ISO/PRF 8600-1

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: Not Published
• 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: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Due Date: 15-Jan-2025
• Completion Date: 15-Jan-2025

Relations

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

Standards Content (Sample)

International
Standard
ISO 8600-1
Fifth edition
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 1:
General requirements
Endoscopes — Endoscopes médicaux et dispositifs
d'endothérapie —
Partie 1: Exigences générales
PROOF/ÉPREUVE
Reference number
ISO 8600-1:2025(en) © ISO 2025

ISO 8600-1:2025(en)
© 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
PROOF/ÉPREUVE
ii
ISO 8600-1:2025(en)
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
PROOF/ÉPREUVE
iii
ISO 8600-1:2025(en)
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.
PROOF/ÉPREUVE
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
PROOF/ÉPREUVE
ISO 8600-1:2025(en)
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 state
...

Formatted
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
ISO/TC 172/SC 5/WG 6
Style Definition
...
Style Definition
...
Secretariat: DIN
Style Definition
...
Date: 2025-1-02xx
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Endoscopes — Medical endoscopes and endotherapy devices — —
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Part 1: Style Definition
...
General requirements Style Definition
...
Style Definition
...
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie — —
Style Definition
...
Partie 1: Exigences générales
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
PROOF .
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Style Definition
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted: Font: Bold
Formatted: HeaderCentered
Formatted: Default Paragraph Font, French (France)
Formatted: French (France)
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,
Formatted: Default Paragraph Font, French (France)
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
Formatted: French (France)
at the address below or ISO’s member body in the country of the requester.
Formatted: Adjust space between Latin and Asian text,
ISO copyright office
Adjust space between Asian text and numbers
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Formatted: French (France)
EmailE-mail: [e-mail]
Formatted: French (France)
Website: www.iso.orgwww.iso.org
Formatted: French (France)
Published in Switzerland
Formatted: FooterPageRomanNumber
ii
Formatted: Font: 11 pt, Bold
Formatted: Font: 11 pt, Bold
Formatted: Font: Bold
Contents Page
Formatted: HeaderCentered, Left
Formatted: Adjust space between Latin and Asian text,
Foreword . v
Adjust space between Asian text and numbers, Tab
1 Scope . 1
stops: Not at 0.71 cm + 17.2 cm
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 . 5
4.5 Field of view . 5
4.6 Direction of view . 5
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
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 . 7
5.5 Field of view . 7
5.6 Direction of view . 7
6 Marking . 8
6.1 Minimum marking . 8
6.2 Marking legibility . 8
6.3 Marking exceptions . 8
7 Instruction manual . 8
8 Packaging . 9
Annex A (informative) Guidelines on the application of risk management to endoscopic system
connector . 10
Bibliography . 12

Foreword . iv
1 Scope . 1
2 Normative references . 1
Formatted: Font: 10 pt
3 Terms and definitions . 1
Formatted: Font: 10 pt
4 Requirements . 5
Formatted: Font: 10 pt
4.1 General. 5
Formatted: FooterCentered, Left, Space Before: 0 pt,
4.2 Surface and edges . 5
Tab stops: Not at 17.2 cm
4.3 Maximum insertion portion width . 5
4.4 Minimum instrument channel width . 5
Formatted: Font: 11 pt
4.5 Field of view . 5
Formatted: FooterPageRomanNumber, Left, Space
4.6 Direction of view . 5
After: 0 pt, Tab stops: Not at 17.2 cm
© ISO 2025 – All rights reserved
iii
Formatted: Font: Bold
Formatted: HeaderCentered
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 . 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 . 6
5 Testing . 8
5.1 General. 8
5.2 Surface and edges . 8
5.3 Maximum insertion portion width . 8
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

Formatted: FooterPageRomanNumber
iv
Formatted: Font: 11 pt, Bold
Formatted: Font: 11 pt, Bold
Formatted: Font: Bold
Foreword
Formatted: HeaderCentered, Left
ISO (the International Organization for Standardization) is a worldwide federation of national standards
Formatted:
...