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CEN - EN ISO 80369-3

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

active, Most Current
Organization: CEN
Publication Date: 1 August 2016
Status: active
Page Count: 52
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

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;

- 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 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.

Document History

EN ISO 80369-3
August 1, 2016
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
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...

References

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