The FAMHP inspection services establish that surgical masks on offer do not include the necessary declarations, certificates and test reports in accordance with European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed that still allows use as surgical masks or comfort masks.
The COVID-19 epidemic is hampering the supply of various healthcare materials, including medical devices such as surgical masks.
The FAMHP inspection services note that the surgical masks on offer are often not accompanied by the necessary declarations, certificates and test reports that unambiguously demonstrate that they meet the requirements of the applicable European standard (EN 14683:2019 + AC:2019) or one of the international standards that are currently also exceptionally accepted (ASTM F2100, YY 0469:2011 and YY/T 0969-2013).
In addition to the guidelines for checking the conformity and suitability of surgical masks published on 30 March 2020, the FAMHP has now developed the Alternative Test Protocol (ATP). Due to the high level of need in this crisis situation and in order to reduce the large shortages of masks, masks can be subjected to a simplified test protocol in which only the test results of the two main parameters are considered
Alternative Test Protocol (ATP)
The ATP only looks at the results for Bacterial Filtration Efficiency and Differential Pressure. These are the most important parameters in the current context. Centexbel, the only accredited laboratory in Belgium that is allowed to test according to the European standard EN 14683, has investigated the correlation between these two parameters over the past weeks. The indications already provided by this study have been taken into account when drawing up this ATP.
Depending on the results according to the ATP, oral masks can be used either as surgical mouth masks or as comfort masks.
Advantages 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.
Specific conditions and only during the current crisis
Both when the ATP determines whether they are surgical masks or comfort masks, suppliers and importers must comply with specific conditions.
Of course, the Alternative Test Protocol can only be used during the current COVID-19 crisis.