DIN EN ISO 11070 – Sterile single-use intravascular introducers, dilators and guidewires

This 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.

The test methods included in the standard are:

• Annex B: Test method for corrosion resistance
• Annex C: Method for determining peak tensile force of introducer catheters, sheath introducers and dilators
• Annex D: Test method for liquid leakage from sheath introducers under pressure
• Annex E: Test method for liquid leakage through haemostasis valves of sheath introducers
• Annex F: Test method for fracture of guidewires
• Annex G: Test method for resistance of guidewires to damage by flexing
• Annex H: Method for determining peak tensile force of guidewires
• Annex I: Determination of strength of union of needle hub and needle