ISO 6335-1:2026

Overview

ISO/FDIS 6335-1:2025, titled "Surgical instruments - Staplers - Part 1: Vocabulary," is an international standard developed by ISO Technical Committee ISO/TC 170. This document provides a comprehensive vocabulary of terms related to surgical staplers, focusing on their components and functional use. Its purpose is to ensure consistent and harmonized terminology across the medical and manufacturing communities involved with surgical stapling devices.

The standard applies broadly to staplers that use surgical staples for wound closure, tissue joining, or anastomosis, but excludes specialized staplers such as vascular, cardiac valve, and circumcision staplers, among others, due to their differing operating principles.

Key Topics

The standard clearly defines essential terms related to staplers and their components to facilitate clear communication and improve understanding in the healthcare sector:

• Stapler Components

  • Stapler body: The main device housing, usually with handles or operational mechanisms.
  • Reload: A refill unit containing surgical staples.
  • Cartridge and cartridge base: Parts that hold and secure staples for deployment.
  • Anvil: Metal part supporting the staple during formation with a grooved surface.
  • Cutting knife and knife seat: Elements responsible for tissue cutting, where applicable.

• Staple Characteristics

  • Surgical staple: The metallic fastener used to approximate tissues via bending deformation.
  • Initial staple height and crown width: Dimensions of the staple before firing.
  • Deformed staple height: Staple dimensions after deployment into tissue.

• Operational Features

  • Clamping activator: Mechanism to close the stapler jaws.
  • Trigger: Initiates the deployment of staples.
  • Reset device: Releases the stapler jaws after firing.
  • Empty cartridge lock: Safety feature preventing refiring on empty cartridges.
  • Rotating device and articulating angle: Mechanisms allowing adjustment and flexible positioning during surgery.

• Types of Staplers

  • Cutter stapler: Capable of cutting tissue while applying staples.
  • Endoscopic stapler: Designed for minimally invasive procedures, operable through a trocar.
  • Powered stapler: Uses electricity or other power sources for staple deployment.

• Staple Line Metrics

  • Staple line: Row of staples connecting tissue.
  • Single-row and total staple line length: Tissue coverage achieved by staples.
  • Inner knife diameter and cutting length: Dimensions related to tissue cutting capacity.

Applications

ISO/FDIS 6335-1:2025 is valuable for:

• Medical device manufacturers developing and refining surgical staplers, ensuring terminology uniformity in product development, labeling, and documentation.
• Healthcare professionals and surgeons, facilitating clear communication and understanding of stapler functions and components during preoperative planning and intraoperative use.
• Regulatory bodies and quality assurance teams to evaluate device compliance, traceability, and safety communication.
• Standardization and research organizations, supporting harmonized language in clinical studies, product comparisons, and safety protocols for surgical stapling devices.

By adopting this standardized vocabulary, users benefit from decreased ambiguity, improved training materials, streamlined regulatory submissions, and enhanced collaboration among multidisciplinary teams.

Related Standards

ISO/FDIS 6335-1 is part of the broader ISO 6335 series on surgical instruments focused on staplers. Relevant complementary standards include:

• Other parts of the ISO 6335 series, which may address performance requirements, testing methods, and technology-specific applications of staplers.
• ISO standards related to general surgical instruments and medical device safety and risk management.
• International Electrotechnical Commission (IEC) standards for powered medical devices, relevant for powered and electric staplers.
• Standards on sterilization and biocompatibility of surgical instruments, impacting stapler design and usage protocols.

For comprehensive updates and access, the ISO Online Browsing Platform (https://www.iso.org/obp) and IEC Electropedia (https://www.electropedia.org/) provide valuable terminology and related standard documents.

Keywords: surgical staplers vocabulary, surgical instruments standards, ISO 6335-1, stapler components, surgical staples, medical device terminology, endoscopic stapler terms, powered stapler definitions, surgical stapler safety, tissue closure devices, international surgical standards