New EU IVD standard for specimen receptacles:
This article was originally published in Clinica
Executive Summary
The European standardisation committee, CEN, has completed a new standard for IVD medical devices on single-use receptacles for the collection of specimens, other than blood, from humans. EN 14254 covers graduation, fill lines and the information that suppliers must provide. It is a harmonised standard, so manufacturers using it can claim compliance with the relevant essential requirements of the EU IVD Directive.