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Page 6 of 12                                    Report No. 60377885 001

                                                     EN 14683:2019+AC:2019
               Clause     Requirement + Test                               Result - Remark                 Verdict

               4          Classification                                                                     P
                          Medical face masks specified in this European    Type IIR                          P
                          Standard are classified into two types (Type I and Type
                          II) according to bacterial filtration efficiency whereby
                          Type II is further divided according to whether or not
                          the mask is splash resistant. The 'R' signifies splash
               5          Requirements                                                                       P

               5.1        General                                                                            P
               5.1.1      Materials and construction                                                         P
                          The medical face mask is a medical device, generally   3 ply designed with two layers of   P
                          composed of a filter layer that is placed, bonded or   polypropylene spunbonded non-
                          moulded between layers of fabric.                woven fabric and one layer of
                                                                           polypropylene melt-blown non-
                                                                           woven fabric.

                          The medical face mask shall not disintegrate, split or                             P
                          tear during intended use.
                          In the selection of the filter and layer materials,                                P
                          attention shall be paid to cleanliness.
               5.1.2      Design                                                                             P
                          The medical face mask shall have a means by which it                               P
                          can be fitted closely over the nose, mouth and chin of
                          the wearer and which ensures that the mask fits closely
                          at the sides.
                          Medical face masks may have different shapes and   With nose clip                  P
                          constructions as well as additional features such as a
                          face shield (to protect the wearer against splashes and
                          droplets) with or without anti-fog function, or a nose
                          bridge (to enhance fit by conforming to the nose
               5.2        Performance requirements                                                           P

               5.2.1      General                                                                            P
                          All tests shall be carried out on finished products or                             P
                          samples cut from finished products.

               5.2.2      Bacterial filtration efficiency (BFE)                                              P
                          When tested in accordance with Annex B, the BFE of   See appended table 5.2.2      P
                          the medical face mask shall conform to the minimum
                          value given for the relevant type in Table 1.
                          For thick and rigid masks such as rigid duckbill or cup   Not such mask.          N/A
                          masks the test method may not be suitable as a proper
                          seal cannot be maintained in the cascade impactor. In
                          these cases, another valid equivalent method shall be
                          used to determine the BFE.
               QMF-RT-33008SHG                                                   Revision number: 1.0                                                  Effective date: 2020-03-12
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