ASTM F921-10(2018)

Standard Terminology Relating to Hemostatic Forceps

SCOPE
1.1 This terminology covers basic terms and considerations for the components of hemostatic forceps. Instruments in this terminology are limited to those fabricated from stainless steel and for general surgical procedures. See Fig. 1 and Fig. 2.
FIG. 1 Components of a Hemostatic Forceps
FIG. 2 Typical Types of Serrations and Teeth for Hemostatic Forceps  
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: 30-Sep-2018
• ICS: 01.040.11 - Health care technology (Vocabularies)
• 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

• Replaces: ASTM F921-10(2011) - Standard Terminology Relating to Hemostatic Forceps
• Effective Date: 01-Oct-2018
• 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 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 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 F899-09e1 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2009
• Refers: ASTM F899-09 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2009
• Refers: ASTM F899-07 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2007
• Refers: ASTM F899-95 - Standard Specification for Stainless Steel for Surgical Instruments
• Effective Date: 10-Apr-2002
• Refers: ASTM F899-02 - Standard Specification for Stainless Steel for Surgical Instruments
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1613-95(2023) - Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
• Effective Date: 01-Oct-2018

Overview

ASTM F921-10(2018), Standard Terminology Relating to Hemostatic Forceps, establishes a comprehensive classification and terminology for the components and performance considerations of hemostatic forceps made from stainless steel. Developed by ASTM International, this standard helps ensure consistency and clarity across surgical instrument design, manufacturing, and clinical use. The terminology is specifically focused on instruments used for general surgical procedures and does not include disposables or devices designed for specialty surgeries.

Key Topics

• Components of Hemostatic Forceps: The standard defines essential parts such as jaws, shanks, finger rings, box locks, ratchets, and both male and female members. Each term describes key aspects of form and function critical to surgical performance.
• Physical Properties: Key terms like hardness, corrosion resistance, elasticity, finish (bright, satin, matte, black), and passivation are described to promote understanding of essential material requirements for safe and effective medical devices.
• Functional Features: Terminology covers serrations and teeth, jaw alignment, the locking mechanism provided by ratchets, and the interdigitation of jaws, ensuring grasping precision and vessel compression during surgical procedures.
• Material Specification: Stainless steel is the required material, with reference to standard ASTM F899 for wrought surgical steel, promoting uniformity and patient safety.
• Junction Types: The terminology highlights the box lock as the most common pivoting feature but does not restrict other technological innovations.

Applications

The ASTM F921-10(2018) standard is crucial for various stakeholders involved in the lifecycle of hemostatic forceps:

• Medical Device Manufacturers: Enables precise communication of design and quality requirements, ensuring products meet industry expectations for reliability and performance.
• Surgical Instrument Designers: Provides standardized language to describe and document new products, supporting innovation while maintaining interoperability with existing systems.
• Surgical Teams and Healthcare Providers: Assists in training, procurement, and clinical usage by offering clear definitions for features and configurations, reducing errors and improving patient safety.
• Regulatory Compliance: Supports alignment with international standards, such as those developed under World Trade Organization (WTO) guidelines, aiding in market access and regulatory approvals.
• Quality Assurance and Inspection: Offers a reference point for product evaluation, testing, and certification, ensuring consistent manufacturing and product traceability.

Related Standards

Utilizing ASTM F921-10(2018) in the context of associated standards enhances both its relevance and applicability:

• ASTM F899: Specification for wrought stainless steels used in surgical instruments, referenced for material compliance.
• ISO 7151: Addresses general requirements for hemostatic forceps, applicable internationally and complementary to ASTM terminology.
• Medical Device Regulatory Standards: Alignment with internationally recognized principles established by the World Trade Organization TBT Committee.
• Other ASTM Standards: Can be used in combination with technical standards focused on surgical materials, design, and performance to cover the full spectrum of medical instrument requirements.

By providing standardized terminology for hemostatic forceps components and their properties, ASTM F921-10(2018) enhances product quality, safety, and global compatibility in the healthcare sector.

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: F921 − 10 (Reapproved 2018)
Standard Terminology Relating to
Hemostatic Forceps
ThisstandardisissuedunderthefixeddesignationF921;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope finger rings—the feature of both the female and the male
members that forms the gripping surface for the surgeon
1.1 This terminology covers basic terms and considerations
(commonly classified as the ring-handled feature in ISO
for the components of hemostatic forceps. Instruments in this
7151).
terminology are limited to those fabricated from stainless steel
and for general surgical procedures. See Fig. 1 and Fig. 2.
hemostatic forceps—an instrument, available in various sizes
and configurations, used in surgical procedures for the
1.2 This international standard was developed in accor-
compression of blood vessels and the grasping of tissue.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
jaws—parts that contain serrations to interrupt the flow of
Development of International Standards, Guides and Recom-
blood through any vessel.
mendations issued by the World Trade Organization Technical
male member—the component that is inserted through the
Barriers to Trade (TBT) Committee.
femalememberandsecuredtothefemalememberatthebox
lock junction.
2. Referenced Documents
proximal end—that portion of the instrument that is closest to
2.1 ASTM Standards:
F899 Specification for Wrought Stainless Steels for Surgical the surgeon when in use.
Instruments
ratchets—the portion of both the female and male members at
2.2 ISO Standard:
the proximal end possessing inclined teeth and that form the
ISO 7151 Instruments for Surgery—Hemostatic Forceps—
locking mechanism.
General Requirements
serrations or teeth—the gripping or clamping surfaces of the
jaws or ratchets.
3. Terminology
shank—the part of either the female or the male member that
Definitions of Hemostatic Forceps
yields configuration, length, and leverage.
box lock—thejunctionwherethefemalememberandthemale
Definitions of Physical Properties of Hemostatic Forceps
member are secured, forming the pivoting feature.
chamfer—the broken edge of the jaw serrations and the
distal end—the working end, comprised of two jaws, that is
external edges of the box lock surfaces.
furthest from the surgeon when in use.
corrosion—the formation of rust.
female member—the component that accommodates and
encloses the male member at the box lock junction.
elasticity—the capacity of the instrument to undergo induced
stress without permanent distortion or breakage of any
component.
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
finish, n—final surface visual appearance classified as follows:
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
bright or mirror finish, n—highly reflective surface.
F04.33 on Medical/Surgical Instruments.
Current edition approved Oct. 1, 2018. Published November 2018. Originally
satin, matte, or black finish, n—reduced reflective surface
approved in 1985. Last previous edition approved in 2011 as F921 – 10(2011). DOI:
(as compared to bright
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