EN ISO 80369-3:2016/A1:2022

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd 1:2019)

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-3:2016/Amd 1:2019)

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del: Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)

General Information

• Status: Published
• Publication Date: 29-Nov-2022
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 30-Nov-2022
• Due Date: 26-Mar-2023
• Completion Date: 30-Nov-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 80369-3:2016/A1:2023 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

Relations

• Amends: EN ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
• Effective Date: 14-Oct-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80369-3:2016/A1:2023
01-februar-2023

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del:

Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen -
Änderung 1 (ISO 80369-3:2016/Amd 1:2019)

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie

3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-
3:2016/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/A1:2022
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-3:2016/A1:2023 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80369-3:2016/A1:2023
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SIST EN ISO 80369-3:2016/A1:2023
EUROPEAN STANDARD EN ISO 80369-3:2016/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2022
ICS 11.040.25
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 3: Connectors for enteral applications -
Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für

dans le domaine de la santé - Partie 3: Raccords Flüssigkeiten und Gase in medizinischen

destinés à des applications entérales - Amendement 1 Anwendungen - Teil 3: Verbindungsstücke für enterale

(ISO 80369-3:2016/Amd 1:2019) Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd
1:2019)

This amendment A1 modifies the European Standard EN ISO 80369-3:2016; it was approved by CEN on 21 November 2022.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for

inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical

references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to

any CEN and CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,

Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,

Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-3:2016/A1:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 80369-3:2016/A1:2023
EN ISO 80369-3:2016/A1:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 80369-3:2016/A1:2023
EN ISO 80369-3:2016/A1:2022 (E)
European foreword

The text of ISO 80369-3:2016/Amd 1:2019 has been prepared by Technical Committee ISO/TC 210

"Quality management and corresponding general aspects for medical devices” of the International

Organization for Standardization (ISO) and has been taken over as EN ISO 80369-3:2016/A1:2022 by

Technical Committee CEN-CENELEC/ JTC 3 “Quality management and corresponding general aspects

for medical devices” the secretariat of which is held by NEN.

This Amendment to the European Standard EN ISO 80369-3:2016 shall be given the status of a national

standard, either by publication of an identical text or by endorsement, at the latest by May 2023, and

conflicting national standards shall be withdrawn at the latest by May 2023.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national standards body.

A complete listing of these bodies can be found on the CEN and CENELEC websites.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the

United Kingdom.
Endorsement notice

The text of ISO 80369-3:2016/Amd 1:2019 has been approved by CEN-CENELEC as EN ISO 80369-

3:2016/A1:2022 without any modification.
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SIST EN ISO 80369-3:2016/A1:2023
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SIST EN ISO 80369-3:2016/A1:2023
INTERNATIONAL ISO
STANDARD 80369-3
First edition
2016-07-01
AMENDMENT 1
2019-02
Small-bore connectors for liquids and
gases in healthcare applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 3: Raccords destinés à des applications entérales
AMENDEMENT 1
Reference number
ISO 80369-3:2016/Amd.1:2019(E)
ISO 2019
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SIST EN ISO 80369-3:2016/A1:2023
ISO 80369-3:2016/Amd.1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 80369-3:2016/A1:2023
ISO 80369-3:2016/Amd.1:2019(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 i
...

SLOVENSKI STANDARD
SIST EN ISO 80369-3:2016/oprA1:2022
01-oktober-2022

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del:

Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen -
Änderung 1 (ISO 80369-3:2016/Amd 1:2019)

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie

3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-
3:2016/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/prA1
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-3:2016/oprA1:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 80369-3:2016/oprA1:2022
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SIST EN ISO 80369-3:2016/oprA1:2022
INTERNATIONAL ISO
STANDARD 80369-3
First edition
2016-07-01
AMENDMENT 1
2019-02
Small-bore connectors for liquids and
gases in healthcare applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 3: Raccords destinés à des applications entérales
AMENDEMENT 1
Reference number
ISO 80369-3:2016/Amd.1:2019(E)
ISO 2019
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SIST EN ISO 80369-3:2016/oprA1:2022
ISO 80369-3:2016/Amd.1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
SIST EN ISO 80369-3:2016/oprA1:2022
ISO 80369-3:2016/Amd.1:2019(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 on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 210, Quality management and corresponding

general aspects for medical devices, and IEC/SC 62D, Electromedical equipment. The draft was circulated

for voting to the national bodies of both ISO and IEC.
A list of all the parts in the ISO 80369 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.
© ISO 2019 – All rights reserved iii
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SIST EN ISO 80369-3:2016/oprA1:2022
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SIST EN ISO 80369-3:2016/oprA1:2022
ISO 80369-3:2016/Amd.1:2019(E)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1
Scope

Remove the following text from the bulleted list under “This part of ISO 80369 does not specify

requirements for small-bore connectors that are used for the following:”

“Medical devices for rectal drainage, rectal administration of medicines or fluid, and any other

rectal access medical device”
Figure B.1
...