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BS EN ISO 10555-4:2023 – TC

BS EN ISO 10555-4:2023 – TC

$186.33

Tracked Changes. Intravascular catheters. Sterile and single-use catheters – Balloon dilatation catheters

Published By Publication Date Number of Pages
BSI 2023 56
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This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. This document does not specify requirements for vascular stents (see ISO 25539-2). NOTE            Guidance on the selection of balloon materials is given in Annex G.

PDF Catalog

PDF Pages PDF Title
31 undefined
35 Foreword
38 1 Scope
2 Normative references
3 Terms and definitions
39 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)
40 4.4.5 Crossing profile
4.4.6 Balloon removal
4.5 Information to be supplied with the catheter
41 Annex A (normative) Test for rated burst pressure (RBP)
43 Annex B (normative) Balloon fatigue test for freedom from leakage and damage on inflation
45 Annex C (normative) Test for balloon deflation time
47 Annex D (normative) Test for balloon diameter to inflation pressure (balloon compliance)
49 Annex E (normative) Determination of crossing profile
51 Annex F (normative) Test method for balloon removal
53 Annex G (informative) Rationale and guidance
54 Bibliography

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BS EN ISO 10555-4:2023 - TC
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