Amendment 1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications

Amendement 1 - Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales

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Status
Published
Publication Date
11-Feb-2019
Current Stage
PPUB - Publication issued
Start Date
18-Apr-2019
Completion Date
13-Feb-2019
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ISO 80369-3:2016/AMD1:2019 - Amendment 1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
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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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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
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Published in Switzerland
ii © ISO 2019 – All rights reserved

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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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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
Revise Figure B.1 to add new dimension a3 and r3 and add a new NOTE 2.
© ISO 2019 – All rights reserved 1

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ISO 80369-3:2016/Amd.1:2019(E)

NOTE 1 Table B.1 contains the dimensions for Figure B.1.
NOTE 2 Dimensions a3 and r3 start at Øf.
Figure B.1 — Male E1 SMALL-BORE CONNECTOR
In Figure B.1, the male ENTERAL SMALL-BORE CONNECTOR may utilize a rotatable collar. The
requirements for dimension c shall be maintained.

Table B.1
Revise Table B.1 as follows:
g
Add superscript " " to Øf.

g
Add a footnote “ ” applicable to designations Øf, a3 and r3, “A minimum diameter of 2,85 for Øf, a
maximum angle of 2° for a3 and a minimum depth of 8,00 for r3 may be required in order to interface
...

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