DIN EN ISO 80369-3/A1:2017-04

This part of ISO 80369 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. The amendment 1 removes the following text from the bulleted list under This part of ISO 80369 does not specify requirements for small-bore connectors that are used for the following: 'Medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device'.