Ishubhu Yokudla Oyinyumba Yokusetshenziswa Okukodwa
Izici Zomkhiqizo
Ukusetshenziswa okuhlosiwe | Lo mkhiqizo ulungele amayunithi ezokwelapha ukujova imisoco ezigulini ezingakwazi ukudla okwesikhashana ngemva kokuhlinzwa. |
Isakhiwo kanye nokuhlanganiswa | Umkhiqizo uqukethe i-catheter nesixhumi, impahla i-polyvinyl chloride, umkhiqizo ukhishwa inzalo nge-ethylene oxide, ukusetshenziswa okukodwa. |
Indaba Eyinhloko | Medical Polyvinyl Chloride PVC(DEHP-Free),ABS |
Impilo yeshelufu | 5 iminyaka |
Isitifiketi Nokuqinisekisa Ikhwalithi | Ngokuhambisana ne-REGULATION (EU) 2017/745 YEPARLIAMENT YASE-EUROPE KANYE NOMKHANDLU(CE Ikilasi: IIa) Inqubo yokukhiqiza ihambisana ne-ISO 13485 Quality System. |
Amapharamitha womkhiqizo
Uhlobo 1 - Ikhala ukudla ithubhu
I-PVC No-DEHP, Isixhumi sekhephu esihlanganisiwe, ukondla ngamakhala
1—Ishubhu 2— Isixhumi sekhephu esihlanganisiwe
Ishubhu OD/Fr | Ubude beshubhu/mm | Umbala Wesixhumi | Isibalo sesiguli esiphakanyisiwe |
5 | 450mm - 600mm | Okumpunga | Ingane 1-6 iminyaka |
6 | 450mm - 600mm | Okuhlaza | |
8 | 450mm - 1400mm | Okuluhlaza okwesibhakabhaka | Ingane - iminyaka engu-6, Omdala, Geriatric |
10 | 450mm - 1400mm | Mnyama |
Uhlobo2 - Isisu ithubhu
I-PVC No-DEHP, Isixhumi sefaneli, Ukondla ngomlomo
I-1-tubing 2-ifaneli yesixhumi
Ishubhu OD/Fr | Ubude beshubhu/mm | Umbala Wesixhumi | Isibalo sesiguli esiphakanyisiwe |
6 | 450mm - 600mm | Okuhlaza | Ingane 1-6 iminyaka |
8 | 450mm - 1400mm | Okuluhlaza okwesibhakabhaka | Ingane>6 iminyaka |
10 | 450mm - 1400mm | Mnyama | |
12 | 450mm - 1400mm | Emhlophe |
Umuntu omdala, Geriatric |
14 | 450mm - 1400mm | Okuhlaza | |
16 | 450mm - 1400mm | iwolintshi | |
18 | 450mm - 1400mm | Okubomvu | |
20 | 450mm - 1400mm | Okuphuzi | |
22 | 450mm - 1400mm | Okunsomi | |
24 | 450mm - 1400mm | Okuluhlaza okwesibhakabhaka | |
25 | 450mm - 1400mm | Mnyama | |
26 | 450mm - 1400mm | Emhlophe | |
28 | 450mm - 1400mm | Okuhlaza | |
30 | 450mm - 1400mm | Okumpunga | |
32 | 450mm - 1400mm | Brown | |
34 | 450mm - 1400mm | Okubomvu | |
36 | 450mm - 1400mm | iwolintshi |
Uhlobo3 - Levin ithubhu
I-PVC No-DEHP, Isixhumi sefaneli,Ukondla ngomlomo
I-1-tubing 2-ifaneli yesixhumi
Ishubhu OD/Fr | Ubude beshubhu/mm | Umbala Wesixhumi | Isibalo sesiguli esiphakanyisiwe |
8 | 450mm - 1400mm | Okuluhlaza okwesibhakabhaka | Ingane>6 iminyaka |
10 | 450mm - 1400mm | Mnyama | |
12 | 450mm - 1400mm | Emhlophe | Umuntu omdala, Geriatric |
14 | 450mm - 1400mm | Okuhlaza | |
16 | 450mm - 1400mm | iwolintshi | |
18 | 450mm - 1400mm | Okubomvu | |
20 | 450mm - 1400mm | Okuphuzi |
Uhlobo4 - ENfit Qondile isixhumi ukudla ithubhu
I-PVC No-DEHP, isixhumi se-ENfit Esiqondile,Ukuphakela ngomlomo/kwamakhala
1—Vikela ikepisi 2—Indandatho yesixhumi 3— Imbobo yokufinyelela 4—Ishubhu
Ishubhu OD/Fr | Ubude beshubhu/mm | Umbala Wesixhumi | Isibalo sesiguli esiphakanyisiwe |
5 | 450mm - 600mm | Okunsomi | Ingane 1-6 iminyaka |
6 | 450mm - 600mm | Okunsomi | |
8 | 450mm - 1400mm | Okunsomi | Ingane>6 iminyaka |
10 | 450mm - 1400mm | Okunsomi | |
12 | 450mm - 1400mm | Okunsomi | Umuntu omdala, Geriatric |
14 | 450mm - 1400mm | Okunsomi | |
16 | 450mm - 1400mm | Okunsomi |
Uhlobo5 - ENfit 3-indlela isixhumi ukudla ithubhu
I-PVC No-DEHP, isixhumi se-ENfit 3-way,Ukuphakelwa ngomlomo/kwamakhala
1—Isixhumi esinendlela engu-3 2— Imbobo yokungena 3—Indandatho yesixhumi 4—Vikela ikepisi 5—Amashubhu
Ishubhu OD/Fr | Ubude beshubhu/mm | Umbala Wesixhumi | Isibalo sesiguli esiphakanyisiwe |
5 | 450mm - 600mm | Okunsomi | Ingane 1-6 iminyaka |
6 | 450mm - 600mm | Okunsomi | |
8 | 450mm - 1400mm | Okunsomi | Ingane>6 iminyaka |
10 | 450mm - 1400mm | Okunsomi | |
12 | 450mm - 1400mm | Okunsomi | Umuntu omdala, Geriatric |
14 | 450mm - 1400mm | Okunsomi | |
16 | 450mm - 1400mm | Okunsomi |