EN ISO 20697:2018

Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09)

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior.
The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation.
This document is not applicable to:
a)    suction catheters;
b)    tracheal catheters;
c)    urethral catheters;
NOTE       See ISO 20696.
d)    ureteral stents, biliary stents, and other stents;
NOTE       See ISO 14630 and ASTM F1828‑97 for stents requirements.
e)    drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;
f)     neuraxial catheters used for removal of cerebrospinal fluid;
NOTE       See ISO 20698.
g)    enteral catheters used for removal of solutions or substances from the gastrointestinal tract;
NOTE       See ISO 20695.
h)    coatings.

Sterile Drainagekatheter und Zubehör zur einmaligen Verwendung (ISO 20697:2018, korrigierte Fassung 2018-09)

Dieses Dokument legt die Anforderungen an sterile Drainagekatheter zur einmaligen Verwendung,
Drainagesysteme für Ansammlungen von Wund- und Körperflüssigkeiten sowie chirurgische Drainagekatheter
und deren Bestandteile fest, wo der Katheter durch chirurgischen Eingriff oder perkutane Punktion
in einer Körperhöhle oder einer Wunde platziert wird, um Flüssigkeit oder Luft nach außen abzuleiten.
Die Ableitung über den Drainagekatheter erfolgt auf natürlichem Wege oder der Katheter wird mit einer
Absaugvorrichtung verbunden, um die schnellere Bildung von Granulationsgewebe zu ermöglichen.
Dieses Dokument ist nicht anwendbar für:
a) Absaugkatheter;
b) Trachealkatheter;
c) Harnblasenkatheter;
ANMERKUNG Siehe ISO 20696.
d) Ureterstents, Gallenstents und andere Stents;
ANMERKUNG Die Anforderungen an Stents sind in ISO 14630 und ASTM F1828-97 festgelegt.
e) Drainagekatheter, die perkutan mittels Gastrostomie im Verdauungstrakt platziert werden;
f) Rückenmarkskatheter zur Entnahme von Rückenmarksflüssigkeit;
ANMERKUNG Siehe ISO 20698.
g) Darmkatheter zur Entfernung von Lösungen oder Substanzen aus dem Magen-Darm-Trakt (Gastrointestinaltrakt);
ANMERKUNG Siehe ISO 20695.
h) Beschichtungen.

Sondes et dispositifs auxiliaires stériles de drainage non réutilisables (ISO 20697:2018, Version corrigée 2018-09)

Le présent document spécifie les exigences applicables aux sondes de drainage stériles non réutilisables, aux systèmes de drainage de plaie et de collection liquidienne, aux sondes de drainage chirurgicales ainsi qu'à leurs éléments constitutifs; la sonde étant placée dans une cavité corporelle ou dans une plaie, par voie chirurgicale ou percutanée, afin d'évacuer le liquide ou l'air vers l'extérieur.
La sonde de drainage est disposée de sorte que le liquide ou l'air s'écoule librement, mais elle peut également être raccordée à une source d'aspiration pour accélérer la granulation des tissus.
Le présent document ne s'applique pas:
a)    aux sondes d'aspiration;
b)    aux sondes endotrachéales;
c)    aux sondes urinaires;
NOTE       Voir l'ISO 20696.
d)    aux endoprothèses urétérales, endoprothèses biliaires et autres endoprothèses;
NOTE       Voir l'ISO 14630 et l'ASTM F1828‑97 pour les exigences applicables aux endoprothèses.
e)    aux sondes de drainage percutanées posées par gastrostomie dans les voies digestives;
f)     aux sondes neuraxiales utilisées pour l'évacuation du liquide céphalorachidien;
NOTE       Voir l'ISO 20698.
g)    aux sondes entérales utilisées pour l'évacuation de solutions ou de substances dans les voies gastro-intestinales;
NOTE       Voir l'ISO 20695.
h)    aux revêtements.

Sterilni drenažni katetri in dodatni pripomočki za enkratno uporabo (ISO 20697:2018)

Ta standard določa zahteve za sterilne drenažne katetre za enkratno uporabo, sisteme za drenažo ran in njihove komponente, zasnovane za drenažo tekočin iz notranjosti s pomočjo težnosti ali negativnega tlaka. Ta evropski standard se ne uporablja za: - katetre z zunanjim premerom, manjšim od 2 mm; - aspiracijske katetre za uporabo v dihalnem traktu (glej prEN 1733); - trahealne katetre (trahealne cevke) (glej prEN 1782). OPOMBA: Urinski katetri so zajeti v standardu prEN 1616.

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 20697:2018 - Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)

Relations

• Replaces: EN 1617:1997 - Sterile drainage catheters and accessory devices for single use
• Effective Date: 15-Jul-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2018
1DGRPHãþD
SIST EN 1617:2000
6WHULOQLGUHQDåQLNDWHWULLQGRGDWQLSULSRPRþNL]DHQNUDWQRXSRUDER,62

Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)
Sterile Drainagekatheter und Zubehör zur einmaligen Verwendung (ISO 20697:2018)
Sondes et dispositifs auxiliaires stériles de drainage non réutilisables (ISO 20697:2018)
Ta slovenski standard je istoveten z: EN ISO 20697:2018
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 20697
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN 1617:1997
English Version
Sterile drainage catheters and accessory devices for single
use (ISO 20697:2018)
Sondes et dispositifs auxiliaires stériles de drainage Sterile Drainagekatheter und Zubehör zur einmaligen
non réutilisables (ISO 20697:2018) Verwendung (ISO 20697:2018)
This European Standard was approved by CEN on 3 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 20697:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20697:2018) 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 1617:1997.
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 20697:2018 has been approved by CEN as EN ISO 20697:2018 without any modification.
INTERNATIONAL ISO
STANDARD 20697
First edition
2018-06
Sterile drainage catheters and
accessory devices for single use
Sondes et dispositifs auxiliaires stériles de drainage non réutilisables
Reference number
ISO 20697:2018(E)
©
ISO 2018
ISO 20697:2018(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
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Phone: [phone]
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Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 20697:2018(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 . 4
5.3 Detectability . 4
5.4 Surface finish . 4
5.5 Size designation . 4
5.5.1 General. 4
5.5.2 Outer diameter . 4
5.5.3 Effective length . 4
5.5.4 Nominal balloon inflation volume . 5
5.6 Connector . 5
5.7 MRI compatibility . 6
5.8 Sterilization . 6
6 Specific requirements . 6
6.1 Kink stability . 6
6.2 Corrosion resistance . 6
6.3 Resistance to deformation . 6
6.4 Peak tensile force . 6
6.4.1 Connections . 6
6.4.2 Drainage catheters and other accessory devices . 7
6.5 Impact resistance . 7
6.6 Flow rate . 7
6.7 Retention strength . 7
6.8 Balloon safety . 7
6.9 Catheter inflation lumen integrity and volume maintenance . 8
6.9.1 General. 8
6.9.2 Compliant balloon. 8
6.9.3 Non-compliant balloon . 8
6.10 Inflated balloon resistance to traction . . 8
6.11 Freedom from leakage during aspiration or vacuum . 8
7 Information supplied by the manufacturer . 9
7.1 General . 9
7.2 Marking on the device and/or packaging . 9
7.3 Instructions for use . 9
Annex A (informative) Test method for determining kink stability .11
Annex B (normative) Test method for corrosion resistance .13
Annex C (normative) Test method for resistance to deformation by suction .14
Annex D (normative) Test method for determining peak tensile force of connections .15
Annex E (normative) Test method for determining peak tensile force of drainage catheter .16
Annex F (normative) Test method for impact resistance of collection device .18
Annex G (normative) Test method for determination of flow rate through catheter .20
Annex H (informative) Test method for retention strength .22
SIST EN
...