Sterile by any other name

Will manufacturers of CE-marked medical devices produced under aseptic conditions be able to label their products with the harmonized symbol for sterile? Perhaps not. This is because there are differences of opinion concerning the sterility assurance level that a European harmonized symbol for sterile should represent. This article will discuss the current proposed criteria for labelling a medical device with the European harmonized symbol for sterile, a more stringent approach, and some factors that should be taken into consideration before reaching any final decisions.