ASTM F1638-95(2023)

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

SCOPE
1.1 This terminology defines basic terms and considerations for components of thumb-type surgical forceps. Instruments with this terminology are limited to those fabricated from stainless steel and used for surgical procedures.  
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-2023
• ICS: 01.040.11 - Health care technology (Vocabularies)
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Overview

ASTM F1638-95(2023): Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type) defines the essential terminology and considerations for thumb-type surgical forceps. Developed by ASTM International, this standard is crucial for ensuring consistency, clarity, and safety in the design and manufacture of stainless steel forceps used during surgical procedures worldwide. By adhering to internationally recognized standardization principles established by the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Committee, ASTM F1638 provides a common language for manufacturers, healthcare providers, and regulatory authorities.

Key Topics

• Standardized Terms: The document explicitly defines basic and advanced terminology, including component names and features relevant to thumb-type surgical forceps. Examples include guide pin, mesh, mouse teeth, scissoring, set, stop pin, atraumatic teeth, and tissue forceps.
• Component Descriptions:
  • Guide pin: A pin on one half of the forceps that aligns with a hole on the other half for precision closure.
  • Mesh: Alignment of opposing teeth-can be in-line or angled-to ensure precise gripping.
  • Mouse teeth: Interdigitated teeth at the distal tip for secure tissue handling.
  • Atraumatic: Design of teeth that minimizes tissue trauma during use.
• Material Limitation: This terminology applies specifically to forceps fabricated from stainless steel, reflecting common clinical requirements for sterility, corrosion resistance, and strength.
• Design Considerations: The standard recognizes the clinical need for diverse instrument configurations and features, without limiting technological innovation or future enhancements in forceps design.

Applications

• Surgical Practices: Used by surgeons and clinicians to describe, select, and use thumb-type forceps in various procedures, reducing ambiguity in instrument handling.
• Manufacturing: Medical device manufacturers utilize ASTM F1638 terminology to standardize product descriptions, quality control processes, and compliance documentation, facilitating clearer communication and interoperability between suppliers and healthcare providers.
• Regulatory Compliance: Adoption of standardized terminology aids in meeting regulatory requirements for medical device registration, import/export, and clinical application, especially for global markets that recognize WTO principles.
• Procurement and Training: Hospitals and clinical training programs benefit from unified terms, supporting effective procurement, inventory management, and staff training regarding surgical tissue forceps.

Related Standards

• ASTM F899: Standard Specification for Stainless Steels for Surgical Instruments – Covers material requirements relevant to instruments defined in ASTM F1638.
• ISO 7153-1: Surgical Instruments - Materials – International standard overlapping with ASTM F1638 in specifying acceptable materials for surgical forceps.
• ASTM F1744: Standard Guide for Care and Handling of Stainless Steel Surgical Instruments – Complements the terminology by providing guidelines for instrument maintenance.
• ISO 13485: Medical Devices – Quality Management Systems – Supports manufacturers in establishing processes to consistently meet customer and regulatory requirements for surgical instruments.
• ASTM Committee F04: Oversight body for standards on medical and surgical materials, including those directly relevant to surgical forceps.

By providing clear terminology and focusing on best practices for thumb-type surgical forceps, ASTM F1638-95(2023) enhances safety, communication, and innovation across the global healthcare industry.

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: F1638 − 95 (Reapproved 2023)
Standard Terminology for
Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
This standard is issued under the fixed designation F1638; 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 guide pin—a pin affixed to the inside of one of the forceps
halves that aligns with a hole on the other tweezer half
1.1 This terminology defines basic terms and considerations
without protruding through when closed.
for components of thumb-type surgical forceps. Instruments
with this terminology are limited to those fabricated from
guide pin hole—the hole in one forceps half into which the
stainless steel and used for surgical procedures.
guide pin fits without passing through when closed.
1.2 This international standard was developed in accor-
mesh—an alignment of opposing teeth. The teeth may be
dance with internationally recognized principles on standard-
in-line or angled.
ization established in the Decision on Principles for the
mouse teeth—distal tip teeth that interdigitate.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
scissoring—lateral misalignment.
Barriers to Trade (TBT) Committee.
set—the at-rest position of the instrument halves that will
2. Terminology
provide the intended closing relationship of fit and force.
2.1 Definitions:
stop pin—a pin of preset length affixed to the inside of one of
atraumatic—teeth that would interdigitate except for being
the tweezer halves and designed to limit teeth contact upon
spaced apart a predesigned distance so they will not stress,
closure and prevent their damage.
crush, or otherwise traumatize the tissue being grasped.
teeth—serrations formed on the inside faces of the distal end
of the tweezer halves.
This terminology is under the jurisdiction of ASTM Committee F04 on Medical
and Surgical Materials and Devices and is t
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