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ISO 10555-4:2023

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

Publication date:   Nov 14, 2023

General information

60.60 Standard published   Nov 14, 2023

ISO

ISO/TC 84 Devices for administration of medicinal products and catheters

International Standard

11.040.25   Syringes, needles and catheters

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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WITHDRAWN
ISO 10555-4:2013

NOW

PUBLISHED
ISO 10555-4:2023
60.60 Standard published
Nov 14, 2023