ISO 10555 Catheter Testing

Medical Murray can help develop and execute catheter testing device protocols according to ISO 10555 standards.

ISO 10555 Catheter Testing

Intravascular catheters are commonly designed to deliver medicine and implantable devices into the human body. The best way to ensure that these devices are safe, retain their quality, and perform successfully is to subject them to a series of rigorous performance and durability tests.

ISO 10555:2013 defines the standards for intravascular sterile and single-use catheters. Medical Murray can perform medical device testing in accordance with ISO 10555-1, 10555-3, 10555-4, and 10555-5 standards. Catheter types that can be tested according to this standard include general intravascular catheters, central venous catheters, balloon dilatation catheters, and over-needle peripheral catheters.

Our catheter testing services are performed according to pre-approved protocols and conform with required ISO and ASTM standards. We can assist you with your testing requirements and prepare your device for regulatory submission.

ISO 10555-1

General Catheter Testing Requirements

  >  Radio-detectability

  >  Biocompatibility (Outsourced)

  >  Surface

  >  Corrosion Resistance

  >  Peak Tensile Force

  >  Freedom from Leakage

  >  Hubs (includes ISO 80369)

  >  Flowrate

  >  Power Injection

  >  Side Holes

  >  Distal Tip

  >  Designation of Nominal Size


ISO 10555-3

Central Venous Catheter Testing Requirements

  >  Distance Markings

  >  Lumen Markings

  >  Peak Tensile Force

ISO 10555-4

Balloon Dilatation Catheter Testing Requirements

  >  Radio-detectability

  >  Designation of Nominal Size

  >  Balloon Rated Burst Pressure (RBP)

  >  Balloon Fatigue

  >  Balloon Deflation Time

  >  Balloon Diameter to Inflation Pressure

ISO 10555-5

Over-Needle Peripheral Catheter Testing Requirements

  >  Lumen Identification

  >  Color Code

  >  Catheter Fit

  >  Needle Material

  >  Needle Point

  >  Needle Hub

  >  Joint Strength

  >  Vent Fitting