Historical

ASTM F899-09

Standard Specification for Wrought Stainless Steels for Surgical Instruments


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 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
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

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 indicated temperature and air cool. Large section sizes require longer time 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, elevators, punches, rounds, dissectors, retractors, skin hooks, needles
420FAcuttersburrs
431cheek retractors, insertion wrenches, orthopeadic instruments
440Cchisels, knives, osteotomes, scalpelsdrills, retractors, spreaders, tongs
420 Modchisels, 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, screwdrivers
630reamers
XM-16scissorsdrills, needles
XM-13reamers, rasps
S46500reamers, scissors, rasps, knivesClamps, punches, impactor guides, strike plates, screwdrivers, hex drivers

A It is not recommended that free-machining grades be used for critical portions of surgical instruments. Free machining grades should only be considered for instrument applications 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 may be used depending on instrument design and application.

C Types 440A, 440B, or 440C may be used depending on instrument design and application.


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Information supplied by the manufacturer of medical devices (British Standard)
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