30. 4. 2021

On Tuesday, 20th of April 2021, by enrolling in the NANDO database at the European Commission, we became the only Notified body in Slovenia for respiratory protective devices: filtering half masks to protect against particles (EN 149:2001+A1:2009), in accordance with the Regulation (EU) 2016/425 on personal protective equipment. This way, we can offer manufacturers a comprehensive service in the field of certification of protective masks, and not just the testing of personal and medical masks.

In response to the pandemic, we set up a testing laboratory in the last year to test personal and medical masks. The laboratory works in consortium with the National Institute of Biology, which performs tests of biocompatibility or cytotoxicity; while tests of bacterial filtration efficiency (BFE) are performed in a joint development project. Through the establishment of the testing laboratory, we wanted to offer assistance to Slovenian manufacturers of face masks, with the rapid and efficient determination of the technical properties of the produced masks. The laboratory also checks the suitability of face masks that arrive in Slovenia from other countries. In the laboratory, we can also test materials intended for use in the manufacture of finished products. We perform all prescribed tests for medical face masks in accordance with the harmonized European standard EN 14683:2019+AC:2019, and personal half-face masks in accordance with the national technical specifications SIS-TS 1200:2020, both with the required testing methods.

Simultaneously with the development of testing methods for personal face masks, we began development to establish a certification body for the conformity assessment of protective masks. ISO 17065 quality management was introduced, and an application was submitted to Ministry of Economic Development and Technology for notification. On the 20th of April, the European Commission completed the process by entering it in the NANDO database and assigning the notified body number NB 2897. Certification of protective masks is a more complex process, where the manufacturer is obliged to include a third independent body (notified body), which assess product conformity. Technical requirements for protective masks have to be confirmed through the performance of 11 tests prescribed in standard EN 149:2001+A1:2009.

With this step, we want to offer domestic manufacturers, who have taken care of self-sufficiency in this area, a comprehensive service at home, which eliminates many obstacles in the way of attesting the conformity of products and, especially, shortens the length of the whole process.