SIST EN 13868:2002
(Main)Catheters - Test methods for kinking of single lumen catheters and medical tubing
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 a la plicature pour cathéters a simple voie et tubes a usage médical
La présente Norme européenne spécifie les méthodes d'essai permettant de déterminer les propriétés de résistance a la plicature des cathéters a simple voie et des tubes a 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 etre 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 a la plicature des tubes.
NOTE Cette méthode est conçue pour les tubes a simple voie, mais elle peut également s'appliquer aux tubes a voies multiples. Il convient de veiller a appliquer la flexion dans la direction la plus défavorable, sauf si cela ne correspond pas a une situation réaliste.
Katetri - Preskusne metode za določanje pregibanja katetrov in cevk z enojno svetlino
General Information
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 test methods for kinking properties for single lumen catheters and medical tubing,as presented for clinical use, when bent in a single plane. It is recognized that other forces e.g. twisting will influencethe behaviour of the product, but no standard test methods are yet available. It is also recognized that such tubing canbe used to transport liquids or gases. However, water is used as a standard test medium, as the purpose of thisstandard is to ensure uniformity in the evaluation of tubing kink properties.NOTEThis method is designed for single-lumen tubing but can also be used for multi-lumen tubing. It should be ensuredthat the bending is done in the worst case direction, unless this would not present a possible real life situation.2 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.2.1kink distanceplate distance at kink in the short term test method2.2kink length Llength of the tubing loop at kink in the kink test tool in the long term test method2.3kink pointtotal collapse or distinct “knee” when kinking (see Figure A.4)2.4plate distance Ddistance between the two plates of the tensile testing apparatus in the short term test method (see Figure A.3)2.5corrected kink distance Cplate distance at kink plus correction for grooves, result of the short term test method (see Figure A.3)SIST EN 13868:2002
EN 13868:2002 (E)53 Test methods and resultsIn order to reflect that plastics materials show different visco-elastic properties and that there are great variations inexposure time for different kinds of medical tubing, it is necessary to have a test method for relatively short term use(< 1 h), the ’short term test method’ and a test method for more static use (> 1 h), the ’long term test method’. Theuser shall choose the test method which best reflects the intended product function.The test methods are specified in annexes A and B.The tests shall be performed on test samples which are as similar as possible to the final product. Unless otherwisespecified in a particular product standard, the tests shall be performed under the same conditions of use as the finalproduct e.g. on sterilized samples if the end products are sterilized and at 37 °C if that is the case for the endproducts in use.SIST EN 13868:2002
EN 13868:2002 (E)6Annex A (normative)Kinking - Short term testA.1 PrincipleThis is a method for determining the kink resistance of medical tubing for short term use (< 1h). The tubing isdefined as being kinked when the bending causes a decrease in flow such that the initial flow through the straighttube is reduced by more than 50 %.NOTEForce measurement. As an alternative principle, it has been verified that the kinking behaviour of tubing can beindicated by force measurement. By following the procedure in A.3, the plate distance at kink is defined as that distance wherethe corresponding force measurement starts decreasing (see Figure A.4).A.2 ApparatusA.2.1 Kink test tool, for short term tes
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