Status : Published
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2023-11
    Stage
    : International Standard published [60.60]
  • Edition
     : 3
    Number of pages
     : 17
  • Technical Committee :
    ISO/TC 84
    ICS :
    11.040.25 
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