, gouges, curettescannula, forceps, guides, needle vents, retractors, specula, spreaders, tendor passers, springs
    303Achisels, curettes, knivescannula, clamps, drills, forceps, handles, hammers, mallets, needle vents, punches, retractors, rulers, screws, skin hooks, specula, spreaders, suction tubes, tendon
    strips, tongs, tunnelers, probes
    304cannula, clamps, forceps, holders, handles, needle vents, retractors, specula, spreaders, suction tubes, tendon passers
    316specula
    410chisels, curettes, dissectors, osteotomes, reamers, scissors with insertsclamps, clip applicators, elevators, forceps, hemostats, holders, needle holders, punches, retractors, skin hooks, sounds, spreaders, probes, dilators
    410Xcurettes, dissectors, rongeursclamps, forceps, hemostats, holders, punches, retractors
    416Achisels, curettes, dissectorsclamps, punches, retractors, skin hooks, spreaders
    420Bchisels, curettes, cutters, bone cutting forceps, knives, scissors, rongeurs, scalpels, skin punches, conchotomesclamps, el


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    A276 Specification for Stainless Steel Bars and Shapes

    A313/A313M Specification for Stainless Steel Spring Wire

    A314 Specification for Stainless Steel Billets and Bars for Forging

    A480/A480M Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip

    A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings

    A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods

    A564/A564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes

    A582/A582M Specification for Free-Machining Stainless Steel Bars

    A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products

    ISO Standards

    ISO9001 Quality Management Systems--Requirements

    American Society for Quality (ASQ) Standard

    ASQC1 Specification of General Requirements for a Quality Program


    ICS Code

    ICS Number Code 11.040.30 (Surgical instruments and materials)

    UNSPSC Code

    UNSPSC Code 42291900(Surgical instrument and tube holders and positioners)


    DOI: 10.1520/F0899-12

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