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

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1   Scope

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.