ASTM F1325-91(1996)
(Specification)Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
SCOPE
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: F 1325 – 91 (Reapproved 1996)
Standard Specification for
Stainless Steel Suture Needle Holders-General
Workmanship Requirements and Corresponding Test
Methods
This standard is issued under the fixed designation F 1325; 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 3.2 Definitions applicable to stainless steel suture needle
holders and the terms specified herein, shall be in accordance
1.1 This specification covers general workmanship aspects
with Definitions of Terms F 921.
of stainless steel suture needle holders intended for reuse in
surgery.
4. Materials
2. Referenced Documents 4.1 All component parts of the instrument other than the
modified working end shall be fabricated from martensitic
2.1 ASTM Standards:
stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F,
E 18 Test Methods for Rockwell Hardness and Rockwell
420F Mod, and 440B per Specification F 899 (see Note 1). The
Superficial Hardness of Metallic Materials
modified working end may be made of stellite, tungsten
E 92 Test Method for Vickers Hardness of Metallic Mate-
carbide, or other suitable material.
rials
E 140 Hardness Conversion Tables for Metals
NOTE 1—Free-machining grades of stainless steel are inappropriate for
F 899 Specification for Stainless Steel Billet, Bar, and Wire use due to their lower corrosion resistance and toughness.
for Surgical Instruments
3 5. Requirements
F 921 Definitions of Terms Relating to Hemostatic Forceps
F 1089 Test Method for Corrosion of Surgical Instruments 5.1 Heat treatment and hardness for component parts.
5.1.1 Stainless steel component parts of the instrument shall
3. Terminology
be heat treated under conditions recommended for the material
3.1 Definition: used.
3.1.1 modified working end—working surfaces possessing 5.1.2 The Rockwell hardness of an instrument with the
superior hardness characteristics which are either the result of working end not modified shall be 42 HRC to 52 HRC.
depositing various materials on the base metal or the result of Instruments where the working end has been modified shall
permanently securing an insert (such as by brazing) to the base have a modified working surface whose Rockwell hardness is
metal. A77 minimum.
3.1.2 Discussion—The typical method of modifying the 5.2 Corrosion Resistance—Holders with working ends not
working end of the suture needle holder is to use jaw inserts or modified shall be subjected to corrosion tests as specified in
to plasma deposit (flame plate) materials with improved wear Test Method F 1089. Holders with modified working ends shall
characteristics such as tungsten carbide or stellite. For the jaw be subject to corrosion tests as specified in Test Method F 1089
insert method, the insert is brazed to the jaw face with a except for the modifying material.
uniform deposit of silver solder which is free of crevices at all
6. Performance Requirements
interfaces. For the flame plating method, a uniform layer of
material is deposited which is 0.004 6 0.001 in. thick. 6.1 Needle retention test—From Table 1, select a n
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