BS EN ISO 10555-4:2023

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

Published By	Publication Date	Number of Pages
BSI	2023	26

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Categories: 11.040.25 - Syringes, needles and catheters, BSI

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Description

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.

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PDF Pages	PDF Title
2	undefined
6	Foreword
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
25	Bibliography

Additional information

Status	Definitive
Pages	26
Publication Date	2023-12-04
ISBN	978 0 539 20328 8
Standard Number	BS EN ISO 10555-4:2023
Title	Intravascular catheters. Sterile and single-use catheters – Balloon dilatation catheters
Identical National Standard Of	EN ISO 10555-4, ISO 10555-4
Replaces	BS EN ISO 10555-4:2013
Descriptors	Leak tests, Cannulas, Instructions for use, Size coding, Medical equipment, Medical instruments, Catheters, Parenteral infusion equipment, Disposable, Sterile equipment, Physical testing, Designations
Publisher	BSI
Committee	CH/84
ICS Codes	11.040.25 - Syringes, needles and catheters

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BS EN ISO 10555-4:2023

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