ASTM F899-10

Standard Specification for Wrought Stainless Steels for Surgical Instruments

ABSTRACT
This specification covers the chemical requirements for wrought stainless steels used for the manufacture of surgical instruments. Classes of stainless steels covered here are Class 3 (austenitic stainless steel), Class 4 (martensitic stainless steel), Class 5 (precipitation hardening stainless steel), and Class 6 (ferritic stainless steel). The data contained in this specification, such as typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, are provided for reference only. Mechanical property, heat treatment, hardness, and all other requirements except for chemical composition, are governed by the appropriate material standards as specified or as agreed upon between purchaser and supplier.
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.

General Information

• Status: Historical
• Publication Date: 30-Nov-2010
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F899-09e1 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Dec-2010
• Replaced By: ASTM F899-11 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Mar-2011
• Referred By: ASTM F1026-86(2022) - Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
• Effective Date: 01-Dec-2010
• Referred By: ASTM F921-10(2018) - Standard Terminology Relating to Hemostatic Forceps
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 01-Dec-2010
• Referred By: ASTM F2062-00(2018) - Standard Specification for Square Drive Interconnections on Surgical Instruments
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1078-10(2018) - Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
• Effective Date: 01-Dec-2010
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 01-Dec-2010
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 01-Dec-2010

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F899 – 10
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
ThisstandardisissuedunderthefixeddesignationF899;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
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.
TABLE 1 Typical Maximum Hardness for Selected Class 4
1. Scope*
A
Martensitic Stainless Steels in The Annealed Condition
1.1 This specification covers the chemistry requirements for
Typical Maximum
Type
wrought stainless steels used for the manufacture of surgical
B
Brinell Hardness
instruments. The data contained in Tables 1-4 of this specifi-
410 210
cation, including typical hardness values, common heat treat-
410X 220
ing cycles, and examples of selected stainless steels that have 416 262
416 Mod 262
been used for surgical instruments, is provided for reference
420A 220
only. Mechanical property requirements, heat treating require-
420B 235
420 Mod 255
ments, hardness requirements and all other requirements ex-
420X 262
cept chemistry are governed by the appropriate material
420C 262
standards as referenced below or as agreed upon between
420F 262
420F Mod 262
purchaser and supplier.
431 285
1.2 The values stated in inch-pound units are to be regarded
440A 285
as standard. The values given in parentheses are mathematical
440B 285
440C 285
conversions to SI units that are provided for information only
440F 285
and are not considered standard.
UNS S42026 260
UNS S42010 235
2. Referenced Documents
A
Excludes billets and bars for forging.
2
B
2.1 ASTM Standards: Or equivalent Rockwell hardness.
A276 Specification for Stainless Steel Bars and Shapes
A313/A313M Specification for Stainless Steel Spring Wire
A751 Test Methods, Practices, andTerminology for Chemi-
A314 Specification for Stainless Steel Billets and Bars for
cal Analysis of Steel Products
Forging
3
2.2 ISO Standards:
A480/A480M Specification for General Requirements for
ISO 7153/1 Instruments For Surgery—Metallic Materials—
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
Part 1: Stainless Steel
Sheet, and Strip
ISO 9001 Quality Management Systems—Requirements
A484/A484M Specification for General Requirements for 4
2.3 American Society for Quality (ASQ) Standard:
Stainless Steel Bars, Billets, and Forgings
ASQ C1 Specification of General Requirements for a Qual-
A555/A555M Specification for General Requirements for
ity Program
Stainless Steel Wire and Wire Rods
A564/A564M Specification for Hot-Rolled and Cold-
3. Classification and Type
Finished Age-Hardening Stainless Steel Bars and Shapes
3.1 Classes—Stainless steel material requirements for sur-
A582/A582M Specification for Free-Machining Stainless
gicalinstrumentsshallconformtooneofthefollowingclasses,
Steel Bars
as specified:
3.1.1 Class 3—Austenitic Stainless Steel.
1
This specification is under the jurisdiction of ASTM Committee F04 on 3.1.2 Class 4—Martensitic Stainless Steel.
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
Subcommittee F04.12 on Metallurgical Materials.
3.1.4 Class 6—Ferritic Stainless Steel.
Current edition approved Dec. 1, 2010. Published December 2010. Originally
´1
approved in 1984. Last previous edition approved in 2009 as F899 – 09 . DOI:
10.1520/F0899-10.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. 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.
1

---------------------- Page: 1 ----------------------
F899 – 10
TABLE 2 Typical Heat Treating Cycles and Resultant Hardness Values for Selected Class 4 Martensitic Stainless Steels
Typical Hardness at Typical Hardness at
A Indicated Tempering A Indicated Tempering
Typical Hardening Typical Hardening
B B
Type Type
Temperature Temperature
Heat Treatment Heat Treatment
°F °C (HRC) °F °C (HRC)
410 1850°F (1010°C) + 500 260 43 420C 1900°F (1038°C) + 300 149 58
Oil quench 700 371 43 Warm oil quench 400 204 55/56
C
or air cool 900 482 42 500 260 53/54
C
1000 538 30 600 315 53/54
1100 593 24 700 371 54/55
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:F899–09 Designation: F899 – 10
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
ThisstandardisissuedunderthefixeddesignationF899;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
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
´ NOTE—“Other Elements” in Table8 were corrected editorially in April 2010.
1. Scope*
1.1 This specification covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical
instruments.The data contained inTables 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
propertyrequirements,heattreatingrequirements,hardnessrequirementsandallotherrequirementsexceptchemistryaregoverned
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
2.1 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
3
2.2 ISO Standards:
ISO 7153/1 Instruments For Surgery—Metallic Materials—Part 1: Stainless Steel
ISO 9001 Quality Management Systems—Requirements
4
2.3 American Society for Quality (ASQ) Standard:
ASQ C1 Specification of General Requirements for a Quality Program
3. Classification and Type
3.1 Classes—Stainless steel material requirements for surgical instruments shall conform to one of the following classes, as
specified:
3.1.1 Class 3—Austenitic Stainless Steel.
3.1.2 Class 4—Martensitic Stainless Steel.
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
3.1.4 Class 6—Ferritic Stainless Steel.
3.2 Type—Where applicable, the commercially recognized type of stainless steel is included in Tables 5 and 6.
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 Feb. 1, 2009. Published February 2009. Originally approved in 1984. Last previous edition approved in 2007 as F899–07. DOI:
10.1520/F0899-09E01.
´1
Current edition approved Dec. 1, 2010. Published December 2010. Originally approved in 1984. Last previous edition approved in 2009 as F899 – 09 . DOI:
10.1520/F0899-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book ofASTM Standards
volume information, refer to the standard’s 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.
1

---------------------- Page: 1 ----------------------
F899 – 10
TABLE 1 Typical Maximum Hardness for Selected Class 4
A
Martensitic Stainless Steels in The Annealed Condition
Typical Maximum
Type
B
Brinell Hardness
410 210
410X 220
416 262
416 Mod 262
420A 220
420B 235
420 Mod 255
420X 262
420C 262
420F 262
420F Mod 262
431 285
440A 285
440B 285
440C 285
440F 285
UNS S42026 260
...