This part of ISO 80369 specifies dimensions and requirements for the design and essential performance of SMALL-BORE CONNECTORS intended to be used on or with intravascular and hypodermic devices. 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.
NOTE The LUER LOCK CONNECTOR was designed for use at pressures of the order of 300 kPa or lower. Its use in other applications can require consideration to establish its suitability. This part of ISO 80369 does not specify requirements for the following CONNECTORS which are specified in other standards:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports [ISO 8637, ISO 8638]
- cardiovascular and cardiac equipment CONNECTORS [ISO 8637, ISO 8638]
- infusion system closure piercing CONNECTORS [ISO 8536-4]
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.
Registration number (WIID)
39370
Scope
This part of ISO 80369 specifies dimensions and requirements for the design and essential performance of SMALL-BORE CONNECTORS intended to be used on or with intravascular and hypodermic devices. 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.
NOTE The LUER LOCK CONNECTOR was designed for use at pressures of the order of 300 kPa or lower. Its use in other applications can require consideration to establish its suitability. This part of ISO 80369 does not specify requirements for the following CONNECTORS which are specified in other standards:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports [ISO 8637, ISO 8638]
- cardiovascular and cardiac equipment CONNECTORS [ISO 8637, ISO 8638]
- infusion system closure piercing CONNECTORS [ISO 8536-4]
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.
