The FAMHP is keeping a close eye on the situation on the ground. Consequently, the Alternative Test Protocol (ATP) is being adapted. From now on, it will no longer be possible to sell surgical masks which do not comply with the ATP as comfort masks. One of the parameters has also been refined based on an evaluation of the new test results. Furthermore, masks that have been subject to the ATP must carry a warning on the packaging. The third version of the ATP is applicable from 04.06.2020.
As a result of the COVID-19 pandemic, the supply of various healthcare materials, including medical devices such as surgical masks, is becoming more difficult. An Alternative Test Protocol (ATP) has been developed for masks that do not have the necessary declarations, certificates and test reports. The FAMHP would like to reiterate that the ATP cannot be considered as a means of demonstrating the conformity of products whose non-conformity has already been established. The ATP is a temporary measure during the current crisis, the purpose of which is to analyse non-compliant masks. In the event of favourable results, these masks can still be released for use as surgical masks.
Changes to the third version of the ATP
There is no longer a shortage of comfort masks on the market. Therefore, there is no longer any reason to authorise non-compliant surgical masks on the market that do not pass the ATP, or that only partially meet its requirements, as comfort masks.
The “Differential Pressure” parameter has been adjusted after the evaluation of the new test results. The 35 to 65 range has now been widened to 35 to 70. Within this range, it is sufficiently certain that the masks have a “Bacterial Filtration Efficiency” (BFE) equal to or greater than 95%. As such, these masks can be marketed as surgical masks according to the conditions of the ATP.
In order to inform the end user more clearly that the masks have been put into circulation in accordance with the provisions of the ATP, a warning must appear on the packaging.
The new version of the ATP is applicable from 04.06.2020.