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This standard BS EN ISO 10555-4:2023 - TC Tracked Changes. Intravascular catheters. Sterile and single-use catheters is classified in these ICS categories:
11.040.25 Syringes, needles and catheters
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.