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.  
1.3 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

Relations

Effective Date
01-Nov-2023
Effective Date
01-Feb-2020
Effective Date
15-Sep-2019
Effective Date
01-Oct-2018
Effective Date
01-Jul-2018
Effective Date
01-Feb-2018
Effective Date
01-Jul-2017
Effective Date
01-Oct-2016
Effective Date
01-Dec-2012
Effective Date
01-Dec-2012
Effective Date
01-Nov-2012
Effective Date
01-Jun-2012
Effective Date
01-Nov-2011
Effective Date
01-Jun-2011
Effective Date
01-Mar-2011

Overview

ASTM F1613-95(2023), Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type), defines the general workmanship and quality requirements for spring-action, thumb-type surgical forceps. These forceps are designed for use in the retraction, grasping, or dissection of tissue during a wide range of surgical procedures. This standard is critical to ensuring consistency, safety, and performance of forceps used in operating rooms globally. Note that this specification excludes delicate tissue forceps used in specialized fields such as microsurgery or neurosurgery.

Key Topics

  • Scope and Purpose

    • Covers thumb-type forceps, including tissue, dressing, and pick-up forceps.
    • Focuses on general workmanship, not including specialized microsurgical instruments.
  • Material Requirements

    • All forceps and their components must be made from Class 4 martensitic stainless steel per ASTM F899.
    • Modified working ends may use alternative wear-resistant materials, such as stellite or tungsten carbide.
  • Workmanship and Performance

    • Forceps must display careful manufacturing, with symmetrical halves, properly formed teeth, and uniform handle serrations.
    • Surfaces must be uniformly finished, free from burrs, sharp edges, cracks, and residual manufacturing debris.
    • Guide pins must fit and function properly without protrusion or binding on instruments exceeding 191 mm (7.5 inches).
  • Testing and Inspection

    • Hardness must meet specified Rockwell standards, with additional requirements for modified working ends.
    • Instruments are tested for corrosion resistance as specified by ASTM F1089.
    • Alignment and scissoring clearance must not exceed 0.015 inches (0.38 mm) on closure.
  • Labeling and Traceability

    • All forceps must be legibly marked with manufacturer details, country of origin (if not manufactured in the US), and other purchaser-required information.

Applications

  • Surgical Procedures

    • Used extensively in hospitals and clinics for handling and manipulating soft tissues during surgery, including general surgery, orthopedic procedures, and wound care.
  • Sterile Instrument Sets

    • Essential component of basic and advanced surgical sets, aiding in efficient tissue grasping and dressing changes.
  • Medical Device Manufacturing

    • Reference standard for manufacturers seeking compliance in addressing global procurement requirements and regulatory controls for surgical instruments.
  • Quality Assurance and Regulatory Compliance

    • Provides a reliable benchmark for healthcare providers, purchasing agents, and regulatory bodies conducting inspections and audits on surgical forceps.

Related Standards

  • ASTM F899 - Specification for Wrought Stainless Steels for Surgical Instruments
  • ASTM F1638 - Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
  • ASTM F1026 - Specification for General Workmanship and Performance of Hemostatic Forceps
  • ASTM F1089 - Test Method for Corrosion of Surgical Instruments
  • ASTM E18, E92, E140 - Methods and conversions for determining metal hardness
  • ASTM F921 - Terminology Relating to Hemostatic Forceps

By adhering to ASTM F1613-95(2023), manufacturers and healthcare professionals can ensure the surgical forceps they use or supply meet internationally recognized quality, safety, and performance standards, promoting positive clinical outcomes and patient safety.

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Frequently Asked Questions

ASTM F1613-95(2023) is a technical specification published by ASTM International. Its full title is "Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)". This standard covers: 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. 1.3 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.

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. 1.3 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.

ASTM F1613-95(2023) is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.

ASTM F1613-95(2023) has the following relationships with other standards: It is inter standard links to ASTM F899-23, ASTM F899-20, ASTM F899-19, ASTM F921-10(2018), ASTM E18-18, ASTM F1089-18, ASTM E18-17, ASTM F1638-95(2016), ASTM F899-12b, ASTM E18-12, ASTM F899-12a, ASTM F899-12, ASTM E18-11, ASTM F921-10(2011), ASTM F899-11. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ASTM F1613-95(2023) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

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: F1613 − 95 (Reapproved 2023)
Standard Specification for
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 3. Terminology
1.1 This specification covers general workmanship aspects 3.1 Definitions:
of spring-action, tissue, dressing, or pick-up forceps (thumb- 3.1.1 Definitions shall be in accordance with Terminology
type) intended for the retraction, grasping, or dissection of F1638.
tissue during surgical procedures. 3.1.2 modified working ends—working surfaces possessing
superior hardness characteristics that are the result of either
1.2 The values stated in inch-pound units are to be regarded
depositing various materials on the base metal or securing an
as the standard. The values given in parentheses are for
insert permanently (such as by brazing) to the base metal (see
information only.
Note 3).
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
4. Material
ization established in the Decision on Principles for the
4.1 All component parts of the instrument shall be fabri-
Development of International Standards, Guides and Recom-
cated from Class 4 martensitic stainless steel in accordance
mendations issued by the World Trade Organization Technical
with Specification F899. The modified working ends may be of
Barriers to Trade (TBT) Committee.
stellite, tungsten carbide, or other suitable material.
2. Referenced Documents
5. Requirements
2.1 ASTM Standards:
5.1 Heat Treatment and Hardness for Component Parts:
E18 Test Methods for Rockwell Hardness of Metallic Ma-
5.1.1 The stainless steel component parts shall be heat
terials
treated under conditions recommended for the material used.
E92 Test Methods for Vickers Hardness and Knoop Hard-
5.1.2 The Rockwell hardness (HRC) of the instrument with
ness of Metallic Materials
the working end not modified shall be 40 to 49 HRC (see Test
E140 Hardness Conversion Tables for Metals Relationship
Methods E18) after appropriate processing. Instruments in
Among Brinell Hardness, Vickers Hardness, Rockwell
which the working end has been modified shall have an HRC
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
of A77.
scope Hardness, and Leeb Hardness
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
5.3 Finish:
F1026 Specification for General Workmanship and Perfor-
5.3.1 Surfaces—Surfaces of the instruments shall be uni-
mance Measurements of Hemostatic Forceps
formly finished and free of burrs, sharp edges, cracks, coarse
F1089 Test Method for Corrosion of Surgical Instruments
marks, and processing materials.
F1638 Terminology for Surgical Tissue/Dressing/Pick-Up
5.3.2 Type—The finish shall be one of the types specified in
Forceps (Thumb-Type)
Terminology F921 or as specified by the purchaser.
5.4 Workmanship:
5.4.1 Symmetry—Excluding functional differences, both
This specification is under the jurisdiction of ASTM Committee F04 on
forceps halves shall be symmetrical.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.33
...

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