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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
ISO 80369-3:2016/Amd.1:2019(E)
© ISO 2019
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ISO 80369-3:2016/Amd.1:2019(E)
Foreword
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electrotechnical standardization.
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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 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 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 req
...