Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2019-12)

This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.
NOTE       Ureteral stents are covered in ASTM F1828‑97.

Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO 20696:2018, korrigierte Fassung 2019-12)

Dieses Dokument legt Anforderungen und Prüfverfahren für sterile Harnblasenkatheter mit und ohne Ballon
zur einmaligen Verwendung fest.
Dieses Dokument schließt nicht Drainagekatheter mit ein, die in ISO 20697 behandelt werden, z. B.
Ureterkatheter, Nephrostomiekatheter und suprapubische Katheter. Des Weiteren sind auch Ureterstents
von diesem Dokument ausgeschlossen.
ANMERKUNG Ureterstents sind Gegenstand der Norm ASTM F1828-97.

Sondes urinaires stériles non réutilisables (ISO 20696:2018, Version corrigée 2019-12)

Le présent document spécifie les exigences et les méthodes d'essai pour les sondes urinaires stériles non réutilisables, avec ou sans ballonnet.
Le présent document n'inclut pas les sondes de drainage couvertes par l'ISO 20697, telles que les sondes urinaires, les sondes de néphrostomie et les cathéters sus-pubiens. Le présent document exclut également les endoprothèses urétérales.
NOTE       Les endoprothèses urétérales sont couvertes par l'ASTM F1828‑97.

Sterilni uretralni katetri za enkratno uporabo (ISO 20696:2018)

Ta standard določa zahteve za sterilne uretralne katetre za enkratno uporabo z balonom ali brez.

General Information

Status
Published
Publication Date
03-Jul-2018
Withdrawal Date
30-Jan-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
04-Jul-2018
Completion Date
04-Jul-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20696:2018
01-september-2018
1DGRPHãþD
SIST EN 1616:2000
SIST EN 1616:2000/A1:2000
Sterilni uretralni katetri za enkratno uporabo (ISO 20696:2018)
Sterile urethral catheters for single use (ISO 20696:2018)
Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO 20696:2018)
Sondes urinaires stériles non réutilisables (ISO 20696:2018)
Ta slovenski standard je istoveten z: EN ISO 20696:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 20696:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20696:2018

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SIST EN ISO 20696:2018


EN ISO 20696
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN 1616:1997
English Version

Sterile urethral catheters for single use (ISO 20696:2018)
Sondes urinaires stériles non réutilisables (ISO Sterile Harnblasenkatheter zur einmaligen
20696:2018) Verwendung (ISO 20696:2018)
This European Standard was approved by CEN on 5 May 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20696:2018 E
worldwide for CEN national Members.

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SIST EN ISO 20696:2018
EN ISO 20696:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 20696:2018
EN ISO 20696:2018 (E)
European foreword
This document (EN ISO 20696:2018) has been prepared by Technical Committee ISO/TC 84 " Devices
for administration of medicinal products and catheters " in collaboration with Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1616:1997.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20696:2018 has been approved by CEN as EN ISO 20696:2018 without any modification.
3

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SIST EN ISO 20696:2018

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SIST EN ISO 20696:2018
INTERNATIONAL ISO
STANDARD 20696
First edition
2018-06
Sterile urethral catheters for single use
Sondes urinaires stériles non réutilisables
Reference number
ISO 20696:2018(E)
©
ISO 2018

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SIST EN ISO 20696:2018
ISO 20696:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unl
...

SLOVENSKI STANDARD
oSIST prEN ISO 20696:2017
01-maj-2017
Sterilni uretralni katetri za enkratno uporabo (ISO/DIS 20696:2017)
Sterile urethral catheters for single use (ISO/DIS 20696:2017)
Sterile Harnblasenkatheter zur einmaligen Verwendung (ISO/DIS 20696:2017)
Sondes urinaires stériles non réutilisables (ISO/DIS 20696:2017)
Ta slovenski standard je istoveten z: prEN ISO 20696
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 20696:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 20696:2017

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oSIST prEN ISO 20696:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20696
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2017-02-07 2017-05-01
Sterile urethal catheters for single use
Titre manque
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 20696:2017(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 2017

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oSIST prEN ISO 20696:2017
ISO/DIS 20696:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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oSIST prEN ISO 20696:2017
ISO/DIS 20696:2017(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 3
5 General requirements . 3
5.1 Risk management . 3
5.2 Biocompatibility . 3
5.3 Detectability . 3
5.4 Surface finish .
...

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