BS EN 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.

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.


Cross References:
ISO 14971:2007
ISO 80369-1:2010
ISO 80369-6:2016
ISO 80369-7
ISO 80369-20:2015
ASTM D638-10
ASTM D790-10
ISO 5356-1:2015
ISO 5356-2:2012
ISO 7886-1:1993
ISO 8185:2007
ISO 10241-1
ISO 10241-2
IEC 60601-1:2005+AMD1:2012
IEC 62366:2007+AMD1:2014
EN 1615:2000
EN 1618:1997
EN 13544-2:2002+A1:2009
CEN CR 13825


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