EN ISO 11070:2014/A1:2018 PDF

Overview

EN ISO 11070:2014/A1:2018 (ISO 11070:2014/Amd 1:2018) is a CEN-endorsed amendment to the international standard for sterile single-use intravascular introducers, dilators and guidewires. Approved July 2018, this amendment clarifies test methods, updates terminology and adds specific test guidance for modern guidewire constructions (including polymer-jacketed wires). The amended standard forms part of the regulatory and quality framework for non‑active vascular access devices and was to be adopted as a national standard across CEN members by January 2019.