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Surgical Masks

Originally intended for use in surgical theatres, medical face masks, also referred to as surgical masks, are designed to limit the transmission of infective agents carried via droplets and sprays from staff to patient during surgical procedures. Additionally, in certain circumstances the masks also protect the wearer against splashes of potentially contaminated liquids.

Medical face masks with an appropriate microbial layer may also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms. In the UK, the wearing of face masks became mandatory in public places during the COVID pandemic. The demands for medical masks were unprecedented during the pandemic which led to questions on the quality of products entering the supply chain. In conjunction with NWSSP Procurement Services, SMTL developed technical assurance checks of masks and other COVID related medical devices and PPE.

SMTL subcontracted testing of medical masks to various laboratories in Europe and the US, however a lack of laboratory testing capabilities resulted in extended lead times for testing and escalating costs. To support NHS Wales and reduce the reliance on subcontracting, SMTL has expanded its testing services to assess medical face masks to the European standard EN 14683 which has the following performance requirements:

  • Breathability – this test assesses the differential pressure across the surgical mask and provides an indication on the breathability of the material.
  • Splash resistance – this tests the resistance of the mask to penetration by synthetic blood.
  • Microbial Cleanliness
  • Biocompatibility
  • Marking, Labelling and Packaging
  • Bacterial Filtration Efficiency (BFE) – In collaboration with partner labs, we can also test the bacterial filter efficiency of the mask which assesses the effectiveness of a surgical mask in capturing aerosol droplets containing bacteria.

These tests ensure that medical face masks are both safe and effective for use. If you have products you wish to have tested or any questions, please contact smtl.info@wales.nhs.uk

Relevant Standards

  • BS EN 14683 Medical face masks. Requirements and test methods
  • ISO 22609 Clothing for protection against infectious agents. Medical face masks. Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
  • BS EN ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
  • BS EN ISO 10993-5 Biological evaluation of medical devices - Tests for in vitro cytotoxicity