ASTM F1026-86(2022)

Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

ABSTRACT
This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and intended for reuse in surgery. All of the component parts of the instruments shall be made of martensitic stainless steel of Type 410, 410X, 416, 416MOD, 420A, or 420B. Materials shall be tested and the individual grades shall conform to physical requirements such as heat treatment, hardness, and passivation; performance requirements such as finger rings, jaw serrations and teeth, box lock, clearance, ratchets, jaw and rachet setting, elasticity, and corrosion resistance. Workmanship, finish, and appearance, are also detailed.
SCOPE
1.1 This specification covers general workmanship aspects of hemostatic forceps fabricated from stainless steel and 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-2022
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

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 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
• Refers: ASTM F921-10 - Standard Terminology Relating to Hemostatic Forceps
• Effective Date: 01-Jun-2010

Overview

ASTM F1026-86(2022), Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps, establishes the requirements for the manufacture and performance of reusable hemostatic forceps made from specific grades of stainless steel. Issued by ASTM International, this standard ensures that surgical hemostatic forceps meet rigorous quality criteria, focusing on aspects such as material selection, hardness, passivation, workmanship, and functional performance. The specification is fundamental for maintaining high standards in surgical instruments used worldwide.

Key Topics

• Materials Requirements
  The standard prescribes the use of martensitic stainless steels, specifically Types 410, 410X, 416, 416MOD, 420A, and 420B. These metals must meet demanding criteria for heat treatment, hardness, and passivation, contributing to the durability and corrosion resistance required for surgical tools.

• Physical and Functional Performance
  Hemostatic forceps are evaluated against physical characteristics (such as uniform hardness and smooth heat treatment) and functional requirements:

  • Well-rounded finger rings with polished internal surfaces.
  • Uniform jaw serrations and interdigitating teeth for effective grip.
  • Secure box lock construction for reliable hinge performance.
  • Precise clearances and dependable ratchet mechanisms for controlled operation.
  • Elasticity and corrosion resistance under test conditions.

• Workmanship, Finish, and Appearance
  Surfaces must be uniformly finished, free of manufacturing defects such as burrs or sharp edges, cracks, or coarse marks, ensuring safety and comfort during surgical use. The finish type should be as defined by ASTM or as specified by the purchaser.

• Testing and Marking
  Comprehensive testing procedures verify hardness (via Rockwell or Vickers methods), elasticity (using specific room-temperature tests with test materials), and corrosion resistance. Instruments must bear clear, permanent markings indicating manufacturer, origin, and other relevant information.

Applications

• Surgical Use
  The primary application of ASTM F1026-compliant hemostatic forceps is in surgical settings, where instrument reliability and reusability are essential for patient safety and effective outcomes.

• Hospitals and Surgical Centers
  Medical facilities benefit from specifying ASTM F1026-86(2022) in procurement, ensuring surgical forceps will withstand repeated sterilization, perform consistently, and comply with recognized international quality standards.

• Manufacturing and Quality Control
  Surgical instrument manufacturers use this standard to guide production and inspection processes, helping ensure products meet global expectations for surgical-grade stainless steel instruments.

• International Trade and Compliance
  Conformity with ASTM F1026 enhances export options and regulatory acceptance, as the standard aligns with globally recognized World Trade Organization (WTO) principles for international standards.

Related Standards

• ASTM F899 - Specification for Wrought Stainless Steels for Surgical Instruments
• ASTM F921 - Terminology Relating to Hemostatic Forceps
• ASTM E18 - Test Methods for Rockwell Hardness of Metallic Materials
• ASTM E92 - Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
• ASTM E140 - Hardness Conversion Tables for Metals

Using ASTM F1026-86(2022) supports best practices in manufacturing, inspection, and purchasing of reusable hemostatic forceps. Adherence ensures high-quality, long-lasting surgical tools and strengthens confidence for healthcare professionals and patients alike.

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:F1026 −86 (Reapproved 2022)
Standard Specification for
General Workmanship and Performance Measurements of
Hemostatic Forceps
This standard is issued under the fixed designation F1026; 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 5. Physical Requirements
1.1 This specification covers general workmanship aspects
5.1 Heat Treatment and Hardness for Component Parts:
of hemostatic forceps fabricated from stainless steel and
5.1.1 The component parts of the instruments shall be heat
intended for reuse in surgery.
treated under conditions recommended for the material used.
Typical heat treating guidelines and hardness values are given
1.2 This international standard was developed in accor-
dance with internationally recognized principles on standard- in Specification F899.
ization established in the Decision on Principles for the
5.1.2 The hardness of all opposing parts of the same
Development of International Standards, Guides and Recom-
instrument shall not vary in hardness by more than four units
mendations issued by the World Trade Organization Technical on the Rockwell Hardness C scale (HRC) or equivalent. (See
Barriers to Trade (TBT) Committee.
Test Methods E18.)
5.2 Passivation—Instruments and instrument components
2. Referenced Documents
shall be passivated after completion of all fabricating and
2.1 ASTM Standards:
finishing operations.
E18 Test Methods for Rockwell Hardness of Metallic Ma-
terials
6. Performance Requirements
E92 Test Methods for Vickers Hardness and Knoop Hard-
ness of Metallic Materials 6.1 FingerRings—Insidesurfacesshallbewellroundedand
E140 Hardness Conversion Tables for Metals Relationship polished and shall comply with the requirements in 7.1.
Among Brinell Hardness, Vickers Hardness, Rockwell
6.2 Jaw Serrations and Teeth—The serrations and teeth
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
shall be of uniform depth and height and well defined to
scope Hardness, and Leeb Hardness
provide effective gripping. The serrations and teeth shall
F899 Specification for Wrought Stainless Steels for Surgical
interdigitate. The edges of the serrations shall be chamfered.
Instruments
6.3 Box Lock—The hemostatic forceps shall be of box lock
F921 Terminology Relating to Hemostatic Forceps
construction,asdefinedinTerminologyF921.Thepin,orother
3. Terminology
fastening component, shall be permanently secured. The joint
performance of the box lock shall be smooth, of equal
3.1 Definitions applicable to hemostatic forceps shall be in
resistance, and non-binding when opening or closing the
accordance with Terminology F921.
forceps to an included angle of 90 6 5° (the lock may be
4. Material
lubricated).
4.1 All of the component parts of the instruments shall be
6.4 Clearance—The maximum clearance between the male
made of martensitic stainless steel of Type 410, 410X, 416,
and female members of the forceps in the lock area shall be
416MOD, 420A, or 420B of Specification F899.
0.4 mm (0.015 in.). The clearance is the visible gap that exists
when the instrument is viewed from both the front and side
This specification is under the jurisdiction of ASTM Committee F04 on
profile or end view of the instrument (excluding bevel) (see
Medical and Surgical Materials and Devices and is the direct responsibility of
Fig. 1).
Subcommittee F04.33 on Medical/Surgical Instruments.
Current edition approved Feb. 1, 2022. Published February 2022. Originally
6.5 Ratchets—Ratchets shall securely engage at each ratchet
approved in 1986. Last previous edition approved in 2014 as F1026 – 86 (2014).
position in a smooth and progressive manner.
DOI: 10.1520/F1026-86R22.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
6.6 Jaw and Ratchet Setting—The jaw tips sh
...