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 |
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 |