Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion

This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.

Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie — Partie 4: Détermination de la largeur maximale de la partie insérée

General Information

Status
Published
Publication Date
09-Jan-2023
Current Stage
6060 - International Standard published
Start Date
10-Jan-2023
Due Date
18-Nov-2023
Completion Date
10-Jan-2023

Relations

Effective Date
06-Jun-2022

Overview

ISO 8600-4:2023 is an international standard developed by ISO that defines a precise method for measuring the maximum width of the insertion portion of medical endoscopes and certain endoscopic accessories. This standard ensures consistency and accuracy in the dimensional assessment of both flexible and rigid endoscopes as well as capsule endoscopes. By providing a clear measurement protocol, ISO 8600-4:2023 supports improved design verification, quality control, regulatory compliance, and safety in endoscopic medical devices.

Key Topics

  • Scope: Specifies measurement methods for the maximum insertion portion width of medical endoscopes and related endoscopic tools.
  • Measurement Conditions: Testing should occur in environments between 15°C and 35°C, using instruments with accuracy to at least 0.05 mm (e.g., vernier calipers). For peripheral length in French size units, accuracy of 0.5 mm is required.
  • Measurement Method for Flexible and Rigid Endoscopes:
    • Maximum diameter is measured as the largest circumscribed circle perpendicular to the insertion axis.
    • Flexible insertion portions must be measured straight.
    • Measurements include diameter indication in millimeters and French size calculation (1 Fr = 1/3 mm diameter) with adaptations for non-circular cross-sections.
    • Detachable hoods are measured both with and without attached to account for dimensional changes.
  • Measurement Method for Capsule Endoscopes:
    • Maximum diameter is taken perpendicular to the longer axis of the capsule, ensuring precise assessment of compact endotherapy devices.

Applications

ISO 8600-4:2023 is critical for:

  • Medical Device Manufacturers: To standardize product specifications and ensure endoscope dimensions align with design requirements and safety standards.
  • Quality Assurance Teams: For routine inspection and verification of the insertion portion width, guaranteeing device consistency and patient safety.
  • Regulatory Compliance: Providing documented measurement methodologies aids in meeting regulatory demands in various global markets.
  • Healthcare Providers and Procurement: Assisting clinicians and purchasing agents in selecting devices that meet size criteria suited for patient safety and procedural effectiveness.

Related Standards

  • ISO 8600-1: General requirements for medical endoscopes and endotherapy devices, establishing foundational definitions and requirements.
  • ISO 8600-6: Vocabulary related to medical endoscopes, ensuring terminology consistency among stakeholders.
  • Additional parts of the ISO 8600 series cover other aspects of endoscope performance and safety, supporting comprehensive standardization across endoscopic technologies.

Keywords: ISO 8600-4:2023, medical endoscopes, insertion portion width, measurement method, flexible endoscope, rigid endoscope, capsule endoscope, French size, quality assurance, regulatory compliance, endotherapy devices, medical device standards, insertion diameter measurement.

Standard

ISO 8600-4:2023 - Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion Released:10. 01. 2023

English language
3 pages
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Frequently Asked Questions

ISO 8600-4:2023 is a standard published by the International Organization for Standardization (ISO). Its full title is "Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion". This standard covers: This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.

This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.

ISO 8600-4:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 8600-4:2023 has the following relationships with other standards: It is inter standard links to ISO 8600-4:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ISO 8600-4:2023 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)


INTERNATIONAL ISO
STANDARD 8600-4
Third edition
2023-01
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 4:
Determination of maximum width of
insertion portion
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie —
Partie 4: Détermination de la largeur maximale de la partie insérée
Reference number
© ISO 2023
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test conditions .1
4.1 Test environments . 1
4.2 Accuracy of measuring instruments . 1
5 Method of measurement .2
5.1 Flexible and rigid endoscope . 2
5.1.1 General . 2
5.1.2 Diameter indication, d . 2
5.1.3 French size indication, Fr . . 2
5.2 Capsule endoscope . 3
iii
Foreword
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