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BS EN ISO 10555-1:2023 – TC

BS EN ISO 10555-1:2023 – TC

$258.95

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

Published By Publication Date Number of Pages
BSI 2023 117
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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
66 undefined
71 Foreword
73 1 Scope
2 Normative references
3 Terms and definitions
77 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
78 4.8 Corrosion resistance
4.9 Peak tensile force
79 4.10 Freedom from leakage during pressurization
4.11 Freedom from leakage during aspiration
4.12 Hubs
80 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
81 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
82 6 Information to be supplied with the catheter
6.1 General
6.2 Marking on the device and/or primary packaging
83 6.3 Instructions for use
6.4 Marking on the secondary packaging
84 Annex A (normative) Test method for corrosion resistance
85 Annex B (normative) Method for determining peak tensile force
88 Annex C (normative) Test method for liquid leakage under pressure
90 Annex D (normative) Test method for air leakage into hub assembly during aspiration
92 Annex E (normative) Determination of flowrate through catheter
94 Annex F (normative) Test for burst pressure under static conditions
97 Annex G (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection)
102 Annex H (informative) Units of measurement systems other than those specified in this document
104 Annex I (normative) Test method for air leakage under water
106 Annex J (informative) Rationale and guidance
113 Annex K (informative) Test methods for distal tip stiffness for neurovascular applications
115 Bibliography

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BS EN ISO 10555-1:2023 - TC
$258.95