ISO 8600-1:2015

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

ISO 8600-1:2015 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: 08-Oct-2015
• 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: 9599 - Withdrawal of International Standard
• Start Date: 04-Mar-2025
• Completion Date: 13-Dec-2025

Relations

• Revised: ISO 8600-1:2025 - Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements
• Effective Date: 06-Jun-2022
• Revises: ISO 8600-1:2013 - Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements
• Effective Date: 11-Oct-2014

Overview

ISO 8600-1:2015 - "Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements" provides core definitions and general requirements for the design, construction, testing and information supplied for medical endoscopes and endotherapy devices. It is the foundational part of the ISO 8600 series and sets baseline expectations for safety, usability and performance for rigid and flexible endoscopes used in clinical practice.

Key topics and technical requirements

• Scope and definitions: Clear definitions for terms such as endoscope, endotherapy device, rigid/flexible endoscope, insertion portion, instrument channel, working length, field of view, direction of view, French (Fr) sizing, and controllable portion.
• Design and safety requirements: Surfaces and edges must avoid pores, cracks and tooling residues to prevent injury or contamination. Devices must be designed to minimize unintentional injury during intended use.
• Dimensional requirements:
  • Maximum insertion portion width must not exceed the value stated in the instruction manual.
  • Minimum instrument channel width must not be smaller than the value stated in the instruction manual.
• Optical performance tolerances:
  • 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.
• Functional controls: Requirements for deflection control systems (up/down, right/left), arrangement of hand wheels and maximum deflection angles for controllable portions.
• Safety and biological compatibility: Conformity with IEC 60601-2-18 for medical electrical safety and with ISO 10993-1 for biological evaluation of materials contacting the patient.
• Fittings/connectors: Requirements for fittings or connectors for liquid or gaseous media, and guidance on associated risk management.
• Testing, marking, documentation and packaging: Specifies test methods, minimum marking and legibility, instruction manual content, and packaging requirements. Annex A gives guidance on risk management for system connectors.

Practical applications and users

ISO 8600-1:2015 is used to:

• Guide medical device manufacturers in design verification, risk assessment and product labeling for endoscopes and endotherapy accessories.
• Inform test laboratories and quality/validation teams when performing dimensional, optical and safety testing.
• Support regulatory submissions and compliance activities (CE marking, FDA dossiers) by documenting adherence to recognized international requirements.
• Help hospital procurement, clinical engineers and endoscopy departments evaluate device specifications and compatibility with existing systems.
• Aid standards writers and risk managers when applying ISO 14971-based risk management principles to endoscopic connectors and interfaces.

Related standards

• ISO 8600 series (Parts 2–7) for particular requirements and test methods (e.g., field of view, maximum width, optical resolution, vocabulary).
• ISO 10993-1 - Biological evaluation of medical devices.
• ISO 14971 - Application of risk management to medical devices.
• IEC 60601-2-18 - Particular requirements for endoscopic medical electrical equipment.

Keywords: ISO 8600-1:2015, endoscopes, medical endoscopes, endotherapy devices, field of view, direction of view, instrument channel, insertion portion width, biological compatibility, IEC 60601-2-18, ISO 10993-1.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8600-1
Fourth edition
2015-10-15
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 1:
General requirements
Endoscopes — Endoscopes médicaux et dispositifs d’endothérapie —
Partie 1: Exigences générales
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
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Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 5
4.1 General . 5
4.2 Surface and edges . 5
4.3 Maximum insertion portion width . 5
4.4 Minimum instrument channel width . 5
4.5 Field of view . 5
4.6 Direction of view . 5
4.7 Safety . 6
4.8 Biological compatibility. 6
4.9 Fittings/connectors for liquid or gaseous media . 6
4.10 Deflection control system for the controllable portion . 6
4.10.1 General. 6
4.10.2 Deflection up and down . 6
4.10.3 Deflection right and left . 6
4.10.4 Arrangement of the hand wheels . 6
4.10.5 Maximum angle of deflection . 7
5 Testing . 7
5.1 General . 7
5.2 Surface and edges . 7
5.3 Maximum insertion portion width . 7
5.4 Minimum instrument channel width . 8
5.5 Field of view . 8
5.6 Direction of view . 8
6 Marking . 8
6.1 Minimum marking . 8
6.2 Marking legibility . 9
6.3 Marking exceptions . 9
7 Instruction manual . 9
8 Packaging .10
Annex A (informative) Guidelines on the application of risk management to endoscopic
system connector .11
Bibliography .13
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5,
Microscopes and endoscopes.
This fourth edition cancels and replaces the third edition (ISO 8600-1:2013), of which it constitutes
a minor revision in order to update the definition and the corresponding Figure 1 for the term
“field of view”.
ISO 8600 consists of the following parts, under the general title Endoscopes — Medical endoscopes and
endotherapy devices:
— Part 1: General requirements
— Part 2: Particular requirements for rigid bronchoscopes
— Part 3: Determination of field of view and direction of view of endoscopes with optics
— Part 4: Determination of maximum width of insertion portion
— Part 5: Determination of optical resolution of rigid endoscopes with optics
— Part 6: Vocabulary
— Part 7: Basic requirements for medical endoscopes of water-resistant type
iv © ISO 2015 – All rights reserved

INTERNATIONAL STANDARD ISO 8600-1:2015(E)
Endoscopes — Medical endoscopes and endotherapy
devices —
Part 1:
General requirements
1 Scope
This part of ISO 8600 gives definitions of terms and requirements for endoscopes and endotherapy
devices used in the practice of medicine.
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 8600–3, Optics and optical instruments — Medical endoscopes and endoscopic accessories — 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.
3.1
endoscope
medical instrument having viewing means, with or without optics, introduced into a body cavity
through a natural or surgically created body opening for examination, diagnosis, or therapy
Note 1 to entry: Endoscopes may be of rigid or flexible type; all types may have different image pick-up systems
(e.g. via lenses or ultrasonic sensors) and different image-transmitting systems (e.g. optical, via lenses, or fibre
bundles, or electrical).
Note 2 to entry: See also ISO 8600-6.
3.2
endotherapy device
medical device intended to be inserted into a natural or surgically created body opening during
endoscopic procedures, whether through the same or a different orifice from the endoscope (3.1) for
examination, diagnosis, or therapy
Note 1 to entry: Endotherapy devices include the instrument to create the body opening and through which
an endoscope (3.1) or endotherapy device is inserted, such as a guide tube, trocar pin, trocar sleeve, or sliding
tube. Endotherapy devices include the devices to be inserted through the openings other than the opening for an
endoscope (3.1), to ensure the safety of the devices for the intended use under the endoscopic view.
Note 2 to entry: See also ISO 8600-6.
3.3
rigid endoscope (endotherapy device)
endoscope (3.1) or endotherapy device (3.2) whose insertion portion is intended to be unyielding to
natural or surgically created body cavities or instrument channels (3.8)
Note 1 to entry: See also ISO 8600-6.
3.4
flexible endoscope (endotherapy device)
endoscope (3.1) or endotherapy device (3.2) whose insertion portion is intended to conform to natural or
surgically created body cavities or instrument channels (3.8)
Note 1 to entry: See also ISO 8600-6.
3.5
French
Charrière
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
Note 1 to entry: See also ISO 8600-6.
3.6
distal
any location of that portion of an endoscope (3.1) or endotherapy device (3.2) which is farther from the
user than some referenced point
Note 1 to entry: See also ISO 8600-6.
3.7
proximal
any location of that portion of an endoscope (3.1) or endotherapy device (3.2) which is closer to the user
than some referenced point
Note 1 to entry: See also ISO 8600-6.
3.8
instrument channel
portion of an endoscope (3.1) or endotherapy device (3.2) through which an endoscope or an endotherapy
device is intended to pass
Note 1 to entry: See also ISO 8600-6.
2 © ISO 2015 – All rights reserved

3.9
insertion portion
insertion tube
portion of an endoscope (3.1) or endotherapy device (3.2) 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 (3.8)
of an endoscope (3.1) or endotherapy device
Note 1 to entry: See also ISO 8600-6.
3.10
maximum insertion portion width
maximum external width of an endoscope (3.1) or endotherapy device (3.2) throughout the length of the
insertion portion (3.9) 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.
Note 2 to entry: See also ISO 8600-6.
3.11
minimum instrument channel width
minimum internal width of an instrument channel (3.8)
Note 1 to entry: See also ISO 8600-6.
3.12
working length
length of the insertion portion (3.9) stated in the instruction manual
Note 1 to entry: See also ISO 8600-6.
3.13
field of view
view of an endoscope (3.1) 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.
Note 3 to entry: See Figure 1.
Note 4 to entry: See also ISO 8600-6.
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
3.14
direction of view
location of the centre of the object field relative to the normal axis of the endoscope (3.1), expressed as
the angle (in degrees) between the normal axis of the endoscope (0°) an
...