EC FDA nwere ike ịwụpụ sirinji Insulin nchekwa na agịga
Video ngwaahịa
Nkọwa
1.The ngwaahịa na-mere nke ọgwụ polymer ihe.
2.The agịga na-obere na nozzle, ukwuu nkọ agịga n'ọnụ, doro anya na nke ziri ezi calibration, na ike n'ụzọ ziri ezi na-ekpebi onunu ogwu.
3.Mounted agịga, Ọ dịghị Nwụrụ Anwụ Space, Ọ dịghị ihe efu
4.Sufficiently transparent gbọmgbọm na-enye ohere mfe nha nke olu dị na sirinji na nchọpụta nke ikuku afụ.
5. Ọnụ ọgụgụ nke gụsịrị akwụkwọ na gbọmgbọm dị mfe ịgụ.A na-eji ink na-adịghị ehichapụ ebipụta akwụkwọ ngụsị akwụkwọ.
6.The plunger dabara n'ime gbọmgbọm nke ọma na-ekwe ka free na-eji ire ụtọ ije.
Njirimara
Insulin sirinji enwere ike iwepu nha dị iche iche
EGWU
Nkọwapụta: 0.3ml, 0.5ml na 1ml (U-100 ma ọ bụ U-40)
Ihe: Emere nke ahụike ọkwa pp
Akwụkwọ: CE, ISO13485 akwụkwọ
Ngwugwu: ngwugwu ọnya
agịga: agịga edobere
Ọkwa: Nnukwu akara nkeji doro anya
Sterile: Site na gas EO
Size: 0.3ml, 0.5ml na 1ml.
agịga: 29G, 30G na 31G.
Nkọwapụta
| Ihe onwunwe | Cap&Barrel & Plunger: ọkwa ahụike PP |
| agịga: igwe anaghị agba nchara | |
| Piston: Latex ma ọ bụ Latex efu | |
| Olu | 0.3ml, 0.5ml, 1ml |
| Ngwa | Ọgwụ |
| Njirimara | Enwere ike iwepu ya |
| Asambodo | CE, ISO |
| agịga | na agịga edozi ma ọ bụ agịga kewapụrụ iche |
| Nozulu | Centric nozzel |
| Agba agba | transperent , ọcha , agba |
| gbọmgbọm | High transperent |
| ngwugwu | Ngwungwu onye ọ bụla: mbukota blister/PE |
| Ngwungwu nke abụọ: Igbe | |
| ngwugwu dị n'èzí: Katọn | |
| Ihe efu | sterile site na EO gas, na-adịghị egbu egbu, na-abụghị pyrogen |
CE
ISO 13485
USA FDA 510K
TS EN ISO 13485: 2016 / AC: 2016 Sistemụ njikwa ogo akụrụngwa ọgwụ maka iwu chọrọ
TS EN ISO 14971 Ngwa ahụike - Ngwa njikwa ihe egwu na ngwaọrụ ahụike
TS EN ISO 11135: 2014 Ngwa ahụike ọgwụ mgbochi nke ethylene oxide nkwenye na njikwa izugbe
ISO 6009: 2016 agịga injection na-adịghị mma nke a na-atụfu ya Chọpụta koodu agba
TS EN ISO 7864: 2016 agịga injection na-enweghị atụ
TS EN ISO 9626: 2016 ọkpọkọ agịga igwe anaghị agba nchara maka imepụta ngwaọrụ ahụike
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