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ISO 10555-4:2023

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

Standard Details

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
Standard Type: Main
Document No: ISO 10555-4:2023
Document Year: 2023
Pages: 17
Edition: 3
  • Section Volume:
  • ISO/TC 84. Devices for administration of medicinal products and catheters
  • ICS:
  • 11.040.25 Syringes, needles and catheters

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ISO 10555-4:2023
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