Intshayelelo kwi
Ulawulo lokutya kunye neDrugs licandelo lesebe lezempilo, imfundo kunye nentlalontle yase-US. Ukuchaneka, i-FDA ilingana nenkonzo yezempilo (inoxanduva lokuvunywa kokutya kwezempilo) kunye nolawulo lweziyobisi lwesizwe (oluxanduva lwezempilo). ukuvunywa kweziyobisi) inoxanduva lweyeza lesizwe, ukutya, iimveliso zebhayoloji, izithambiso, amayeza ezilwanyana, izixhobo zeYliao kunye neemveliso zokuxilonga kunye nolunye ulawulo kunye nokusebenza ukukhusela, ukukhuthaza nokuphucula impilo yesizwe, ukuqinisekisa ukuba intengiso yentengiso yaseMelika ukutya, amayeza, izithambiso kunye nezixhobo zeYliao zokhuseleko kunye nokusebenza kakuhle komzimba womntu.Igunya lamachiza e-FDA, i-arhente, i-ofisi yonyango lwezilwanyana, i-ofisi yezempilo, i-bureau yeemveliso zebhayoloji, izixhobo ze-Yliao kunye ne-diagnostic supply bureau kunye namaziko ophando lwe-toxicology kazwelonke, amaziko olawulo lomsebenzi wengingqi, oko kukuthi ama-innings amathandathu (ezinye iimpapasho nazo zithi iziko ezintandathu), a iziko kunye namaziko olawulo lwengingqi.
Umda we-FDA
Iimveliso zonyango
- X-ray diagnostic Yliao imveliso (ukusetyenziswa ngokubanzi, fluorescent X - ray, CT, njl) Utyando kunye nezinye izixhobo laser kunye nezixhobo ngeyunithi laser-- iimveliso laser ngeenjongo ezikhethekileyo (kubandakanywa ukubonisa, ukujonga kunye nokusetyenziswa kwezonyango)- uv izixhobo zonyango (isibane se-uv kunye neemveliso zeYliao)Ezinye izixhobo zonyango ze-ultrasound zonyango olungelulo olomzimba kunye noxilongo-- microwave diathermy therapy kunye ne-microwave blood heater-- izixhobo zonyango lomzimba lwe-ultrasonic
Umxholo onxulumene nesatifikethi se-ETL
Isatifikethi se-ETL siyadingeka ukuze kuthunyelwe ngaphandle e-United States naseCanada.Uphawu lwe-ETL lubonisa ukuba imveliso iphumelele uvavanyo lokuvunywa kwe-NRTL e-United States kunye ne-SCC e-Canada.Intertek yenye yezigqeba ezimbalwa zokuqinisekisa eziqatshelwe yi-OSHA kunye ne-SCC. I-Shenzhen anbo inobudlelwane obusondeleyo ne-Intertek, enokunceda imveliso yakho ifumane isatifikethi se-ETL kwaye ibonelele ngeenkonzo ezibanzi.Uphawu lwe-ETL lulingana nophawu lwe-UL okanye lwe-CSA kwaye luyahlangabezana nemigangatho yokhuseleko efanelekileyo.Ukuba neflegi yekholamu ye-ETL yemveliso kuthetha ukuba ifikelele kwiimfuno ezincinci zemigangatho yokhuseleko lwemveliso.Ukongezelela, i-logo ye-ETL ikwabonisa ukuba indawo yokuvelisa umenzi ihlangabezana noluhlu oluthile lweemfuno ezisemgangathweni, kwaye iphonononga uphicotho oluthe gqolo lwefektri yokulandelela ukuqinisekisa ukuba consistency.ETL ibikho ngaphezu kwe-100. iminyaka.Iileta ezintathu ze-ETL zimfutshane kwiiLebhu zoVavanyo loMbane eyasekwa ngumqambi uMnu Edison ngo-1896.ETL imele izinto ezintsha, ezinempembelelo, ezizimeleyo.nt kwaye uvule uvavanyo lwemveliso kunye namava atyebileyo.Isiqinisekiso se-ETLus (thina kuphela, akukho c): isatifikethi se-cETL (kuphela c, akukho kuthi): isatifikethi se-cETlus (kuphela c, akukho kuthi): isatifikethi se-cETlus (kuphela c, akukho kuthi): cETlus isiqinisekiso (kuphela c, akukho kuthi) : isiqinisekiso se-cETlus (kuphela c, hayi thina)Ukuba unazo zombini, ufumana amaxesha ama-4 ngonyaka.
Iimveliso ze-elektroniki ezinemitha ye-ionizing
-- Umboniso weTV kunye nevidiyo kwimowudi yokubonisa yeCRT
Iimveliso zombane ezinemitha ye-non-ionizing
I-oveni yeMicrowave, isibane selanga kunye neemveliso zesibane selanga (ilanga) imveliso ye-laser yeselula engenanto-kuquka isikhombisi selaser, i-laser, isiboniso selaser kunye neemveliso zeyunithi yelaser (i-CD player, iDVD, cd-rom, iiprinta zelaser, njl.njl.), Ukhuseleko kunye neemveliso zokuhlangula-igobolondo elikhuselayo lezixhobo ze-X-reyi (ezifana neenkqubo zokuhlola i-X-ray, inkqubo yokucinga nge-X-ray, inkqubo yokuhlola ukhuseleko lwe-X-ray, inkqubo yokuhlola imithwalo ye-X-ray)
Iimveliso zemizi-mveliso kunye nophando
Izixhobo zeLaser kunye nezixhobo zelasernon-yliao diagnostic X-ray izixhobo-radiofrequency kunye neemveliso zemicrowave (non-microwave ovens) non-diagnostic and therapeutic ultrasound productsfda uneentlobo ezimbini zemimiselo yokutya, iziyobisi, kunye nezixhobo: imvume kunye nesaziso.
Ukuhlelwa kolawulo lwemveliso yezonyango
IBanga I olu hlobo lwemveliso luya kuba nengozi encinci kumsebenzisi, uyilo luhlala lulula kuneklasi ye-II kunye ne-III, efana ne-47% enemas yeemveliso zeYliao zeli nqanaba, i-95% yazo ayifuni imimiselo yolawulo lweklasi II. uninzi lweemveliso zeYliao zeyeklasi ye-II, ziyimveliso yeklasi ye-II ibalwa kwi-43%, ezifana nesitulo esinamavili sombane abasetyhini abakhulelweyo banikezela kwinqanaba le-III le nqanaba leemveliso lidla ngokusetyenziswa ukugcina okanye ubomi bakhe, ekusebenziseni kunokubangela ingozi okanye ingozi ebantwini. , njengale: faka i-cardiac pacing implants yesifuba, njl., kunye ne-10% yeemveliso zeYliao zikwinqanaba le-III leklasi I, i-95% yeyokukhulula ukulawulwa kwezixhobo ze-Yliao, ayifuni ukuphatha isibhengezo phambi kweemveliso kwiimarike. (isaziso) okanye ilayisenisi (imvume) kodwa kubavelisi kwiinkqubo zobhaliso lwe-arhente ye-FDA, dwelisa iimveliso eziphambili zolu hlobo lolawulo olufana ne-stethoscope eyenziweyo, i-thermometer ye-mercury, i-sit implement, njl.
Intshayelelo kwisatifikethi se-FDA sokukhutshwa kwemitha (engeyonyukliya) iimveliso zombane
Uninzi lolawulo lwayo olungeniswa kumazwe angaphandle lwe-FDA eUnited States Abenzi bokutya kunye neDRUG bayazazi izithambiso izixhobo ze-Yliao zegunya elinobuchule, kodwa ngamanye amaxesha abantu abaninzi bayakutyeshela ukukhutshwa kweradiation ye-radiation (i-radiation ekhupha imveliso) yenye yemveliso yesebe yenkcazo ye-FDA umgangatho wokukhululwa. Umthombo wemitha yeemveliso ze-elektroniki kwi-canto yesihlanu ye-FEDERAL FOOD DRUG AND COSMETIC ACT (542-531 FEDERAL FOOD, DRUG, AND COSMETIC ACT, ekubhekiselwa kuyo njenge-FD&
C) ukukhutshwa kwento ebizwa ngokuba yimitha yeemveliso zombane, kubandakanywa i-eriyali ye-TV esebenzisa isikrini isixhobo se-X-reyi sokuxilonga kunye ne-microwave okanye iimveliso zelaser (ezifana ne-cd-rom kunye ne-laser designator (isalathisi selaser)) Imveliso ye-elektroniki ayiyi kuchongwa njengesixhobo sokukhutshwa kwemitha ye-Yliao, kodwa ukuba umenzi okanye umsasazi ubanga umsebenzi weYliao kunye nemveliso, imveliso kwaye iya kuthobela i-FDA malunga nezixhobo ze-Yliao zokucaciswa komthetho we-congressional ukukhutshwa kwemitha yeemveliso zombane ngokusebenzisa ezo zinto. iimveliso, esona sizathu siphambili kukuthintela abathengi impembelelo kwimpilo
Iimveliso ezinxulumene neLaser, umzekelo, eyona mveliso iphambili yaseTshayina yokuthumela ngaphandle kufuneka ihambelane nemigaqo ye-FDA kunye nezinye iimveliso eziqulathe i-optical drive nayo ikwingcaciso, efana nekhompyuter ye-notebook ngokwemigaqo ye-cd-rom, i-FDA ngokwe Ubungakanani radiation yahlulwe ngokweendidi ezine, abathengi jikelele ukusebenzisa laser optical drive iqulathe abaninzi bangabakhe kumngcipheko ophantsi weklasi yokuqala (iklasi 1) phambi kokuba i-pin yokuqala drive mei, abaqhubi kufuneka bathobele FDA le migaqo ilandelayo: 1 self itafile yesibhengezo;
2. Ukubhaliswa kwemveliso;
3 imigangatho yovavanyo;
4. Iingxelo zeMveliso;
Iingxelo zoNyaka;
Ingxelo yonyaka iya kuthunyelwa kwi-FDA nge-1 kaSeptemba ngonyaka.Ukuba ingxelo ayihlaziywa rhoqo, imveliso iya kubanjwa ngamasiko ngexesha lokukhutshwa kwempahla.
Iirekhodi ezisi-7 ezinxulumeneyo;
Amalungiselelo kwiimpawu ezilumkisayo
Inkqubo yokuqinisekiswa kwe-FDA
1. Ikopi yelayisenisi yomntu osemthethweni kwinqanaba lokulungiselela;Ikopi yelayisenisi yemveliso (yococeko) kunye nesiqinisekiso sesiqinisekiso;2.Yamkela kwaye ungenise amaxwebhu esiNgesi e-DMF(uxwebhu lwechiza olungundoqo) kunye ne-SOP(inkqubo yokusebenza eqhelekileyo) kwi-arhente;3.Uphononongo lwezixhobo zeDMF;I-FDA iya kuphonononga ngononophelo kwaye ihlole umzi-mveliso kwindawo apho ukujonga ukuba ngaba amaxwebhu abhaliweyo e-DMF ayinyaniso;4. Ukuhlolwa kwe-FDA.Ukuba kukho ukungathandabuzeki, igosa liya kunika ifom 483 (isiphakamiso sokulungiswa).Ukuba ingxaki inkulu, igosa aliyi kunika ifomu 483 (5). Imibuzo engacacanga kumtshutshisi iya kuchazwa kwaye ingqinwe.
