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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 10555:2023

ISO 10555:2023 Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters

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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.

Edition

3

Published Date

2023-11-14

Status

PUBLISHED

Pages

17

Language Detail Icon

English

Format Secure Icon

Secure PDF

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.

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