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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 requirement listed on below.
NPTesting Lab will continue to be able to provide all testing required by both types of surgical masks. Also In Europe, surgical masks must wear a CE-mark and comply with the requirements defined in
14683: Medical face masks – Requirements and test methods.
The standard defines surgical masks as: medical devices, covering the mouth, nose and chin ensuring a barrier that limits the transition of an infective agent between the hospital staff and the patient.
In respect of the performances, the mask is tested as a final product and has to comply with different requirements.
The classification of the masks in 3 types is based on the results from the following tests:
Because surgical masks are considered medical devices of class I, the manufacturer has to run a risk analysis and additional tests if needed to respond to the European Medical Device Regulation 2017/745.
There are no requirements regarding barrier against inert particles.
