Medical Device ịkụ akara — Ngwa nkenke maka nlekọta ahụike
imepụta ngwaọrụ ahụike chọrọ ọkwa kachasị elu nke izi ezi, ịdị ọcha na traceability. Anyị na-emepụta ihe stampụ maka ngwa ịwa ahụ, akụrụngwa nyocha, ụlọ akụrụngwa etinyere, yana sistemu nlekota ndị ọrịa - arụpụtara niile n'okpuru ụkpụrụ ụkpụrụ siri ike dabara na ISO 13485 na FDA chọrọ.
Site na oghere ịwa ahụ pere mpe ruo n'ogige ịwa ahụ dị mgbagwoju anya, ike stampụ anyị na-arụ ọrụ ngwa ngwa ngwaọrụ ahụike zuru oke. A na-emepụta akụkụ ọ bụla site na nchọta ihe zuru oke, akwụkwọ ọkwa ọkwa, yana njikwa usoro ọnụ ọgụgụ iji gboo mkpa siri ike nke ụlọ ọrụ ahụike.
Medical Components Anyị Stampụ
- Akụkụ akụrụngwa ịwa ahụ - oghere oghere scalpel, okpokolo agba retractor, agba mgide, ndụmọdụ mmanye, na ihe njide agịga na igwe anaghị agba nchara ahụike.
- Ụlọ akụ na ihe mkpuchi - pacemaker shields, cochlear implant case, na neurostimulator homes na titanium na ígwè ịwa ahụ
- Akụkụ ngwaọrụ nyocha - okpokolo agba katrij nke ọbara, kọntaktị mpempe ule, na ihe mmetụta electrode substrates
- Ngwa nlekota onye ọrịa kọntaktị na ECG snap.
- Ngwa nnyefe ọgwụ - isi iyi valvụ inhaler, ihe nchekwa agịga auto-injector, na brackets infusion
- Ngwa eze - brackets orthodontic, ụdị okpueze, na ntinye ihe n'ime oghere
Ikike nkenke maka ahụike ahụike
| Ike | nkọwapụta |
|---|---|
| ndidi | ± 0.0100mm (± 0.0130mm) |
| ọkpụrụkpụ ihe | 0.05mm ruo 3.0mm |
| elu elu | Ra 0.4μm (polish enyo dị) |
| nkwakọ ụlọ dị ọcha | Klas 100,000 ngwugwu dị ọcha dị |
| Traceability | Nza zuru oke na asambodo ihe |
| Ọrụ nke abụọ | Passivation, electropolishing, laser marking |
Ihe maka ịkụ akara Medical
- 316L igwe anaghị agba nchara - nhọrọ izizi maka ngwa ịwa ahụ na ngwa ntinye ọkwa, ezigbo nguzogide corrosion.
- 17-4 PH igwe anaghị agba nchara - Ngwá ọrụ ịwa ahụ dị elu na akụrụngwa akụrụngwa
- Titanium ọkwa 2 & ọkwa 5 - Ụlọ ihe nkwụnye bioc dakọtara, dị fechaa na corrosion-proof
- Nitinol (NiTi) ntụ ntụ na ebe nchekwa stents
- Ọla kọpa C110 - kọntaktị dị elu maka nlekota na nyocha electrodes
Ogo nkwa maka ahụike
Ngwa ngwaọrụ ahụike chọrọ protocol kacha sie ike. Usoro ịdị mma anyị gụnyere nkwenye ihe na-abata na asambodo igwe igwe, nleba anya SPC na-arụ ọrụ, nyocha 100% maka akụkụ dị oke egwu, nkwenye ikpeazụ CMM, yana akwụkwọ nchọta nza zuru oke. Anyị na-akwado nyocha ndị ahịa ma nye ngwugwu akwụkwọ ọkwa PPAP Ọkwa 3.
Ihe metụtara
- igwe anaghị agba nchara - ikike akụrụngwa anyị bụ isi maka ngwa ahụike
- Na-aga n'ihu Die ịkụ akara - mmepụta dị elu maka ihe oriri ahụike.
- Ntuziaka njikwa mma - usoro nyocha na akwụkwọ anyị
Chọrọ akụrụngwa akara akara ahụike?
Zitere anyị nkọwapụta gị. Ndị otu injinia anyị nwere ahụmịhe na ihe chọrọ ngwaọrụ ahụike ma ga-enye nkọwapụta nkọwapụta yana ndụmọdụ ihe yana atụmatụ akwụkwọ mma.
Ihe metụtara
- Ntuziaka ịkụ akara Device Medical - Nkwenye, ngwa na nnabata maka stampụ ngwaọrụ ahụike.