【ISO10555-4-2023】_extract

INTERNATIONAL STANDARDIS010555-4:2023E)Intravascular catheters-Sterile and single-usecatheters-Part 4:Balloon dilatation catheters1 ScopeThis document specifies requirements for balloon dilatation catheters supplied sterile and intended forsingle useThis document does not specify requirements for vascular stents(see ISO 25539-2).NOTEGuidance on the selection of balloon materials is given in Annex G.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document.For dated references,only the edition cited applies.Forundated references,the latest edition of the referenced document (including any amendments)applies.ISO 10555-1:2023,Intravascular catheters -Sterile and single-use catheters -Part 1:Generalrequirements3 Terms and definitionsFor the purposes of this document,the terms and definitions given in ISO 10555-1 and the followingapply.ISO and IEC maintain terminology databases for use in standardization at the following addresses:-ISO Online browsing platform:available at https://www.iso.org/obp-IEC Electropedia:available at https://www.electropedia.org/3.1balloon dilatation catheterintravascular catheter fitted with a balloon,which is introduced into an artery or vein to dilate a partor parts ofthe vascular system3.2balloon rated burst pressureRBPpressure at which the balloon bursts or leaks with an appropriate safety margin3.3crossing profilemaximum outer diameter found between the proximal end of the uninflated balloon and the distal tipof the catheter3.4effective length of the balloonlength of the balloon intended to treat the lesioncopmge mematoralo rights reserved2