NF EN ISO 11070 : 2015

1 Scope
2 Normative references
3 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 guide wires
9 Additional requirements for dilators
10 Additional requirements for kits containing combinations of
    devices specified in this International Standard
Annexes
A Guidance on materials and design
B Test for corrosion resistance
C Determination of force at break of introducer catheters, sheath
    introducers and dilators
D Test for liquid leakage from sheath introducers under pressure
E Test for liquid leakage through haemostasis valves of sheath
    introducers
F Test for fracture of guide wires
G Test for resistance of guide wires to damage by flexing
H Test for strength of union of core wire and coil of guide wire and
    union of coil and safety wire
J Bibliography

Defines requirements for introducer needles, introducer catheters, sheath introducers, guide wires and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555. NOTE - Guidance on materials and design of accessory devices is given in annex A.