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ISO 20696:2018

(Main)

Sterile urethral catheters for single use

Sterile urethral catheters for single use

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.

Sondes urinaires stériles non réutilisables

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.

General Information

Status
Published
Publication Date
04-Jun-2018
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
ISO/TC 84 - Devices for administration of medicinal products and catheters
Drafting Committee
ISO/TC 84/WG 9 - Catheters
Current Stage
9093 - International Standard confirmed
Completion Date
05-Oct-2023
Ref Project

Relations

Consolidates
ISO 25649-3:2017 - Floating leisure articles for use on and in the water — Part 3: Additional specific safety requirements and test methods for Class A devices
Effective Date
06-Jun-2022

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Standards Content (Sample)

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

---------------------- Page: 1 ----------------------
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

---------------------- Page: 2 ----------------------
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 . 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 com
...

INTERNATIONAL ISO
STANDARD 20696
First edition
2018-06
Corrected version
2019-12
Sterile urethral catheters for single use
Sondes urinaires stériles non réutilisables
Reference number
ISO 20696:2018(E)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 20696:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

---------------------- Page: 2 ----------------------
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 .
...

NORME ISO
INTERNATIONALE 20696
Première édition
2018-06
Version corrigée
2019-12
Sondes urinaires stériles non
réutilisables
Sterile urethral catheters for single use
Numéro de référence
ISO 20696:2018(F)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 20696:2018(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2018 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 20696:2018(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Performances prévues . 3
5 Exigences générales . 3
5.1 Gestion des risques . 3
5.2 Biocompatibilité. 3
5.3 Détectabilité . 3
5.4 État de surface . 3
5.5 Désignation dimensionnelle . 3
5.5.1 Généralités . 3
5.5.2 Diamètre extérieur . 4
5.5.3 Longueurs utiles du corps de la sonde . 4
5.6 Compatibilité avec l'IRM . 5
5.7 Raccord . 5
5.8 Stérilisation . 6
6 Exigences spécifiques .
...

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