Pūwero Insulin Haumaru Whakahoki a CE FDA me te Ngira
Ataata Hua
Whakaahuatanga
1. He mea hanga te hua i te rauemi polymer hauora.
2. Kei te pūmau te ngira ki te pūwero, he koi rawa te pito o te ngira, he mārama, he tika hoki te whakatikatika, ā, ka taea te whakatau tika i te horopeta.
3.Ngira kua whakanohoia, Kāore he Wāhi Mate, Kāore he Para
4. Mā te mārama o te oko ka māmā ake te ine i te rōrahi o te ngira me te kite i te mirumiru hau.
5. He māmā noa te pānui i te tauine kua oti te whakarōpūtia ki runga i te oko. Ka tāia te whakarōpūtanga ki te mangumangu pumau.
6. He tino pai te uru o te pūwero ki roto i te oko kia pai ai te nekeneke haere.
Āhuatanga
Pūwero insulin whakakorekore, rerekē ngā rahi
ĀHUATANGA
Whakatakotoranga: 0.3ml, 0.5ml me te 1ml (U-100, U-40 rānei)
Rauemi: Hangaia ki te pepa pp kounga hauora
Tiwhikete: Tiwhikete CE, ISO13485
Mōkihi: Mōkihi mirumiru
Ngira: Ngira pumau
Tauine: Ngā tohu waeine nui mārama
Parakore: Mā te hau EO
Rahi: 0.3ml, 0.5ml me te 1ml.
Ngira: 29G, 30G me te 31G.
Whakatakotoranga
| Rauemi | Taupoki me te Pēra me te Pūwero: PP kounga hauora |
| Ngira: Kowiri tira | |
| Pītona: Kore Rāpeti, Kore Rāpeti rānei | |
| Rōrahi | 0.3ml, 0.5ml, 1ml |
| Tono | Hauora |
| Āhuatanga | Mea whakakorekore |
| Tiwhikete | CE, ISO |
| Ngira | me te ngira pumau, te ngira wehe rānei |
| Pūwero | Pūwero pokapū |
| Tae pūwero | Mārama, mā, tae |
| Pēra | Teitei te Mārama |
| Mōkihi | Mōkihi takitahi: Tākai mirumiru/PE |
| Mōkihi tuarua: Pouaka | |
| Mōkihi o waho: Kātene | |
| Parakore | parakore mā te hau EO, kore-paitini, kore-pyrogen |
CE
ISO13485
Te Tari Whakahaere Hauora o Amerika 510K
EN ISO 13485: 2016/AC:2016 Pūnaha whakahaere kounga taputapu hauora mō ngā whakaritenga ture
EN ISO 14971: 2012 Ngā taputapu hauora - Te whakamahinga o te whakahaere mōrearea ki ngā taputapu hauora
ISO 11135:2014 Te whakahoromata i ngā taputapu hauora Te whakaū me te whakahaere whānui
ISO 6009:2016 Ngā ngira werohanga parakore ka taea te whakakore Tāutuhia te waehere tae
ISO 7864:2016 Ngā ngira werohanga parakore ka taea te whakakore
ISO 9626:2016 Ngā ngongo ngira kowiri tira mō te hanga taputapu hauora
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