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.
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.
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.