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ASTM F899-07

(Specification)

Standard Specification for Wrought Stainless Steels for Surgical Instruments

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 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.

General Information

Status
Historical
Publication Date
31-Jan-2007
ICS
11.040.30 - Surgical instruments and materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F899-02 - Standard Specification for Stainless Steel for Surgical Instruments
Effective Date
01-Feb-2007
Replaced By
ASTM F899-09 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Feb-2009
Referred By
ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
Effective Date
01-Feb-2007
Referred By
ASTM F1611-20 - Standard Specification for Intramedullary Reamers
Effective Date
01-Feb-2007
Referred By
ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
Effective Date
01-Feb-2007
Referred By
ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
Effective Date
01-Feb-2007
Referred By
ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
Effective Date
01-Feb-2007
Referred By
ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
Effective Date
01-Feb-2007
Referred By
ASTM F1026-86(2022) - Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
Effective Date
01-Feb-2007
Referred By
ASTM F921-10(2018) - Standard Terminology Relating to Hemostatic Forceps
Effective Date
01-Feb-2007
Referred By
ASTM F2062-00(2018) - Standard Specification for Square Drive Interconnections on Surgical Instruments
Effective Date
01-Feb-2007
Referred By
ASTM F1078-10(2018) - Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
Effective Date
01-Feb-2007
Referred By
ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
Effective Date
01-Feb-2007

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ASTM F899-07 - Standard Specification for Wrought Stainless Steels for Surgical InstrumentsASTM F899-07 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
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ASTM F899-07 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
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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: F 899 – 07
Standard Specification for
1
Wrought Stainless Steels for Surgical Instruments
This standard is issued under the fixed 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 (e) 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
440A 285
2. Referenced Documents
440B 285
2
440C 285
2.1 ASTM Standards:
440F 285
A 276 Specification for Stainless Steel Bars and Shapes
UNS42010 235
A 314 Specification for Stainless Steel Billets and Bars for
A
Excludes billets and bars for forging.
Forging B
Or equivalent Rockwell hardness.
A 480/A 480M Specification for General Requirements for
3
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
2.2 ISO Standards:
Sheet, and Strip
ISO 7153/1 Instruments For Surgery—Metallic Materials—
A 484/A 484M Specification for General Requirements for
Part 1: Stainless Steel
Stainless Steel Bars, Billets, and Forgings
ISO 9001 Quality Management Systems—Requirements
A 555/A 555M Specification for General Requirements for 4
2.3 American Society for Quality (ASQ) Standard:
Stainless Steel Wire and Wire Rods
ASQ C1 Specification of General Requirements for a Qual-
A 564/A 564M Specification for Hot-Rolled and Cold-
ity Program
Finished Age-Hardening Stainless Steel Bars and Shapes
A 582/A 582M Specification for Free-Machining Stainless 3. Classification and Type
Steel Bars
3.1 Classes—Stainless steel material requirements for sur-
A 751 Test Methods, Practices, and Terminology for
gicalinstrumentsshallconformtooneofthefollowingclasses,
Chemical Analysis of Steel Products
as specified:
3.1.1 Class 3—Austenitic Stainless Steel.
3.1.2 Class 4—Martensitic Stainless Steel.
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. 3.1.4 Class 6—Ferritic Stainless Steel.
Current edition approved Feb. 1, 2007. Published March 2007. Originally
approved in 1984. Last previous edition approved in 2002 as F 899 – 02.
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 service@astm.org. 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 ----------------------
F899–07
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
D
410X 1875°F (1024°C) + 500 260 46 800 427 55
Oil quench 700 371 46/47 420F 1900°F (1038°C) + 300 149 52
C
or air cool 900 482 48 Warm oil quench 400 204 52
C
1000 538 44 500 260 50
1100 593 31 600 315 50
416 Mod 1800°F (982°C) + 300 149 38 700 371 49
D
Oil quench 500 260 37 800 427 4
...

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