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Page 7 of 12                                    Report No. 60377885 001

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

                          When a mask consists of two or more areas with   Same characteristics and same    N/A
                          different characteristics or different layer-composition,  layer-composition declared by
                          each panel or area shall be tested individually.   manufacturer.

                          The lowest performing panel or area shall determine   See above                   N/A
                          the BFE value of the complete mask
               5.2.3      Breathability                                                                      P

                          When tested in accordance with Annex C, the      See appended table 5.2.3          P
                          differential pressure of the medical face mask shall
                          conform to the value given for the relevant type in Table
                          If the use of a respiratory protective device as face                             N/A
                          mask is required in an operating theatre and/or other
                          medical settings, it might not fulfil the performance
                          requirements with regard to differential pressure as
                          defined in this European Standard. In such case, the
                          device should fulfil the requirement as specified in the
                          relevant Personal Protective Equipment (PPE)
               5.2.4      Splash resistance                                                                  P

                          When tested in accordance with ISO 22609:2004 the   See appended table 5.2.4       P
                          resistance of the medical face mask to penetration of
                          splashes of liquid shall conform to the minimum value
                          given for Type IIR in Table 1.

               5.2.5      Microbial cleanliness (Bioburden)                                                  P
                          When tested according to EN ISO 11737-1:2018 the   See appended table 5.2.5        P
                          bioburden of the medical mask shall be ≤ 30 CFU/g
                          tested (see Table 1).
               5.2.6      Biocompatibility                                                                  N/E
                          According to the definition and classification in EN ISO  The biocompatibility is not   N/E
                          10993-1:2009, a medical face mask is a surface device  evaluated in this test report.
                          with limited contact.

                          The manufacturer shall complete the evaluation of the                             N/E
                          medical face mask according to EN ISO 10993-1:2009
                          and determine the applicable toxicology testing regime.
                          The results of testing should be documented according                             N/E
                          to the applicable parts of the EN ISO 10993 series.

                          The test results shall be available upon request.                                 N/E
               6          Marking, labelling and packaging                                                   P
                          Annex I, §13, of the Medical Devices Directive   See attachment.                   P
                          (93/42/EEC) or Annex I, §23, of the Medical Device
                          Regulation (EU) 2017/745 specifies the information that
                          should be specified on the packaging in which the
                          medical face mask is supplied.
               QMF-RT-33008SHG                                                   Revision number: 1.0                                                  Effective date: 2020-03-12
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