Dab tsi yog "Medical device"?

Cov cuab yeej siv kho mob suav nrog tshuaj, tshuab, khoom siv hluav taws xob, plastics thiab lwm yam lag luam, nws yog kev lag luam ntau yam, kev txawj ntse, kev lag luam-kev lag luam high-tech.muaj ntau txhiab yam khoom siv kho mob, los ntawm ib qho me me ntawm cov ntaub qhwv ntsej mus rau lub tshuab MRI loj, nws yooj yim heev kom pom tshwj xeeb tshaj yog thaum peb nyob hauv tsev kho mob lossis chaw kho mob.Yog li dab tsi yog cov cuab yeej kho mob?Raws li GHTF/SG1/N071:2012,5.1, Lub ntsiab lus ntawm cov cuab yeej kho mob yog raws li hauv qab no:
Cov cuab yeej, cov cuab yeej siv, siv, tshuab, khoom siv, cog cog, reagent rau hauv vitro siv, software, khoom siv los yog lwm yam zoo sib xws los yog cov tshooj lus, npaj los ntawm cov chaw tsim khoom siv, ib leeg lossis ua ke, rau tib neeg, rau ib lossis ntau dua. lub hom phiaj kho mob tshwj xeeb ntawm:
- Kev kuaj mob, tiv thaiv, saib xyuas, kho lossis txo tus kab mob;xws li tus pas ntsuas kub digital, ntsuas ntshav siab, aneroid sphygmomanometer, stethoscope, nebulizer, fetal doppler;
- Kev kuaj mob, saib xyuas, kev kho mob, txo qis lossis them nyiaj rau qhov raug mob;xws li Artificial ligament, Artificial meniscus, Gynecological infrared therapy instrument;
- Kev soj ntsuam, hloov, hloov kho, lossis kev txhawb nqa ntawm lub cev lossis cov txheej txheem physiological;xws li hniav hniav, Joint prosthesis;
- Txhawb nqa lossis txhawb nqa lub neej;xws li lub tshuab ua pa thaum muaj xwm ceev, Cardiac pacemaker;
- Tswj kev xav;xws li latex condom, Contraceptive gel;
- Disinfection ntawm cov cuab yeej kho mob;xws li ethylene oxide sterilizer, chav sterilizer;
- Muab cov ntaub ntawv los ntawm kev soj ntsuam hauv vitro ntawm cov qauv muab los ntawm tib neeg lub cev;xws li kev kuaj cev xeeb tub, COVID-19 nucleic acid reagent;
Thiab tsis ua tiav nws qhov kev npaj ua thawj zaug los ntawm kev siv tshuaj, tshuaj tiv thaiv kab mob lossis tshuaj tiv thaiv kab mob metabolic, hauv lossis hauv tib neeg lub cev, tab sis uas yuav pab tau rau hauv nws qhov kev npaj ua haujlwm los ntawm txoj kev.
Thov nco ntsoov cov khoom uas tej zaum yuav raug suav hais tias yog cov cuab yeej kho mob hauv qee lub tebchaws tab sis tsis nyob hauv lwm tus suav nrog: tshuaj tua kab mob;kev pab rau cov neeg tsis taus;cov cuab yeej siv cov tsiaj thiab/los yog tib neeg cov ntaub so ntswg;cov cuab yeej siv rau hauv vitro fertilization los yog pab txhawb kev tsim cov thev naus laus zis.


Post lub sij hawm: Feb-13-2023