Ishubhu Lokondla Eliyinyumba Lokusetshenziswa Kanye

● Ipulasitiki ye-polyvinyl chloride yezokwelapha

● Izinketho ezahlukene zobulukhuni, ukumelana nokugoba

● Izimbobo ezimbili ezibushelelezi neziyindilinga ekhanda, imiphetho yembobo ebushelelezi nengenamigoqo

● Umehluko wekhodi yombala ohlangene

Sithumelele i-imeyili

Imininingwane Yomkhiqizo

Ukusetshenziswa okuhlosiwe	Lo mkhiqizo ufanelekela amayunithi ezokwelapha ukufaka izakhamzimba ezigulini ezingakwazi ukudla okwesikhashana ngemva kokuhlinzwa.
Isakhiwo kanye nomanyolo	Umkhiqizo uqukethe i-catheter kanye nesixhumi, izinto zokwakha ziyi-polyvinyl chloride, umkhiqizo uhlanzwa nge-ethylene oxide, ukusetshenziswa kanye.
Izinto Eziyinhloko	I-Medical Polyvinyl Chloride PVC (engenayo i-DEHP), i-ABS
Isikhathi sokuphelelwa yisikhathi	Iminyaka emi-5
Isitifiketi kanye nokuqinisekiswa kwekhwalithi	Ngokuhambisana noMthethonqubo (i-EU) 2017/745 wePhalamende laseYurophu kanye noMkhandlu (Isigaba se-CE: IIa) Inqubo yokukhiqiza ihambisana ne-ISO 13485 Quality System.

Uhlobo 1 - Impumulo ukondla ipayipi

I-PVC No-DEHP, Isixhumi sesivalo esihlanganisiwe, ukuphakelwa kwamakhala

1—Ipayipi 2— Isixhumi sesivalo esihlanganisiwe

I-Tube OD/Fr	Ubude beshubhu/mm	Umbala Wokuxhuma	Isibalo seziguli esiphakanyisiwe
5	450mm - 600mm	Okumpunga	Ingane eneminyaka engu-1-6 ubudala
6	450mm - 600mm	Okuluhlaza okotshani	Ingane eneminyaka engu-1-6 ubudala
8	450mm - 1400mm	Okuluhlaza okwesibhakabhaka	Ingane ＞ Iminyaka eyi-6, Omdala, Okhulile
10	450mm - 1400mm	Okumnyama	Ingane ＞ Iminyaka eyi-6, Omdala, Okhulile

Uhlobo2 - Isisu ipayipi

I-PVC No-DEHP, Isixhumi se-Funnel, Ukudla ngomlomo

Isixhumi se-2-funnel esinepayipi elilodwa

I-Tube OD/Fr	Ubude beshubhu/mm	Umbala Wokuxhuma	Isibalo seziguli esiphakanyisiwe
6	450mm - 600mm	Okuluhlaza okotshani	Ingane eneminyaka engu-1-6 ubudala
8	450mm - 1400mm	Okuluhlaza okwesibhakabhaka	Ingane＞Iminyaka eyi-6
10	450mm - 1400mm	Okumnyama	Ingane＞Iminyaka eyi-6
12	450mm - 1400mm	Okumhlophe	Umuntu Omdala, Ogugile
14	450mm - 1400mm	Okuluhlaza okotshani
16	450mm - 1400mm	iwolintshi
18	450mm - 1400mm	Okubomvu
20	450mm - 1400mm	Ophuzi
22	450mm - 1400mm	Ophuzi
24	450mm - 1400mm	Okuluhlaza okwesibhakabhaka
25	450mm - 1400mm	Okumnyama
26	450mm - 1400mm	Okumhlophe
28	450mm - 1400mm	Okuluhlaza okotshani
30	450mm - 1400mm	Okumpunga
32	450mm - 1400mm	Insundu
34	450mm - 1400mm	Okubomvu
36	450mm - 1400mm	iwolintshi

Uhlobo3 - ULevin ipayipi

I-PVC No-DEHP, Isixhumi se-Funnel, Ukudla ngomlomo

Isixhumi se-2-funnel esinepayipi elilodwa

I-Tube OD/Fr	Ubude beshubhu/mm	Umbala Wokuxhuma	Isibalo seziguli esiphakanyisiwe
8	450mm - 1400mm	Okuluhlaza okwesibhakabhaka	Ingane＞Iminyaka eyi-6
10	450mm - 1400mm	Okumnyama	Ingane＞Iminyaka eyi-6
12	450mm - 1400mm	Okumhlophe	Umuntu Omdala, Ogugile
14	450mm - 1400mm	Okuluhlaza okotshani
16	450mm - 1400mm	iwolintshi
18	450mm - 1400mm	Okubomvu
20	450mm - 1400mm	Ophuzi

Uhlobo4 - I-ENfit Qondile isixhumi ukondla ipayipi

I-PVC No-DEHP, isixhumi se-ENfit Straight, Ukudla ngomlomo/empumlweni

1—Vikela isivalo 2—Indandatho yokuxhuma 3— Imbobo yokufinyelela 4—Ipayipi

I-Tube OD/Fr	Ubude beshubhu/mm	Umbala Wokuxhuma	Isibalo seziguli esiphakanyisiwe
5	450mm - 600mm	Ophuzi	Ingane eneminyaka engu-1-6 ubudala
6	450mm - 600mm	Ophuzi	Ingane eneminyaka engu-1-6 ubudala
8	450mm - 1400mm	Ophuzi	Ingane＞Iminyaka eyi-6
10	450mm - 1400mm	Ophuzi	Ingane＞Iminyaka eyi-6
12	450mm - 1400mm	Ophuzi	Umuntu Omdala, Ogugile
14	450mm - 1400mm	Ophuzi
16	450mm - 1400mm	Ophuzi

Uhlobo5 - I-ENfit 3-indlela isixhumi ukondla ipayipi

I-PVC No-DEHP, isixhumi se-ENfit esinezindlela ezintathu, Ukuphakelwa ngomlomo/empumlweni

Isixhumi esinezindlela ezintathu 2— Imbobo yokufinyelela 3—Indandatho yesixhumi 4—Isivalo sokuvikela 5—Ipayipi

I-Tube OD/Fr	Ubude beshubhu/mm	Umbala Wokuxhuma	Isibalo seziguli esiphakanyisiwe
5	450mm - 600mm	Ophuzi	Ingane eneminyaka engu-1-6 ubudala
6	450mm - 600mm	Ophuzi	Ingane eneminyaka engu-1-6 ubudala
8	450mm - 1400mm	Ophuzi	Ingane＞Iminyaka eyi-6
10	450mm - 1400mm	Ophuzi	Ingane＞Iminyaka eyi-6
12	450mm - 1400mm	Ophuzi	Umuntu Omdala, Ogugile
14	450mm - 1400mm	Ophuzi
16	450mm - 1400mm	Ophuzi