FprEN ISO 10555-4

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

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter (ISO/FDIS 10555-4:2023)

Dieses Dokument legt Anforderungen an Ballondilatationskatheter fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
Dieses Dokument legt keine Anforderungen für Gefäßstents fest (siehe ISO 25539 2).
ANMERKUNG   Ein Leitfaden hinsichtlich der Auswahl von Ballonwerkstoffen ist in Anhang G angegeben.

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters de dilatation à ballonnets (ISO/FDIS 10555-4:2023)

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za širjenje žil (ISO/FDIS 10555-4:2023)

General Information

• Status: Not Published
• Publication Date: 22-Jan-2024
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 23-Oct-2023
• Completion Date: 23-Oct-2023
• Ref Project: kSIST FprEN ISO 10555-4:2023 - Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO/FDIS 10555-4:2023)

Relations

• Revises: EN ISO 10555-4:2013 - Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
• Effective Date: 07-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 10555-4:2023
01-januar-2023
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za
širjenje žil (ISO/DIS 10555-4:2022)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation
catheters (ISO/DIS 10555-4:2022)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4:
Ballondilatationskatheter (ISO/DIS 10555-4:2022)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters
de dilatation à ballonnets (ISO/DIS 10555-4:2022)
Ta slovenski standard je istoveten z: prEN ISO 10555-4
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 10555-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 10555-4:2023

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oSIST prEN ISO 10555-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2022-11-22 2023-02-14
Intravascular catheters — Sterile and single-use
catheters —
Part 4:
Balloon dilatation catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 4: Cathéters de dilatation à ballonnets
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10555-4:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:

Intravascular catheters — Sterile and single-use
catheters —
Part 4:
Balloon dilatation catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 4: Cathéters de dilatation à ballonnets
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 10555-4:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope .
...