CE Marking for Face Mask

CE Marking for Face Mask


CE Marking is the authentication of the quality of facemask which can be marketed in European market.
There are three types of face masks. They are single-use face mask, surgical mask and respirator mask. The difference is based on filtration effectiveness. The filtration efficiency of the single-use face mask is 3.0 microns > 95% & 0.1 microns-nil. The filtration efficiency of surgical mask is 3.0 microns >95%; and 0.1 microns >30%. The filtration efficiency of respiratory masks such as N95/KN95 is 0.3 microns >95.
For getting CE marking the face masks should be tested as per EN 14683:2019 are
·         Bacterial filtration efficiency
·         Differential Pressure
·         Splash resistance pressure
·         Microbial Cleanliness
The face mask is coming under class 1 of medical device directive 93/42/EEC. If the face mask is supplied in non-sterile condition, the face mask can be self-certified. If the facemask is supplied in sterile condition, then European Union Notified body is reputed for CE Certification.

For More details
Contact: +91 9383565502
Visit: www.bmqr.com / www.bmqr.in

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