Sprutor, kanyler och katetrar

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 5 feb 2023
Se merSe mindre
 

This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.
This document is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 5 feb 2023
Se merSe mindre
 

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.