ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewires
ISO 11070:2014 specifies 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Sterilization
4.2 Biocompatibility
4.3 Surface
4.4 Corrosion resistance
4.5 Radio-detectability
4.6 Information to be supplied by the manufacturer
5 Additional requirements for introducer needles
5.1 General
5.2 Size designation
5.3 Needle point
5.4 Hub
5.5 Information to be supplied by the manufacturer
6 Additional requirements for introducer catheters
6.1 General
6.2 Tip
6.3 Peak tensile force
6.4 Hub
6.5 Size designation
6.6 Information to be supplied by the manufacturer
7 Additional requirements for sheath introducers
7.1 General
7.2 Size designation
7.3 Freedom from leakage from sheath introducer
7.4 Freedom from leakage through haemostasis valve
7.5 Hub
7.6 Peak tensile force
7.7 Information to be supplied by the manufacturer
8 Additional requirements for guidewires
8.1 General
8.2 Size designation
8.3 Safety wire
8.4 Fracture test
8.5 Flexing test
8.6 Peak tensile force of guidewire
8.7 Information to be supplied by the manufacturer
9 Additional requirements for dilators
9.1 General
9.2 Size designation
9.3 Hub
9.4 Information to be supplied by the manufacturer
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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Sterilization
4.2 Biocompatibility
4.3 Surface
4.4 Corrosion resistance
4.5 Radio-detectability
4.6 Information to be supplied by the manufacturer
5 Additional requirements for introducer needles
5.1 General
5.2 Size designation
5.3 Needle point
5.4 Hub
5.5 Information to be supplied by the manufacturer
6 Additional requirements for introducer catheters
6.1 General
6.2 Tip
6.3 Peak tensile force
6.4 Hub
6.5 Size designation
6.6 Information to be supplied by the manufacturer
7 Additional requirements for sheath introducers
7.1 General
7.2 Size designation
7.3 Freedom from leakage from sheath introducer
7.4 Freedom from leakage through haemostasis valve
7.5 Hub
7.6 Peak tensile force
7.7 Information to be supplied by the manufacturer
8 Additional requirements for guidewires
8.1 General
8.2 Size designation
8.3 Safety wire
8.4 Fracture test
8.5 Flexing test
8.6 Peak tensile force of guidewire
8.7 Information to be supplied by the manufacturer
9 Additional requirements for dilators
9.1 General
9.2 Size designation
9.3 Hub
9.4 Information to be supplied by the manufacturer
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