Endoscopes -- Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable. It also specifies the design, testing and labelling of endotherapy devices which are inserted through these trocar sleeves and are also universally interchangeable and reuseable. This document specifies the minimum requirements for the production of the products mentioned.

Endoscopes -- Mandrins de trocart, fourreaux de trocart et dispositifs d'endothérapie à utiliser avec des fourreaux de trocart

General Information

Status
Published
Publication Date
14-Jul-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
27-Jun-2020
Completion Date
26-Jun-2020
Ref Project

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ISO 18340:2020 - Endoscopes -- Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves
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INTERNATIONAL ISO
STANDARD 18340
First edition
2020-07
Endoscopes — Trocar pins, trocar
sleeves and endotherapy devices for
use with trocar sleeves
Endoscopes — Mandrins de trocart, fourreaux de trocart et dispositifs
d'endothérapie à utiliser avec des fourreaux de trocart
Reference number
ISO 18340:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 18340:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 18340:2020(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 Dimensions ................................................................................................................................................................................................................. 2

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

4.2 Trocar pin and trocar sleeve ....................................................................................................................................................... 2

4.3 Endotherapy device for use through a trocar sleeve .............................................................................................. 4

4.3.1 Not dismountable endotherapy devices ...................................................................................................... 5

4.3.2 Dismountable endotherapy devices ................................................................................................................ 5

4.4 Endotherapy device with spring handle for use through a trocar sleeve ............................................ 6

5 Material .......................................................................................................................................................................................................................... 8

6 Marking .......................................................................................................................................................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 18340:2020(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 adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 172 Optics and photonics,

Subcommittee SC 5, Microscopes and endoscopes.
This first edition cancels and replaces the first edition of ISO/TS 18340:2015.

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.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 18340:2020(E)
Introduction

This document is intended to help manufacturers to produce universally interchangeable and reusable

trocar sleeves and trocar pins and endotherapy devices which are inserted through these trocar sleeves.

© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 18340:2020(E)
Endoscopes — Trocar pins, trocar sleeves and endotherapy
devices for use with trocar sleeves
1 Scope

This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are

universally interchangeable and reusable.

It also specifies the design, testing and labelling of endotherapy devices which are inserted through

these trocar sleeves and are also universally interchangeable and reuseable.

This document specifies the minimum requirements for the production of the products mentioned.

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 8600-1, Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements

ISO 8600-6, Optics and photonics
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18340
ISO/TC 172/SC 5
Endoscopes — Trocar pins, trocar
Secretariat: DIN
sleeves and endotherapy devices for
Voting begins on:
2020­05­01 use with trocar sleeves
Voting terminates on:
Endoscopes — Mandrins de trocart, fourreaux de trocart et dispositifs
2020­06­26
d'endothérapie à utiliser avec des fourreaux de trocart
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 18340:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 18340:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 18340:2020(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 Dimensions ................................................................................................................................................................................................................. 2

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

4.2 Trocar pin and trocar sleeve ....................................................................................................................................................... 2

4.3 Endotherapy device for use through a trocar sleeve .............................................................................................. 4

4.3.1 Not dismountable endotherapy devices ...................................................................................................... 5

4.3.2 Dismountable endotherapy devices ................................................................................................................ 5

4.4 Endotherapy device with spring handle for use through a trocar sleeve ............................................ 6

5 Material .......................................................................................................................................................................................................................... 8

6 Marking .......................................................................................................................................................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 18340:2020(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 non­governmental, 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 adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 172 Optics and photonics,

Subcommittee SC 5, Microscopes and endoscopes.
This first edition cancels and replaces the first edition of ISO/TS 18340:2015.

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.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 18340:2020(E)
Introduction

This document is intended to help manufacturers to produce universally interchangeable and reusable

trocar sleeves and trocar pins and endotherapy devices which are inserted through these trocar sleeves.

© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 18340:2020(E)
Endoscopes — Trocar pins, trocar sleeves and endotherapy
devices for use with trocar sleeves
1 Scope

This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are

universally interchangeable and reusable.

It also specifies the design, testing and labelling of endotherapy devices which are inserted through

these trocar sleeves and are also universally interchangeable and reuseable.

This document specifies the minimum requirements for the production of the products mentioned.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its applicati
...

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