Iisirinji ze-OEM/ODM eziLahlwayo zezonyango eziKhuselekayo ngokuzenzekelayo ezinenaliti
Isirinji ye-AD (ekhutshazwe ngokuzenzekelayo) ithintela ukuphinda isetyenziswe kwaye ke ngoko inceda ekuthinteleni ukudluliselwa kwezifo ezidluliselwa ngegazi phakathi kwezigulane. Isirinji ayichaphazeli kakhulu ukudluliselwa phakathi kwezigulane kunye nabasebenzi bezempilo okubangelwa yinaliti enobungozi, kwaye ayibonisi umngcipheko ophantsi weengozi kuluntu xa ilahlwe ngendlela engafanelekanga. Nangona kunjalo, iyathintela ukuthengiswa kwakhona emva kokusetyenziswa. Kwiimeko ezininzi apho iisirinji zisetyenziswa kwakhona, ukuqaliswa kwesirinji ye-AD kufuna ukwanda kwenani leesirinji ezithengiweyo kunye nokunyuka okufanayo kweendleko. Isirinji ye-AD inegalelo kukhuseleko ikakhulu kumazwe asakhasayo apho ukuphinda kusetyenziswe iisirinji ezilahlwayo eziqhelekileyo kuxhaphake kakhulu, iinkqubo zokulahla azinelanga, kwaye ukuthengiswa kwakhona kwezixhobo zonyango ezisetyenzisiweyo kuxhaphakile.
Inkcazo
Ubungakanani besirinji: 0.5ml, 1ml, 3ml, 5ml, 10ml kunye ne-20ml
Igeyiji yenaliti: 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G kunye ne-30G.
Ubude benaliti: 6mm-38mm
Uphawu
Emva kokuba inaliti igqityiwe, rhoxa i-plunger uze uyiqhekeze ukuze inaliti ingaveli. Oku kuya kunciphisa umngcipheko wokwenzakala kwenaliti kwaye kuthintele ukusetyenziswa kwakhona kwesirinji.
Ayinazintsholongwane: Yigesi ye-EO.
I-WHO, i-CE, i-ISO13485 kunye ne-FDA 510K.
CE
I-ISO13485
I-USA FDA 510K
EN ISO 13485 : 2016/AC: 2016 Inkqubo yolawulo lomgangatho wezixhobo zonyango ngokweemfuno zomthetho
I-EN ISO 14971: Izixhobo zonyango zika-2012 - Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135:2014 Izixhobo zonyango Ukucoca i-ethylene oxide Ukuqinisekiswa kunye nolawulo ngokubanzi
I-ISO 6009:2016 Iinaliti zokujova ezingafunekiyo nezilahlwayo Chonga ikhowudi yombala
I-ISO 7864:2016 Iinaliti zokujova ezingasetyenziswanga nezingenazintsholongwane
I-ISO 9626:2016 Iityhubhu zeenaliti zentsimbi engenasici zokwenza izixhobo zonyango
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