DIN EN ISO 80369-3/A2:2017-04

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. This draft amendment to this part of ISO 80369-3 revises and amends Figure B.1 (Male E1 small-bore connector) including the related Table B.1, Figure C.3 (Male reference connector for testing female enteral connector for leakage, disconnection by unscrewing, separation from unscrewing, stress cracking, and non-interconnectable characteristics) and Figure C.4 (Male reference connector for testing female enteral connector for separation from axial load, resistance to overriding, and non-interconnectable characteristics).