ASTM F899-12b

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 the 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-2012
• 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 F899-12a - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Dec-2012
• Replaced By: ASTM F899-19 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 15-Sep-2019
• 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-2012
• Referred By: ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
• Effective Date: 01-Dec-2012
• Referred By: ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 01-Dec-2012
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 01-Dec-2012
• Referred By: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Dec-2012
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 01-Dec-2012
• Referred By: ASTM F921-10(2018) - Standard Terminology Relating to Hemostatic Forceps
• Effective Date: 01-Dec-2012
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Dec-2012
• Referred By: ASTM F1078-10(2018) - Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
• Effective Date: 01-Dec-2012
• Referred By: ASTM F1026-86(2022) - Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
• Effective Date: 01-Dec-2012
• Referred By: ASTM F2062-00(2018) - Standard Specification for Square Drive Interconnections on Surgical Instruments
• Effective Date: 01-Dec-2012

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 −12b
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. Scope* A582/A582M Specification for Free-Machining Stainless
Steel Bars
1.1 This specification covers the chemistry requirements for
A751 Test Methods, Practices, and Terminology for Chemi-
wrought stainless steels used for the manufacture of surgical
cal Analysis of Steel Products
instruments. The data contained in Tables 1-4 of this
3
2.2 ISO Standards:
specification, including typical hardness values, common heat
ISO 7153/1 Instruments For Surgery—Metallic Materials—
treating cycles, and examples of selected stainless steels that
Part 1: Stainless Steel
have been used for surgical instruments, is provided for
ISO 9001 Quality Management Systems—Requirements
reference only. Mechanical property requirements, heat treat-
4
2.3 American Society for Quality (ASQ) Standard:
ing requirements, hardness requirements and all other require-
ASQ C1 Specification of General Requirements for a Qual-
ments except chemistry are governed by the appropriate
ity Program
material standards as referenced below or as agreed upon
between the purchaser and supplier.
3. Classification and Type
1.2 The values stated in inch-pound units are to be regarded
3.1 Classes—Stainless steel material requirements for sur-
as standard. The values given in parentheses are mathematical
gicalinstrumentsshallconformtooneofthefollowingclasses,
conversions to SI units that are provided for information only
as specified:
and are not considered standard.
3.1.1 Class 3—Austenitic Stainless Steel.
3.1.2 Class 4—Martensitic Stainless Steel.
2. Referenced Documents
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
2
2.1 ASTM Standards:
3.1.4 Class 6—Ferritic Stainless Steel.
A276 Specification for Stainless Steel Bars and Shapes
3.2 Type—Where applicable, the commercially recognized
A313/A313M Specification for Stainless Steel Spring Wire
type of stainless steel is included in Tables 5 and 6.
A314 Specification for Stainless Steel Billets and Bars for
Forging
4. Ordering Information
A480/A480M Specification for General Requirements for
Flat-Rolled Stainless and Heat-Resisting Steel Plate, 4.1 Inquiries and orders for material under this specification
Sheet, and Strip shall include the following information as agreed upon by the
A484/A484M Specification for General Requirements for purchaser and supplier:
Stainless Steel Bars, Billets, and Forgings 4.1.1 Quantity (weight or number of pieces),
A555/A555M Specification for General Requirements for 4.1.2 Classification, optional,
Stainless Steel Wire and Wire Rods 4.1.3 Type,
A564/A564M Specification for Hot-Rolled and Cold- 4.1.4 Form,
4.1.5 Condition (see 5.1),
Finished Age-Hardening Stainless Steel Bars and Shapes
4.1.6 Finish (see 5.3),
4.1.7 Mechanical properties or hardness, and
1
This specification is under the jurisdiction of ASTM Committee F04 on 4.1.8 Applicable dimensions including size, thickness,
Medical and Surgical Materials and Devices and is the direct responsibility of
width, and length (exact, random, or multiples) or drawing
Subcommittee F04.12 on Metallurgical Materials.
number.
Current edition approved Dec. 1, 2012. Published December 2012. Originally
approved in 1984. Last previous edition approved in 2012 as F899 – 12a. DOI:
10.1520/F0899-12B.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American 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 ----------------------
F899−12b
TABLE 1 Typical Maximum Hardness for Selected Class 4
7.2 Unified Numbering System (UNS) designations have
A
Martensitic Stainless Steels in The Annealed Condition
been added to Tables 5-8 to provide an easy cross reference to
Typical Maximum
acommonnumberingsystem.Inordertoensureconsistencyin
Type
B
Brinell Hardness
the materials used for the manufact
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: F899 − 12a F899 − 12b
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
This standard is issued under the fixed 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*
1.1 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 the 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 Nov. 1, 2012Dec. 1, 2012. Published December 2012. Originally approved in 1984. Last previous edition approved in 2012 as
F899 – 12.F899 – 12a. DOI: 10.1520/F0899-12A.10.1520/F0899-12B.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 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 − 12b
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
UNS S42027 255
431 285
440A 285
440B 285
440C 285
440F 285
UNS S42026 260
UNS S42010 235
A
Excludes billets and bars for forging.
B
Or equivalent Rockwell hardness.
4. Ordering Information
4.1 Inquiries and orders for material unde
...