ISO 80369-3 Scope
ISO 80369-3 specifies the dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used as connections in enteral applications of medical devices and accessories which are intended for use with a patient and on enteral medical devices, syringes and related accessories.ISO 80369-3 does not specify the dimensions and requirements for the medical devices or accessories that use these conectors. Those requirements are given in other International Standards
related to the specific medical devices or accessories. Enteral medical devices include enteral feeding sets and patient interface devices and include access ports.
ISO 80369-3 does not specify requirements for connectors which are used for:
- Medical devices used for gastric suction only
- Medical devices used only orally
- Pressurizing and depressurizing inflation cuffs used to hold invasive medical devices in place (ISO
- Skin level gastrostomy medical devices
- Accessing eneral feeding reservoirs (ISO 18250)
ISO 80369-3 Reference Fittings
ISO 80369-3 specifies the Reference Fittings to be use to functionally testing these connectors. The test methodology is defined in ISO 80369-20. We also offer extra-specification ISO 80369-3 Gages to test the physical attributes of the ISO 80369-3 Connectors.
This data is provided for general information only. The intention
is to provide accurate information; regardless; errors may exist
in the supplied information. If accuracy is critical, base your
final decisions on the data provided in the root document: ISO80369-3:2016; which is a copyrighted document. To purchase a copy visit
an Authorized Reseller.
Original Posting: 1/24/2014
Last Revision: 7/22/2016
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