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BS EN ISO 10555-1:2023

BS EN ISO 10555-1:2023

$198.66

Intravascular catheters. Sterile and single-use catheters – General requirements

Published By Publication Date Number of Pages
BSI 2023 52
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This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
9 1 Scope
2 Normative references
3 Terms and definitions
13 4 Requirements
4.1 Risk approach
4.2 Usability engineering
4.3 Sterilization
4.4 Shelf life
4.5 Detectability
4.6 Biocompatibility
4.7 Surface
14 4.8 Corrosion resistance
4.9 Peak tensile force
15 4.10 Freedom from leakage during pressurization
4.11 Freedom from leakage during aspiration
4.12 Hubs
16 4.13 Flowrate
4.14 Power injection burst pressure
4.15 Packaging system
4.16 Simulated use, kink and/or torque testing to consider depending on device design, intended use, and risk analysis
17 4.17 Coating integrity and/or particulate testing to consider depending on device design, intended use, and risk analysis
4.18 Distal tip stiffness testing to consider for neurovascular applications
5 Designation of nominal size
5.1 Nominal outside diameter
5.2 Nominal inside diameter
5.3 Nominal effective length
18 6 Information to be supplied with the catheter
6.1 General
6.2 Marking on the device and/or primary packaging
19 6.3 Instructions for use
6.4 Marking on the secondary packaging
20 Annex A (normative) Test method for corrosion resistance
21 Annex B (normative) Method for determining peak tensile force
24 Annex C (normative) Test method for liquid leakage under pressure
26 Annex D (normative) Test method for air leakage into hub assembly during aspiration
28 Annex E (normative) Determination of flowrate through catheter
30 Annex F (normative) Test for burst pressure under static conditions
33 Annex G (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection)
38 Annex H (informative) Units of measurement systems other than those specified in this document
40 Annex I (normative) Test method for air leakage under water
42 Annex J (informative) Rationale and guidance
49 Annex K (informative) Test methods for distal tip stiffness for neurovascular applications
51 Bibliography

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BS EN ISO 10555-1:2023
$198.66