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EVS-EN ISO 10555-4:2023

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

General information

Valid from 15.12.2023
Base Documents
ISO 10555-4:2023; EN ISO 10555-4:2023
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.12.2023
Main
EVS-EN ISO 10555-4:2023
05.08.2013
Main
EVS-EN ISO 10555-4:2013

ISO 10555-4 specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. ISO 10555-4 does not specify requirements for vascular stents. Guidance on the selection of balloon materials is given in Annex G. The text of ISO 10555-4:2023 has been approved in Europe as EN ISO 10555-4:2023 without any changes.

Some of the changes in the standard are:

— added definitions and requirements,  
— added test methods (see Annex E and F),
— added guidance on the endpoint of the deflation period (see Annex C),
— defined effective length of the balloon,
— added annex for the rationale of changes and guidance (see Annex G).

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Standard monitoring
English (PDF 600 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English