I.S. EN ISO 11070:2014&A1:2018&LC:2018
Current
The latest, up-to-date edition.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
Hardcopy , PDF
English
05-10-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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