I-INSULIN PEN ANALITHI CE ISO 510K YAMKELWA
Iimpawu zeMveliso
| Ukusetyenziswa okucwangcisiweyo | Inaliti yepeni ye-insulin isetyenziselwa ulwelo lwe-insulin olungaphambi kwesifo seswekileifayilishiweipeni ye-insulin yokufaka inaliti ye-insulin. |
| Ulwakhiwo kunye nokwakheka | Niseti yeedle, isikhuseli sencam yenaliti, isikhuseli seseti yenaliti, iphepha elitywiniweyo eline-dialyzed |
| Izinto eziphambili | I-PE, i-PP, i-SUS304 i-Stainless Steel Cannula, i-Silicone Oil |
| Beka ubomi kwishelufa | Iminyaka emi-5 |
| Isiqinisekiso kunye noQinisekiso loMgangatho | Ukuvumelana ne-ISO11608-2 Ngokuhambelana ne-European Medical Device Directive 93/42/EEC (Udidi lwe-CE: Ila) Inkqubo yokuvelisa ihambelana ne-ISO 13485 kunye neNkqubo yoMgangatho ye-ISO9001. |
Iiparamitha zeMveliso
| Ubungakanani benaliti | 29-33G |
| Ubude benaliti | 4mm-12mm |
Intshayelelo yeMveliso
Iinaliti zepeni ye-insulin ye-KDL zenziwe ngezinto ezikumgangatho ophezulu, kubandakanya i-needle hub, inaliti, isiciko esincinci sokukhusela, isiciko esikhulu sokukhusela, kunye nezinye izinto ezibalulekileyo. Yenzelwe ngokukodwa ukusetyenziswa neepeni ze-insulin ezizaliswe lulwelo ezifana neNovo Pen, imveliso yethu ibonelela ngesisombululo esilula nesisebenzayo sokujova i-insulin.
Njengemveliso ekumgangatho wezonyango, sibeka phambili ukhuseleko nempilo yabathengi bethu. Zonke izinto ezisetyenzisiweyo, kuquka i-rubber stopper, i-adhesive, kunye nezinye iindawo, zidlula kwimigangatho yezonyango engqongqo ngaphambi kokuba zihlanganiswe. Iinaliti zethu zikwafakwa iintsholongwane ngenkqubo yokubulala iintsholongwane ye-ETO (Ethylene Oxide) kwaye azina-pyrogen. Ezi nkqubo ziqinisekisa ukuba iinaliti azinazo izifo kwaye ziyahlangabezana neemfuno zonyango.
Iinaliti zethu ze-Insulin Pen ziphambili kuyilo nakwizinto ezintsha ukuqinisekisa amava akhuselekileyo nakhululekileyo. Izigqubuthelo zethu ezincinci nezinkulu ziqinisekisa ukhuseleko olupheleleyo ngaphambi nasemva kokusetyenziswa ukunciphisa umngcipheko wokwenzakala okanye ungcoliseko. Inaliti yenzelwe ngokuchanekileyo iinaliti ezingenantlungu ngobunzulu kunye nomgama ofanelekileyo wokufakwa. Ihabhu yenaliti kulula ukuyibamba kwaye ivumela inkqubo yokujova ezinzileyo. Ezi mpawu zenzelwe ukubonelela ngentuthuzelo ephezulu ngexesha lenkqubo yokujova.
Ngeenaliti ze-Insulin Pen, ungenza i-insulin injection yakho ngokulula nangokuqiniseka. Imveliso yethu inika uxolo lwengqondo kwizigidi zabantu kwihlabathi liphela abafuna i-insulin injection. Ubuchwepheshe bethu obuphambili kunye noyilo olutsha kwizixhobo kunye noyilo luqinisekisa ukuba imveliso ayifikeleli nje kuphela kodwa idlula imigangatho yoshishino.
