SIST EN ISO 20696:2018

Sterile urethral catheters for single use (ISO 20696:2018)

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)

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)

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
• Public Enquiry End Date: 09-May-2017
• Publication Date: 23-Aug-2018
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Jul-2018
• Due Date: 20-Sep-2018
• Completion Date: 24-Aug-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 20696:2018 - Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2019-12)

Relations

• Replaces: SIST EN 1616:2000 - Sterile urethral catheters for single use
• Effective Date: 01-Sep-2018
• Replaces: SIST EN 1616:2000/A1:2000 - Sterile urethral catheters for single use
• Effective Date: 01-Sep-2018

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO 20696:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 20696:2018(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 . 3
5.5 Size designation . 3
5.5.1 General. 3
5.5.2 Outer diameter . 3
5.5.3 Effective shaft lengths . 4
5.6 MRI compatibility . 5
5.7 Connector . 5
5.8 Sterilization . 5
6 Specific requirements . 5
6.1 Strength . 5
6.2 Connector security . . 5
6.3 Balloon safety . 5
6.4 Catheter inflation lumen integrity and volume maintenance . 5
6.4.1 General. 5
6.4.2 Compliant balloon. 6
6.4.3 Non-compliant balloon . 6
6.5 Flow rate . 6
6.6 Corrosion resistance . 7
6.7 Kink stability . 7
6.8 Peak tensile force . 7
6.9 Inflated balloon resistance to traction . . 7
7 Information to be supplied by the manufacturer . 8
7.1 General . 8
7.2 Marking on the device and/or packaging . 8
7.3 Instructions for use . 8
Annex A (normative) Test method for determining the strength of the catheter .10
Annex B (normative) Test method for determining the security of fit of the drainage funnel .14
Annex C (normative) Test method for determining balloon safety .16
Annex D (normative) Test method for determining inflation lumen leakage and/or function
and/or balloon deflation (catheter with compliant balloon) .19
Annex E (normative) Test method for determination of flow rate through catheter .21
Annex F (normative) Test method for corrosion resistance .23
Annex G (informative) Test method for determining kink stability .24
Annex H (normative) Test method for determining peak tensile force of urethral catheter .26
Annex I (normative) Test method for determining balloon size deflation reliability
(catheter with non-compliant balloon) .28
Annex J (normative) Test method for determining inflated balloon resistance to traction .30
ISO 20696:2018(E)
Bibliography .34
iv © ISO 2018 – All rights reserved

ISO 20696:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The w
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