NF EN ISO 20697

NF EN ISO 20697

July 2018
Standard Current

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.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

July 2018

Number of pages

47 p.

Reference

NF EN ISO 20697

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-041

Print number

2 - 01/05/2019

International kinship

ISO 20697:2018

European kinship

EN ISO 20697:2018
Sumary
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.

Replaced standards (1)
NF EN 1617
June 1997
Standard Cancelled
Sterile drainage catheters and accessory devices for single use.

Le présent document fixe des prescriptions pour les sondes de drainage dont le diamètre extérieur est supérieur à 2 mm, les systèmes de drainage des plaies et leurs composants stériles, non réutilisables, ainsi que certains essais spécifiques.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Performances prévues
  • 5 Exigences générales
  • 6 Exigences spécifiques
  • 7 Informations fournies par le fabricant
  • Annexe A Méthode d'essai pour la détermination de la résistance au coquage
  • Annexe B Méthode d'essai pour la détermination de la résistance à la corrosion
  • Annexe C Méthode d'essai pour la détermination de la résistance à la déformation sous aspiration
  • Annexe D Méthode d'essai pour la détermination de la force de traction de crête des raccords
  • Annexe E Méthode d'essai pour la détermination de la force de traction de crête de la sonde de drainage
  • Annexe F Méthode d'essai pour la détermination de la résistance aux chocs du dispositif de collecte
  • Annexe G Méthode d'essai pour la détermination du débit traversant la sonde de drainage
  • Annexe H Méthode d'essai de la résistance à l'arrachement
  • Annexe I Méthode d'essai pour la détermination de la sécurité du ballonnet
  • Annexe J Méthode d'essai pour la détermination de fuites de la lumière pour gonflage et/ou du fonctionnement et/ou du dégonflage du ballonnet (sonde de drainage avec ballonnet souple)
  • Annexe K Méthode d'essai pour la détermination des dimensions du ballonnet et de la fiabilité de dégonflage (sonde de drainage avec ballonnet rigide)
  • Annexe L Méthode d'essai pour la détermination de la résistance à la traction du ballonnet gonflé
  • Annexe M Méthode d'essai pour la détermination de la résistance aux fuites pendant l'aspiration ou la mise sous vide
  • Bibliographie
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ