Designation:F899–09
Standard Specification for
Wrought Stainless Steels for Surgical Instruments1
This standard is issued under thefixed designation F899;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*
1.1This specification covers the chemistry requirements for
wrought stainless steels used for the manufacture of surgical
instruments.The data contained in Tables1-4of this specifi-
cation,including typical hardness values,common heat treat-
ing cycles,and examples of selected stainless steels that have
been used for surgical instruments,is provided for reference
only.Mechanical property requirements,heat treating require-
ments,hardness requirements and all other requirements ex-
cept chemistry are governed by the appropriate material
standards as referenced below or as agreed upon between
purchaser and supplier.
1.2The 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
2.1ASTM Standards:2
A276Specification for Stainless Steel Bars and Shapes
A314Specification 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
A751Test Methods,Practices,and Terminology for
Chemical Analysis of Steel Products
2.2ISO Standards:3
ISO7153/1Instruments For Surgery—Metallic Materials—Part1:Stainless Steel
ISO9001Quality Management Systems—Requirements 2.3American Society for Quality(ASQ)Standard:4
ASQ C1Specification of General Requirements for a Qual-ity Program
3.Classification and Type
3.1Classes—Stainless steel material requirements for sur-gical instruments shall conform to one of the following classes, as specified:
3.1.1Class3—Austenitic Stainless Steel.
3.1.2Class4—Martensitic Stainless Steel.
3.1.3Class5—Precipitation Hardening Stainless Steel. 3.1.4Class6—Ferritic Stainless Steel.
1This specification is under the jurisdiction of ASTM Committee F04on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12on Metallurgical Materials.
Current edition approved Feb.1,2009.Published February2009.Originally approved in1984.Last previous edition approved in2007as F899–07.
2For referenced ASTM standards,visit the ASTM website,,or contact ASTM Customer Service at For Annual Book of ASTM Standards volume information,refer to the standard’s Document Summary page on the ASTM website.
3Available from American National Standards Institute(ANSI),25W.43rd St., 4th Floor,New York,NY10036,
4Available from American Society for Quality(ASQ),600N.Plankinton Ave., Milwaukee,WI53203,
TABLE1Typical Maximum Hardness for Selected Class4
Martensitic Stainless Steels in The Annealed Condition A
Type
Typical Maximum
Brinell Hardness B 410210
410X220
416262
416Mod262
420A220
420B235
420Mod255
420X262
420C262
420F262
420F Mod262
431285
440A285
440B285
440C285
440F285
UNS S4*******
UNS S4*******
A Excludes billets and bars for forging.
B Or equivalent Rockwell hardness.
*A Summary of Changes section appears at the end of this standard. Copyright©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959,United States.
3.2Type—Where applicable,the commercially recognized type of stainless steel is included in Tables5and6.
4.Ordering Information
4.1Inquiries and orders for material under this specification shall include the following information as agreed upon by purchaser and supplier:4.1.1Quantity(weight or number of pieces), 4.1.2Classification,optional,
4.1.3Type,
4.1.4Form,
4.1.5Condition(see
5.1),
4.1.6Finish(see
5.3),
4.1.7Mechanical properties or hardness,and
TABLE2Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class4Martensitic Stainless Steels 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 of750/1050°F(399/566°C)results in decreased impact strength and reduced corrosion resistance.
D Tempering over800°F(427°C)results in reduced corrosion resistance.
E Tempering above600°F(316°C)results in reduced toughness.
4.1.8Applicable dimensions including size,thickness, width,and length(exact,random,or multiples)or drawing number.
5.Manufacture
5.1Condition—Stainless steels shall be furnished to the purchaser,as specified,in the hot-finished,cold-finished, annealed,solution-treated,solution-treated and aged,quench-hardened and tempered,or as specified by the purchaser.(
Note that highly hardenable martensitic stainless billets and bars such as Types420A,420B,420C,420Mod,420F,420F Mod., 440A,440B,and440C intended for forging are commonly annealed prior to shipment and so specified in order to avoid the possibility of thermal cracking.Other hardenable marten-sitic grades such as Types403,410,416,416Mod.,and431, which also may require annealing,depending on their compo-sition and size,are furnished suitable for cold cutting when so specified on the purchase order.)
5.2Conditioning—Billet and bar intended for forging may be conditioned by chipping,grinding,or other suitable means to remove injurious surface defects.
5.3Finish—Types offinish available for bar and wire products are cold drawn,pickled,ground,ground and polished, or as specified in the purchase order.
6.General Requirements for Delivery
6.1In addition to the chemistry requirements of this speci-fication,all requirements of the current editions of Specifica-tions A276,A314,A480/A480M,A484/A484M,A555/ A555M,A564/A564M,A582/A582M,and A751shall apply where applicable,as agreed upon between purchaser and supplier.
TABLE3Examples of Selected Stainless Steels That Have Been Used for Surgical Instruments in Accordance with ISO7153/1 Type Cutting Instruments Non-Cutting Instruments
303Chisels and gouges,bone curettes probes
304retractors
410tissue,forceps,dressing forceps,retractors,
probes
420A Bone rongeurs,conchotomes,bone cutting
forceps,chisels and gouges,bone curettes,
scissors with carbide inserts forceps,retractors,probes,forceps with bow handles,branch forceps
420B bone rongeurs,scissors
420C scissors,bone rongeurs,bone cutting forceps,
conchotomes,scalpels,knives,bone curettes,
chisels and gouges
420Mod 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
TABLE4Examples of Selected Stainless Steels That Have Been Used For Surgical Instruments in the United States Type Cutting Instruments Non-Cutting Instruments
302knives,chisels,gouges,curettes cannula,forceps,guides,needle vents,retractors,specula,spreaders,tendor
passers,springs
303A chisels,curettes,knives cannula,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 inserts clamps,clip applicators,elevators,forceps,hemostats,holders,needle holders,punches,retractors,skin hooks,sounds,spreaders,probes,dilators
410X curettes,dissectors,rongeurs clamps,forceps,hemostats,holders,punches,retractors 416A chisels,curettes,dissectors clamps,punches,retractors,skin hooks,spreaders
420B chisels,curettes,cutters,bone cutting forceps,
knives,scissors,rongeurs,scalpels,skin punches,
conchotomes clamps,elevators,punches,rounds,dissectors,retractors,skin hooks, needles
420F A cutters burrs
431cheek retractors,insertion wrenches,orthopeadic instruments 440C chisels,knives,osteotomes,scalpels drills,retractors,spreaders,tongs
420Mod chisels,curettes,cutters,bone cutting forceps,
knives,scissors,rongeurs,scalpels,skin punches,
conchotomes,ostoetomes,reamers clamps,elevators,punches,rounds,dissectors,retractors,skin hooks, needles,cheek retractors,insertion wrenches,orthopaedic instruments,drills, spreaders,tongs,screwdrivers
630reamers
XM-16scissors drills,needles
XM-13reamers,rasps
S46500reamers,scissors,rasps,knives 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
1038grades 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 section10.1)
B Types420A,420B,420C,or UNS S42026may be used depending on instrument design and application.
C Types440A,440B,or440C may be used depending on instrument design and application.
6.2This specification 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
7.1The heat analysis shall conform to the requirements as to chemical composition specified in Tables 5-8.
7.2UNS designations have been added to Tables 5-8to 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 specified in Table 7.
7.3The 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 5Composition of Class 3,Austenitic Stainless Steels,%
UNS Type
Carbon,max Manganese Phosphorus,
max
Sulfur Silicon,max Chromium Nickel Other Elements S301003010.15 2.00max 0.0450.030max 1.0016.00–18.00 6.00–8.00—
S302003020.15 2.00max 0.0450.030max 1.0017.00–19.008.00–10.00N 0.10max A S303003030.12A 2.00max 0.06A 0.15–0.35A 1.0017.00–19.008.00–10.00Mo 0.70max A S304003040.07A 2.00max 0.0450.030max 1.0017.0
0–19.00A 8.00–11.00A N 0.10max A S316003160.07A 2.00
max
0.0450.030max 1.0016.50–18.50A 10.50–13.50A Mo 2.00–2.50A N 0.10max A S317003170.08 2.00max 0.0450.030max 1.0018.00–20.0011.00–15.00Mo 3.00–4.00N 0.10max A S30430XM-7
0.1 2.00max 0.0450.030max 1.0017.00–19.008.00–10.00
Cu 3.00–4.00S28200
0.15
17.00–19.00
0.040
0.04max
1.00
17.00–19.00
—
Mo 0.75–1.25Cu 0.75–1.25N 0.40–0.60S201610.15 4.0–6.00.0450.030 3.0–4.015.00–18.00 4.0–6.0N 0.08–0.20S201620.15 4.0–8.00.0400.040 2.5–4.516.50–21.00 6.0–10.0N 0.05–0.25S21800
0.107.0–9.00.0600.030 3.5–4.516.0–18.08.0–9.0
N 0.08–0.18
A
Denotes more restrictive limit than UNS.
TABLE 6Composition of Class 6,Ferritic Stainless Steels,%
UNS Type Carbon,max Manganese,
max
Phosphorus,
max
Sulfur Silicon,Max Chromium Other Elements S4*******F 0.08A 1.250.060.15–0.35A 1.0016.00–18.00Mo 0.60max Ni 1.00max A S18200
XM-34
0.08
1.25–
2.5A
0.04
0.28–0.41A
1.00
17.50–19.50
Mo 1.50–2.50
A
Denotes more restrictive limit than UNS.
TABLE 7Composition of Class 4,Martensitic Stainless Steels,%
UNS Type
Carbon A Manganese Max Phosphorus
Max
Sulfur A
Silicon Max Chromium Other S410004100.09–0.15A 1.000.040.030max 1.0011.50–13.50Ni 1.00max A S4*******X 0.16–0.21A 1.000.040.030max 1.0011.50–13.50Ni 1.00max A
S4*******
0.09–0.15A 1.250.060.15–0.27A 1.0012.00–S4*******Mod 0.09–0.15A 1.250.060.28–0.41A 1.0012.00–
S4*******A 0.16–0.25A 1.000.040.030max 1.0012.00–14.00Ni 1.00max A S4*******B 0.26–0.35A 1.000.040.030ma
x 1.0012.00–14.00Ni 1.00max A S42000
420Mod
0.37–0.45A
0.60
0.02
0.005max
0.60
15.00–16.50
Mo 1.50–1.90V 0.20–0.40N 0.16–0.25S42000420X 0.36–0.41A 1.000.040.030max 1.0012.00–14.50Ni 1.00max A S4*******C 0.42–0.50A 1.000.040.030max 1.0012.50–14.50Ni 1.00max A S4*******F 0.30–0.40A 1.250.060.20–0.34A 1.0012.50–14.00Cu 0.60max B Ni 0.50max B 420F Mod
0.20–0.26A 2.000.040.15–0.27A 1.0012.50–14.00Mo 1.10–1.50Ni 0.75–0.33–0.43 1.000.030.030ma
x 1.0012.5–14.5Ni 1.00max Mo 0.8–1.2S431004310.20max 1.000.040.030max 1.0015.00–17.00Ni 1.25–2.50S44002440A 0.60–0.75 1.000.040.030max 1.0016.00–18.00Mo 0.75max S4*******B 0.75–0.95 1.000.040.030max 1.0016.00–18.00Mo 0.75max S4404440C 0.95–1.20 1.000.040.030max 1.0016.00–18.00Mo 0.75max S4*******F
0.95–1.20 1.250.060.15–0.27A 1.0016.00–18.00Cu 0.60max B Ni 0.50max B S42010
0.15–0.30
1.00
0.04
0.03
1.00
13.5–15.0
Ni 0.35–0.85Mo 0.40–0.85
A Denotes more restrictive limit than UNS.B
Optional per UNS designation.
7.4Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods,Practices,and Terminology A 751.
8.Mechanical Requirements
8.1Material 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.
8.2When 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 4martensitic stainless steels in the annealed condition are listed in Table 1.These typical hardness values are provided for reference only.
9.Heat Treatment
9.1Material shall be heat treated per the applicable refer-enced ASTM standard (see 2.1)for the selected stainless steel.9.2Commonly used heat treating cycles guidelines and the resulting typical hardness values for selected Class 4marten-sitic stainless steels are listed in Table 2and are provided for reference only.
9.3Heat treating guidelines for Class 5precipitation hard-ening stainless steels are included in Specification A 564/A 564M .
9.4Specifying a hardness requirement appropriate for the selected alloy and intended application is the responsibility of the purchaser.
10.Special Information
10.1Some examples of selected stainless steels that have been used for various surgical instrument applications are listed in Table 3and Table 4for information purposes.
N OTE 1—Re-sulphurized free-machining grades can exhibit lower gen-eral 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
11.1The supplier shall maintain a quality program,such as defined in ASQ C1and ISO 9001.
11.2The purchaser may audit the supplier’s quality program for conformance to the intent of ASQ C1,or other recognized program.12.Keywords
12.1austenitic;ferritic;instruments;martensitic;precipita-tion hardenable;stainless steel;surgical
APPENDIX
(Nonmandatory Information)
X1.STATEMENT OF RATIONALE FOR SPECIFICATION F 899
X1.1The primary reason for this specification is to char-acterize 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.
X1.2The chemical compositions of certain grades covered by this specification have been modified in order to meet the
TABLE 8Composition of Class 5,Precipitation Hardening Stainless Steels,%
UNS Type Carbon,max Man-ganese,max Phos-phorus,max Sulfur,max Silicon,max Chromium
Nickel
Copper Nb+Ta Other Elements S174006300.07 1.000.0400.030 1.0015.00–17.50 3.00–5.00 3.00–5.000.15–
S177006310.09 1.000.0400.030 1.0016.00–18.00 6.50–Al 0.75–1.50S45000XM-250.05 1.000.0300.030 1.0014.00–16.00 5.00–7.00 1.25–Mo 0.50–1.00Cb 8x C min S45500XM-160.030.500.015A 0.015A 0.5011.00–12.507.50–9.50 1.50–2.50
0.10–0.50
Ti 0.90–1.40Mo 0.50max S13800
XM-13
0.05
0.1A
0.01A
0.008
0.10
12.25–13.257.50–8.50
...
...
Al 0.90–1.35Mo 2.00–2.50N 0.01max S465000.020.250.0150.0100.2511.00–12.5010.75–
Ti 1.50–1.80Mo 0.75–1.25N .01max S46910
0.030 1.000.0300.0150.7011.0–13.08.0–10.0 1.5–3.5
Al 0.15–0.50
A
Denotes more restrictive limit than
UNS.
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