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ASTM F1325-91(2023)

(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.  
1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
31-Jan-2023
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

Refers
ASTM F899-23 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Nov-2023
Refers
ASTM F899-20 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Feb-2020
Refers
ASTM F899-19 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
15-Sep-2019
Refers
ASTM F921-10(2018) - Standard Terminology Relating to Hemostatic Forceps
Effective Date
01-Oct-2018
Refers
ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
Effective Date
01-Jul-2018
Refers
ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
Effective Date
01-Feb-2018
Refers
ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
Effective Date
01-Jul-2017
Refers
ASTM E18-12 - Standard Test Methods for Rockwell Hardness of Metallic Materials
Effective Date
01-Dec-2012
Refers
ASTM F899-12b - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Dec-2012
Refers
ASTM F899-12a - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Nov-2012
Refers
ASTM F899-12 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Jun-2012
Refers
ASTM E18-11 - Standard Test Methods for Rockwell Hardness of Metallic Materials
Effective Date
01-Nov-2011
Refers
ASTM F921-10(2011) - Standard Terminology Relating to Hemostatic Forceps
Effective Date
01-Jun-2011
Refers
ASTM F899-11 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Mar-2011
Refers
ASTM F899-10 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
Effective Date
01-Dec-2010

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ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test MethodsASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
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ASTM F1325-91(2023) - Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
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Standards Content (Sample)


This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1325 − 91 (Reapproved 2023)
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.
1. Scope depositing various materials on the base metal or the result of
permanently securing an insert (such as by brazing) to the base
1.1 This specification covers general workmanship aspects
metal.
of stainless steel suture needle holders intended for reuse in
3.1.1.1 Discussion—The typical method of modifying the
surgery.
working end of the suture needle holder is to use jaw inserts or
1.2 This international standard was developed in accor-
to plasma deposit (flame plate) materials with improved wear
dance with internationally recognized principles on standard-
characteristics such as tungsten carbide or stellite (trade-
ization established in the Decision on Principles for the
marked). For the jaw insert method, the insert is brazed to the
Development of International Standards, Guides and Recom-
jaw face with a uniform deposit of silver solder which is free
mendations issued by the World Trade Organization Technical
of crevices at all interfaces. For the flame plating method, a
Barriers to Trade (TBT) Committee.
uniform layer of material is deposited which is 0.004 6
0.001 in. thick.
2. Referenced Documents
2 3.2 Definitions applicable to stainless steel suture needle
2.1 ASTM Standards:
holders and the terms specified herein shall be in accordance
E18 Test Methods for Rockwell Hardness of Metallic Ma-
with Terminology F921.
terials
E92 Test Methods for Vickers Hardness and Knoop Hard-
4. Materials
ness of Metallic Materials
E140 Hardness Conversion Tables for Metals Relationship
4.1 All component parts of the instrument other than the
Among Brinell Hardness, Vickers Hardness, Rockwell
modified working end shall be fabricated from martensitic
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F,
scope Hardness, and Leeb Hardness
420F Mod, and 440B per Specification F899 (see Note 1). The
F899 Specification for Wrought Stainless Steels for Surgical
modified working end may be made of stellite (trademarked),
Instruments
tungsten carbide, or other suitable material.
F921 Terminology Relating to Hemostatic Forceps
NOTE 1—Free-machining grades of stainless steel are inappropriate for
F1089 Test Method for Corrosion of Surgical Instruments
use due to their lower corrosion resistance and toughness.
3. Terminology
5. Requirements
3.1 Definitions:
5.1 Heat Treatment and Hardness for Component Parts:
3.1.1 modified working end—working surfaces possessing
5.1.1 Stainless steel component parts of the instrument shall
superior hardness characteristics which are either the result of
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
Subcommittee F04.33 on Medical/Surgical Instruments. Instruments where the working end has been modified shall
Current edition approved Feb. 1, 2023. Published February 2023. Originally
have a modified working surface whose Ro
...

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