DANSK DSF/PREN ISO/IEC 80369-6 PDF

This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used in NEURAXIAL APPLICATIONS. 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. NOTE 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 device standards. It is expected that when the relevant particular 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 will need to be developed for all MEDICAL DEVICES used for NEURAXIAL APPLICATIONS.