http://www.documentbays.org/89967-bs-en-13868-2002.html

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.NOTE This 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)

3 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.