NF EN ISO 11070 : 2015
Current
The latest, up-to-date edition.
STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
01-12-2013
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
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