ʻO ka pale maka ʻokiʻoki (F-Y1-A Type IIR)
haku mele
Hoʻolālā ʻia ka ʻōnaehana kānana a hoʻopaʻa ʻia e ka ʻili 25g ʻaʻole i ulana ʻia, ka papa ʻelua 25g BFE99 kānana mea, ʻo loko 25g ʻaʻole i ulana ʻia.
Ka laulā o ka noi
Hoʻohana ʻia ia e uhi i ka waha, ka ihu a me ka ʻāwae o ka mea hoʻohana, a hāʻawi i kahi pale kino e pale ai i ka hoʻouna pololei ʻana o nā microorganism pathogenic, nā wai kino, nā ʻāpana, etc.
ʻO ka F-Y1-A he pale maka o ke kino.
Helu UMDN: 12-458
Papahana: Papa 1
Rula: E like me ka Rula 1, Annex V111, Mokuna III o (EU) MDR 2017/745
Alana loiloi kūpono: ANNEX II + ANNEX III + Paukū 19 o (EU) MDR 2017/745
Ua haʻi ʻia e ka mea hana ua hoʻokō ʻo F-Y1-A i ka hāʻawi ʻana o ka Medical Device Regulation (EU) MDR 2017/745 o ka European Parliament a me ka Council of 5 April 2017 ma nā mea lapaʻau.Hoʻohana ʻia ka conformity ʻōlelo EU ma lalo o ke kuleana o ka mea hana.
Hoʻohana ʻia ka maʻamau F-Y1-A:
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:201090: EN ISO 15223-1:2016 ISO 10993-10:2010, EN 1041:2008
