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BSI 22/30447838 DC 2022

$13.70

BS EN ISO 10555-4. Intravascular catheters. Sterile and single-use catheters – Part 4. Balloon dilatation catheters

Published By Publication Date Number of Pages
BSI 2022 26
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PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Requirements
4.1 General
4.2 Detectability of the balloon position
4.3 Designation of nominal size
4.4 Physical requirements
4.4.1 Balloon rated burst pressure (RBP)
4.4.2 Balloon fatigue; freedom from leakage and damage on inflation
4.4.3 Balloon deflation time
4.4.4 Balloon diameter to inflation pressure (balloon compliance)
11 4.4.5 Crossing profile
4.4.6 Balloon removal
4.5 Information to be supplied with the catheter
12 Annex€A (normative) Test for Rated Burst Pressure (RBP)
14 Annex€B (normative) Balloon fatigue test for freedom from leakage and damage on€inflation
16 Annex€C (normative) Test for balloon deflation time
18 Annex€D (normative) Test for balloon diameter to inflation pressure (balloon compliance)
20 Annex€E (normative) Determination of crossing profile
22 Annex€F (normative) Test method for balloon removal
24 Annex€G (informative) Rationale and guidance
26 Bibliography
BSI 22/30447838 DC 2022
$13.70