标准摘要
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.
英文名称Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters