Selected article for: "approval process and large number"

Author: Dellweg, D; Quast, R; Haidl, P
Title: [Investigation of the Filter Performance in a Sample of Standardised Particle-filtering Half Masks].
  • Cord-id: wesczmhj
  • Document date: 2021_1_25
  • ID: wesczmhj
    Snippet: BACKGROUND Thanks to a simplified special approval process that was valid until October 1st, 2020, a large number of particle-filtering half masks have come onto the German market. When caring for SARS-CoV-2 infected patients, the RKI recommends wearing particle-filtering half masks with a filter performance of at least 94 %, which corresponds to FFP class 2 according to EN 149:2001+A1:2009. We have examined 15 particle-filtering half masks with different specifications for their filter performa
    Document: BACKGROUND Thanks to a simplified special approval process that was valid until October 1st, 2020, a large number of particle-filtering half masks have come onto the German market. When caring for SARS-CoV-2 infected patients, the RKI recommends wearing particle-filtering half masks with a filter performance of at least 94 %, which corresponds to FFP class 2 according to EN 149:2001+A1:2009. We have examined 15 particle-filtering half masks with different specifications for their filter performance METHOD: The masks were clamped in a jig in an airtight test box. Radioactive particles with a size of 0.6 ± 0.4 µm were nebulized into the box and sucked into a filter through the port of the jig and an unfiltered reference port using an artificial lung. The activity deposited on the filter was measured by means of a gamma camera. The filter performance was calculated from this. RESULTS Five of the 15 masks tested had a filter performance of less than 94 % and therefore do not meet the FFP2 standard. The filter performance of these masks was 71.8 ± 2.3 %, 73.2 ± 2.3 %, 78.2 ± 6.7 %, 92.2 ± 0.5 % and 85.9 ± 1.6 %. CONCLUSION One third of the examined masks did not meet the recommended FFP2 standard, which is recommended for the care of SARS-CoV-2 infected patients. A comprehensive review of already approved products by the supervisory authorities is advisable.

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