EN 14683

EN14683 Harmonizes Bacterial Filtration Efficiency and Differential Pressure with ASTM F2100

Over the past several years the European Committee for Standardization (CEN), has been working to align the Bacterial Filtration Efficiency (BFE) test requirements for medical facemasks (EN 14683) with its counterpart committee requirements in the U.S. (ASTM F2101).  The goal was to update the standard and align the pre-conditioning parameters in both Europe and the U.S. so that manufacturers would only need to test their facemasks once to meet both requirements.  The good news is that the CEN committee has recently released their latest revision of EN 14683 standard aligning these requirements.

Previously, manufacturers had to conduct tests using two methods for BFE and Differential Pressure to comply with the standards in Europe and the U.S. This was due to the difference in preconditioning requirements as shown in Table 1. Needing to conduct two very similar tests ultimately cost manufacturers both time and money.  As a result of the 2014 revision for EN 14683, which aligned preconditioning requirements to the ASTM F2100 standard, manufacturers can now use one, combined BFE and Differential Pressure testing method.

EN14683 Harmonization Preconditioning Requirements

Table 1: EN14683 Harmonization Preconditioning Requirements

Because of this revision which aligns the method of preconditioning, manufacturers  can now perform BFE and Differential Pressure testing at Nelson Labs using one test code, one testing method, and only one test report will be generated. The final report will list both standards and all results required such as, both mmH2O/cm2 and Pa/cm2 units for Differential Pressure.

One important note, although the preconditioning requirements align the BFE and Differential Pressure testing methods, the tests that are necessary to perform will remain different between the two standards. Depending on your mask claim, the performance results required will also remain different between the two standards as shown in Table 2 below.

EN14683 Harmonization: Test Requirements and Performance Requirements by Type in EN14683:2014 and Level Barrier in ASTM F2100-11

Table 2: Test Requirements and Performance Requirements by Type in EN14683:2014 and Level Barrier in ASTM F2100-11

Manufacturers who wish to market their medical face masks in both the United States and Europe will still need to perform the tests required by both standards and meet the differing performance requirements—listed in Table 2.

Nelson Labs will continue to be able to provide all testing required by both standards.  Please contact your Nelson Laboratories sales representative if you have any questions.

Europe Working to Update Facemask Standard to Align with United States

By Todd Hillam, Protective Barriers Section Leader MBA, SM(NRCM)Bacterial-Filtration-Efficiency-test

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.