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Return to EU conformity for FFP masks

Redaktion PSI Journal

Published on 03.12.2020

At the beginning of the pandemic, medical protection products became scarce very quickly. In order to meet the greatly increased demand, the requirements for the conformity of FFP masks were partially revoked. Since the supply shortfall has been remedied in the meantime, all exceptions for placing particle-filtrating half-masks based on Article 9, Paragraphs 1 and 2 of the German Ordinance for Ensuring the Supply of Medical Products (MedBVSV) ended on 1 October 2020. This means that only particle-filtrating half-masks in accordance with EU Ordinance 2016/425 may be put on the market since that day. These are marked with a CE label (CE followed by the four-digit number of the monitoring body) and, as a rule, also inspected in accordance with EN 149 (divided into the classes FFP1, FFP2 and FFP3). Masks with the label N95 based on US standards and KN95 based on Chinese standards are thus no longer allowed. However, masks which have already been put on the market in accordance with Article 9 Paragraph 1, 2 and 3 (MedBVSV) may still be used. Employers may also continue to provide these masks to their employees. The extent to which particle-filtrating half-masks may be used for a certain purpose and what limits on their usage are to be considered are described in rule 112-190 of the German Social Accident Insurance, “Usage of Respiratory Protection Device”.