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ISO 10555-4:2023

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

General information
Valid from 14.11.2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
14.11.2023
Main
06.06.2013
Main
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.
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