DANSK DSF/PREN ISO/IEC 80369-3 PDF

This part of ISO 80369 specifies the interface dimensions and requirements for connectors intended to be used on ENTERAL DEVICES, ENTERAL syringes and related ACCESSORIES. This part of ISO 80369 does not specify requirements for CONNECTORS which are used for: - Suction only applications - Oral only applications - Inflation of balloon retention devices -Accessing ENTERAL feeding reservoirs 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 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.