Isirinji yentengiso evunyiweyo yi-CE FDA ISO ekhubaza ngokuzenzekelayo
Iisirinji ezizicima ngokuzenzekelayo zenzelwe ukuthintela ukusetyenziswa kwazo kwakhona, ngaloo ndlela kunciphisa umngcipheko wokusasaza usulelo nezifo. Ezi sirinji zihlala zisetyenziswa kwiindawo zonyango kwaye zinezicelo ezininzi ezibalulekileyo, kuquka:
- Amaphulo Okugonya.
- Ukunika izigulane amayeza, imijovo, kunye nezinye izitofu.
- Ukuqokelelwa Kwegazi.
- Ukwenziwa kwamayeza.
Isirinji yentengiso evunyiweyo yi-CE FDA ISO ekhubaza ngokuzenzekelayo
Inkcazelo: 1ml, 2-3ml, 5ml, 10ml, 20ml, 30ml, 50ml;
Icebiso: I-Luer slip;
Ayinazintsholongwane: Yigesi ye-EO, Ayinatyhefu, Ayina-Pyrogenic
Isatifikethi: CE kunye ne-ISO13485
Iingenelo zemveliso:
Ukusebenza ngesandla esinye kunye nokusebenza;
Iminwe ihlala emva kwenaliti ngamaxesha onke;
Akukho tshintsho kwindlela yokujova;
I-Luer slip ingena kuzo zonke iinaliti eziqhelekileyo ze-hypodermic
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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