Catheters

BS EN 1618 specifies test methods for common properties for catheters other than intravascular catheters. Tests listed below are conducted according to BS EN 1618 standard in Labiotech.

• Test method for corrosion resistance of metallic components
• Test method for tensile properties
• Test method for resistance to liquid leakage under pressure
• Test method for resistance to leakage during aspiration or vacuum
• Test method for determining the flow rate of water through the catheter
• Test method for security of connectors

ISO 10555-1 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. Tests listed below are conducted according to
ISO 10555-1 standard in Labiotech.

• Test method for corrosion resistance
• Test method for determining peak tensile force
• Test method for liquid leakage under pressure
• Test method for air leakage into hub assembly during aspiration
• Determination of flowrate through catheter
• Test for burst pressure under static conditions
• Power injection test for flowrate and device pressure (only for products indicated for power injection)

ISO 11070 standard specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1. Tests listed below are conducted according to ISO 11070 standard in Labiotech.

• Test method for corrosion resistance
• Method for determining peak tensile force of introducer catheters, sheath introducers, and dilators
• Test method for liquid leakage from sheath introducers under pressure
• Test method for liquid leakage through hemostasis valves of sheath introducers
• Test method for fracture of guidewire
• Test method for resistance of guidewire to damage by flexing
• Method for determining peak tensile force of guidewire
• Determination of strength of union of needle hub and needle

The purpose of this test method is to determine pressure continuity of inflation devices under specific pressure.