[co-author: Vicky Vlontzou]
On 3 June 2020, the AFMPS issued the third version of the Agency’s alternative test protocol (ATP) for surgical face masks. The alternative test protocol was initially published on 14 April 2020, and allowed masks that had not undergone a conformity assessment procedure in accordance with applicable standards to be placed on the Belgian market. The purpose of this protocol is to facilitate the supply of face masks during the COVID-19 pandemic. The previous versions of the protocol permitted surgical face masks that did not comply with the alternative test protocol to be placed on the market as comfort masks. In light of the fact that Belgium no longer faces a shortage of comfort masks on the market, the latest version of the protocol no longer offers such a possibility.
On 3 June 2020, the AFMPS issued the third version of the Agency’s alternative test protocol, which was originally published on 14 April 2020. The second version of the protocol had been released on 29 April 2020.
The alternative test protocol permits masks that do not conform with the applicable European standard (EN 14683:2019+AC:2019) or one of the international standards currently acceptable on an exceptional basis (ASTM F2100, YY 0469:2011 and YT/T 0969-2013) to be placed on the market. This simplified protocol is intended to facilitate the supply of face masks within the context of the COVID-19 pandemic.
The previous versions of the protocol provided that surgical face masks for which test results did not meet the requirements of the alternative test protocol could be placed on the market as comfort masks.
In light of the fact that Belgium no longer faces a shortage of comfort masks on the market, the latest version of the protocol no longer allows surgical masks whose test results do not meet the requirements of the protocol to be placed on the market.
More specifically, masks for which the differential pressure is less than 35 (ΔΡ < 35) and with a bacterial filtration efficiency of less than 95% may no longer be placed on the market.
The third version of the protocol also provides that, where the differential pressure of masks ranges between 35 and 70 (35 ≤ ΔΡ ≤ 70), it is not necessary for a bacterial filtration efficiency test to be performed. This is because the relevant test results will exceed 95%.
In the previous versions of the protocol the differential pressure range on the basis of which a bacterial filtration efficiency test did not need to be performed, was between 35 and 65.
The AFMPS notes that this adjustment was based on the evaluation of the new test results.
The AFMPS recalls that surgical masks which have been released in accordance with the alternative test protocol must bear a warning on their packaging in order to inform users.
The new version of the protocol is applicable from 4 June 2020.
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