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ISO 20697:2018

(Main)

Sterile drainage catheters and accessory devices for single use

Sterile drainage catheters and accessory devices for single use

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.

Sondes et dispositifs auxiliaires stériles de drainage non réutilisables

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.

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 25649-4:2017 - Floating leisure articles for use on and in the water — Part 4: Additional specific safety requirements and test methods for Class B devices
Effective Date
06-Jun-2022

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Standards Content (Sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 20697
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2017-02-07 2017-05-01
Sterile drainage catheters and accessory devices 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 20697:2017(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 20697:2017(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 20697:2017(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 . 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 .
...

INTERNATIONAL ISO
STANDARD 20697
First edition
2018-06
Corrected version
2018-09
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

---------------------- Page: 1 ----------------------
ISO 20697:2018(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 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 .
...

NORME ISO
INTERNATIONALE 20697
Première édition
2018-06
Version corrigée
2018-09
Sondes et dispositifs auxiliaires
stériles de drainage non réutilisables
Sterile drainage catheters and accessory devices for single use
Numéro de référence
ISO 20697:2018(F)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 20697:2018(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 20697:2018(F)

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

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