CE FDA Ikoreshwa rishobora gukururwa Umutekano Insuline Syringe hamwe nurushinge
Video y'ibicuruzwa
Ibisobanuro
1.Ibicuruzwa bikozwe mubikoresho bya polymer.
2.Urushinge rushyizwe kuri nozzle, urushinge rukarishye cyane, rusobanutse neza, kandi rushobora kumenya neza dosiye.
3.Urushinge rwabitswe, Nta mwanya wapfuye, Nta myanda
4.Icyuma kibonerana gihagije cyemerera gupima byoroshye ingano iri muri syringe no gutahura umwuka mubi.
5. Impamyabumenyi yarangije kuri barrale iroroshye gusoma. Impamyabumenyi yacapishijwe na wino idasibangana.
6.Pungeri ihuza imbere ya barrale neza kugirango yemere kugenda neza kandi neza.
Ikiranga
Ikoreshwa rya insuline inshinge zingana
IBIKURIKIRA
Ibisobanuro: 0.3ml, 0.5ml na 1ml (U-100 cyangwa U-40)
Ibikoresho: Byakozwe mubyiciro byubuvuzi pp
Icyemezo: CE, ISO13485 icyemezo
Ipaki: Blister pack
Urushinge: Urushinge ruhamye
Igipimo: Ibimenyetso binini bisobanutse
Sterile: Na gaze ya EO
Ingano: 0.3ml, 0.5ml na 1ml.
Urushinge: 29G, 30G na 31G.
Ibisobanuro
| Ibikoresho | Cap & Barrel & Plunger: Urwego rwubuvuzi PP |
| Urushinge: Icyuma | |
| Piston: Latex cyangwa Latex Ubuntu | |
| Umubumbe | 0.3ml, 0.5ml, 1ml |
| Gusaba | Ubuvuzi |
| Ikiranga | Kujugunywa |
| Icyemezo | CE, ISO |
| Urushinge | hamwe nurushinge ruhamye cyangwa urushinge rwatandukanijwe |
| Nozzle | Nozzel |
| Ibara | Mucyo, cyera, amabara |
| Barrel | Birenzeho |
| Amapaki | Igipapuro cyumuntu ku giti cye: Gupakira Blister / PE |
| Igice cya kabiri: Agasanduku | |
| Igipapuro cyo hanze: Ikarito | |
| Sterile | sterile na gaze ya EO, idafite uburozi, itari pyrogene |
CE
ISO13485
Amerika FDA 510K
EN ISO 13485: 2016 / AC: 2016 Sisitemu yubuvuzi bwiza bwibikoresho byubuvuzi kubisabwa byubuyobozi
EN ISO 14971: 2012 Ibikoresho byubuvuzi - Gukoresha uburyo bwo gucunga ibyago kubikoresho byubuvuzi
ISO 11135: 2014 Igikoresho cyubuvuzi Kurandura okiside ya Ethylene Kwemeza no kugenzura rusange
ISO 6009: 2016 Urushinge rushobora guterwa inshinge Menya kode yamabara
ISO 7864: 2016 Urushinge rwo gutera inshinge
ISO 9626: 2016 Imiyoboro y'urushinge idafite ibyuma kugirango ikore ibikoresho byubuvuzi
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Hamwe nimyaka irenga 10 yuburambe bwo gutanga ubuvuzi, dutanga ibicuruzwa byinshi byatoranijwe, ibiciro byapiganwa, serivisi zidasanzwe za OEM, hamwe no gutanga ku gihe ku gihe. Twabaye isoko ry’ishami ry’ubuzima rya leta ya Ositaraliya (AGDH) n’ishami ry’ubuzima rusange rya Californiya (CDPH). Mubushinwa, dushyira mubambere batanga Infusion, Injection, Access Vascular Access, ibikoresho byo gusubiza mu buzima busanzwe, Hemodialysis, Urushinge rwa Biopsy nibicuruzwa bya Paracentezi.
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