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ASTM F1325-91(2008)e1

(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(2008) - 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)e1 - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test MethodsASTM F1325-91(2008)e1 - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
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ASTM F1325-91(2008)e1 - Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
´1
Designation:F1325 −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 F1325; 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 (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—Subsections 3.1.2 and 4.1 were editorially corrected in December 2008.
1. Scope 3.1.2 Discussion—The typical method of modifying the
working end of the suture needle holder is to use jaw inserts or
1.1 This specification covers general workmanship aspects
to plasma deposit (flame plate) materials with improved wear
of stainless steel suture needle holders intended for reuse in
characteristics such as tungsten carbide or stellite (trade-
surgery.
marked). For the jaw insert method, the insert is brazed to the
jaw face with a uniform deposit of silver solder which is free
2. Referenced Documents
of crevices at all interfaces. For the flame plating method, a
2.1 ASTM Standards:
uniform layer of material is deposited which is 0.004 6 0.001
E18 Test Methods for Rockwell Hardness of Metallic Ma-
in. thick.
terials
3.2 Definitions applicable to stainless steel suture needle
E92 Test Method forVickers Hardness of Metallic Materials
holders and the terms specified herein, shall be in accordance
(Withdrawn 2010)
with Definitions of Terms F921.
E140 Hardness Conversion Tables for Metals Relationship
Among Brinell Hardness, Vickers Hardness, Rockwell
4. Materials
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
scope Hardness, and Leeb Hardness
4.1 All component parts of the instrument other than the
F899 Specification for Wrought Stainless Steels for Surgical
modified working end shall be fabricated from martensitic
Instruments
stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F,
F921 Terminology Relating to Hemostatic Forceps
420F Mod, and 440B per Specification F899 (see Note 1). The
F1089 Test Method for Corrosion of Surgical Instruments
modified working end may be made of stellite (trademarked),
tungsten carbide, or other suitable material.
3. Terminology
NOTE 1—Free-machining grades of stainless steel are inappropriate for
3.1 Definitions:
use due to their lower corrosion resistance and toughness.
3.1.1 modified working end—working surfaces possessing
superior hardness characteristics which are either the result of 5. Requirements
depositing various materials on the base metal or the result of
5.1 Heat treatment and hardness for component parts.
permanently securing an insert (such as by brazing) to the base
5.1.1 Stainless steel component parts of the instrument shall
metal.
be heat treated under conditions recommended for the material
used.
5.1.2 The Rockwell hardness of an instrument with the
This specification is under the jurisdiction of ASTM Committee F04 on
working end not modified shall be 42 HRC to 52 HRC.
Medical and Surgical Materials and Devices and is the direct responsibility of
Instruments where the working end has been modified shall
Subcommittee F04.33 on Medical/Surgical Instruments.
have a modified working surface whose Rockwell hardness is
Current edition approved Feb. 1, 2008. Published March 2008. Originally
approved in 1991. Last previous edition approved in 2002 as F1325 – 91 (2002).
A77 minimum.
DOI: 10.1520/F1325-91R08E01.
5.2 Corrosion Resistance—Holders with working ends no
...

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