Catheter Testing

There are several international test standards that provide guidance for catheter testing. ISO 10555 (parts 1 – 5) is the major catheter testing standard and includes performance tests such as leakage, corrosion resistance, tensile force, flow rate, burst and power injection.  ASTM F623 tests the performance characteristics for Foley catheters. Kinking for single lumen catheters is tested under DIN EN 13686. ISO 594 is utilized for testing the conical fittings associated with catheter designs.

As an independent and established leader in medical device and materials testing, DDL’s Product & Materials Division has studied these test standards. DDL welcomes the opportunity to guide medical device manufacturers and assist them with their catheter testing needs.

Test Standards for Catheters

  • ASTM F623 - Standard Performance Specification for Foley Catheter
  • BS EN 1618 - Catheters other than intravascular catheters. Test methods for common properties
  • DIN EN 13868 - Test methods for kinking of single lumen catheters and medical tubing
  • ISO 594-1 - Conical fittings with 6% (Luer) taper - Part 1: General Requirements
  • ISO 594-2 - Conical fittings with 6% (Luer) taper - Part 2: Lock Fittings
  • ISO 10555-1 - Intravascular Catheters - Sterile and Single-use Catheters - Part 1: General Requirements
  • ISO 10555-3 - Intravascular Catheters - Sterile and Single-use Catheters - Part 3: Central Venous Catheters
  • ISO 10555-4 - Intravascular Catheters - Sterile and Single-use Catheters - Part 4: Balloon Dilation Catheters
  • ISO 10555-5 - Intravascular Catheters - Sterile and Single-use Catheters - Part 5: Over-needle Peripheral Catheters

Have a question about ISO 10555, ISO 594 or other catheter testing standards? Please contact us or Ask our Product & Material Testing Expert about your catheter testing needs.

You can also call us at 1-800-229-4235.

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DDL's Testing Locations

DDL’s testing laboratories are located in Eden Prairie, MN and Fountain Valley, CA. Learn more about the different testing services provided at each location.

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