ISO 8600-8:2021

Endoscopes - Medical endoscopes and endotherapy devices - Part 8: Particular requirements for capsule endoscopes

This document applies to capsule endoscopes used for clinical practice. The document defines relevant terms and gives requirements for them.

Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie — Partie 8: Exigences particulières pour les endoscopes à capsule

General Information

• Status: Published
• Publication Date: 13-May-2021
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 37.020 - Optical equipment
• Technical Committee: ISO/TC 172/SC 5 - Microscopes and endoscopes
• Drafting Committee: ISO/TC 172/SC 5/WG 6 - Endoscopes
• Current Stage: 6060 - International Standard published
• Start Date: 14-May-2021
• Due Date: 13-Aug-2021
• Completion Date: 14-May-2021

Overview - ISO 8600-8:2021 (Capsule endoscopes)

ISO 8600-8:2021 is the ISO part that sets particular requirements for capsule endoscopes used in clinical practice. It defines key terms (maximum diameter, maximum length, recording time) and specifies product requirements, testing, marking, instruction content and packaging expectations for capsule-shaped medical endoscopes. The standard supports safe design, consistent testing and clear labeling of capsule endoscopes for manufacturers, test laboratories and healthcare providers.

Key topics and technical requirements

• Defined terms: clear definitions for maximum diameter, maximum length (measured in millimetres) and recording time used throughout design, testing and labeling.
• Physical limits: maximum diameter and maximum length shall not exceed values stated in the device instruction manual; measurements follow ISO 8600-4 methods.
• EMC / EMI: capsule endoscopes must conform to IEC 60601-1-2 for electromagnetic compatibility and immunity to electromagnetic interference.
• Field of view / direction of view: to be determined according to Method B in ISO 8600-3.
• Testing: application of ISO 8600-1 general test principles plus ISO 8600-4 for dimensional measurement (diameter and length).
• Minimum marking: each capsule must carry at least model identification/manufacturer, maximum diameter and length (mm), field/direction of view (if relevant), lot/serial number (if applicable) and expiration date.
• Instruction manual requirements: must include data transfer technology (e.g., radio transmission, body communication), modulation method and transmit/receive frequency characteristics when applicable, recording time, storage environment (temperature/humidity) and battery type and rated watt-hours.
• Packaging: follows ISO 8600-1 packaging requirements where applicable.

Practical applications - who uses ISO 8600-8:2021

• Medical device manufacturers: design, test and label capsule endoscopes to meet regulatory and market expectations.
• Regulatory bodies / Notified bodies: evaluate conformity for clinical use and market authorization, including EMC compliance.
• Test laboratories and conformity assessors: apply the referenced test methods (ISO 8600-3, ISO 8600-4, IEC 60601-1-2) to verify dimensional, optical and electromagnetic requirements.
• Hospitals and procurement teams: interpret labeling and instruction data (dimensions, field of view, recording time, battery info) to select appropriate capsule endoscopes for clinical workflows.
• Clinical engineers and biomedical technicians: ensure device compatibility with receiving units and safe storage/handling per instructions.

Related standards

• ISO 8600-1:2015 - General requirements for endoscopes
• ISO 8600-3 - Determination of field of view and direction of view (Method B referenced)
• ISO 8600-4 - Determination of maximum width/length of insertion portion (dimensional measurement)
• ISO 8600-6 - Vocabulary for endoscopes
• IEC 60601-1-2 - Medical electrical equipment - EMC requirements

Keywords: ISO 8600-8:2021, capsule endoscopes, medical endoscopes, EMC, field of view, maximum diameter, recording time, device marking, instruction manual.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8600-8
First edition
2021-05
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 8:
Particular requirements for capsule
endoscopes
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie —
Partie 8: Exigences particulières pour les endoscopes à capsule
Reference number
©
ISO 2021
© ISO 2021
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
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Published in Switzerland
ii © ISO 2021 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Requirements specific for capsule endoscopes . 2
4.2.1 Maximum diameter . 2
4.2.2 Maximum length . 2
4.2.3 EMC/EMI . 2
5 Testing . 2
5.1 General . 2
5.2 Testing specific for capsule endoscopes . 2
5.2.1 Maximum diameter . 2
5.2.2 Maximum length . 2
5.2.3 Field of view and direction of view . 3
6 Marking . 3
6.1 General . 3
6.2 Minimum marking specific for capsule endoscopes . 3
7 Instruction manual . 3
7.1 General . 3
7.2 Information specific for capsule endoscopes . 3
8 Packaging . 3
Bibliography . 4
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 fur
...