Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE Guidance on the selection of balloon materials is given in Annex G.
ΚΩΔΙΚΟΣ ΠΡΟΪΟΝΤΟΣ:
CYS EN ISO 10555-4:2023
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE Guidance on the selection of balloon materials is given in Annex G.