EVS-EN ISO 80369-3:2016+A1:2022

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

General information
Valid from 30.12.2022
Base Documents
ISO 80369-3:2016; EN ISO 80369-3:2016; EN ISO 80369-3:2016/A1:2022; ISO 80369-3:2016/Amd 1:2019
Directives or regulations

Standard history

Main + amendment
This part of ISO 80369 specifies the dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS on ENTERAL MEDICAL DEVICES and ACCESSORIES.
NOTE 1  ENTERAL MEDICAL DEVICES include ENTERAL feeding sets, ENTERAL drainage sets, ENTERAL syringes, and PATIENT interface devices including access ports.
This part of ISO 80369 does not specify the dimensions and requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
This part of ISO 80369 does not specify requirements for SMALL-BORE CONNECTORS that are used for the following:
—  gastric suction-only MEDICAL DEVICES;
—  oral-only MEDICAL DEVICES;
EXAMPLE  An oral tip syringe that is not intended to connect to another MEDICAL DEVICE. It is intended to administer directly to the PATIENT’S mouth.
—  pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive ENTERAL MEDICAL DEVICES in place;
—  gastrointestinal endoscopy equipment;
—  skin level gastrostomy MEDICAL DEVICES.
NOTE 2  MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 into ENTERAL MEDICAL DEVICES or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS, as specified in ISO 80369, will be included.
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