Astmf899 11
Astmf899 11
Astmf899 11
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
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.
Type
410
410X
416
416 Mod
420A
420B
420 Mod
420X
420C
420F
420F Mod
431
440A
440B
440C
440F
UNS S42026
UNS S42010
2. Referenced Documents
2.1 ASTM Standards:2
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 ColdFinished Age-Hardening Stainless Steel Bars and Shapes
A582/A582M Specification for Free-Machining Stainless
Steel Bars
A
B
Typical Maximum
Brinell HardnessB
210
220
262
262
220
235
255
262
262
262
262
285
285
285
285
285
260
235
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
2.2 ISO Standards:3
ISO 7153/1 Instruments For SurgeryMetallic Materials
Part 1: Stainless Steel
ISO 9001 Quality Management SystemsRequirements
2.3 American Society for Quality (ASQ) Standard:4
ASQ C1 Specification of General Requirements for a Quality Program
3. Classification and Type
3.1 ClassesStainless steel material requirements for surgical 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 Stainless Steel.
3.1.4 Class 6Ferritic Stainless Steel.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved March 1, 2011. Published May 2011. Originally
approved in 1984. Last previous edition approved in 2010 as F899 10. DOI:
10.1520/F0899-11.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standards Document Summary page on
the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
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.
F899 11
TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless Steels
410
1850F (1010C) +
Oil quench
or air cool
410X
1875F (1024C) +
Oil quench
or air cool
416 Mod
416
Typical Hardness at
Indicated Tempering
TemperatureB
Typical HardeningA
Heat Treatment
1800F (982C) +
Oil quench
1800F (982C) +
Oil quench
(HRC)
500
700
900C
1000C
1100
500
700
900C
1000C
1100
300
500
700
900C
1000C
1100
300
500
700
260
371
482
538
593
260
371
482
538
593
149
260
371
482
538
593
149
260
371
43
43
42
30
24
46
46/47
48
44
31
38
37
37
35
30
22
41
39
41
900
1000C
1100
482
538
593
36
31
26
300
400
500
600
700
800D
300
400
500
600
700
800D
350
400
500
600
300
400
500
600
700
800D
400
500
600E
700
850
149
204
260
315
371
427
149
204
260
315
371
427
177
204
260
315
149
204
260
315
371
427
204
260
316
371
454
53
50
48
48
48
48
52
52
50
50
49
49
56/57
55
54
53
52
52
50
50
49
49
50
47
47
48
48
420A
1850F (1010C) +
Warm oil quench
420B
1900F (1038C) +
Warm oil quench
420 Mod
180F (1010C)
+ oil quench or
pressure gas
420X
1900F (1038C) +
Warm oil quench
S42010
1900F
(1038C) + Warm
Oil Quench
420C
1900F (1038C) +
Warm oil quench
420F
1900F (1038C) +
Warm oil quench
420F Mod
1900F (1038C) +
Warm oil quench
UNS
S42026
1920F
(1050C)+
oil quench or
pressure gas
1900F (1038C) +
Oil quench
431
Typical Hardness at
Indicated Tempering
TemperatureB
Typical HardeningA
Heat Treatment
Type
440A
1900F (1038C) +
Warm oil quench
440B
1900F (1038C) +
Warm oil quench
440C
1900F (1038C) +
Warm oil quench
440F
1900F (1038C) +
Warm oil quench
(HRC)
300
400
500
600
700
800D
300
400
500
600
700
800D
300
400
500
600
700
800D
400
149
204
260
315
371
427
149
204
260
315
371
427
149
204
260
315
371
427
204
58
55/56
53/54
53/54
54/55
55
52
52
50
50
49
49
53
50
48
48
48
48
56
500
600
500
700
900C
1100C
300
400
500
600
700
800D
300
400
500
600
700
800D
260
315
260
371
482
593
149
204
260
315
371
427
149
204
260
315
371
427
54/55
53/54
42
42
45
34
56/57
56
54
51/52
51
50
58/59
56/57
53/54
53
54
54
300
400
500
600
700
800D
300
400
500
600
700
800D
149
204
260
315
371
427
149
204
260
315
371
427
60
59
57
56
56
56
60
59
57
56
56
56
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 750/1050F (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.
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.1.7
--`,`,,,`,,```,,``,`````,`,,,,``-`-`,,`,,`,`,,`---
Type
F899 11
TABLE 3 Examples of Selected Stainless Steels That Have Been Used for Surgical Instruments in Accordance with ISO 7153/1
Type
Cutting Instruments
303
304
410
420A
420B
420C
420 Mod
Non-Cutting Instruments
probes
retractors
tissue, forceps, dressing forceps, retractors,
probes
forceps, retractors, probes, forceps with bow
handles, branch forceps
TABLE 4 Examples of Selected Stainless Steels That Have Been Used For Surgical Instruments in the United States
Type
Cutting Instruments
302
303A
Non-Cutting Instruments
cannula, forceps, guides, needle vents, retractors, specula, spreaders, tendor
passers, springs
cannula, clamps, drills, forceps, handles, hammers, mallets, needle vents,
punches, retractors, rulers, screws, skin hooks, specula, spreaders, suction
tubes, tendon
strips, tongs, tunnelers, probes
cannula, clamps, forceps, holders, handles, needle vents, retractors, specula,
spreaders, suction tubes, tendon passers
specula
clamps, clip applicators, elevators, forceps, hemostats, holders, needle
holders, punches, retractors, skin hooks, sounds, spreaders, probes, dilators
clamps, forceps, hemostats, holders, punches, retractors
clamps, punches, retractors, skin hooks, spreaders
clamps, elevators, punches, rounds, dissectors, retractors, skin hooks,
needles
304
316
410
410X
416A
420B
420FA
431
440C
420 Mod
630
XM-16
XM-13
S11100
S46500
burrs
cheek retractors, insertion wrenches, orthopeadic instruments
drills, retractors, spreaders, tongs
clamps, elevators, punches, rounds, dissectors, retractors, skin hooks,
needles, cheek retractors, insertion wrenches, orthopaedic instruments, drills,
spreaders, tongs, screwdrivers
drills, needles
Clamps, punches, impactor guides, strike plates, screwdrivers, hex drivers
Clamps, 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.
sition 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 conditioned by chipping, grinding, or other suitable means
to remove injurious surface defects.
5.3 FinishTypes of finish available for bar and wire
products are cold drawn, pickled, ground, ground and polished,
or as specified in the purchase order.
5. Manufacture
5.1 ConditionStainless steels shall be furnished to the
purchaser, as specified, in the hot-finished, cold-finished,
annealed, solution-treated, solution-treated and aged, quenchhardened and tempered, or as specified by the purchaser. (Note
that highly hardenable martensitic stainless billets and bars
such as Types 420A, 420B, 420C, 420 Mod, 420F, 420F Mod.,
440A, 440B, and 440C intended for forging are commonly
annealed prior to shipment and so specified in order to avoid
the possibility of thermal cracking. Other hardenable martensitic grades such as Types 403, 410, 416, 416 Mod., and 431,
which also may require annealing, depending on their compo-
F899 11
TABLE 5 Composition of Class 3, Austenitic Stainless Steels, %
UNS
Type
Carbon,
max
Phosphorus,
max
Sulfur
Silicon,
max
Chromium
Nickel
2.00 max
1.502.00
0.045
0.025
0.030 max
0.010 max
1.00
1.201.80
16.0018.00
16.018.0
6.008.00
7.09.0
Manganese
Other
Elements
S30100
S30151
301
0.15
0.070.09
S30200
S30300
S30400
S31600
302
303
304
316
0.15
0.12A
0.07A
0.07A
2.00
2.00
2.00
2.00
max
max
max
max
0.045
0.06A
0.045
0.045
0.030 max
0.150.35A
0.030 max
0.030 max
1.00
1.00
1.00
1.00
17.0019.00
17.0019.00
17.0019.00A
16.5018.50A
8.0010.00
8.0010.00
8.0011.00A
10.5013.50A
S31700
317
0.08
2.00 max
0.045
0.030 max
1.00
18.0020.00
11.0015.00
S30430
S28200
XM-7
0.1
0.15
2.00 max
17.0019.00
0.045
0.040
0.030 max
0.04 max
1.00
1.00
17.0019.00
17.0019.00
8.0010.00
0.15
0.15
0.10
4.06.0
4.08.0
7.09.0
0.045
0.040
0.060
0.030
0.040
0.030
3.04.0
2.54.5
3.54.5
15.0018.00
16.5021.00
16.018.0
4.06.0
6.010.0
8.09.0
S20161
S20162
S21800
A
Cu 0.40 max
Mo 0.501.00
N 0.070.11
N 0.10 maxA
Mo 0.70 maxA
N 0.10 maxA
Mo 2.002.50A
N 0.10 maxA
Mo 3.004.00
N 0.10 maxA
Cu 3.004.00
Mo 0.751.25
Cu 0.751.25
N 0.400.60
N 0.080.20
N 0.050.25
N 0.080.18
UNS
Type
Carbon,
max
Manganese,
max
Phosphorus,
max
Sulfur
Silicon,
Max
Chromium
S43020
430 F
0.08A
1.25
0.06
0.150.35A
1.00
16.0018.00
S18200
XM-34
0.08
1.252.5A
0.04
0.280.41A
1.00
17.5019.50
Other
Elements
Mo 0.60 max
Ni 1.00 maxA
Mo 1.502.50
Type
CarbonA
A
Manganese Phosphorus
Max
Max
SulfurA
Silicon
Max
Chromium
Other
Ni 1.00 maxA
Ni 1.00 maxA
...
...
Ni 1.00 maxA
Ni 1.00 maxA
Mo 1.501.90
V 0.200.40
N 0.160.25
Ni 1.00 maxA
Ni 1.00 maxA
Cu 0.60 maxB
Ni 0.50 maxB
Mo 1.101.50
Ni 0.751.50
Ni 1.00 max
Mo 0.81.2
Ni 1.252.50
Mo 0.75 max
Mo 0.75 max
Mo 0.75 max
Cu 0.60 maxB
Ni 0.50 maxB
Ni 0.350.85
Mo 0.400.85
S41000
S41000
S41600
S41600
S42000
S42000
S42000
410
410X
416
416 Mod
420A
420B
420 Mod
0.090.15
0.160.21A
0.090.15A
0.090.15A
0.160.25A
0.260.35A
0.370.45A
1.00
1.00
1.25
1.25
1.00
1.00
0.60
0.04
0.04
0.06
0.06
0.04
0.04
0.02
0.030 max
0.030 max
0.150.27A
0.280.41A
0.030 max
0.030 max
0.005 max
1.00
1.00
1.00
1.00
1.00
1.00
0.60
11.5013.50
11.5013.50
12.0014.00
12.0014.00
12.0014.00
12.0014.00
15.0016.50
S42000
S42000
S42020
420X
420C
420F
0.360.41A
0.420.50A
0.300.40A
1.00
1.00
1.25
0.04
0.04
0.06
0.030 max
0.030 max
0.200.34A
1.00
1.00
1.00
12.0014.50
12.5014.50
12.5014.00
420F Mod
0.200.26A
2.00
0.04
0.150.27A
1.00
12.5014.00
...
0.330.43
1.00
0.03
0.030 max
1.00
12.514.5
431
440A
440B
440C
440F
0.20 max
0.600.75
0.750.95
0.951.20
0.951.20
1.00
1.00
1.00
1.00
1.25
0.04
0.04
0.04
0.04
0.06
0.030 max
0.030 max
0.030 max
0.030 max
0.150.27A
1.00
1.00
1.00
1.00
1.00
15.0017.00
16.0018.00
16.0018.00
16.0018.00
16.0018.00
0.150.30
1.00
0.04
0.03
1.00
13.515.0
S42026
S42010
A
B
--`,`,,,`,,```,,``,`````,`,,,,``-`-`,,`,,`,`,,`---
S43100
S44002
S44003
S4404
S44020
F899 11
TABLE 8 Composition of Class 5, Precipitation Hardening Stainless Steels, %
UNS
Type
Carbon,
max
Manganese,
max
Phosphorus,
max
Sulfur,
max
Silicon,
max
Chromium
Nickel
Copper
Nb+Ta
1112.5
10.2511.25
...
...
S11100
...
0.02
0.25
0.015
0.01
0.25
S17400
S17700
S45000
630
631
XM-25
0.07
0.09
0.05
1.00
1.00
1.00
0.040
0.040
0.030
0.030
0.030
0.030
1.00
1.00
1.00
15.0017.50 3.005.00
16.0018.00 6.507.75
14.0016.00 5.007.00
3.005.00
...
1.251.75
0.150.45
...
...
S45500
XM-16
0.03
0.50
0.015A
0.015A
0.50
11.0012.50 7.509.50
1.502.50
0.100.50
S13800
XM-13
0.05
0.1A
0.01A
0.008
0.10
12.2513.25 7.508.50
...
...
S46500
0.02
0.25
0.015
0.010
0.25
11.0012.50 10.7511.25
...
...
S46910
0.030
1.00
0.030
0.015
0.70
11.013.0
8.010.0
1.53.5
Other
Elements
Al 1.351.75
Mo 1.752.25
Ti 0.20.5
N 0.01 max
...
Al 0.751.50
Mo 0.501.00
Cb 8 x C min
Ti 0.901.40
Mo 0.50 max
Al 0.901.35
Mo 2.002.50
N 0.01 max
Ti 1.501.80
Mo 0.751.25
N .01 max
Al 0.150.50
Mo 3.05.0
Ti 0.501.20
9.3 Heat treating guidelines for Class 5 precipitation hardening stainless steels are included in Specification A564/
A564M.
9.4 Specifying a hardness requirement appropriate for the
selected alloy and intended application is the responsibility of
the purchaser.
8. Mechanical Requirements
8.1 Material shall conform to the mechanical property
requirements cited in the appropriate ASTM standards (see 2.1)
or shall meet the mechanical property requirements specified
by the purchaser.
8.2 When desired, Brinell hardness number (HB), Rockwell
hardness, B 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 listed in Table 1. These typical hardness values are
provided for reference only.
--`,`,,,`,,```,,``,`````,`,,,,``-`-`,,`,,`,`,,`---
NOTE 1Re-sulphurized free-machining grades can exhibit lower general corrosion resistance, lower pitting corrosion resistance, and difficulty
in polishing or welding. It is suggested that these grades be utilized only
for applications where the appropriate steps in manufacture can be taken
in order to avoid such issues thus resulting in satisfactory long-term
performance of the device.
9. Heat Treatment
9.1 Material shall be heat treated per the applicable referenced ASTM standard (see 2.1) for the selected stainless steel.
9.2 Commonly used heat treating cycles guidelines and the
resulting typical hardness values for selected Class 4 martensitic stainless steels are listed in Table 2 and are provided for
reference only.
12. Keywords
12.1 austenitic; ferritic; instruments; martensitic; precipitation hardenable; stainless steel; surgical
F899 11
APPENDIX
(Nonmandatory Information)
X1. STATEMENT OF RATIONALE FOR SPECIFICATION F899
X1.1 The primary reason for this specification is to characterize composition requirements to ensure consistency in
wrought materials used directly or modified by forging in the
manufacture of stainless steel surgical instruments. Mechanical
property requirements are not contained specifically within this
specification. Those requirements are found in the appropriate
specifications as referenced in section 2.1.
and heat-treating guidelines for Class 5 martensitic precipitation hardening grades are included in specification A564/
A564M.
X1.7 Examples of selected stainless steels that have been
used for surgical instrument applications are included in this
standard for information purposes.
X1.8 UNS designations are documented in the appropriate
ASTM specifications listed in 2.1, Referenced Documents.
X1.4 Acceptable metal conditions supplied to the instrument manufacturer include hot-finished, cold-finished, annealed, solution-treated, solution-treated and aged, or quenchhardened and tempered, the choice dependent upon the alloy
type, instrument design, and application.
X1.5 Mechanical requirements for Classes 3, 5, and 6
stainless steels covered in this specification are included in the
appropriate ASTM standards listed in Section 2.
X1.6 Typical heat-treating cycles and resultant hardness
values for selected Class 4 stainless steels are included in this
specification since the martensitic grades are a very common
class of stainless steel used for surgical instruments. Hardness
--`,`,,,`,,```,,``,`````,`,,,,``-`-`,,`,,`,`,,`---
F899 11
TABLE X1.1 Chemistry and Mechanical Property Data
C
Mn
P
S
Si
Cr
Ni
Mo
Al
Ti
N
Size
UTSA [MPa]
YSA [MPa]
AA in 5d [%]
RA [%]
Heat
HS444001
Heat
HS153902
Heat
HS360203
0.002
<0.030
<0.005
<0.0020
0.03
11.83
10.71
2.09
1.56
0.31
0.0014
9.5 mm
1772
1674
11.5
59
0.004
<0.03
<0.005
<0.0020
0.03
11.93
10.59
2.10
1.47
0.31
0.0012
72 mm
1733
1627
10.5
56
0.003
<0.03
<0.005
<0.0020
0.04
11.79
10.65
2.18
1.53
0.29
0.0011
87 mm
1780
1660
12.1
51
SUMMARY OF CHANGES
Committee F04 has identified the location of selected changes to this standard since the last issue (F899 10)
that may impact the use of this standard. (Approved March 1, 2011.)
(1) Added UNS S11100 to Table 4 and Table 8.
Committee F04 has identified the location of selected changes to this standard since the last issue
(F899 091) that may impact the use of this standard. (Approved Dec. 1, 2010.)
(1) Added Specification A313/A313M to 2 and 6.1 and UNS
S30151 to Table 5.
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in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk
of infringement of such rights, are entirely their own responsibility.
--`,`,,,`,,```,,``,`````,`,,,,``-`-`,,`,,`,`,,`---
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