Izinaliti Zokufaka Imithambo Yesikhumba Esilahlwayo Sezokwelapha Zokufaka
Isethi yemithambo yekhanda elahlwayo ivame ukusetshenziswa ochwepheshe bezokwelapha ngenhloso yokuthola ukufinyelela emthanjeni wekhanda. Lokhu kuvame ukwenziwa ukunikeza imithi, uketshezi, noma ukuqoqa amasampula egazi ezinsaneni nasezinsaneni. Isethi yemithambo yekhanda inomklamo webhabhathane, okuvumela ukufakwa kalula nokunciphisa ukulimala emthanjeni. Kubalulekile ukuqinisekisa ukuthi inqubo efanele kanye nezinqubo ze-aseptic ziyalandelwa lapho kusetshenziswa isethi yemithambo yekhanda elahlwayo ukuze kuncishiswe ingozi yokutheleleka futhi kwandiswe induduzo yesiguli.
Izinaliti Zokufaka Imithambo Yesikhumba Esilahlwayo Sezokwelapha Zokufaka
| Igama Lomkhiqizo | Izinaliti Zokufaka Imithambo Yesikhumba Esilahlwayo Sezokwelapha Zokufaka |
| Umthamo | 19-27G |
| Isikhathi sokuphelelwa yisikhathi | Iminyaka emi-5 |
| Ayinamagciwane | Ukuhlanza inzalo kwe-EO, Okungenazinzalo, okungena-pyrogen |
| Izinto | 1. Isibambi senaliti esinamaphiko amabili senziwe nge-PVC yezokwelapha eguquguqukayo ngokuyibumba ngomjovo, ukubukeka kuhlanzekile futhi kusobala. |
| 2. Ishubhu elithambile lokufaka amanzi lenziwe nge-PVC, kunezinhlobo ezintathu ezitholakalayo--okubonakalayo okuvamile, okubonakalayo okuguquguqukayo kanye nobuso obuguquguqukayo obungacwebezeli. | |
| Ukupakisha | Iphakheji ngayinye ye-blister, iphakethe ngalinye lesikhwama se-PE kanye nephakheji enkulu |
| Isitifiketi | I-CE, ISO13485 |
| Isicelo | Izinaliti zokufaka ezifakwa ngemithambo yegazi ezilahlwayo zisetshenziselwa ukuxhuma amasirinji, amadivayisi okufaka, kanye nemithambo yegazi ukuze kufakwe ngemithambo yegazi kanye nokumpontshelwa igazi. |
| Izinzuzo | 1. Usayizi wezinaliti ohlukene uyatholakala ukumboza iminyaka ehlukene kusukela ezinganeni kuya kubantu abadala ukuze kufakwe. Amaphiko ezinaliti namabhabhathane aqiniswa ngeglue ye-UV ecacile, eqinile futhi ekhanyayo. |
| 2. Umklamo wesihloko senalithi muhle kakhulu, ubukhali, ubhobokile, ubuhlungu obuncane, umonakalo omncane wezicubu. | |
| 3. Ububanzi bangaphakathi bepayipi yenaliti bukhulu futhi izinga lokugeleza liphezulu. |
CE
I-ISO13485
I-USA FDA 510K
I-EN ISO 13485: 2016/AC: 2016 Uhlelo lokuphatha ikhwalithi yemishini yezokwelapha lwezidingo zomthetho
I-EN ISO 14971: Amadivayisi ezokwelapha ka-2012 - Ukusetshenziswa kokuphathwa kwezingozi kumadivayisi ezokwelapha
I-ISO 11135:2014 Idivayisi yezokwelapha Ukuhlanza i-ethylene oxide Ukuqinisekiswa nokulawulwa okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane Khomba ikhodi yombala
I-ISO 7864:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane
ISO 9626:2016 Amashubhu enaliti yensimbi engagqwali yokwenziwa kwamadivayisi ezokwelapha
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