Coronavirus: new version of Alternative Test Protocol (ATP) for surgical face masks

An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.

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 had noticed that the surgical face masks offered often lack 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). Consequently, an Alternative Test Protocol (ATP) was developed.

New version of the ATP

A new version of the ATP is available. This new version complies with the Bureau for Standardisation (NBN)’s most recent directives regarding comfort masks. When the masks reach a Bacterial Filtration Efficiency of at least 70%, they can be released as comfort masks. More information on the procedure to be followed and the current waiting times for tests is also available from Centexbel, the laboratory authorised to carry out the tests.

Test results available

The FAMHP will now make the results of the face mask tests publicly available. This will allow end users to verify information about the masks that have been tested after the inspection and that have been released by the FAMHP based on the ATP results. The list of batches released will be regularly updated.

Last updated on
07/05/2020