Update on technical specification for transparent face masks

Since the beginning of the pandemic of Covid-19, the usage of face mask has increased, and so has the demand for transparent face masks that allow better communication for people with hearing difficulties or with other cognitive disabilities. Thanks to the mask’s transparency, it is possible to see the wearer’s mouth and to facilitate lip reading, which is very important for both patients and health workers.

However, there are certain requirements that transparent masks must meet to guarantee the same protection as other protective masks. For this reason, the NHS Transparent Face Mask Working group has worked to provide technical specification for the manufacturers.

According to the technical specification guidance, transparent face masks shall:

  • Cover the user’s nose, mouth, and chin without sliding and fit closely to prevent the transmission of bacteria;
  • Allow comfortable breathing to the wearer, without distorting or reducing the volume of the voice and not have any valves;
  • Be labelled and marked accordingly to the applicable regulations;
  • Be considered and labelled as single use only and not be considered as Type IIR medical masks;
  • Be made of materials that are appropriate for the period of usage of the masks and compliant to the biocompatibility requirements;
  • Have a bacteria filtration efficiency of ≥ 98% and have performed the tests for wet bacterial penetration;
  • Comply with the bioburden requirements for microbial cleanliness;
  • Resist to fogging and allow correct vision of mouth area;
  • Comply with other important design requirements for specific users.

It is interesting to notice that masks complying with this technical specification cannot be referred to as Type IIR medical masks, although they are designed to give comparable protection and can still meet some of the requirements of EN 14683:2019 related to Type IIR masks.

Nevertheless, the fulfilment of this specification cannot be used as the only path towards conformity to essential requirements, as other solutions can also prove the safety of transparent face masks.

Should you wish to enter the UK market with your devices, please do not hesitate and contact our experts.

Carla Pintor

Regulatory Affairs Department

25/08/2021

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