Masks
Leitat has been notified as a Control Body by the Ministry of Industry, Trade and Tourism and the European Commission, for the certification of respiratory protection devices, thus expanding its scope of products to be certified according to Regulation (EU) 2016/425 on to personal protective equipment.
Leitat has the capacity to carry out the tests according to the EN 14683:2019+AC:2019 standard, so that the manufacturer can carry out the self-certification of surgical masks as a sanitary product according to Directive 93/42/EEC.
Certification of hygienic masks, which do not correspond to an EPI or a PS
- Filter masks + protection filters, according to EN 149: 2001 + A1: 2009, EN 143: 2000 and EN 143: 2000 / A1: 2006 (FILTER)
- Self-filtering masks, according to EN 149: 2001 + A1: 2009
- Dual masks, when in addition to avoiding the transmission of infectious agents from the person wearing it, are also intended to protect them against microbial or virus infections, then they must also be PPE, and therefore, must also comply with regulations of PPE (according to EN 149: 2001 + A1: 2009 standards)
Additionally, it has the capacity to carry out the tests according to the EN 14683: 2019 + AC: 2019 standard, so that the manufacturer can carry out the self-certification of surgical masks as a sanitary product according to Directive 93/42 / EEC.
In addition, as long as the exceptional situation lasts, according to Resolution of March 20, 2020, of the General Secretariat for Industry and Small and Medium-sized Enterprises, on alternative specifications to EPI masks with European CE marking, Notified Control Bodies can validate EPIS in other scenarios or with technical specifications other than harmonized standards.
For more information contact: sartigas@leitat.org