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BSI 22/30447834 DC 2022

BSI 22/30447834 DC 2022

$13.70

BS EN ISO 10555-1. Intravascular catheters. Sterile and single-use catheters – Part 1. General requirements

Published By Publication Date Number of Pages
BSI 2022 51
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PDF Catalog

PDF Pages PDF Title
7 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
15 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
16 4.8 Corrosion resistance
4.9 Peak tensile force
17 4.10 Freedom from leakage during pressurization
4.11 Freedom from leakage during aspiration
18 4.12 Hubs
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
19 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
20 6 Information to be supplied with the catheter
6.1 General
6.2 Marking on the device and/or primary packaging
21 6.3 Instructions for use
6.4 Marking on the secondary packaging
22 Annex€A (normative) Test method for corrosion resistance
23 Annex€B (normative) Method for determining peak tensile force
26 Annex€C (normative) Test method for liquid leakage under pressure
28 Annex€D (normative) Test method for air leakage into hub assembly during aspiration
30 Annex€E (normative) Determination of flowrate through catheter
32 Annex€F (normative) Test for burst pressure under static conditions
35 Annex€G (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection)
40 Annex€H (informative) Units of measurement systems other than those specified in this€document, which may additionally be used
42 Annex€I (normative) Test method for air leakage under water
44 Annex€J (informative) Rationale and guidance
50 Annex€K (informative) Test methods
51 Bibliography

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BSI 22/30447834 DC 2022
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