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This part of DIN EN ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use. The underlying international document (EN ISO 10555-4:2011) has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) with the collaboration of German experts. The committee responsible for this standard is NA 063-01-02 AA "Katheter, Drainagen" ("Catheters, drainages") at DIN.
This document replaces DIN EN ISO 10555-4:1997-11 .
This document has been replaced by: DIN EN ISO 10555-4:2024-03 .