scope:

This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS either as an ancillary port CONNECTION in the BREATHING SYSTEM or in the respirable driving gas APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.

This part of ISO 80369 does not specify 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 part of ISO 80369 does not specify requirements for pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive respiratory MEDICAL DEVICES in place.

NOTE 1 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS, as specified in this part of ISO 80369, will be included. Furthermore, it is recognised that standards need to be developed for many MEDICAL DEVICES used for the BREATHING SYSTEM and respirable driving gas APPLICATIONS.

NOTE 2 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for SMALL BORE CONNECTORS intended for use as an ancillary port CONNECTION in the BREATHING SYSTEM or in the respirable driving gas APPLICATIONS of MEDICAL DEVICES or ACCESSORIES, which do not comply with this part of ISO 80369.