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
English
Format
Secure PDF
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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.
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