In December 2019, ISO80369-3, a new standard that defines the shapes of male and female connectors to prevent accidental connection of nutritional solutions to intravenous or tracheal tubes, was introduced in the field of enteral nutrition. Previously, our company had developed and marketed adapters that attach to spouts in response to the introduction of the ISO80369-3 standard. However, the usage method in this case required three steps: ① breaking off the spout’s tear-off section, ② attaching the adapter to the spout, and ③ connecting the connector to the adapter, which resulted in low convenience for users.Therefore, we decided to develop a spout that could be directly connected to ISO80369-3 standard connectors.

Compliance with ISO80369-3 standards and spout set performance requirements

Since instruments used in the ISO80369-3 standard have certain shape constraints, it was necessary to ensure compliance with both the standard and the performance requirements for spout sets.

The greatest challenge during the product development stage was achieving sealing performance with ISO80369-3 standard connectors.
Since the spout is equipped with threads, the threaded section becomes thick-walled, which causes molding-induced depressions on the inner circumferential surface.

When this section overlapped with the connector’s seal point, sealing performance was significantly reduced. Therefore, by changing the inner circumferential surface shape of the spout and eliminating the impact on the seal point, we successfully achieved significant improvement in sealing performance.