Nigute washyira mubikorwa ibikoresho byubuvuzi?

Gutondekanya neza ibicuruzwa byawe byubuvuzi nicyo kintu cyo kwinjira ku isoko, Kumenya ibikoresho byawe byubuvuzi nibyiciro ni ngombwa cyane kuko:
-Ibicuruzwa byashyizwe ahagaragara bizagena icyo ugomba gukora mbere yuko ugurisha ibicuruzwa byawe byemewe.
-Icyiciro kizagufasha gushiraho ibisabwa mugihe cyiterambere ryibicuruzwa, byumwihariko kugenzura.nuburyo winjira mumasoko yawe.
-Icyiciro nikintu cyingenzi muguhitamo amafaranga uzashora kugirango winjire mubikoresho byawe kumasoko byemewe kandi biguhe igitekerezo kitoroshye cyigihe bizatwara.
Kubera iyo mpamvu, ngiye kuguha ubuyobozi buke kugirango wumve neza icyo gukora nuburyo wabikora.
Ibikurikira ntabwo arubuyobozi bwuzuye kubitekerezo byatanzwe, ariko bigomba kuguha ubuyobozi bwibanze nubuyobozi muburyo bwo kubishyira mubikorwa.
Hano tuzashyiraho urutonde "amasoko 3 yingenzi" nkuko bikurikira:
1.USUBIKORWA BIKORWA & Ibiyobyabwenge, Ikigo cyibikoresho & Ubuzima bwa Radiologiya (FDA CDRH); Amerika FDA yashyize ibikoresho byubuvuzi mubyiciro bitatu - Icyiciro cya I, II, cyangwa III - hashingiwe ku ngaruka zabo hamwe n’ubugenzuzi bukenewe mu gutanga ibyiringiro bifatika byumutekano ningirakamaro.urugero urugero rwa tometrometero ya digitale na infragre ya termometero yashyizwe mubyiciro II.
2. Komisiyo y’Uburayi, nk’uko ikinyamakuru cyemewe cy’ubumwe bw’ibihugu by’Uburayi (EU) MDR 2017/745 Umugereka wa VIII, ushingiye ku gihe cyo gukoresha, gutera / Kudatera, ibikoresho bikora cyangwa bidakora, ibikoresho biri mu cyiciro cya I, icyiciro cya IIa, Icyiciro cya IIb n'icyiciro cya III.Kurugero urwego rwo hejuru rwamaraso yumuvuduko wamaraso hamwe nuburyo bwamaboko ni Icyiciro cya IIa.
3.Ubuyobozi bukuru bw’ibicuruzwa by’ubuvuzi by’Ubushinwa, hakurikijwe Amabwiriza agenga ubugenzuzi n’imicungire y’ibikoresho by’ubuvuzi (OYA 739 y’Inama y’igihugu), bishingiye ku byago by’ibikoresho by’ubuvuzi, bishyirwa mu byiciro 3, icyiciro cya I, icyiciro cya II na icyiciro III.kandi Ubushinwa NMPA yasohoye ububiko bwibikoresho byubuvuzi kandi buvugururwa buri gihe.Kurugero stethoscope nicyiciro cya I, therometero na monitor yumuvuduko wamaraso nicyiciro cya II.
Kuburyo burambuye bwo gutondekanya hamwe nibindi bihugu inzira yo gutondekanya, tugomba kumvira amabwiriza nubuyobozi bijyanye.