AAMI - CN3
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
|Publication Date:||1 January 2014|
This part of ISO 80369 specifies the dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used on ENTERAL MEDICAL DEVICES and ACCESSORIES.
NOTE 1 ENTERAL MEDICAL DEVICES include ENTERAL feeding 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, which are used for:
- gastric suction only MEDICAL DEVICES;
- oral only MEDICAL DEVICES;
- pressurizing and depressurizing inflation cuffs used to hold invasive ENTERAL MEDICAL DEVICES in place (ISO 80369-7);
- skin level gastrostomy MEDICAL DEVICES; and
- accessing ENTERAL feeding reservoirs (ISO 18250-3).
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.