Smda yog dab tsi?

2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17

Txoj Cai Safe Medical Devices Act of 1990 ( SMDA ) yog tsoomfwv txoj cai lij choj uas xav kom cov tuam txhab tsim khoom thiab cov neeg siv khoom siv thiab tshaj tawm cov xwm txheej tsis zoo cuam tshuam nrog cov cuab yeej kho mob rau FDA.

Tsis tas li ntawd, Smda txhais li cas?

Txoj Cai Kho Mob Muaj Kev Nyab Xeeb Zoo Xyoo 1990

dab tsi xav tau nyob hauv Txoj Cai Kev Nyab Xeeb Kev Nyab Xeeb Khoom Noj Xyoo 1990? Safe Medical Devices Act of 1990 - Kho Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj, thiab Tshuaj pleev ib ce Ua (FDCA) rau xav tau kev kho mob cov neeg siv khoom siv los qhia rau Tus Tuav Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg, cov chaw tsim khoom, lossis ob qho tib si thaum twg lawv ntseeg tias muaj qhov tshwm sim uas kho mob ntaus ntawv tau ua lossis ua rau tuag, Ntxiv mus, Smda cov cuab yeej yog dab tsi?

Cov cuab yeej kho mob yuav tsum tau taug qab

• Defibrillator, pab fais fab mov (AC LOSSIS DC) rau lub zog qis DC defibrillator.
• Defibrillator, tsis siv neeg, sab nrauv, hnav tau.
• Defibrillators, automated external (AEDs) (non-wearable)
• Saib xyuas, apnea, siv hauv tsev.
• Saib xyuas, ua pa ntau zaus.
• Pump, infusion, implanted, programmable.

Cov cuab yeej kho mob dab tsi yog txhais los ntawm Txoj Cai Safe Medical Device Act?

A khoom siv kho mob yog txhais los ntawm Txoj Cai Kev Nyab Xeeb Kev Nyab Xeeb xyoo 1990 kom suav nrog cov cuab yeej, cuab yeej, lossis lwm yam khoom siv los tiv thaiv, kuaj xyuas, txo lossis kho tus kab mob kom cuam tshuam rau cov qauv lossis kev ua haujlwm ntawm lub cev nrog rau kev zam ntawm cov tshuaj.