EN 13868:2002

Catheters - Test methods for kinking of single lumen catheters and medical tubing

This Standard specifies test methods for kinking properties for single lumen catheters and medical tubing as they relate to the device ready for clinical use. The purpose of the standard is to ensure uniformity in the evaluation of tubing kink properties.

Katheter - Prüfverfahren für die Knickbildung von Kathetern mit Einzellumen und Schläuchen zur medizinischen Anwendung

Diese Norm legt Prüfverfahren für die Knickeigenschaften von Kathetern mit Einzellumen und Schläuchen zur medizinischen Anwendung im gebrauchsfertigen Zustand fest. Zweck dieser Norm ist die Sicherung der Einheitlichkeit bei der Knickeigenschaften von Schläuchen.

Cathéters - Méthodes d'essai de résistance à la plicature pour cathéters à simple voie et tubes à usage médical

La présente Norme européenne spécifie les méthodes d'essai permettant de déterminer les propriétés de résistance à la plicature des cathéters à simple voie et des tubes à usage médical, sous la présentation utilisée pour l'usage clinique, lorsqu'ils sont pliés sur un plan unique. On sait que d'autres forces, par exemple les forces de torsion, influent sur le comportement du produit, mais il n'existe pas actuellement de méthodes d'essai normalisées. On sait également que ces tubes peuvent être utilisés pour transporter des liquides ou des gaz. Cependant le milieu normalisé utilisé pour l'essai est de l'eau, car l'objectif de la présente norme est de garantir l'uniformité lors de l'évaluation des propriétés de résistance à la plicature des tubes.
NOTE   Cette méthode est conçue pour les tubes à simple voie, mais elle peut également s'appliquer aux tubes à voies multiples. Il convient de veiller à appliquer la flexion dans la direction la plus défavorable, sauf si cela ne correspond pas à une situation réaliste.

Katetri - Preskusne metode za določanje pregibanja katetrov in cevk z enojno svetlino

General Information

• Status: Published
• Publication Date: 27-Aug-2002
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 6 - Catheters and enteral feeding tubes
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 05-Jun-2023
• Ref Project: SIST EN 13868:2002 - Catheters - Test methods for kinking of single lumen catheters and medical tubing

Relations

• Revised: EN ISO 13958:2015 - Concentrates for haemodialysis and related therapies (ISO 13958:2014)
• Effective Date: 11-Jun-2014

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.VYHWOLQRKatheter - Prüfverfahren für die Knickbildung von Kathetern mit Einzellumen und Schläuchen zur medizinischen AnwendungCathéters - Méthodes d'essai de résistance a la plicature pour cathéters a simple voie et tubes a usage médicalCatheters - Test methods for kinking of single lumen catheters and medical tubing11.040.25Injekcijske brizge, igle in katetriSyringes, needles an cathetersICS:Ta slovenski standard je istoveten z:EN 13868:2002SIST EN 13868:2002en01-november-2002SIST EN 13868:2002SLOVENSKI
STANDARD



SIST EN 13868:2002



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13868August 2002ICS 11.040.20English versionCatheters - Test methods for kinking of single lumen cathetersand medical tubingCathéters - Méthodes d'essai de résistance à la plicaturepour cathéters à simple voie et tubes à usage médicalKatheter - Prüfverfahren für die Knickbildung von Katheternmit Einzellumen und Schläuchen zur medizinischenAnwendungThis European Standard was approved by CEN on 10 May 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13868:2002 ESIST EN 13868:2002



EN 13868:2002 (E)2ContentspageForeword.3Introduction.41Scope.42Terms and definitions.43Test methods and results.5Annex A (normative)
Kinking - Short term test.6Annex B (normative)
Kinking - Long term test.11SIST EN 13868:2002



EN 13868:2002 (E)3ForewordThis European Standard has been prepared by Technical Committee CEN/TC 205 "Non-active medical devices",the secretariat of which is held by BSI.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by February 2003, and conflicting national standards shall be withdrawn at the latestby February 2003.Annexes A and B are normative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SIST EN 13868:2002



EN 13868:2002 (E)4IntroductionTubes for catheters and for certain other medical uses have to be flexible, but simultaneously they need also tohave an appropriate minimum strength. The strength and flexibility allow the tube to be handled easily, so it can bebent around obstacles, for example within the human anatomy. However, not all flexible tubes show the samebehaviour during bending. Some tubes can bend considerably without kinking i.e without collapsing and therebydrastically reducing the cross sectional area, while others kink easily. In catheter applications, this reduction of theflow area can cause severe reduction in the flow of fluids.1 ScopeThis European Standard specifies tes
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