EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3§3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3§3 of this Pressure Vessel Directive, this product does not bear the CE mark.These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.This product was manufactured with materials that meet the criteria for a \"non-fiber releasing\" filter as defined in 21CFR210.3(b)(6).After a controlled water flush of 50L/m², samples exhibited less than 500ppb TOC per USP 643 and less than 1.3µS/cm per USP 645 .Membrane: Polyethersulfone (PES); Gaskets: Silicone; Housing: Polyvinylidene fluoride (PVDF)