Designation: F 899 09

Standard Specication for

Wrought Stainless Steels for Surgical Instruments1

This standard is issued under the xed designation F 899; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon () 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 specication covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments. The data contained in Tables 1-4 of this specication, 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. 2. Referenced Documents 2.1 ASTM Standards:2 A 276 Specication for Stainless Steel Bars and Shapes A 314 Specication for Stainless Steel Billets and Bars for Forging A 480/A 480M Specication for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip A 484/A 484M Specication for General Requirements for Stainless Steel Bars, Billets, and Forgings A 555/A 555M Specication for General Requirements for Stainless Steel Wire and Wire Rods A 564/A 564M Specication for Hot-Rolled and ColdFinished Age-Hardening Stainless Steel Bars and Shapes A 582/A 582M Specication for Free-Machining Stainless Steel Bars A 751 Test Methods, Practices, and Terminology for
A B

TABLE 1 Typical Maximum Hardness for Selected Class 4 Martensitic Stainless Steels in The Annealed ConditionA
Type 410 410X 416 416 Mod 420A 420B 420 Mod 420X 420C 420F 420F Mod 431 440A 440B 440C 440F UNS S42026 UNS S42010 Excludes billets and bars for forging. Or equivalent Rockwell hardness. Typical Maximum Brinell HardnessB 210 220 262 262 220 235 255 262 262 262 262 285 285 285 285 285 260 235

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 Specication of General Requirements for a Quality Program 3. Classication and Type 3.1 ClassesStainless steel material requirements for surgical instruments shall conform to one of the following classes, as specied: 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 specication 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 Feb. 1, 2009. Published February 2009. Originally approved in 1984. Last previous edition approved in 2007 as F 899 07. 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.

*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.

F 899 09
TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless Steels
Typical HardeningA Heat Treatment F 410 1850F (1010C) + Oil quench or air cool 500 700 900C 1000C 1100 500 700 900C 1000C 1100 300 500 700 900C 1000C 1100 300 500 700 900C 1000C 1100 Typical Hardness at Indicated Tempering TemperatureB C 260 371 482 538 593 260 371 482 538 593 149 260 371 482 538 593 149 260 371 482 538 593 (HRC) 43 43 42 30 24 46 46/47 48 44 31 38 37 37 35 30 22 41 39 41 36 31 26 420C 1900F (1038C) + Warm oil quench Typical HardeningA Heat Treatment F 300 400 500 600 700 800D 300 400 500 600 700 800D 300 400 500 600 700 800D 400 500 600 500 700 900C 1100C 300 400 500 600 700 800D 300 400 500 600 700 800D Typical Hardness at Indicated Tempering TemperatureB C 149 204 260 315 371 427 149 204 260 315 371 427 149 204 260 315 371 427 204 260 315 260 371 482 593 149 204 260 315 371 427 149 204 260 315 371 427 (HRC) 58 55/56 53/54 53/54 54/55 55 52 52 50 50 49 49 53 50 48 48 48 48 56 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

Type

Type

410X

1875F (1024C) + Oil quench or air cool

420F

1900F (1038C) + Warm oil quench

416 Mod

1800F (982C) + Oil quench

420F Mod

1900F (1038C) + Warm oil quench

416

1800F (982C) + Oil quench

UNS S42026

431

1920F (1050C)+ oil quench or pressure gas 1900F (1038C) + Oil quench

420A

1850F (1010C) + Warm oil quench

420B

1900F (1038C) + Warm oil quench

420 Mod

180F (1010C) + oil quench or pressure gas 1900F (1038C) + Warm oil quench

420X

S42010

1900F (1038C) + Warm Oil Quench

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

440A

1900F (1038C) + Warm oil quench

440B

1900F (1038C) + Warm oil quench

440C

1900F (1038C) + Warm oil quench

440F

1900F (1038C) + Warm oil quench

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.

3.2 TypeWhere applicable, the commercially recognized type of stainless steel is included in Tables 5 and 6. 4. Ordering Information 4.1 Inquiries and orders for material under this specication shall include the following information as agreed upon by purchaser and supplier:
2

4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7

Quantity (weight or number of pieces), Classication, optional, Type, Form, Condition (see 5.1), Finish (see 5.3), Mechanical properties or hardness, and

F 899 09
TABLE 3 Examples of Selected Stainless Steels That Have Been Used for Surgical Instruments in Accordance with ISO 7153/1
Type 303 304 410 420A Cutting Instruments Chisels and gouges, bone curettes Non-Cutting Instruments probes retractors tissue, forceps, dressing forceps, retractors, probes forceps, retractors, probes, forceps with bow handles, branch forceps

420B 420C

420 Mod

Bone rongeurs, conchotomes, bone cutting forceps, chisels and gouges, bone curettes, scissors with carbide inserts bone rongeurs, scissors scissors, bone rongeurs, bone cutting forceps, conchotomes, scalpels, knives, bone curettes, chisels and gouges bone rongeurs, conchotomes, bone cutting forceps, chisels and gouges, bone curettes, scissors with carbide inserts, scissors, scalpels, knives

tissue 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
Type 302 303
A

Cutting Instruments knives, chisels, gouges, curettes chisels, curettes, knives

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 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

304 316 410 410X 416A 420B

420FA 431 440C 420 Mod

chisels, curettes, dissectors, osteotomes, reamers, scissors with inserts curettes, dissectors, rongeurs chisels, curettes, dissectors chisels, curettes, cutters, bone cutting forceps, knives, scissors, rongeurs, scalpels, skin punches, conchotomes cutters chisels, knives, osteotomes, scalpels chisels, curettes, cutters, bone cutting forceps, knives, scissors, rongeurs, scalpels, skin punches, conchotomes, ostoetomes, reamers reamers scissors reamers, rasps reamers, scissors, rasps, knives

630 XM-16 XM-13 S46500

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.

4.1.8 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number. 5. Manufacture 5.1 ConditionStainless steels shall be furnished to the purchaser, as specied, in the hot-nished, cold-nished, annealed, solution-treated, solution-treated and aged, quenchhardened and tempered, or as specied 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 specied 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 compo3

sition and size, are furnished suitable for cold cutting when so specied 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 nish available for bar and wire products are cold drawn, pickled, ground, ground and polished, or as specied in the purchase order. 6. General Requirements for Delivery 6.1 In addition to the chemistry requirements of this specication, all requirements of the current editions of Specications A 276, A 314, A 480/A 480M, A 484/A 484M, A 555/ A 555M, A 564/A 564M, A 582/A 582M, and A 751 shall apply where applicable, as agreed upon between purchaser and supplier.

F 899 09
TABLE 5 Composition of Class 3, Austenitic Stainless Steels, %
UNS S30100 S30200 S30300 S30400 S31600 S31700 S30430 S28200 301 302 303 304 316 317 XM-7 Type Carbon, max 0.15 0.15 0.12A 0.07A 0.07A 0.08 0.1 0.15 Manganese 2.00 2.00 2.00 2.00 2.00 max max max max max Phosphorus, max 0.045 0.045 0.06A 0.045 0.045 0.045 0.045 0.040 Sulfur 0.030 max 0.030 max 0.150.35A 0.030 max 0.030 max 0.030 max 0.030 max 0.04 max Silicon, max 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 Chromium 16.0018.00 17.0019.00 17.0019.00 17.0019.00A 16.5018.50A 18.0020.00 17.0019.00 17.0019.00 Nickel 6.008.00 8.0010.00 8.0010.00 8.0011.00A 10.5013.50A 11.0015.00 8.0010.00 Other Elements 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

2.00 max 2.00 max 17.0019.00

S20161 S20162 S21800

A

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

Denotes more restrictive limit than UNS.

TABLE 6 Composition of Class 6, Ferritic Stainless Steels, %

UNS S43020 S18200
A

Type 430 F XM-34

Carbon, max 0.08A 0.08

Manganese, max 1.25 1.252.5A

Phosphorus, max 0.06 0.04

Sulfur 0.150.35A 0.280.41A

Silicon, Max 1.00 1.00

Chromium 16.0018.00 17.5019.50

Other Elements Mo 0.60 max Ni 1.00 maxA Mo 1.502.50

Denotes more restrictive limit than UNS.

6.2 This specication compliments the ISO applicable document covering stainless steel for surgical instruments and, by reference, includes all of the stainless grades in ISO 7153/1. 7. Chemical Requirements 7.1 The heat analysis shall conform to the requirements as to chemical composition specied 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. In order to ensure consistency in the materials used for the manufacture of surgical instruments, compositional limits tighter than typical UNS limits have been established for certain elements (as denoted by an asterisk). For example, more restrictive carbon and sulfur limits are specied in Table 7. 7.3 The chemical composition requirements for Types 301, 303, 304, 316, 410, 420A, 420B, 420C, and 430F also meet the composition requirements in ISO 7153/1.

TABLE 7 Composition of Class 4, Martensitic Stainless Steels, %

UNS S41000 S41000 S41600 S41600 S42000 S42000 S42000 Type 410 410X 416 416 Mod 420A 420B 420 Mod CarbonA 0.090.15A 0.160.21A 0.090.15A 0.090.15A 0.160.25A 0.260.35A 0.370.45A Manganese Phosphorus Max Max 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 SulfurA 0.030 max 0.030 max 0.150.27A 0.280.41A 0.030 max 0.030 max 0.005 max Silicon Max 1.00 1.00 1.00 1.00 1.00 1.00 0.60 Chromium 11.5013.50 11.5013.50 12.0014.00 12.0014.00 12.0014.00 12.0014.00 15.0016.50 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

S42000 S42000 S42020

420X 420C 420F 420F Mod

0.360.41A 0.420.50A 0.300.40A 0.200.26A 0.330.43 0.20 max 0.600.75 0.750.95 0.951.20 0.951.20 0.150.30

1.00 1.00 1.25 2.00 1.00 1.00 1.00 1.00 1.00 1.25 1.00

0.04 0.04 0.06 0.04 0.03 0.04 0.04 0.04 0.04 0.06 0.04

0.030 max 0.030 max 0.200.34A 0.150.27A 0.030 max 0.030 max 0.030 max 0.030 max 0.030 max 0.150.27A 0.03

1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00

12.0014.50 12.5014.50 12.5014.00 12.5014.00 12.514.5 15.0017.00 16.0018.00 16.0018.00 16.0018.00 16.0018.00 13.515.0

S42026 S43100 S44002 S44003 S4404 S44020 S42010

A B

... 431 440A 440B 440C 440F

Denotes more restrictive limit than UNS. Optional per UNS designation.

F 899 09
TABLE 8 Composition of Class 5, Precipitation Hardening Stainless Steels, %
UNS S17400 S17700 S45000 S45500 S13800 Type 630 631 XM-25 XM-16 XM-13 Carbon, max 0.07 0.09 0.05 0.03 0.05 Manganese, max 1.00 1.00 1.00 0.50 0.1A Phosphorus, max 0.040 0.040 0.030 0.015A 0.01A Sulfur, max 0.030 0.030 0.030 0.015A 0.008 Silicon, max 1.00 1.00 1.00 0.50 0.10 Chromium Nickel Copper 3.005.00 ... 1.251.75 1.502.50 ... Nb+Ta 0.150.45 ... ... 0.100.50 ... Other Elements ... 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

15.0017.50 3.005.00 16.0018.00 6.507.75 14.0016.00 5.007.00 11.0012.50 7.509.50 12.2513.25 7.508.50

S46500

0.02

0.25

0.015

0.010

0.25

11.0012.50 10.7511.25

...

...

S46910
A

0.030

1.00

0.030

0.015

0.70

11.013.0

8.010.0

1.53.5

Denotes more restrictive limit than UNS.

7.4 Methods and practices relating to chemical analysis required by this specication shall be in accordance with Test Methods, Practices, and Terminology A 751. 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 specied 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 specied. 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. 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. 9.3 Heat treating guidelines for Class 5 precipitation hardening stainless steels are included in Specication A 564/ A 564M.

9.4 Specifying a hardness requirement appropriate for the selected alloy and intended application is the responsibility of the purchaser. 10. Special Information 10.1 Some examples of selected stainless steels that have been used for various surgical instrument applications are listed in Table 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 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.

11. Quality Program Requirements 11.1 The supplier shall maintain a quality program, such as dened in ASQ C1 and ISO 9001. 11.2 The purchaser may audit the suppliers quality program for conformance to the intent of ASQ C1, or other recognized program. 12. Keywords 12.1 austenitic; ferritic; instruments; martensitic; precipitation hardenable; stainless steel; surgical

APPENDIX
(Nonmandatory Information) X1. STATEMENT OF RATIONALE FOR SPECIFICATION F 899

X1.1 The primary reason for this specication is to characterize composition requirements to ensure consistency in wrought materials used directly or modied by forging in the manufacture of stainless steel surgical instruments. Mechanical property requirements are not contained specically within this

specication. Those requirements are found in the appropriate specications as referenced in section 2.1. X1.2 The chemical compositions of certain grades covered by this specication have been modied in order to meet the

F 899 09
composition requirements in the most recent ISO 7153/1 standard for stainless steels used in the manufacture of surgical instruments. X1.3 Carbon and sulfur limits have been modied to provide an extra measure of uniformity for certain Class 4 stainless steel compositions used in the manufacture of surgical instruments. X1.4 Acceptable metal conditions supplied to the instrument manufacturer include hot-nished, cold-nished, 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 specication 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 specication since the martensitic grades are a very common class of stainless steel used for surgical instruments. Hardness and heat-treating guidelines for Class 5 martensitic precipitation hardening grades are included in specication A 564/ A 564M. 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 specications listed in 2.1, Referenced Documents. X1.9 ISO standards are listed for reference only. Although the ISO standards listed in section 2 are similar to the corresponding ASTM standards, they may not be identical. Use of an ISO standard in addition to or instead of a preferred ASTM standard may be negotiated between the purchaser and the supplier. X1.10 The committee responsible for this specication (F04.12) has adopted bylaws similar to the A01 committee regarding the addition of new alloys to this specication. In order to add a new alloy to this specication the following minimum requirements must be satised: X1.10.1 Provide statements from at least one user that the alloy to be added is commercially available and there is a need for inclusion in this specication. X1.10.2 Provide chemistry and mechanical property data from at least three commercial heats. X1.10.3 Recommend chemical, mechanical and any special processing requirements. X1.10.4 Inform the subcommittee if the grade or alloy is currently covered by patent.

SUMMARY OF CHANGES Committee F04 has identied the location of selected changes to this standard since the last issue (F 899 07) that may impact the use of this standard. (Approved Feb. 1, 2009.) (1) Added UNS S42026 to Table 1, Table 2, Table 4, and Table 7.
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