ISO 10555-4:2023

Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters ISO 10555-4:2023

General information

Current stage: 60.60 Standard published Nov 14, 2023

Originator: ISO

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

Type: International Standard

ICS: 11.040.25 Syringes, needles and catheters

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WITHDRAWN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