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BS EN ISO 11070:2014+A1:2018

BS EN ISO 11070:2014+A1:2018

$167.15

Sterile single-use intravascular introducers, dilators and guidewires

Published By Publication Date Number of Pages
BSI 2018 34
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This International Standard 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 specified in ISO 10555‑1.

NOTE Guidance on materials and design of accessory devices is given in Annex A.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
Anchor 2
Foreword to amendment A1
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
13 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
14 5 Additional requirements for introducer needles
5.1 General
5.2 Size designation
5.3 Needle point
5.4 Hub
5.4.1 Conical fitting
5.4.2 Strength of union of needle tube and needle hub
5.5 Information to be supplied by the manufacturer
15 6 Additional requirements for introducer catheters
6.1 General
6.2 Tip
6.3 Peak tensile force
6.4 Hub
16 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
17 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
18 8.7 Information to be supplied by the manufacturer
9 Additional requirements for dilators
9.1 General
9.2 Size designation
9.3 Hub
9.3.1 General
9.3.2 Conical fitting
9.3.3 Strength of union between hub and dilator
9.4 Information to be supplied by the manufacturer
19 10 Additional requirements for kits containing combinations of devices specified in this International Standard
20 Annex A (informative) Guidance on materials and design
21 Annex B (normative) Test method for corrosion resistance
22 Annex C (normative) Method for determining peak tensile force of introducer catheters, sheath introducers, and dilators
24 Annex D (normative) Test method for liquid leakage from sheath introducers under pressure
26 Annex E (normative) Test method for liquid leakage through haemostasis valves of sheath introducers
27 Annex F (normative) Test method for fracture of guidewires
29 Annex G (normative) Test method for resistance of guidewires to damage by flexing
31 Annex H (normative) Method for determining peak tensile force of guidewires
32 Annex I (normative) Determination of strength of union of needle hub and needle
33 Bibliography

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BS EN ISO 11070:2014+A1:2018
$167.15