.
Tlhaho ea lintho tse bonahalang
Sistimi ea ho sefa e entsoe le ho rala ka holim'a 25g e sa lohiloeng, lera la bobeli la 25g BFE99, thepa e ka hare ea 25g e sa lohiloeng.
Sebaka sa kopo
E sebelisoa ho koahela molomo, nko le mohlahare oa mosebedisi, mme e fana ka thibelo ea 'mele ho thibela phetiso e tobileng ea likokoana-hloko tsa pathogenic, maro a' mele, likaroloana, joalo-joalo.
F-Y1-A ke mask a sefahleho sa ho buuoa.
UMDN khoutu: 12-458
Sehlopha: Sehlopha sa 1
Molao: Ho ea ka Molao oa 1, Annex V111, Khaolo ea III ea (EU) MDR 2017/745
Tsela ea tlhahlobo ea tumellano: ANNEX II + ANNEX III + Article 19 of (EU) MDR 2017/745
E phatlalalitsoe ke moetsi hore F-Y1-A e kopana le tokisetso ea Medical Device Regulation (EU) MDR 2017/745 ea Paramente ea Europe le ea Lekhotla la 5 April 2017 ka lisebelisoa tsa bongaka.Tumellano ea phatlalatso ea EU e sebelisoa tlas'a boikarabello ba moetsi feela.
F-Y1-A maemo a sebelisitsoe:
EN ISO 13485:2016, EN ISO 14971:2012, EN 14683:2019 +AC:2019, BS EN ISO 15223-1:2016, EN ISO 10933-1:2009/AC:2010: 2010: 9 EN ISO 15223-1:2016 ISO 10993-10:2010, EN 1041:2008