ISO/FDIS 6335-1
(Main)Surgical instruments - Staplers - Part 1: Vocabulary
Surgical instruments - Staplers - Part 1: Vocabulary
This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
Instruments chirurgicaux — Agrafeuses — Partie 1: Vocabulaire
General Information
- Status
- Not Published
- Technical Committee
- ISO/TC 170 - Surgical instruments
- Drafting Committee
- ISO/TC 170 - Surgical instruments
- Current Stage
- 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
- Start Date
- 19-Nov-2025
- Completion Date
- 19-Nov-2025
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
ISO/FDIS 6335-1 - Surgical instruments — Staplers — Part 1: Vocabulary Released:5. 11. 2025
REDLINE ISO/FDIS 6335-1 - Surgical instruments — Staplers — Part 1: Vocabulary Released:5. 11. 2025
Frequently Asked Questions
ISO/FDIS 6335-1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Surgical instruments - Staplers - Part 1: Vocabulary". This standard covers: This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
This document defines common terms for stapler in terms of its components and use, and elaborates their specific meanings. This document applies to staplers and their components. This document does not apply to special vascular stapler, cardiac valve stapler, circumcision stapler, purse-string suture device, or other staplers to which this standard does not apply due to different working principle or for other reasons.
ISO/FDIS 6335-1 is classified under the following ICS (International Classification for Standards) categories: 01.040.11 - Health care technology (Vocabularies); 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/FDIS 6335-1 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)
FINAL DRAFT
International
Standard
ISO/TC 170
Surgical instruments — Staplers —
Secretariat: DIN
Part 1:
Voting begins on:
2025-11-19
Vocabulary
Voting terminates on:
2026-01-14
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 170
Surgical instruments — Staplers —
Secretariat: DIN
Part 1:
Voting begins on:
Vocabulary
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Index . 5
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 170, Surgical instruments.
A list of all parts in the ISO 6335 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
...
ISO/DIS 6335-1:2025(en)
ISO/TC 170
Secretariat: DIN
Date: 2025-06-26 Meeting 11-05
Surgical instruments — Staplers —
Part 1:
Vocabulary
FDIS stage
ISO/DISFDIS 6335-1:2025(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 6335-1:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Index 7
iii
ISO/DISFDIS 6335-1:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO'sISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 170, Surgical instruments.
A list of all parts in the ISO 6335 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DISFDIS 6335-1:2025(en)
Introduction
This document includes multiple common terms for staplerstaplers. It is intended to facilitate the consistent
description of the staplerstaplers and to harmonize the terms within the stapler field.
v
Surgical instruments — Staplers —
Part 1:
Vocabulary
1 Scope
This document defines terms for stapler in terms of its components and use and elaborates their specific
meanings. This document appliesrelated to staplers and their components.
This document only applies to instruments, which uses that use staples.
NOTE Commonly used forms of staples can be found in Figure 1Figure 1. .
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
stapled anastomosis
action or state in which two tissues are connected together by means of non-suture
3.2
stapler
medical device used to close wounds, joint tissues or create anastomosis by mechanically inserting surgical
staple
...
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