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About This Item

 

Full 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.
 

Document History

  1. ISO 10555-4:2023

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

    • Most Recent
  2. ISO 10555-4:2013


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

    • Historical Version
  3. ISO 10555-4:1996


    Sterile, single-use intravascular catheters -- Part 4: Balloon dilatation catheters

    • Historical Version