EN 13868:2002

Overview

EN 13868:2002 (CEN) defines standardized test methods for kinking of single-lumen catheters and medical tubing as presented for clinical use. The standard aims to ensure uniform, reproducible evaluation of kink resistance so that flexible tubing used in catheter applications maintains lumen patency when bent. Tests address both short-term (≤1 h) and long-term (>1 h) behavior and use water as the reference test medium.

Key topics and technical requirements

• Scope: Applies to single-lumen tubing presented for clinical use; can be used for multi-lumen tubing when worst-case bending direction is tested.
• Kink definition: A tube is considered kinked when bending reduces flow to 50% or less of the straight-tube flow.
• Two test methods (normative):
  • Short-term test (Annex A) - intended for use < 1 hour:
    • Tubing is arched between grooved parallel plates in a kink-test tool.
    • Plate is driven at a controlled rate (40 mm/min ± 20 mm/min) using a tensile tester.
    • Flow monitored under a constant hydrostatic head (1 000 ± 50 mm) until flow ≤50%; record plate distance at kink.
    • Results reported as a corrected kink distance (measured plate distance adjusted for groove depth and tube outside diameter).
    • Minimum of five determinations (one initial + at least four new tubes).
  • Long-term test (Annex B) - intended for use > 1 hour:
    • Tubing formed into loops in a long-term kink tool and conditioned at test temperature/time (e.g., intended-use temperature).
    • After conditioning, flow through each loop is measured; the kink length is the loop circumference where 50% of samples show flow ≤50% of straight-tube flow.
    • Typical sample sets: ~10 test pieces plus samples to measure full straight-tube flow.
• Test conditions: Samples should reflect final product condition (e.g., sterilized if applicable) and be tested at intended-use temperature (37 °C when specified).
• Instrumentation: flow meters, tensile testing apparatus, calibrated kink test tools, constant-pressure water system, and recording equipment.

Applications and who uses it

• Medical device manufacturers (design, validation, and QC of catheters and tubing)
• Test laboratories and certification bodies performing performance verification
• Regulatory and quality engineers documenting device reliability and safety
• R&D teams optimizing material formulations and wall geometry to reduce kinking risk

Practical uses include validating catheter designs, comparing materials/processes for kink resistance, and establishing production quality acceptance criteria.

Related standards and context

• Prepared by CEN/TC 205 (Non‑active medical devices).
• EN 13868 focuses on kinking only; complementary product or material standards may specify additional mechanical, biocompatibility, or sterilization requirements.

Keywords: EN 13868:2002, catheters, kinking test, single lumen catheters, medical tubing, kink resistance, short-term test, long-term test, corrected kink distance, kink length, CEN.