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
Current Stage
6060 - International Standard published
Due Date
18-Nov-2023
Completion Date
10-Jan-2023
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ISO 8600-4:2023 - Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion Released:10. 01. 2023
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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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© 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)
Style Definition: Heading 2: Font: Bold, Tab stops: Not
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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Font: Bold

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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46.3 pt, List tab
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Hanging: 18 pt, No bullets or numbering, Tab stops:
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: +41 22 749 01 11
Email: copyright@iso.org
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
...

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