ISO 10555-4:2023

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Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation 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.

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Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters

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ISO 10555-4:2023

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters

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