ISO 8600-1:2025

Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements

This document gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie — Partie 1: Exigences générales

General Information

• Status: Published
• Publication Date: 03-Mar-2025
• 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 - Microscopes and endoscopes
• Current Stage: 6060 - International Standard published
• Start Date: 04-Mar-2025
• Due Date: 29-Nov-2025
• Completion Date: 04-Mar-2025

Relations

• Revises: ISO 8600-1:2015 - Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements
• Effective Date: 06-Jun-2022

Overview

ISO 8600-1:2025 - "Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements" is the fifth edition of the international standard that defines core terminology and general design, safety and performance requirements for medical endoscopes and endotherapy devices. It governs how manufacturers describe device geometry and optics, how devices are marked and documented, and which basic safety, biocompatibility and connector rules apply.

Key topics and technical requirements

• Scope and terminology: Standardizes terms such as insertion portion, instrument channel, maximum insertion portion width, field of view, direction of view and controllable portion. The 2025 edition updates the definition and illustration for field of view.
• Design and surfaces: Devices must be designed to prevent unintentional injury; outer surfaces must be free of pores, cracks and tooling residues.
• Dimensional requirements:
  • Maximum insertion portion width and minimum instrument channel width shall not exceed or be smaller than values stated in the instruction manual.
  • Working length is defined as insertion portion length stated in the manual.
• Optical performance:
  • Field of view deviation from the manufacturer-stated value shall not exceed 15% (unless otherwise specified).
  • Direction of view deviation for rigid endoscopes shall not exceed 10° (unless otherwise specified).
• Deflection control: Requirements for hand-wheel (knob) deflection systems are specified; if a different control layout is used, clear labeling must indicate controller movement versus tip deflection.
• Safety and biocompatibility:
  • Conformity to IEC 60601-2-18 for electrical and basic safety.
  • Materials in contact with patients evaluated per ISO 10993-1 for biological compatibility.
• Connectors and risk management:
  • ISO 80369‑7 connectors are recommended for liquid/gas fittings; if alternate connectors are used, a risk management process (e.g., ISO 14971) must demonstrate acceptable risk.
• Ancillary topics: Testing methods, minimum marking, instruction manuals, packaging and informative Annex A with guidance on connector risk management.

Practical applications and who uses this standard

• Medical device manufacturers - design validation, labeling, user instructions and compliance strategy for endoscopes and endotherapy tools.
• Regulatory and quality teams - technical files, conformity assessment and risk management evidence for market approval.
• Clinical engineers and procurement - device specifications, compatibility checks (connectors, channel sizes, optics) when selecting or integrating equipment.
• Sterilization and maintenance services - guidance on materials and surface requirements affecting cleaning and reprocessing.

Related standards

• ISO 8600-3 (field of view/direction of view testing)
• ISO 8600-4 (maximum insertion width testing)
• ISO 8600-6 (instrument channel and insertion portion terminology)
• ISO 10993-1 (biological evaluation)
• ISO 14971 (risk management)
• IEC 60601-2-18 (endoscopic equipment safety)
• ISO 80369-7 (small-bore connectors for liquids/gases)

For manufacturers and clinical users, ISO 8600-1:2025 is the foundational document to ensure safe, interoperable and clearly specified endoscopic devices.

Standards Content (Sample)

International
Standard
ISO 8600-1
Fifth edition
Endoscopes — Medical endoscopes
2025-03
and endotherapy devices —
Part 1:
General requirements
Endoscopes — Endoscopes médicaux et dispositifs
d'endothérapie —
Partie 1: Exigences générales
Reference number
© ISO 2025
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: [phone]
Email: [e-mail]
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 Requirements . 4
4.1 General .4
4.2 Surface and edges .4
4.3 Maximum insertion portion width .4
4.4 Minimum instrument channel width .4
4.5 Field of view .4
4.6 Direction of view.4
4.7 Safety.5
4.8 Biological compatibility .5
4.9 Fittings/connectors for liquid or gaseous media .5
4.10 Deflection control system for the controllable portion .5
4.10.1 General .5
4.10.2 Deflection up and down .5
4.10.3 Deflection right and left .5
4.10.4 Arrangement of the hand wheels .5
4.10.5 Maximum angle of deflection .5
5 Testing. 6
5.1 General .6
5.2 Surface and edges .7
5.3 Maximum insertion portion width .7
5.4 Minimum instrument channel width .7
5.5 Field of view .7
5.6 Direction of view.7
6 Marking . . 7
6.1 Minimum marking . .7
6.2 Marking legibility .7
6.3 Marking exceptions .7
7 Instruction manual . 8
8 Packaging. 9
Annex A (informative) Guidelines on the application of risk management to endoscopic system
connector . 10
Bibliography .12

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 document 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.
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5,
Microscopes and endoscopes.
This fifth edition cancels and replaces the fourth edition (ISO 8600-1:2015), which has been technically
revised.
The main changes are as follows:
— update of the definition and the corresponding Figure 1 for the term “field of view”.
A list of all parts in the ISO 8600 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
International Standard ISO 8600-1:2025(en)
Endoscopes — Medical endoscopes and endotherapy
devices —
Part 1:
General requirements
1 Scope
This document gives definitions of terms and requirements for endoscopes and endotherapy devices used in
the practice of medicine.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 8600-3, Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of
view and direction of view of endoscopes with optics
ISO 8600-4, Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum
width of insertion portion
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
IEC 60601-2–18, Medical electric equipment — Part 2-18: Particular requirements for the basic safety and
essential performance of endoscopic equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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
French
Fr
measure of the size of certain circular or non-circular cross-section endoscopes defined as
Fr= 3u π
where u is the perimeter of the cross-section, expressed in millimetres

3.2
distal
any location of that portion of an endoscope or endotherapy device which is farther from the user than some
referenced point
3.3
proximal
any location of that portion of an endoscope or endotherapy device which is closer to the user than some
referenced point
3.4
instrument channel
portion of an endoscope or endotherapy device through which an endoscope or an endotherapy device is
intended to pass
Note 1 to entry: See also ISO 8600-6.
3.5
insertion portion
portion of an endoscope or endotherapy device which is intended to be inserted into a natural or surgically
created body opening or which is intended to be inserted into the instrument channel (3.4) of an endoscope
or endotherapy device
Note 1 to entry: See also ISO 8600-6.
3.6
maximum insertion portion width
maximum external width of an endoscope or endotherapy device throughout the length of the insertion
portion (3.5) to be inserted
Note 1 to entry: The maximum width of any expandable or transformable portion of the insertion portion is not
considered as a maximum insertion portion width, such as balloons, controllable parts, jaws and the like having
variable insertion portion widths.
3.7
minimum instrument channel width
minimum internal width of an instrument channel (3.4)
3.8
working length
length of the insertion portion (3.5) stated in the instruction manual
3.9
field of view
view of an endoscope with optics as stated by the manufacturer or distributor
Note 1 to entry: The field of view is not appropriate when the endoscope is intended to be in contact with the object.
Note 2 to entry: For non-circular images, the field of view may be the largest visible circle. (If the endoscope rotates,
the definition doesn’t change because of vertical and horizontal symmetry.)
Note 3 to entry: See Figure 1.

Key
1 field of view
2 visible area of a circular image
3 visible area of a non-circular image
4 non-visible area of a non-circular image
Figure 1 — Field of view
3.10
direction of view
location of the centre of the object field relative to the normal axis of the endoscope, expressed as the angle
(in degrees) between the normal axis of the endoscope (0°) and the central axis of the field of view (3.9)
Note 1 to entry: See Figure 2.
Key
1 endoscope normal axis
2 direction of view
3 central axis of field of view
Figure 2 — Direction of view
3.11
controllable portion
part of the insertion portion (3.5) of an endoscope or endotherapy device who
...