ASTM F899-02

Standard Specification for Stainless Steel for Surgical Instruments

SCOPE
1.1 This specification covers the requirements for stainless steel billet, bar, and wire used for the manufacture of surgical instruments. Billet or bar intended for forging into special shapes may also be purchased in accordance with this specification.

General Information

• Status: Historical
• Publication Date: 09-Apr-2002
• 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 F899-95 - Standard Specification for Stainless Steel for Surgical Instruments
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F899-07 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2007
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 10-Apr-2002
• Referred By: ASTM F921-10(2018) - Standard Terminology Relating to Hemostatic Forceps
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1079-87(2022) - Standard Specification for Inserted and Noninserted Surgical Scissors
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2062-00(2018) - Standard Specification for Square Drive Interconnections on Surgical Instruments
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1026-86(2022) - Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1078-10(2018) - Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
• Effective Date: 10-Apr-2002

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 – 02
Standard Specification for
1
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.
1. Scope* 3. Classification and Type
1.1 This specification covers the requirements for stainless 3.1 Classes—Stainless steel material requirements for sur-
steels used for the manufacture of surgical instruments. gicalinstrumentsshallconformtooneofthefollowingclasses,
as specified:
2. Referenced Documents
3.1.1 Class 3—Austenitic Stainless Steel.
2.1 ASTM Standards: 3.1.2 Class 4—Martensitic Stainless Steel.
A 276 Specification for Stainless and Heat-Resisting Steel
3.1.3 Class 5—Precipitation Hardening Stainless Steel.
2
Bars and Shapes 3.1.4 Class 6—Ferritic Stainless Steel.
A 314 Specification for Stainless and Heat-Resisting Steel
3.2 Type—Where applicable, the commercially recognized
2
Billets and Bars for Forging type of stainless steel is included in Tables 1 and 2.
A 480/A 480M Specification for General Requirements for
3
4. Ordering Information
Stainless and Heat-Resisting Steel Plate, Sheet, and Strip
A 484/A484M Specification for General Requirements for 4.1 Inquiries and orders for material under this specification
2
Stainless and Heat-Resisting Bars, Billets, and Forgings shall include the following information:
A 555/A555M Specification for General Requirements for 4.1.1 Quantity (weight or number of pieces),
3
Stainless and Heat-Resisting Steel Wire and Wire Rods 4.1.2 Classification, optional,
A 564 Specification for Hot-Rolled and Cold-FinishedAge- 4.1.3 Type,
Hardening Stainless and Heat-Resisting Steel Bars and 4.1.4 Form,
2
Shapes 4.1.5 Condition,
A 582 SpecificationforFree-MachiningStainlessandHeat- 4.1.6 Finish,
2
Resisting Steel Bars, Hot-Rolled or Cold-Finished 4.1.7 Mechanical properties or hardness, and
A 751 Test Methods, Practices, and Terminology for 4.1.8 Applicable dimensions including size, thickness,
3
Chemical Analysis of Steel Products width, and length (exact, random, or multiples) or drawing
2.2 ISO Standard: number.
ISO 7153/1 Instruments For Surgery—Metallic Materials—
4 5. Manufacture
Part 1: Stainless Steel
5.1 Condition—Stainless steels shall be furnished to the
2.3 American Society for Quality (ASQ) Standard:
C1 Specification of General Requirements for a Quality purchaser, as specified, in the hot finished, cold finished,
5
annealed, solution treated, solution treated and aged, quench
Program
hardened, quench hardened and tempered, or as specified by
the purchaser. (Warning—Highly hardenable martensitic
1
This specification is under the jurisdiction of ASTM Committee F04 on
stainless billets and bars such asTypes 420A, 420B, 420C, 420
Medical and Surgical Materials and Devices and is the direct responsibility of
Mod, 420F, 420F Mod., 440A, 440B, and 440C intended for
Subcommittee F04.12 on Metallurgical Materials.
forging are commonly annealed prior to shipment and so
Current edition approved Apr. 10, 2002. Published June 2002. Originally
published as F 899 – 84. Last previous edition F 899 – 95.
specified in order to avoid the possibility of thermal cracking.
2
Annual Book of ASTM Standards, Vol 01.05.
Other hardenable martensitic grades such as Types 403, 410,
3
Annual Book of ASTM Standards, Vol 01.03.
4 416, 416 Mod., and 431, which also may require annealing,
Available from American National Standards Institute, 25 W. 43rd St., 4th
Floor, New York, NY 10036. depending on their composition and size, are furnished suitable
5
Available fromAmerican Society for Quality Control, 600 N. PlankintonAve.,
for cold cutting when so specified on the purchase order.)
Milwaukee, WI 53203.
*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.
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F899–02
TABLE 1 Composition of Class 3, Austenitic Stainless Steels, %
Carbon, Phosphorus, Silicon, Other
Type Manganese Sulfur Chromium Nickel
max max max Elements
301 0.15 2.00 max 0.045 0.030 max 1.00 16.00–18.00 6.00–8.00 —
302 0.15 2.00 max 0.045 0.030 max 1.00 17.00–19.00 8.00–10.00 N 0.10 max
A
303 0.12 2.00 max 0.060 0.15–0.35 1.00 17.00–19.00 8.00–10.00 Mo 0.70 max
304 0.07 2.00 max 0.045 0.030 max 1.00 17.00–19.00 8.00–11.00 N 0.10 max
316 0.07 2.00 max 0.045 0.030 max 1.00 16.50–18.50 10.50–13.50 Mo 2.00–2.50
N0.10max
317 0.08 2.00 max 0.045 0.030 max 1.00 18.00–20.00 11
...