Standard

BS EN ISO 10555-4:2023

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

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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.

BSI recommends this version of standard for organisations operating in or with the UK. The ISO edition is available here if required.

Product Details

Descriptors

Leak tests

Cannulas

Instructions for use

Size coding

Medical equipment

Medical instruments

Catheters

Parenteral infusion equipment

Disposable

Sterile equipment

Physical testing

Designations

ICS Codes

11.040.25 Syringes, needles and catheters

Committee

CH/84

International relationships

Identical to:

EN ISO 10555-4

ISBN

978 0 539 20328 8

Publisher

BSI