Kedu ka esi ekewa ngwaọrụ ahụike?

Nhazi nke ọma nke ngwaahịa ahụike gị bụ ntọala nke ịbanye n'ahịa, ịmara na ngwaọrụ ahụike gị bụ nhazi ọkwa dị ezigbo mkpa n'ihi na:
-Nhazi ngwaahịa ga-ekpebi ihe ị ga-eme tupu ị ree ngwaahịa gị n'ụzọ iwu kwadoro.
-Nhazi ga-enyere gị aka guzobe chọrọ n'oge ngwaahịa mmepe na-adọ, kpọmkwem chepụta controls.na otú ịbanye ahịa gị.
-The classification bụ ihe dị mkpa akụrụngwa na-ekpebi ole ị ga-etinye ego ịbanye ngwaọrụ gị ahịa n'ụzọ iwu kwadoro na-enye gị ike ike echiche nke ogologo oge ọ ga-ewe.
N'ihi nke a, m ga-enye gị ntakịrị ntụzịaka ka ị ghọta nke ọma ihe ị ga-eme na otu esi eme ya.
Ọdịnaya na-esote abụghị ntuziaka zuru oke maka ntinye iwu, mana ọ kwesịrị inye gị ụfọdụ ntụzịaka na ntụzịaka maka otu esi ekewa ya.
Ebe a anyị ga-edepụta "3 isi ahịa" dị ka n'okpuru:
1.US Food & Drug Administration, Center for Devices & Radiological Health (FDA CDRH); FDA US na-ekewa ngwaọrụ ahụike n'ime otu klas atọ - Klas I, II, ma ọ bụ III - dabere na ihe ize ndụ ha na njikwa nchịkwa dị mkpa iji nye. nkwenye ezi uche dị na ya maka nchekwa na ịdị irè. dịka ọmụmaatụ temometa dijitalụ na temometa infrared bụ nkewa na klas II.
2.European Commission, dị ka akwụkwọ akụkọ gọọmentị nke European Union Regulation (EU) MDR 2017/745 Annex VIII si kwuo, dabere na oge ojiji, invasive/Non-invasive, arụ ọrụ ma ọ bụ na-adịghị arụ ọrụ ngwaọrụ, ngwaọrụ na-na klas I, Klas IIa, Klas IIb na klaasị III.Dịka ọmụmaatụ ihe nleba anya ọbara mgbali elu ogwe aka dijitalụ na ụdị nkwojiaka bụ klaasị IIa.
3.China National Medical Products Administration,dị ka ụkpụrụ na nlekọta na nchịkwa nke ọgwụ ngwaọrụ (NO. 739 nke State Council), dabeere n'ihe ize ndụ nke ọgwụ ngwaọrụ, ha na-nkewa n'ime 3 etoju, klas I, klas II na class III.nakwa China NMPA ewepụtala akwụkwọ ndekọ aha nhazi ọkwa ngwaọrụ ahụike na emelitere site n'oge ruo n'oge.Dịka ọmụmaatụ, stethoscope bụ klas I, thermometer na nyocha ọbara mgbali bụ klas II.
Maka usoro nhazi ọkwa zuru ezu na ụzọ nhazi mba ndị ọzọ, anyị kwesịrị irubere ụkpụrụ na nduzi metụtara ya isi.