I.S. EN ISO 11070:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
Hardcopy , PDF
01-28-2020
12-01-2014
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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