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ISO 10555-4:2023Published

Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters

Cathéters intravasculaires — Cathéters stériles et non réutilisables — Partie 4: Cathéters de dilatation à ballonnets

Abstract / scope

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.

Life cycle

Replaces

ISO 10555-4:2013WithdrawnIntravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation cathetersInternational Standard · Published 6 Jun 2013 · ISO/TC 84