DIN EN ISO 10555-4
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023); German version EN ISO 10555-4:2023
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter (ISO 10555-4:2023); Deutsche Fassung EN ISO 10555-4:2023
Overview
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). The responsible national standardization committee is NA 176-04-01 AA "Katheter, Drainagen" ("Catheters, drainages") at DIN Standards Committee Health Technologies (NAGesuTech).
Document: references other documents
Responsible national committee
NA 176-04-01 AA - Catheters, drainages
Responsible european committee
CEN/TC 205 - Non-active medical devices