This amendment
(1) modifies the scope by removing the following exclusion: "Medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device" and
(2) makes dimensional changes to revise the through bore of the male connector to return to the dimension that was used for all of the misconnection analysis which was performed during the development of the connector. The through bore will also be further specified denoting a maximum draft angle for a minimum distance.

This second edition cancels and replaces the first edition (ISO 80369-1:2010), which has been technically revised.