By Todd Hillam, Protective Barriers Section Leader MBA, SM(NRCM)
There is an initiative afloat within the CEN Committee, the European Standards committee, to align the Bacterial Filtration Efficiency (BFE) test for medical facemasks with its counterpart in the U.S. The move will make it easier for facemask manufacturers to comply with the BFE test method requirements for both the EN 14683 standard in Europe and the ASTM F2101 standard in the U.S.
Right now, the BFE method differs in Europe and US by the pre-conditioning requirements. Manufacturers have to test a set of masks for each standard increasing time and cost. The goal is to update the standard and align the pre-conditioning parameters so manufacturers will only have to test their facemasks once to meet each of the standard method requirements.
The benefit to manufacturers of the standard change is that they can conduct one BFE test that will be the same in each standard. It will help cut down on the number of submissions, save time, save on test costs and ultimately save in what manufacturers will need to charge for their products.
The committee decided to add a bioburden or microbial cleanliness test to the European standard as well as emphasize the requirement for Biocompatibility (ISO10993). These additions will help in controlling the manufacturing process and ensure the products are safe for use.
There are two other tests referenced in the EN 14683, Differential Pressure and Splash Resistance. Differential Pressure will still not be aligned as it requires pre-conditioning in the EN standard but the US test uses an old military standard that does not require pre-conditioning. Efforts are still being made to align the two methods. Splash Resistance is being updated in the EN standard to reference ISO 22609 rather than ASTM F1862 (method used in US). The two methods are the same so there should not be any concerns with this change.
The change to EN 14683 is in the ballot stage among the CEN Committee until a rejection of the changes or a final acceptance is made. Nelson Laboratories is currently equipped to provide testing services for both standards.
Editors note: Nelson Laboratories’ own Todd Hillam, who sits as a member on the U.S. ASTM committee, was invited to attend and make a presentation to the CEN Committee to help as an independent resource with the revisions.