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EN ISO 10555-4:2023

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023) EN ISO 10555-4:2023

Publication date:   Feb 19, 2024

General information

60.60 Standard published   Nov 29, 2023

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

Buying

Published

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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

PREVIOUSLY

WITHDRAWN
EN ISO 10555-4:2013

NOW

PUBLISHED
EN ISO 10555-4:2023
60.60 Standard published
Nov 29, 2023