BS EN ISO 11070 : 2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Additional requirements for introducer needles
6 Additional requirements for introducer catheters
7 Additional requirements for sheath introducers
8 Additional requirements for guidewires
9 Additional requirements for dilators
10 Additional requirements for kits containing
   combinations of devices specified in this
   International Standard
Annex A (informative) - Guidance on materials
        and design
Annex B (normative) - Test method for corrosion
        resistance
Annex C (normative) - Method for determining
        peak tensile force of introducer catheters,
        sheath introducers, and dilators
Annex D (normative) - Test method for liquid
        leakage from sheath introducers under
        pressure
Annex E (normative) - Test method for liquid
        leakage through haemostasis valves of
        sheath introducers
Annex F (normative) - Test method for fracture
        of guidewires
Annex G (normative) - Test method for resistance
        of guidewires to damage by flexing
Annex H (normative) - Method for determining
        peak tensile force of guidewires
Annex I (normative) - Determination of strength
        of union of needle hub and needle
Bibliography

Describes 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.