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CEN

EN ISO 20696:2018

(Main)

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

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
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205/WG 16 - Catheters
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
04-Jul-2018
Completion Date
04-Jul-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
SIST EN ISO 20696:2018 - Sterile urethral catheters for single use (ISO 20696:2018)

Relations

Replaces
EN 1616:1997 - Sterile urethral catheters for single use
Effective Date
08-Jun-2022
Replaces
EN 1616:1997/A1:1999 - Sterile urethral catheters for single use
Effective Date
15-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
...

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