prBAS EN ISO 10555-4:2025

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


General information
Status:Project
Number of pages:24
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:08.10.2024
Forseen date for next stage code:09.10.2024
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.25, Syringes, needles and catheters

Abstract
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.

Lifecycle
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Original document and degree of correspondence
EN ISO 10555-4:2023, identical
ISO 10555-4:2023, identical

Relation to BAS standards

Work material

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