ISO-80369-3 › Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
The following bibliographic material is provided to assist you with your purchasing decision:
Included in this current edition are the following subparts:
FOR 1ST EDITION AMENDMENT 1 SEE - Feb. 1, 2019
ISO 80369-3:2016 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.
It 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.
It 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;
- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;
- gastrointestinal endoscopy equipment;
- skin level gastrostomy medical devices.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 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.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
July 1, 2016