The requirements of DIN EN 149: 2001 A1: 2009 must be met, a corresponding type approval must be available (CE mark with notified body number)

The permeability of the filter with NaCl aerosol according to DIN EN 13274-7: 2019 with a median diameter of the aerosol between 60 and 100 nm, a standard deviation of 2.0 to 3.0 and additional measurement of the penetration at 150 nm must be carried out through regular tests be made. The transmittance must not exceed 6% for all measurements. The breathing resistance must correspond to the limit values of DIN EN 149

For each meltblown roll used, 3 masks made from them are to be archived as a reserve sample, and one of these masks must also be checked for breathing resistance and filter effect. The results of the test are to be documented and submitted to medical consult upon request or as part of an audit.

A quality management system must be established which at least has the content that a material incoming inspection (per roll of meltblown) is carried out and documented for all meltblown products. This must include the measurement of the breathing resistance and the filter passage according to the measurement conditions. If available, an outgoing material inspection by the supplier company should also be available and archived.

All masks must be marked in such a way that each mask can be traced back to the meltblown roll used. This can e.g. B. by using a time stamp (day, hour, min) or a batch number. In the latter case, the batch number may only refer to the use of a special meltblown roller. In this way, a possible recall of masks should also be triggered in the event of quality problems.

The standards and requirements mentioned must be verified by medical consult in audits that take place at least once a year.