EVS-EN ISO 10555-4:2023

ISO 10555-4 specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. ISO 10555-4 does not specify requirements for vascular stents. Guidance on the selection of balloon materials is given in Annex G. The text of ISO 10555-4:2023 has been approved in Europe as EN ISO 10555-4:2023 without any changes.

Some of the changes in the standard are:

— added definitions and requirements,  

— added test methods (see Annex E and F),

— added guidance on the endpoint of the deflation period (see Annex C),

— defined effective length of the balloon,

— added annex for the rationale of changes and guidance (see Annex G).