NEN EN ISO 11070 : 2014/A1:2018
Current
The latest, up-to-date edition.
STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
Hardcopy
English
20-07-2018
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, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1.
| DocumentType |
Amendment
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| Pages |
0
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| PublisherName |
Netherlands Standards
|
| Status |
Current
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