ISO 18340:2020

Endoscopes - Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable. It also specifies the design, testing and labelling of endotherapy devices which are inserted through these trocar sleeves and are also universally interchangeable and reuseable. This document specifies the minimum requirements for the production of the products mentioned.

Endoscopes — Mandrins de trocart, fourreaux de trocart et dispositifs d'endothérapie à utiliser avec des fourreaux de trocart

General Information

• Status: Published
• Publication Date: 14-Jul-2020
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 172/SC 5 - Microscopes and endoscopes
• Drafting Committee: ISO/TC 172/SC 5/WG 6 - Endoscopes
• Current Stage: 9060 - Close of review
• Completion Date: 02-Dec-2030

Relations

• Revises: ISO/TS 18340:2015 - Endoscopes - Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves
• Effective Date: 23-Apr-2020

Overview

ISO 18340:2020 - Endoscopes: Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves specifies design, testing and labelling requirements for universally interchangeable and reusable trocar pins, trocar sleeves and endotherapy devices. The standard sets minimum production requirements to ensure compatibility, safety and reliable performance when these components are used with medical endoscopes.

Key topics and technical requirements

• Scope and purpose: Requirements cover design, testing and labelling for trocar assemblies and endotherapy instruments intended to be mutually compatible and reusable.
• Dimensions and compatibility:
  • Defines key dimensional terms: nominal diameter (ND), minimum inner diameter (IDts,min), maximum insertion portion width (OD).
  • Compatibility rule: OD of an endotherapy device must be ≤ IDts,min of the trocar sleeve; OD must not exceed the nominal diameter.
  • Dimensional tolerances (Table 1):
    • If ND < 5 mm → IDts,min ≥ ND + 0.05 mm
    • If ND ≥ 5 mm → IDts,min ≥ ND + 0.10 mm
  • Sheath and length relationships: sheath length shall be longer than the total length (TL) of the trocar sleeve to ensure safe insertion and retraction.
• Device types:
  • Not dismountable and dismountable endotherapy devices - the standard addresses both configurations and their length/working-length implications.
  • Spring-handle (non-jointed) devices - warns about relative movement needed to open branches and reduced maximum opening compared with jointed forceps.
• Materials: Metallic, non‑metallic or hybrid constructions are permitted provided materials meet medical device requirements.
• Marking and labelling: Marking shall comply with ISO 8600-1 (medical endoscopes and endotherapy devices - general requirements).
• Normative references and safety: Uses terminology from ISO 8600-6; biological evaluation referenced in the bibliography (ISO 10993 series).

Applications and who uses ISO 18340

• Medical device manufacturers designing trocar systems, trocar-compatible endotherapy instruments (forceps, graspers, etc.), and suppliers of reusable endoscopic tools.
• Design and R&D teams ensuring interchangeability across product lines and suppliers.
• Quality assurance, regulatory, and compliance teams validating product labelling, testing and dimensional conformity.
• Hospitals, clinical engineering and procurement teams specifying compatible trocar and endotherapy instruments to maintain safe, minimal-incision procedures.

Related standards

• ISO 8600-1 - Endoscopes: General requirements and marking
• ISO 8600-6 - Vocabulary for endoscopes and endotherapy devices
• ISO 10993 (bibliography) - Biological evaluation of medical devices

Keywords: ISO 18340, trocar sleeves, trocar pins, endotherapy devices, reusable, interchangeable, endoscopes, design, testing, labelling, medical device standards.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18340
First edition
2020-07
Endoscopes — Trocar pins, trocar
sleeves and endotherapy devices for
use with trocar sleeves
Endoscopes — Mandrins de trocart, fourreaux de trocart et dispositifs
d'endothérapie à utiliser avec des fourreaux de trocart
Reference number
©
ISO 2020
© ISO 2020
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
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Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 2
4.1 General . 2
4.2 Trocar pin and trocar sleeve . 2
4.3 Endotherapy device for use through a trocar sleeve . 4
4.3.1 Not dismountable endotherapy devices . 5
4.3.2 Dismountable endotherapy devices . 5
4.4 Endotherapy device with spring handle for use through a trocar sleeve . 6
5 Material . 8
6 Marking . 8
Bibliography . 9
Foreword
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This document was prepared by Technical Committee ISO/TC 172 Optics and photonics,
Subcommittee SC 5, Microscopes and endoscopes.
This first edition cancels and replaces the first edition of ISO/TS 18340:2015.
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 2020 – All rights reserved

Introduction
This document is intended to help manufacturers to produce universally interchangeable and reusable
trocar sleeves and trocar pins and endotherapy devices which are inserted through these trocar sleeves.
INTERNATIONAL STANDARD ISO 18340:2020(E)
Endoscopes — Trocar pins, trocar sleeves and endotherapy
devices for use with trocar sleeves
1 Scope
This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are
universally interchangeable and reusable.
It also specifies the design, testing and labelling of endotherapy devices which are inserted through
these trocar sleeves and are also universally interchangeable and reuseable.
This document specifies the minimum requirements for the production of the products mentioned.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 8600-1, Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements
ISO 8600-6, Optics and photonics
...