ISO 8600-4:2023

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
• ICS: 11.040.55 - Diagnostic 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: 10-Jan-2023
• Due Date: 18-Nov-2023
• Completion Date: 10-Jan-2023

Relations

• Revises: ISO 8600-4:2014 - Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
• Effective Date: 06-Jun-2022

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 8600-4:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 8600-4:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 8600-4:2023(E)
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
© ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO 8600-4:2023(E)
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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as informa
...

2022-10-25
Style Definition: Heading 1: Indent: Left: 0 pt, First
line: 0 pt, Tab stops: Not at 21.6 pt
ISO/PRF 8600-4:2022(E)
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at 18 pt
ISO TC 172/SC 5/WG 6
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DATE: 2022-xx
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Secretariat: DIN
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Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of
maximum width of insertion portion Style Definition: List Bullet: Indent: Left: 0 pt, Hanging:
18 pt, No bullets or numbering, Tab stops: 18 pt, List
tab
Endoscopes — Endoscopes médicaux et certains de leurs accessoires — Partie 4: Détermination
de la largeur maximale de la partie insérée
Style Definition: List Bullet 2: Indent: Left: 14.15 pt,
Hanging: 18 pt, No bullets or numbering, Tab stops:
32.15 pt, List tab
Style Definition: List Bullet 3: Indent: Left: 28.3 pt,
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74.6 pt, List tab

---------------------- Page: 1 ----------------------
ISO/PRF 8600-4:2022(E)
© ISO 2022
Formatted: Pattern: Clear
Formatted: Pattern: Clear
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.orgwww.iso.org
Published in Switzerland
ii © ISO 2022 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/PRF 8600-4:2022(E)
Contents
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
5.3 Capsule endoscope . 4
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
5.3 Capsule endoscope . 4
© ISO 2022 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/PRF 8600-4:2022(E)
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/directiveswww.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
...

INTERNATIONAL ISO
STANDARD 8600-4
Third edition
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
PROOF/ÉPREUVE
Reference number
ISO 8600-4:2022(E)
© ISO 2022

---------------------- Page: 1 ----------------------
ISO 8600-4:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
PROOF/ÉPREUVE © ISO 2022 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 8600-4:2022(E)
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
© ISO 2022 – All rights reserved PROOF/ÉPREUVE

---------------------- Page: 3 ----------------------
ISO 8600-4:2022(E)
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 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
...