BAS EN ISO 10555-4:2025
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
General Information
Status: Published
No. of pages: 21
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 18.06.2025
Technical committee:
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10555-4:2023, identical
- ISO 10555-4:2023, identical