ASTM F1325-91(2016)

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: 30-Sep-2016
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F1325 − 91 (Reapproved 2016)
Standard Specification for
Stainless Steel Suture Needle Holders-General
Workmanship Requirements and Corresponding Test
1
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 marked). For the jaw insert method, the insert is brazed to the
jaw face with a uniform deposit of silver solder which is free
1.1 This specification covers general workmanship aspects
of crevices at all interfaces. For the flame plating method, a
of stainless steel suture needle holders intended for reuse in
uniform layer of material is deposited which is 0.004 6 0.001
surgery.
in. thick.
2. Referenced Documents
3.2 Definitions applicable to stainless steel suture needle
2
holders and the terms specified herein, shall be in accordance
2.1 ASTM Standards:
with Terminology F921.
E18 Test Methods for Rockwell Hardness of Metallic Ma-
terials
4. Materials
E92 Test Methods for Vickers Hardness and Knoop Hard-
ness of Metallic Materials
4.1 All component parts of the instrument other than the
E140 Hardness Conversion Tables for Metals Relationship
modified working end shall be fabricated from martensitic
Among Brinell Hardness, Vickers Hardness, Rockwell
stainless steel type 410, 410X, 416, 420A, 420B, 420C, 420F,
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
420F Mod, and 440B per Specification F899 (see Note 1). The
scope Hardness, and Leeb Hardness
modified working end may be made of stellite (trademarked),
F899 Specification for Wrought Stainless Steels for Surgical
tungsten carbide, or other suitable material.
Instruments
NOTE 1—Free-machining grades of stainless steel are inappropriate for
F921 Terminology Relating to Hemostatic Forceps
use due to their lower corrosion resistance and toughness.
F1089 Test Method for Corrosion of Surgical Instruments
5. Requirements
3. Terminology
5.1 Heat treatment and hardness for component parts.
3.1 Definitions:
5.1.1 Stainless steel component parts of the instrument shall
3.1.1 modified working end—working surfaces possessing
be heat treated under conditions recommended for the material
superior hardness characteristics which are either the result of
used.
depositing various materials on the base metal or the result of
5.1.2 The Rockwell hardness of an instrument with the
permanently securing an insert (such as by brazing) to the base
working end not modified shall be 42 HRC to 52 HRC.
metal.
Instruments where the working end has been modified shall
3.1.2 Discussion—The typical method of modifying the
have a modified working surface whose Rockwell hardness is
working end of the suture needle holder is to use jaw inserts or
A77 minimum.
to plasma deposit (flame plate) materials with improved wear
5.2 Corrosion Resistance—Holders with working ends not
characteristics such as tungsten carbide or stellite (trade-
modified shall be subjected to corrosion tests as specified in
Test Method F1089. Holders with modified working ends shall
1
be subject to corrosion tests as specified in Test Method F1089
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of except for the modifying material.
Subcommittee F04.33 on Medical/Surgical Instruments.
Current edi
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: F1325 − 91 (Reapproved 2008) F1325 − 91 (Reapproved 2016)
Standard Specification for
Stainless Steel Suture Needle Holders-General
Workmanship Requirements and Corresponding Test
1
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
ε NOTE—Subsections 3.1.2 and 4.1 were editorially corrected in December 2008.
1. Scope
1.1 This specification covers general workmanship aspects of stainless steel suture needle holders intended for reuse in surgery.
2. Referenced Documents
2
2.1 ASTM Standards:
E18 Test Methods for Rockwell Hardness of Metallic Materials
E92 Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E140 Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness,
Superficial Hardness, Knoop Hardness, Scleroscope Hardness, and Leeb Hardness
F899 Specification for Wrought Stainless Steels for Surgical Instruments
F921 Terminology Relating to Hemostatic Forceps
F1089 Test Method for Corrosion of Surgical Instruments
3. Terminology
3.1 Definitions:
3.1.1 modified working end—working surfaces possessing superior hardness characteristics which are either the result of
depositing various materials on the base metal or the result of permanently securing an insert (such as by brazing) to the base metal.
3.1.2 Discussion—The typical method of modifying the working end of the suture needle holder is to use jaw inserts or to
plasma deposit (flame plate) materials with improved wear characteristics such as tungsten carbide or stellite (trademarked). For
the jaw insert method, the insert is brazed to the jaw face with a uniform deposit of silver solder which is free of crevices at all
interfaces. For the flame plating method, a uniform layer of material is deposited which is 0.004 6 0.001 in. thick.
3.2 Definitions applicable to stainless steel suture needle holders and the terms specified herein, shall be in accordance with
Definitions of Terms Terminology F921.
4. Materials
4.1 All component parts of the instrument other than the modified working end shall be fabricated from martensitic stainless
steel type 410, 410X, 416, 420A, 420B, 420C, 420F, 420F Mod, and 440B per Specification F899 (see Note 1). The modified
working end may be made of stellite (trademarked), tungsten carbide, or other suitable material.
NOTE 1—Free-machining grades of stainless steel are inappropriate for use due to their lower corrosion resistance and toughness.
5. Requirements
5.1 Heat treatment and hardness for component parts.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.33 on Medical/Surgical Instruments.
Current edition approved Feb. 1, 2008Oct. 1, 2016. Published March 2008October 2016. Originally approved in 1991. Last previous edition approved in 20022008 as
ɛ1
F1325 – 91 (2002).(2008) . DOI: 10.1520/F1325-91R08E01.10.1520/F1325-91R16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’sstandard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1325 − 91 (2016)
TABLE 1 Suture/Needle/Holder Relationship
Recommended Corresponding
Compatible
Suture Needle Most Common Teeth Wire Size
Suture Size Per
Holder Use Per (Diameter)
A
USP
Square Inch of Needle
Debakey 7 thru 12 in. vascular and 2500 0 0.16 in. 0.035 in.
valve 2-0 0.14 0.24
Hufnagel 8 thru 10 in. replacement 2500 3-0 0.010 0.024
4-0 0.008 0.015
Webster coronary 3500 or 5-0 0.006 0.015
Hegar-Mayo bypass smooth 6-0 0.004 0.009
Brown 7-0 0.003 0.009
Castrovieijo microsurgery smooth 8-0 0.002 0.006
9-0 0.0015 0.006
Kalt smooth 10-0 0.0008 0.006
A
Mean average of USP absorbable and non-absorbable and Suture size averages.
5.1.1 Stainless steel component parts of the instrument shall be heat treated under conditions recommended for the material
used.
5.1.2 The Rockwell hardness of an instrument with the working end not modified
...