The "ASTM F899-02 Standard Specification for Stainless Steels for Surgical Instruments," published by the American Society for Testing and Materials (ASTM), describes the requirements for stainless steels used in the manufacture of surgical instruments.
Stainless steel material requirements for surgical instruments must conform to one of the following classes as specified:
Where applicable, commercially recognized stainless steel type standards are shown in the corresponding tables.
Inquiries and orders for material covered by this specification must include the following information:
Stainless steels are supplied hot worked, cold worked, annealed, solution treated, solution treated and aged, quench hardened, quench hardened and tempered, or as specified by the purchaser. Highly hardenable martensitic stainless steel ingots and bars, such as Types 420A, 420B, 420C, 420 Mod, 420F, 420F Mod, 440A, 440B, and 440C, for forging purposes are generally annealed prior to shipment and are so specified to prevent the possibility of thermal cracking. Other hardenable martensitic grades, such as Types 403, 410, 416, 416 Mod, and 431, which may require annealing depending on their composition and size, are supplied suitable for cold cutting if specified in the purchase order.)
Billet and bar intended for forging may be conditioned by chipping, grinding or other suitable methods to remove detrimental surface defects.
Finish types available for rod and wire products are cold drawn, pickled, ground, polished and ground, or as specified on the purchase order.
In addition to the requirements of this standard, all the requirements of the standards “ASTM A484/A484M-21 Standard specification for general requirements for stainless steel bars, billets, and forgings” and “ASTM A555/A555M-97 Standard specification for general requirements for stainless steel wire and wire rods” apply.
This ASTM standard specification complements the ISO applicable document covering stainless steel for surgical instruments and includes by reference all stainless grades in “ISO 7153-1 Surgical instruments - Materials - Part 1: Metals”.
In terms of chemical requirements, the heat analysis must comply with the chemical composition requirements specified in the table within the standard. Restricted carbon and sulfur limits are specified for certain Class 4 martensitic stainless steels to ensure consistency in materials used in the manufacture of surgical instruments. The chemical composition requirements for Types 301, 303, 304, 316, 410, 420A, 420B, 420C and 430F also meet the composition requirements of the ISO 7153-1 standard.
The methods and practices related to chemical analysis required in this standard must comply with the "ASTM A751-21 Standard test methods and practices for chemical analysis of steel products" standard.
For mechanical requirements, the material shall conform to the mechanical property requirements specified in the appropriate ASTM standards or shall meet the mechanical property requirements specified by the purchaser. Brinell hardness number, Rockwell hardness, B scale, or Rockwell hardness, C scale, limits may be specified when desired. Hardness guidelines for selected Class 4 martensitic stainless steels in the annealed condition are listed in the table.
The material is heat treated as applicable for the particular stainless composition. Heat treatment guidelines and typical hardness values for selected Class 4 martensitic stainless steels are listed in the table. Heat treatment guidelines for Class 5 precipitation hardening stainless steels are found in ASTM A564/A564M-13.
Some examples of selected stainless steels used for various surgical instrument applications are listed in the tables included in the standard for informational purposes.
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