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Further Medical Devices - Testing Procedures

Here you find the most important standard test procedures for catheters, stents and hypodermic needles:

 

Catheters:

  • ISO 10555-1, ISO 10555-3, ISO 10555-4, ISO 10555-5:  Intravascular catheters
  • ISO 20697: Sterile drainage catheters and accessory devices for single use
  • ISO 11070: Sterile single-use intravascular introducers, dilators and guidewires

 

Stents:

  • ASTM F2942: Axial, bending, and torsional durability testing of vascular stents
  • ASTM F2606: Three-point bending of balloon expandable vascular stents and stent systems
  • ASTM F3067: Radial loading of balloon expandable and self-expanding vascular stents
  • ISO 25539-2: Requirements for the evaluation of vascular stents and delivery systems
  • ASTM F1828: Specifications for ureteral stents

 

Hypodermic needles:

  • ISO 7864: Requirements and test methods for hypodermic needles