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ASTM F1325-91(2008)

(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

ABSTRACT
This specification covers general workmanship and test method requirements of stainless steel suture needle holders intended for reuse in surgery. Materials of all component parts shall be fabricated from martensitic stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F, 420F Mod, and 440B. The material shall be heat treated and shall conform to the specified hardness, corrosion resistance, workmanship, finish, and appearance.
SCOPE
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.

General Information

Status
Historical
Publication Date
31-Jan-2008
ICS
11.040.30 - Surgical instruments and materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.33 - Medical/Surgical Instruments
Current Stage
Ref Project

Relations

Replaces
ASTM F1325-91(2002) - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
Effective Date
01-Feb-2008
Replaced By
ASTM F1325-91(2008)e1 - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
Effective Date
01-Feb-2008
Referred By
ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
Effective Date
01-Feb-2008

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ASTM F1325-91(2008) - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test MethodsASTM F1325-91(2008) - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
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ASTM F1325-91(2008) - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 1325 – 91 (Reapproved 2008)
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 insert method, the insert is brazed to the jaw face with a
uniform deposit of silver solder which is free of crevices at all
1.1 This specification covers general workmanship aspects
interfaces. For the flame plating method, a uniform layer of
of stainless steel suture needle holders intended for reuse in
material is deposited which is 0.004 6 0.001 in. thick.
surgery.
3.2 Definitions applicable to stainless steel suture needle
2. Referenced Documents holders and the terms specified herein, shall be in accordance
with Definitions of Terms F 921.
2.1 ASTM Standards:
E 18 Test Methods for Rockwell Hardness of Metallic
4. Materials
Materials
4.1 All component parts of the instrument other than the
E 92 Test Method for Vickers Hardness of Metallic Mate-
modified working end shall be fabricated from martensitic
rials
stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F,
E 140 Hardness ConversionTables for Metals Relationship
420F Mod, and 440B per Specification F 899 (see Note 1).The
Among Brinell Hardness, Vickers Hardness, Rockwell
modified working end may be made of stellite, tungsten
Hardness, Superficial Hardness, Knoop Hardness, and
carbide, or other suitable material.
Scleroscope Hardness
F 899 Specification for Wrought Stainless Steels for Surgi-
NOTE 1—Free-machining grades of stainless steel are inappropriate for
cal Instruments
use due to their lower corrosion resistance and toughness.
F 921 Terminology Relating to Hemostatic Forceps
5. Requirements
F 1089 Test Method for Corrosion of Surgical Instruments
5.1 Heat treatment and hardness for component parts.
3. Terminology
5.1.1 Stainless steel component parts of the instrument shall
3.1 Definition: be heat treated under conditions recommended for the material
3.1.1 modified working end—working surfaces possessing used.
superior hardness characteristics which are either the result of 5.1.2 The Rockwell hardness of an instrument with the
depositing various materials on the base metal or the result of working end not modified shall be 42 HRC to 52 HRC.
permanently securing an insert (such as by brazing) to the base Instruments where the working end has been modified shall
metal. have a modified working surface whose Rockwell hardness is
3.1.2 Discussion—The typical method of modifying the A77 minimum.
working end of the suture needle holder is to use jaw inserts or 5.2 Corrosion Resistance—Holders with working ends not
to plasma deposit (flame plate) materials with improved wear modified shall be subjected to corrosion tests as specified in
characteristics such as tungsten carbide or stellite. For the jaw TestMethodF 1089.Holderswithmodifiedworkingendsshall
be subject to corrosion tests as specified inTest Method F 1089
except for the modifying material.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and
...

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