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ILNAS-EN ISO 10555-4:2023 Edition 11/2023
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
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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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    24/11/2022   date of ratification (dor)    24/11/2023
end of the vote on the project    14/02/2023   date of anouncement (doa)    29/02/2024
start of the vote on the final project    31/08/2023   date of publication (dop)    31/05/2024
end of the vote on the final project    23/10/2023   date of withdrawal (dow)    31/05/2024


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ILNAS-EN ISO 10555-4:2013

Relations to international standards
ISO 10555-4 
ISO 10555-4:2023 

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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