EndoLab - Implant Testing Services Implant Testing

Intravascular catheters ISO 10555-1, -3, -4, -5

Normative References  



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 dilatation catheters

ISO 10555-5: Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters

ISO 11070: Sterile single-use intravascular catheter introducers

DIN EN 12006-3: Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Blutgefäßstents und Hohlvenenfilter

ASTM F2528: Standard Test Methods for Enteral Feeding Devices with Retention Balloon  


EndoLab®GmbH performs different tests on intravascular catheters, e.g.:

  • Test for corrosion resistance
  • Determination of peak tensile force
  • Test method for liquid leakage under pressure
  • Test for balloon rated burst pressure (RBP)
  • Test for balloon deflation time
  • Test for balloon diameter to inflation pressure
  • Determination of strength of union of needle hub and needle tube