UNE-EN ISO 80369-3:2017

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 1ENTERAL 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:¾ðgastric suction only MEDICAL DEVICES;¾ðoral only MEDICAL DEVICES;¾ðpressurizing and depressurizing inflation cuffs used to hold invasive ENTERAL MEDICAL DEVICES in place (ISO 80369-7);¾ðskin level gastrostomy MEDICAL DEVICES; and¾ðaccessing ENTERAL feeding reservoirs (ISO 18250-3).NOTE 2MANUFACTURERS 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.