ASTM F1613-95(2016)

Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

ABSTRACT
This specification covers general workmanship requirements of spring-action, surgical tissue, dressing, or pick-up forceps (thumb type) for use in the retraction, grasping, or dissection of tissue during surgical procedures. However, this specification does not cover delicate tissue forceps such as employed in microsurgery or neurosurgery. The forceps and all component parts shall be manufactured from Class 4 martensitic stainless steel (heat treated), while modified working ends may be manufactured from stellite, tungsten carbide, or other suitable material. The forcep halves shall be symmetrical, with the teeth well formed, uniform in depth and spacing, and mesh without binding, and the surfaces uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and processing materials. In addition, the forceps shall have handle serrations that are uniform in depth and spacing. Tests for hardness and corrosion resistance shall be performed and shall conform to the requirements specified.
SCOPE
1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumb-type) intended for the retraction, grasping, or dissection of tissue during surgical procedures.  
1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F1613 − 95 (Reapproved 2016)
Standard Specification for
1
Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
This standard is issued under the fixed designation F1613; 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 securing an
insert permanently (such as by brazing) to the base metal (see
1.1 This specification covers general workmanship aspects
Note 3).
of spring-action, tissue, dressing, or pick-up forceps (thumb-
type) intended for the retraction, grasping, or dissection of
4. Material
tissue during surgical procedures.
4.1 All component parts of the instrument shall be fabri-
1.2 The values stated in inch-pound units are to be regarded
cated from Class 4 martensitic stainless steel in accordance
as the standard. The values given in parentheses are for
with Specification F899. The modified working ends may be of
information only.
stellite, tungsten carbide, or other suitable material.
2. Referenced Documents
2
5. Requirements
2.1 ASTM Standards:
E18 Test Methods for Rockwell Hardness of Metallic Ma-
5.1 Heat Treatment and Hardness for Component Parts:
terials
5.1.1 The stainless steel component parts shall be heat
E92 Test Methods for Vickers Hardness and Knoop Hard-
treated under conditions recommended for the material used.
ness of Metallic Materials
5.1.2 The Rockwell hardness (HRC) of the instrument with
E140 Hardness Conversion Tables for Metals Relationship
the working end not modified shall be 40–49 HRC (see Test
Among Brinell Hardness, Vickers Hardness, Rockwell
Methods E18) after appropriate processing. Instruments in
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
which the working end has been modified shall have an HRC
scope Hardness, and Leeb Hardness
of A77.
F899 Specification for Wrought Stainless Steels for Surgical
5.2 Corrosion Resistance—Instruments shall be subjected to
Instruments
corrosion tests as specified in Test Method F1089.
F921 Terminology Relating to Hemostatic Forceps
F1026 Specification for General Workmanship and Perfor-
5.3 Finish:
mance Measurements of Hemostatic Forceps
5.3.1 Surfaces—Surfaces of the instruments shall be uni-
F1089 Test Method for Corrosion of Surgical Instruments
formly finished and free of burrs, sharp edges, cracks, coarse
F1638 Terminology for Surgical Tissue/Dressing/Pick-Up
marks, and processing materials.
Forceps (Thumb-Type)
5.3.2 Type—The finish shall be one of the types specified in
Terminology F921 or as specified by the purchaser.
3. Terminology
5.4 Workmanship:
3.1 Definitions:
5.4.1 Symmetry—Excluding functional differences, both
3.1.1 Definitions shall be in accordance with Terminology
forceps halves shall be symmetrical.
F1638.
5.4.2 Teeth—Teeth shall be well formed, uniform in depth
3.1.2 modified working ends—working surfaces possessing
and spacing, and mesh without binding, unless designed
superior hardness characteristics that are the result of either
otherwise.
5.4.3 Handle Serrations—Handle serrations shall be uni-
1
This specification is under the jurisdiction of ASTM Committee F04 on
form in depth and spacing.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.33 on Medical/Surgical Instrument
...

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: F1613 − 95 (Reapproved 2008) F1613 − 95 (Reapproved 2016)
Standard Specification for
1
Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
This standard is issued under the fixed designation F1613; 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—Editorial changes were made throughout in June 2008.
1. Scope
1.1 This specification covers general workmanship aspects of spring-action, tissue, dressing, or pick-up forceps (thumb-type)
intended for the retraction, grasping, or dissection of tissue during surgical procedures.
1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information
only.
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
F1026 Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
F1089 Test Method for Corrosion of Surgical Instruments
F1638 Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
3. Terminology
3.1 Definitions:
3.1.1 Definitions shall be in accordance with Terminology F1638.
3.1.2 modified working ends—working surfaces possessing superior hardness characteristics that are the result of either
depositing various materials on the base metal or securing an insert permanently (such as by brazing) to the base metal (see Note
3).
4. Material
4.1 All component parts of the instrument shall be fabricated from Class 4 martensitic stainless steel in accordance with
Specification F899. The modified working ends may be of stellite, tungsten carbide, or other suitable material.
5. Requirements
5.1 Heat Treatment and Hardness for Component Parts:
5.1.1 The stainless steel component parts shall be heat treated under conditions recommended for the material used.
5.1.2 The Rockwell hardness (HRC) of the instrument with the working end not modified shall be 40–49 HRC (see Test
Methods E18) after appropriate processing. Instruments in which the working end has been modified shall have an HRC of A77.
5.2 Corrosion Resistance—Instruments shall be subjected to corrosion tests as specified in Test Method F1089.
5.3 Finish:
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 1995. Last previous edition approved in 20022008 as
ɛ1
F1613 – 95 (2002).(2008) . DOI: 10.1520/F1613-95R08E01.10.1520/F1613-95R16.
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.
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F1613 − 95 (2016)
5.3.1 Surfaces—Surfaces of the instruments shall be uniformly finished and free of burrs, sharp edges, cracks, coarse marks, and
processing materials.
5.3.2 Type—The finish shall be one of the types specified in DefinitionsTerminology F921 or as specified by the purchaser.
5.4 Workmanship:
5.4.1 Symmetry—Excluding functional differences, both forceps halves shall be symmetrical.
5.4.2 Teeth—Teeth shall be well formed, uniform in depth and spacing, and mesh without binding, unless designed otherwise.
5.4.3 Handle Serrations—Handle serrations shall be uniform in depth and spacing.
5.5 Guide Pin and Guide Pin Hole:
5.5.1 The guide pin shall pass through the guide pin hole without binding.
5.5.2 The guide pin length shall not protrude past the outside surface of the guide pin hole when the forceps’forceps’ tips come
in contact.
1
NOTE 1—Guide pin/guide pin holes
...