Isingeniso:
Amasethi wokuncishiswa alahliweyo, owaziwa nangokuthi amasethi wokumnika we-IV, adlale indima ebalulekile ezinhlelweni zesimanje zezempilo. Lo mbhalo uhlose ukuhlinzeka ngesibukezo esibanzi senqubo yokukhiqiza kanye nobuchwepheshe obubandakanyekile ekukhiqizeni la madivayisi abalulekile ezokwelapha. Kuyaqapheleka ukuthi amasethi wokumthela okuxoxwe lapha aqinisekisiwe yi-FDA CE eqinisekisiwe, eqinisekisa ukuphepha kwawo kanye nekhwalithi.
1. Ukuqonda Ukutholwa Kwesethi:
Amasethi wokumnika amadivaysi ezokwelapha asetshenziselwa ukuletha uketshezi, njengemithi, igazi, noma izakhi zomzimba, ngqo egazini lesiguli. Ziqukethe izakhi ezahlukahlukene, kufaka phakathi i-Dripter Chamber, tubing, umlawuli wokugeleza, inaliti noma i-catheter, nesixhumi. Lawa masethi enzelwe ukusetshenziswa okukodwa ukuvimbela ukungcoliswa kokuwela futhi aqinisekise ukuphepha kweziguli.
2. Inqubo yokukhiqiza yesethi yokungena elahlekile:
Ukukhiqizwa kwamasethi wokuncishiswa okulahlwayo kubandakanya izinyathelo ezimbalwa ezibalulekile, kubandakanya nokukhethwa kwezinto ezibonakalayo, ukubumba, umhlangano, inzalo, kanye nokulawulwa kwekhwalithi. Ake sihlanganise kuleso naleso salezi zinqubo:
2.1 Ukukhethwa Kwezinto Ezibonakalayo:
Ukuqinisekisa ikhwalithi ephezulu kakhulu nokuphepha, inqubo yokukhiqiza iqala ngokukhethwa ngokwezinto ezibonakalayo. Izinto ezisetshenziswa ekukhiqizweni kokuminyanisa ezibekwe ngokuvamile zifaka phakathi i-PVC yezokwelapha, irabha elingenakuvuza, insimbi engenacala, kanye nezakhi zepulasitiki ezinobunjiniyela.
2.2 Ukubumba:
Lapho nje izinto zokwakha zikhethiwe, isinyathelo esilandelayo siyabumba. Imishini yokuhlanganisa yokujova isetshenziselwa ukwakheka izingxenye ezahlukahlukene zesethi yokumnika, efana ne-Dripter Chamber, umlawuli we-Flow, nesixhumi. Le nqubo iqinisekisa ukukhiqizwa okuqondile nokungaguquguquki.
2.3 Umhlangano:
Ngemuva kokubumba, izingxenye ngazinye zihlangene ukudala isethi yokumnika ephelele. Ochwepheshe abanamakhono baxhuma ngokucophelela i-Dripter Chamber, ishubhu, umlawuli we-Flow, nenaliti noma i-catheter, ukuqinisekisa ukuxhumana okuphephile nokunokwethenjelwa.
2.4 inzalo:
I-Sterilization iyisinyathelo esibalulekile sokususa noma yikuphi ukungcola okungaba khona futhi kuqinisekiswe amasethi wokumthela aphephile ukusetshenziswa kweziguli. Amasethi ngokuvamile afakwa ngaphansi kwe-ethylene oxide (ETO) inzalo, ebulala ama-microorganisms ngenkathi egcina ubuqotho bemikhiqizo.
I-2.5 control control:
Kuyo yonke inqubo yokukhiqiza, izindlela zokulawula ezisezingeni eliphakeme zenzelwe ukuqinisekisa ukuthi amasethi wokumthela ahlangabezana namazinga aphezulu kakhulu. Ukuhlolwa okuhlukahlukene, okubandakanya ukuhlolwa okuvuzayo, ukuhlolwa kwesilinganiso sokugeleza, kanye nokuhlola okubukwayo, kwenziwa ukuqinisekisa ukuthembeka nokusebenza kwesethi ngayinye.
3. Isitifiketi se-FDA CE:
Kubaluleke kakhulu ukuthi amasethi wokumila alahliwe ahambisana namazinga alawulayo ukuqinisekisa ukuphepha nokusebenza kwawo. Isitifiketi se-FDA CE sibonisa ukuthi imikhiqizo ihlangabezana nezidingo eziqinile ezibekwe yi-United States Food and Drug Administration (FDA) kanye ne-euronveité ye-European Union nase-CE). Lesi sitifiketi sibonisa ukuzibophezela komenzi kokukhiqiza amasethi wokuvumela osezingeni eliphakeme ahlangabezana namazinga aphesheya.
Isiphetho:
Inqubo yokukhiqiza yesethi yokungena ekunciphisekayo ifaka ukunakwa ngokucophelela imininingwane, ekukhetheni kwezinto ezibonakalayo ekusebenzeni kwezimali nokulawulwa kwekhwalithi. Ngesitifiketi se-FDA CE, la masethi ahlinzeka ngochwepheshe bezokunakekelwa kwezempilo ngesiqinisekiso sokuphepha nekhwalithi lapho kunikeza uketshezi ezigulini. Njengengxenye ebalulekile ekunakekelweni kwezempilo kwanamuhla, okulahlwayo kwemishini kudlala indima ebalulekile ekwenzeni ngcono imiphumela yeziguli kanye nokuqinisekisa ukulethwa kokwelashwa okunembile nokwethembekile kwezokwelashwa.