ASTM F1613-95(2023)
(Specification)Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
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
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.33 - Medical/Surgical Instruments
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
- Refers
ASTM F1638-95(2016) - Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type) - 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 workmanship, material, and performance requirements for spring-action forceps designed for surgical applications, notably tissue retraction, grasping, or dissection. Published by ASTM International, this standard ensures the reliability, safety, and consistent quality of thumb-type forceps commonly used in surgical settings. Notably, it does not address delicate tissue forceps intended for microsurgery or neurosurgery. All instruments under this standard must be produced from high-quality, heat-treated Class 4 martensitic stainless steel, with provisions for working ends to incorporate enhanced materials such as stellite or tungsten carbide.
Adherence to ASTM F1613-95(2023) supports regulatory compliance, international trade, and product quality in the field of surgical instruments.
Key Topics
- Scope and Applicability: Covers general surgical forceps (thumb type) for retraction, grasping, and dissection of tissue; excludes microsurgical or neurosurgical forceps.
- Material Requirements: Mandates use of Class 4 martensitic stainless steel (as defined in ASTM F899). Working ends may be constructed with enhanced materials like stellite or tungsten carbide for improved performance.
- Workmanship and Design:
- Forceps must be symmetrical, with well-formed teeth of uniform depth and spacing, and handles featuring consistent serrations.
- Surfaces must be finished uniformly, free of burrs, sharp edges, cracks, coarse marks, and processing residues.
- Guide pin and pin holes must function smoothly, with the pin not protruding beyond instrument surfaces.
- Mechanical and Performance Testing:
- Hardness values for unmodified working ends must fall within specified Rockwell hardness (HRC) standards.
- Instruments with modified working ends must meet alternative hardness requirements.
- Corrosion resistance is verified through standardized testing.
- Alignment and closure tolerances are clearly defined to ensure clinical reliability.
- Marking and Labeling: Clearly stipulates legibility, manufacturer identification, country of origin, and other relevant markings.
Applications
Surgical forceps conforming to ASTM F1613-95(2023) are used extensively in:
- General Surgery: For tissue handling, retraction, and positioning during various operations.
- Medical Clinics and Hospitals: As essential disposable or reusable tools for procedures requiring tissue manipulation.
- OEM and Contract Manufacturing: Ensures manufacturers meet international specifications for export, tender requirements, and hospital supply chains.
- Compliance and Quality Assurance: Provides a reference benchmark for procurement decisions, regulatory submissions, and third-party audits.
Adopting this standard enhances patient safety and operational efficiency by ensuring all spring-action thumb forceps perform reliably under clinical conditions.
Related Standards
Users of ASTM F1613-95(2023) should also be aware of key referenced and related documents for comprehensive surgical instrument compliance:
- ASTM F899: Wrought Stainless Steels for Surgical Instruments
- ASTM E18: Test Methods for Rockwell Hardness of Metallic Materials
- ASTM F1089: Test Method for Corrosion of Surgical Instruments
- ASTM F1638: Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
- ASTM F921: Terminology Relating to Hemostatic Forceps
- ASTM F1026: Specification for General Workmanship and Performance of Hemostatic Forceps
These related standards complement ASTM F1613 by providing detailed material, testing, and terminology guidance needed for the holistic production and assessment of surgical forceps and allied medical devices.
ASTM F1613-95(2023) plays a critical role in advancing the consistency, safety, and performance of surgical tissue/dressing/pick-up forceps across global healthcare environments. Compliance ensures optimal functionality and confidence for both medical professionals and manufacturers.
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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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