Endoscopes -- Medical endoscopes and endotherapy devices

This document applies to capsule endoscopes used for clinical practice. The document defines relevant terms and gives requirements for them.

Endoscopes -- Endoscopes médicaux et dispositifs d'endothérapie

General Information

Status
Published
Publication Date
13-May-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
14-Apr-2021
Completion Date
14-Apr-2021
Ref Project

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ISO 8600-8:2021 - Endoscopes -- Medical endoscopes and endotherapy devices
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Standards Content (sample)

INTERNATIONAL ISO
STANDARD 8600-8
First edition
2021-05
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 8:
Particular requirements for capsule
endoscopes
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie —
Partie 8: Exigences particulières pour les endoscopes à capsule
Reference number
ISO 8600-8:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 8600-8:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8600-8:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Requirements specific for capsule endoscopes .......................................................................................................... 2

4.2.1 Maximum diameter ....................................................................................................................................................... 2

4.2.2 Maximum length .............................................................................................................................................................. 2

4.2.3 EMC/EMI ................................................................................................................................................................................ 2

5 Testing ............................................................................................................................................................................................................................. 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Testing specific for capsule endoscopes ........................................................................................................................... 2

5.2.1 Maximum diameter ....................................................................................................................................................... 2

5.2.2 Maximum length .............................................................................................................................................................. 2

5.2.3 Field of view and direction of view .................................................................................................................. 3

6 Marking .......................................................................................................................................................................................................................... 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Minimum marking specific for capsule endoscopes .............................................................................................. 3

7 Instruction manual ............................................................................................................................................................................................ 3

7.1 General ........................................................................................................................................................................................................... 3

7.2 Information specific for capsule endoscopes ............................................................................................................... 3

8 Packaging ..................................................................................................................................................................................................................... 3

Bibliography ................................................................................................................................................................................................................................ 4

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 8600-8:2021(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 fur
...

INTERNATIONAL ISO
STANDARD 8600-8
First edition
Endoscopes — Medical endoscopes
and endotherapy devices —
Part 8:
Particular requirements for capsule
endoscopes
Endoscopes — Endoscopes médicaux et dispositifs d'endothérapie —
Partie 8: Exigences particulières pour les endoscopes à capsule
PROOF/ÉPREUVE
Reference number
ISO 8600-8:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 8600-8:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 8600-8:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Requirements specific for capsule endoscopes .......................................................................................................... 2

4.2.1 Maximum diameter ....................................................................................................................................................... 2

4.2.2 Maximum length .............................................................................................................................................................. 2

4.2.3 EMC/EMI ................................................................................................................................................................................ 2

5 Testing ............................................................................................................................................................................................................................. 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Testing specific for capsule endoscopes ........................................................................................................................... 2

5.2.1 Maximum diameter ....................................................................................................................................................... 2

5.2.2 Maximum length .............................................................................................................................................................. 2

6 Marking .......................................................................................................................................................................................................................... 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Minimum marking specific for capsule endoscopes .............................................................................................. 3

7 Instruction manual ............................................................................................................................................................................................ 3

7.1 General ........................................................................................................................................................................................................... 3

7.2 Information specific for capsule endoscopes ............................................................................................................... 3

8 Packaging ..................................................................................................................................................................................................................... 3

Bibliography ................................................................................................................................................................................................................................ 4

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO 8600-8:2021(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 a

...

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