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2020-9-13 · If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the face mask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask. The CE has 3 levels of certification – FFP1 ...

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2020-9-13 · Non Sterile Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.. Since it falls under Class 1, Non-Sterile Surgical Mask can be self Certified as per MDD 93/42/EEC.

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2020-9-10 · SURGICAL FACE MASK PRODUCT LIFECYCLE QUALITY MANAGEMENT ... the testing and certification requirements for USA (ASTM) and Europe (EN) are detailed in the table below: ... 2020/403 of 13 March 2020 was released within the context of the COVID-19 threat to address the shortage of surgical face masks. Where non-CE marked surgical face masks are ...

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