Taw qhia rau lub
Kev Tswj Xyuas Khoom Noj thiab Tshuaj yog ib ceg ntawm US Department of Health, Education thiab Welfare.Yuav kom muaj tseeb, FDA yog qhov sib npaug ntawm Ministry of Health (lub luag haujlwm rau kev pom zoo ntawm cov zaub mov noj qab haus huv) thiab kev tswj hwm tshuaj hauv tebchaws (lub luag haujlwm rau kev pom zoo ntawm cov tshuaj).Nws yog lub luag hauj lwm rau lub teb chaws tshuaj, khoom noj khoom haus, tshuaj lom neeg cov khoom, tshuaj pleev ib ce, veterinary tshuaj, Yliao khoom thiab kuaj cov khoom thiab lwm yam kev tswj thiab ua hauj lwm los tiv thaiv, txhawb thiab txhim kho lub teb chaws kev noj qab haus huv, xyuas kom meej tias cov American lag luam muag khoom. zaub mov, tshuaj, tshuaj pleev ib ce thiab Yliao cov cuab yeej rau kev nyab xeeb thiab kev ua tau zoo ntawm tib neeg lub cev.FDA cov cai tswj hwm tshuaj, lub koom haum, chaw saib xyuas tshuaj kho tsiaj, chaw saib xyuas kev noj qab haus huv, chaw ua haujlwm ntawm cov khoom siv roj ntsha, Yliao cov cuab yeej thiab cov khoom siv tshuaj ntsuam xyuas thiab cov chaw tshawb fawb hauv tebchaws toxicology, cov chaw tswj xyuas haujlwm hauv cheeb tsam, uas yog rau lub sijhawm ua haujlwm (qee cov ntawv tshaj tawm kuj hais tias rau lub chaw), a center thiab lub regional tswj tsev.
Qhov Scope ntawm FDA
Cov khoom siv kho mob
- X - ray diagnostic Yliao cov khoom (kev siv dav dav, fluorescent X - ray, CT, thiab lwm yam.) Kev phais thiab lwm yam khoom siv laser thiab cov khoom siv nrog lub tshuab laser - cov khoom siv laser rau lub hom phiaj tshwj xeeb (xws li zaub, kev soj ntsuam thiab kev siv kho mob)- uv Cov khoom siv kho mob (uv teeb thiab cov khoom lag luam rau Yliao) Lwm cov khoom siv kho mob ultrasound rau kev kho mob tsis yog lub cev thiab kev kuaj mob - microwave diathermy therapy thiab microwave ntshav rhaub - ultrasonic lub cev kho cov cuab yeej
ETL daim ntawv pov thawj ntsig txog cov ntsiab lus
ETL daim ntawv pov thawj yuav tsum tau xa tawm mus rau Tebchaws Meskas thiab Canada.Lub cim ETL qhia tias cov khoom tau dhau qhov kev pom zoo ntawm NRTL hauv Tebchaws Meskas thiab SCC hauv Canada.Intertek yog ib qho ntawm ob peb daim ntawv pov thawj uas tau lees paub los ntawm OSHA thiab SCC. Shenzhen anbo muaj kev sib raug zoo nrog Intertek, uas tuaj yeem pab koj cov khoom tau txais ntawv pov thawj ETL thiab muab cov kev pabcuam zoo.ETL cim kev lees paub yog sib npaug rau UL lossis CSA cim thiab ua tau raws li cov qauv kev nyab xeeb.Muaj ETL kab npe chij rau ib yam khoom txhais tau tias nws tau ua tau raws li qhov yuav tsum tau ua yam tsawg kawg nkaus ntawm cov qauv kev nyab xeeb khoom.Ntxiv, lub logo ETL kuj qhia tau hais tias cov chaw tsim khoom lag luam ua tau raws li qee qhov ntawm cov qauv yuav tsum tau ua, thiab kev tshawb fawb kev soj ntsuam xyuas lub Hoobkas tsis tu ncua los xyuas kom meej qhov sib xws.ETL tau nyob ib puag ncig rau ntau tshaj 100 xyoo.Cov peb tsab ntawv ETL yog luv luv rau Kev Ntsuas Hluav Taws Xob tau tsim los ntawm tus neeg tsim khoom Mr. Edison hauv xyoo 1896.ETL sawv cev rau lub tswv yim tshiab, muaj txiaj ntsig, muaj kev ywj pheej.nt thiab qhib cov khoom kuaj thiab kev nplua nuj kev paub.ETLus ntawv pov thawj (tsuas yog peb, tsis muaj c): cETL ntawv pov thawj (tsuas yog c, tsis yog peb): cETLus ntawv pov thawj (tsuas yog c, tsis yog peb): cETLus ntawv pov thawj (tsuas yog c, tsis muaj peb): cETLus daim ntawv pov thawj (tsuas yog c, tsis muaj peb): cETLus ntawv pov thawj (tsuas yog c, tsis muaj peb) Yog tias koj muaj ob qho tib si, koj tau txais 4 zaug hauv ib xyoos.
Cov khoom siv hluav taws xob nrog cov hluav taws xob ionizing
-- TV thiab video qhia hauv CRT zaub hom
Cov khoom siv hluav taws xob uas tsis yog-ionizing hluav taws xob
Microwave qhov cub, hnub ci teeb thiab hnub ci khoom lag luam (lub hnub) liab qab-cellular xov tooj ntawm tes-laser cov khoom suav nrog laser pointer, laser, laser zaub nrog cov khoom siv laser (CD player, DVD, cd-rom, laser printers, thiab lwm yam), Kev nyab xeeb thiab cov khoom cawm siav - lub plhaub tiv thaiv ntawm cov khoom siv xoo hluav taws xob (xws li cov khoom siv hluav taws xob xoo hluav taws xob, X-ray imaging system, X-ray ruaj ntseg tshuaj xyuas qhov system, X-ray lub nra kuaj xyuas qhov system)
Cov khoom lag luam thiab kev tshawb fawb
Cov cuab yeej laser thiab cov cuab yeej laser non-yliao kuaj cov khoom siv xoo hluav taws xob-radiofrequency thiab cov khoom siv microwave (non-microwave ncu) non-diagnostic and therapeutic ultrasound productsfda muaj ob hom kev cai rau zaub mov, tshuaj, thiab khoom siv: kev pom zoo thiab kev ceeb toom
Kev tswj cov khoom lag luam kho mob
Qib I cov khoom zoo li no yuav muaj kev phom sij me ntsis rau tus neeg siv, tus qauv tsim feem ntau yooj yim dua li qib II thiab qib III, xws li 47% enemas Yliao cov khoom muaj nyob rau qib no, 95% ntawm lawv tsis xav tau kev tswj hwm chav kawm II Feem ntau Yliao cov khoom muaj nyob rau hauv chav kawm II, nyob rau hauv chav kawm II cov khoom suav txog 43%, xws li hluav taws xob lub rooj zaum lub rooj zaum cev xeeb tub cov khoom siv qib III cov khoom siv no feem ntau yog siv los tswj lossis nws lub neej, hauv kev siv tuaj yeem ua rau muaj kev phom sij lossis kev puas tsuaj rau tib neeg. , xws li: ntxig lub plawv pacing lub mis cog, thiab lwm yam., nrog 10% ntawm Yliao cov khoom muaj nyob rau qib III rau chav kawm I, 95% ntawm cov uas tau raug zam Yliao cov cuab yeej tswj hwm, tsis tas yuav ua cov lus tshaj tawm ua ntej cov khoom lag luam hauv khw. (daim ntawv ceeb toom) lossis daim ntawv tso cai (kev tshem tawm) tab sis rau cov tuam txhab tsim khoom hauv FDA lub koom haum sau npe, teev cov khoom tseem ceeb ntawm cov kev tswj hwm zoo li no xws li khoom siv stethoscope, mercury thermometer, zaum siv, thiab lwm yam.
Taw qhia rau FDA daim ntawv pov thawj ntawm hluav taws xob tso tawm (non-nuclear) cov khoom siv hluav taws xob
Feem ntau ntawm nws cov kev tswj hwm los ntawm FDA hauv Tebchaws Meskas FOOD THIAB DRUG cov neeg tsim khoom paub cov khoom siv tshuaj pleev ib ce Yliao ntawm cov neeg muaj peev xwm, tab sis qee zaum ntau tus neeg tsis quav ntsej txog kev tso tawm hluav taws xob hluav taws xob (kua hluav taws xob emitting cov khoom) yog ib qho ntawm cov khoom lag luam specification FDA tus qauv f tso tawm. ntawm hluav taws xob qhov chaw ntawm cov khoom siv hluav taws xob rau lub thib tsib canto ntawm FEDERAL FOOD DRUG THIAB COSMETIC ACT (542-531 FEDERAL FOOD, DRUG, AND COSMETIC ACT, hu ua FD&
C) kev tso tawm cov hluav taws xob hluav taws xob ntawm cov khoom siv hluav taws xob, suav nrog TV kav hlau txais xov nrog lub vijtsam siv X-ray kuaj cov khoom siv hluav taws xob thiab cov khoom siv microwave lossis laser (xws li cd-rom thiab laser designator (laser pointer)) thiab feem ntau ntawm cov khoom siv hluav taws xob yuav tsis raug txheeb xyuas tias yog Yliao tso cov khoom siv hluav taws xob, tab sis yog tias cov chaw tsim khoom lossis cov neeg muag khoom thov Yliao ua haujlwm nrog cov khoom, cov khoom thiab yuav tsum ua raws li FDA hais txog Yliao cov cuab yeej specification ntawm Congressional txoj cai specification tso tawm hluav taws xob cov khoom siv hluav taws xob los ntawm kev siv xws li cov khoom, qhov laj thawj tseem ceeb yog los tiv thaiv cov neeg siv khoom cuam tshuam rau kev noj qab haus huv
Cov khoom lag luam laser, piv txwv li, Tuam Tshoj cov khoom xa tawm tseem ceeb tsav tsheb yuav tsum ua raws li cov lus qhia ntawm FDA thiab lwm yam khoom uas muaj cov khoom siv kho qhov muag kuj yog nyob rau hauv cov lus qhia, xws li lub khoos phis tawj phau ntawv hauv cov ntsiab lus ntawm cd-rom, FDA raws li cov khoom siv laser. qhov loj ntawm hluav taws xob tau muab faib ua plaub pawg, cov neeg siv khoom siv dav dav siv laser kho qhov muag tsav muaj ntau yam muaj feem tsawg ntawm thawj chav kawm (chav kawm 1) ua ntej thawj tus tsav pin mei, cov neeg ua haujlwm yuav tsum ua raws li FDA cov cai hauv qab no: 1 tus kheej daim ntawv tshaj tawm;
2. Cov khoom sau npe;
3 cov qauv xeem;
4. Cov Khoom Qhia;
Daim Ntawv Qhia Txhua Xyoo;
Daim ntawv tshaj tawm txhua xyoo yuav tsum xa mus rau FDA thaum lub Cuaj Hlis 1 txhua xyoo.Yog tias daim ntawv tshaj tawm tsis tau hloov kho tsis tu ncua, cov khoom yuav raug ntes los ntawm kev lis kev cai thaum lub sijhawm kev lis kev cai.
7 cov ntaub ntawv ntsig txog;
Cov kev cai ntawm cov cim ceeb toom
FDA tau ntawv pov thawj txheej txheem
1. Luam daim ntawv tso cai neeg ua haujlwm raug cai nyob rau theem kev npaj; Daim ntawv luam ntawm kev tsim khoom (kev huv huv) daim ntawv tso cai thiab daim ntawv pov thawj ntawm kev tsim nyog; 2.Txais thiab xa cov ntaub ntawv txhais lus Askiv ntawm DMF (cov ntaub ntawv tseem ceeb ntawm cov tshuaj) thiab SOP (tus txheej txheem kev ua haujlwm) rau tus neeg sawv cev; 3.Kev tshuaj xyuas cov ntaub ntawv DMF;FDA yuav tsum ua tib zoo tshuaj xyuas thiab tshuaj xyuas lub Hoobkas ntawm qhov chaw los xyuas seb cov ntawv sau DMF puas muaj tseeb; Yog tias FDA tsis pom cov khoom siv yuam kev thiab txiav txim siab tias nws ua tau raws li qhov yuav tsum tau ua, nws yuav tsum tshaj tawm cov phiaj xwm tshuaj xyuas ua ntej.4. FDA tshuaj xyuas.Yog tias muaj kev tsis ntseeg, tus neeg ua haujlwm yuav muab daim ntawv 483 (kev pom zoo rau kev kho).Yog tias qhov teeb meem loj heev, tus thawj coj yuav tsis muab daim ntawv 483 (5). Cov lus nug tsis meej rau tus kws lij choj yuav tsum tau piav qhia thiab ua pov thawj.
