National foreword

This British Standard is the official English language version of EN 13868:2002.

The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes, which has the responsibility to:

aid enquirers to understand the text;
present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.

A list of organizations represented on this committee can be obtained on request to its secretary.

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled "International Standards Correspondence Index", or by using the "Search" facility of the BSI Electronic Catalogue or of British Standards Online.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

This 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This 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 or by endorsement, at the latest by February 2003, and conflicting national standards shall be withdrawn at the latest by February 2003.

Annexes A and B are normative.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries 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.

Introduction

Tubes for catheters and for certain other medical uses have to be flexible, but simultaneously they need also to have an appropriate minimum strength. The strength and flexibility allow the tube to be handled easily, so it can be bent around obstacles, for example within the human anatomy. However, not all flexible tubes show the same behaviour during bending. Some tubes can bend considerably without kinking i.e without collapsing and thereby drastically reducing the cross sectional area, while others kink easily. In catheter applications, this reduction of the flow area can cause severe reduction in the flow of fluids.

1 Scope

This 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 influence the behaviour of the product, but no standard test methods are yet available. It is also recognized that such tubing can be used to transport liquids or gases. However, water is used as a standard test medium, as the purpose of this standard is to ensure uniformity in the evaluation of tubing kink properties.

NOTE This method is designed for single-lumen tubing but can also be used for multi-lumen tubing. It should be ensured that the bending is done in the worst case direction, unless this would not present a possible real life situation.

2 Terms and definitions

3 Test methods and results

BS EN 13868:2002

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

Current

Published:

13 Sep 2002