The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. These guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
In order to help companies, authorities and healthcare institutions meet the minimum requirements in the current circumstances, guidelines were drafted in late March 2020 to check the conformity of the products.
The changes in the new version concern:
- clarification on test reports. As part of the conformity assessment of products bearing the CE marking during the current crisis, the FAMHP may request test reports from an accredited laboratory for tests according to EN 14683 standard and for sterility tests.
- an update to the list of Chinese inspection bodies/laboratories.