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Iiseti zokuhombisa ezilahlayo nge-FDA Cekisi

Intshayelelo:

Iiseti zokuhombisa ezilahlayo, ezikwabizwa ngokuba ziiseti zokuhonjiswa kwe-IV, zidlala indima ebalulekileyo kwizicwangciso zonyango. Eli nqaku lijolise ekuboneleleni ngesishwankathelo esibanzi senkqubo yemveliso kunye netekhnoloji ebandakanyekayo kwimveliso yezi izixhobo zonyango ziyimfuneko. Kufanelekile ukuba uqaphele ukuba iindidi zokuhombisa ezixoxwe apha yi-FDA kufuneka iqinisekiswe, iqinisekisa ukhuseleko lwabo kunye nomgangatho.

1. Ukuqonda iiseti zengeniso:

Iiseti zonyango zizixhobo zonyango ezisetyenziselwa ukuhambisa amanzi, ezinje ngamayeza, igazi, okanye izondlo, ngqo kwigazi legazi lesigulana. Ziqulathe izinto ezahlukeneyo, kubandakanya igumbi lokudada, ityhubhu, umlawuli ohamba phambili, inaliti okanye i-catheter, kunye nesinxibelelanisi. Ezi seti zenzelwe ukuba zisetyenziselwe ukusetyenziswa okungatshatanga ukukhusela ungcoliseko longcoliseko kunye nokuqinisekisa ukhuseleko lwezigulana.

I-2. Inkqubo yokuvelisa iiseti zokuhombisa okuzimeleyo:

Ukuveliswa kweeseti zokuhonjiswa okuhluliweyo kubandakanya amanyathelo amaninzi, kubandakanya ukhetho lwezinto ezibonakalayo, ukubumba, iNdibano, iSterilization, kunye nolawulo oluphambili. Makhe sijonge kwi-propi nganye:

2.1 Ukukhetha izinto:

Ukuqinisekisa owona mgangatho uphezulu kunye nokhuseleko, inkqubo yemveliso iqala ngokukhetha ngononophelo. Izixhobo ezisetyenziswa kwimveliso ye-insulion zihlala zibandakanya i-PVC yebanga lezonyango, irabha ye-Latex-free, intsimbi engenazibala, kunye ne-iplanga elichanekileyo.

2.2 Ukubuyisa:

Nje ukuba izinto zikhethiwe, inyathelo elilandelayo kukubumba. Inaliti yoomatshini bokubumba isetyenziselwa ukubumba izinto ezahlukeneyo zokuthambisa, ezinje ngegumbi le-drip, umlawuli ohambahambayo, kunye nomnxibelelanisi. Le nkqubo iqinisekisa ukuba ukwenziwa kwemveliso nokungaguquki.

2.3 INdibano:

Emva kokubumba, izinto ezizodwa zihlanganisene ukuze kudalwe ukubekwa kwembeko ngokupheleleyo. Iingcali ezinobuchule qhagamshela igumbi ledriphi, ityhubhu, umlawuli ohambayo, kunye nenaliti okanye i-catheter, uqinisekisa unxibelelwano olukhuselekileyo noluthembekileyo.

2.4 I-Sterilization:

I-Sterilization linyathelo elibalulekileyo lokuphelisa nayiphi na into engcolisayo kwaye iqinisekise ukuba iiseti zengeniso zikhuselekile ukusetyenziswa kwesigulana. Iiseti zihlala ziphantsi kwe-Ethylene oxide (i-ETO), ezibulala ngokufanelekileyo iintsholongwane ngelixa zigcina ingqibelelo yemveliso.

I-2.5 yolawulo lomgangatho:

Kuyo yonke inkqubo yokuvelisa, amanyathelo angqongqo olawulo lomgangatho amiliselwe ukuqinisekisa ukuba iiseti zengeniso zihlangabezana nemigangatho ephezulu. Iimvavanyo ezahlukeneyo, kubandakanya uvavanyo lokuvavanya, ukuvavanywa kwenqanaba lokuhamba, kunye nokuhlolwa kokubonwa, kufakwa ukuqinisekisa ukuthembeka kunye nokusebenza kweseti nganye.

I-3. I-FDA ye-FE:

Kubaluleke kakhulu ukuba i-insulion ye-insulion ithobela imigangatho yomthetho ukuqinisekisa ukhuseleko lwabo kunye nokusebenza kakuhle. Isatimenti se-FDA sibonisa ukuba iimveliso zihlangabezana neemfuno ezinqabileyo ezibekwe kuzo zombini i-United States yokutya kunye nolawulo lweziyobisi (i-FDA) kunye ne-European Union (CE). Esi siqinisekiso sibonisa ukuzibophelela komenzi wokuvelisa i-incophotion ephezulu ekumgangatho ophezulu ehlangabezana nemigangatho yamazwe.

ISIQINISEKISO:

Inkqubo yemveliso yokufunyanwa kwemveliso ibandakanya ukutyeshelwa ngendlela efanelekileyo kwiinkcukacha, ukusuka ekukhetheni ngezinto ezibonakalayo kwi-sterilization kunye nolawulo oluphambili. Ngoqinisekiso lwe-FDA, ezi zicekeceli zibonelela ngoqeqesho lwempilo ngesiqinisekiso sokhuseleko kunye nomgangatho xa ulawula ulwelo kwizigulana. Njengenxalenye ebalulekileyo kwimpilo yempilo yanamhlanje, ukulahla inkunkuma idlala indima ebalulekileyo ekuphuculeni iziphumo zoguli kunye nokuqinisekisa ukuhanjiswa konyango oluchanekileyo nothembekileyo.

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