Catheter Testing

There are several international test standards that specify catheter performance requirements. As an established leader in medical device and materials testing, DDL’s Product and Materials Division is fluent in these requirements. DDL welcomes the opportunity to guide medical device manufacturers through the requirements and assist them with their catheter testing needs.

Common 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
  • BS EN 13868 – Catheters – Test methods for kinking of single lumen catheters and medical tubing
  • 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
  • ISO 10555-6 – Intravascular Catheters – Sterile and Single-use Catheters – Part 6: Subcutaneous implanted ports

Please contact us about your catheter testing needs.