The FAMHP inspection services have noted that the surgical face masks offered do not have the declarations, certificates and test reports necessary according to European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed to ensure they can still be permitted for use as a surgical mask or comfort mask.
Due to the COVID-19 pandemic, the supply of various health care materials, including medical devices such as surgical masks, is becoming more difficult.
The FAMHP inspection services have noted that the surgical face masks offered often do not have the declarations, certificates and test reports necessary to demonstrate unequivocally that they meet the requirements of the applicable European standard (EN 14683: 2019 + AC: 2019) or one of the international standards which are currently also authorised on an exceptional basis (ASTM F2100, YY 0469: 2011 and YY / T 0969-2013).
In addition to the guidelines for checking the compliance and suitability of certain surgical face masks published on 30 March 2020, the FAMHP has now developed an alternative test protocol: Alternative Test Protocol (ATP). Due to the high level of demand in this crisis situation, and in order to reduce the significant shortage of masks, the masks can now be subjected to a simplified test protocol which only takes into account the test results of two important parameters.
Alternative Test Protocol (ATP)
The ATP only examines the results of the bacterial filtration efficiency and differential pressure tests. These are the most important parameters in the current context. Centexbel, the only accredited laboratory in Belgium authorised to carry out tests in accordance with European standard EN 14683, has studied the correlation between these two parameters in recent weeks. The indications already provided by this study were taken into account during the development of this ATP.
Depending on the results obtained from the ATP, the face masks can be used either as a surgical face mask or as a comfort mask.
Benefits of the Alternative Test Protocol (ATP)
This protocol makes it possible to determine whether the non-compliant masks, which could not be released under normal circumstances, are of sufficient quality to be used as surgical masks in the current crisis situation.
Under specific conditions and only in the current crisis situation
Suppliers and importers must comply with specific conditions, regardless of whether their masks have been determined to be surgical face masks or comfort masks under the ATP.
Furthermore, it goes without saying that the alternative test protocol can only be applied during the current COVID-19 crisis.