Isingeniso ku
Ukuphathwa Kwezokudla Nezidakamizwa kuyigatsha lomnyango wezempilo, imfundo kanye nenhlalakahle yase-US. Uma sikhuluma ngqo, i-FDA ilingana nomnyango wezempilo (obhekele ukugunyazwa kokudla kwezempilo) kanye nokuphathwa kwezidakamizwa kuzwelonke (okubhekelela ukunakekelwa kwezempilo kanye nezempilo). ukugunyazwa kwezidakamizwa).Inomthwalo wemfanelo wemithi kazwelonke, ukudla, imikhiqizo yezinto eziphilayo, izimonyo, imithi yezilwane, imishini ye-Yliao kanye nemikhiqizo yokuxilonga kanye nokunye ukuphathwa kanye nokusebenza ukuvikela, ukukhuthaza kanye nokwenza ngcono impilo yezwe, ukuqinisekisa ukuthi ukuthengiswa kwemakethe yaseMelika ukudla, imithi, izimonyo kanye nezinsimbi ze-Yliao zokuphepha nokusebenza kahle komzimba womuntu.Isikhulu sezidakamizwa se-FDA, i-ejensi, isikhungo semithi yezilwane, ihhovisi lezempilo, ihhovisi lemikhiqizo yebhayoloji, i-Yliao instruments and diagnostic supply bureau kanye nezikhungo zocwaningo lwe-toxicology kazwelonke, izikhungo zokuphatha umsebenzi wesifunda, okuyizi-innings eziyisithupha (ezinye izincwadi nazo zithi isikhungo esiyisithupha), a isikhungo kanye nezikhungo zokuphatha zesifunda.
Ububanzi be-FDA
Imikhiqizo yezokwelapha
- Umkhiqizo we-X ray wokuxilonga we-Yliao (ukusetshenziswa okuvamile, i-fluorescent X - ray, i-CT, njll.)Imishini yokuhlinza nezinye ze-laser kanye namathuluzi aneyunithi ye-laser-- imikhiqizo ye-laser ngezinjongo ezikhethekile (okuhlanganisa ukubonisa, ukubuka nokusetshenziswa kwezokwelapha)- uv izinto zokwelapha (isibani se-uv nemikhiqizo ye-Yliao)Eminye imishini yezokwelapha ye-ultrasound yokwelapha okungekona okomzimba kanye nokuxilongwa-- microwave diathermy therapy kanye ne-microwave blood heater-- imishini yokwelapha ngokomzimba ye-ultrasonic
Okuqukethwe okuhlobene nesitifiketi se-ETL
Isitifiketi se-ETL siyadingeka ukuze kuthekeliswe e-United States nase-Canada.Umaki we-ETL ubonisa ukuthi umkhiqizo uphumelele ukuhlolwa kokugunyazwa kwe-NRTL e-United States kanye ne-SCC e-Canada.I-Intertek ingenye yezinhlangano ezimbalwa zokunikeza izitifiketi eziqashelwa i-OSHA ne-SCC. I-Shenzhen anbo inobudlelwano obuseduze ne-Intertek, engasiza imikhiqizo yakho ithole isitifiketi se-ETL futhi ikunikeze ngamasevisi aphelele.Ukuqashelwa kophawu lwe-ETL kulingana nomaka we-UL noma i-CSA futhi kuhlangabezana nezindinganiso zokuphepha ezifanele.Ukuba nefulegi lekholomu ye-ETL yomkhiqizo kusho ukuthi uhlangabezane nezimfuneko eziphansi zezindinganiso zokuphepha komkhiqizo.Ngaphezu kwalokho, uphawu lwe-ETL luphinde lubonise ukuthi indawo yokukhiqiza yomkhiqizi ihlangabezana nezimfuneko ezithile ezijwayelekile, futhi icwaninga ngokulandela ukucwaninga kwefekthri kokulandelela ukuze kuqinisekiswe ukufana.I-ETL isineminyaka engaphezu kuka-100 ikhona. iminyaka.Izinhlamvu ezintathu ze-ETL zimfushane ze-Electrical Testing Labs eyasungulwa umsunguli uMnu. Edison ngo-1896.I-ETL imele ukuqamba okusha, okunomthelela, ukuzimela.nt nokuhlola umkhiqizo ovulekile kanye nolwazi olucebile. Isitifiketi se-ETLus (thina kuphela, akukho c) : Isitifiketi se-cETL (kuphela c, akukho nathi) : Isitifiketi se-cETlus (kuphela c, no us) : Isitifiketi se-cETlus (kuphela c, no us) : cETlus isitifiketi (kuphela c, no us) : Isitifiketi se-cETlus (kuphela c, no us)Uma unazo zombili, uthola izikhathi ezi-4 ngonyaka.
Imikhiqizo kagesi enemisebe ye-ionizing
-- Izibonisi ze-TV nevidiyo kwimodi yokubonisa ye-CRT
Imikhiqizo kagesi enemisebe engeyona i-ionizing
Ihhavini ye-Microwave, isibani selanga kanye nemikhiqizo yesibani selanga (ilanga) imikhiqizo yelaser yamaselula engenaluthoKuhlanganisa i-laser pointer, i-laser, isibonisi se-laser esinemikhiqizo yeyunithi ye-laser (isidlali se-CD, i-DVD, i-cd-rom, amaphrinta we-laser, njll.),Ukuphepha kanye nemikhiqizo yokuhlenga-igobolondo elivikelayo lezinto ze-X-ray (ezifana nezinhlelo zokuhlola i-X-ray, isistimu ye-X-ray imaging, uhlelo lokuhlola ukuphepha kwe-X-ray, uhlelo lokuhlola imithwalo ye-X-ray)
Imikhiqizo yezimboni nocwaningo
Amathuluzi e-laser namathuluzi e-lasernon-yliao diagnostic X-ray imishini-radiofrequency kanye nemikhiqizo ye-microwave (amahhavini angewona ama-microwave) imikhiqizo ye-ultrasound engaxilonga futhi yokwelapha i-fda inezinhlobo ezimbili zemithethonqubo yokudla, izidakamizwa, kanye namadivayisi: ukugunyazwa nesaziso.
Ukuhlukaniswa kokuphathwa komkhiqizo wezokwelapha
I-Grade I lolu hlobo lomkhiqizo luzoba nengozi encane kumsebenzisi, umklamo ngokuvamile ulula kunezinga lesigaba II kanye ne-III, njenge-47% enemas imikhiqizo ye-Yliao ingeyaleli zinga, i-95% yayo ayidingi i-regulatory management class II. imikhiqizo eminingi ye-Yliao ingeyesigaba II, ingeyemikhiqizo yekilasi II ebalelwa ku-43%, njengesihlalo sabakhubazekile sikagesi abesifazane abakhulelwe bahlinzeka ngezinga III leli zinga lemikhiqizo livame ukusetshenziselwa ukulondoloza noma ukuphila kwakhe, lapho lisetshenziswa kungabangela ukulimala okungaba khona noma ukulimaza abantu. , njengokuthi: faka izimila zesifuba ezinyakazayo zenhliziyo, njll., ngo-10% wemikhiqizo ye-Yliao eyeleveli III yekilasi I, u-95% wawo okungewokuphathwa kwemishini ye-Yliao ekhululiwe, ayidingi ukuphatha isimemezelo ngaphambi kwemikhiqizo emakethe. (isaziso) noma ilayisense (imvume) kodwa kubakhiqizi ezicikweni zokubhalisa ze-ejensi ye-FDA, babala imikhiqizo eyinhloko yalolu hlobo lokuphatha njenge-stethoscope yokwenziwa, i-mercury thermometer, i-sit implement, njll.
Isingeniso sesitifiketi se-FDA semikhiqizo kagesi ekhipha imisebe (okungeyona eyenuzi).
Iningi labaphathi bayo be-FDA abangenisiwe e-United States Abenzi BOKUDLA NEZIDAKAMIZWA bayazazi izimonyo Imishini ye-Yliao yesiphathimandla esinekhono, kodwa ngezinye izikhathi abantu abaningi abakunaki ukukhishwa kwe-radiation electronics (i-radiation etting the product) ingenye yomkhiqizo wokucaciswa komnyango we-FDA standard f release. umthombo wemisebe yemikhiqizo kagesi ye-canto yesihlanu ye-FEDERAL FOOD DRUG AND COSMETIC ACT (542-531 FEDERAL FOOD, DRUG, AND COSMETIC ACT, ebizwa ngokuthi i-FD&
C) ukukhishwa kwalokho okubizwa ngokuthi imisebe yemikhiqizo kagesi, okuhlanganisa i-antenna ye-TV esebenzisa isikrini okokusebenza kwe-X-ray yokuxilonga kanye nemikhiqizo ye-microwave noma ye-laser (efana ne-cd-rom ne-laser designator (isikhombi se-laser)) kanye neningi umkhiqizo we-elekthronikhi ngeke ukhonjwe njengemishini yokukhishwa kwemisebe ye-Yliao, kodwa uma umkhiqizi noma umsabalalisi ethi i-Yliao isebenza nomkhiqizo, umkhiqizo futhi uzohambisana ne-FDA mayelana nencazelo yemishini ye-Yliao yokucaciswa kwemithetho yenhlangano yokukhishwa kwemisebe yemikhiqizo kagesi ngokusebenzisa leyo mikhiqizo. imikhiqizo, isizathu esiyinhloko ukuvimbela umthelela wabathengi empilweni
Imikhiqizo ehlobene ne-laser, ngokwesibonelo, idrayivu eyinhloko yemikhiqizo ethunyelwa ngaphandle yaseChina idinga ukuhambisana nezicaciso ze-FDA kanye neminye imikhiqizo equkethe i-optical drive nayo isesimisweni, njengekhompyutha yamanothi ngokuya nge-cd-rom, i-FDA ngokomthetho. ubukhulu bemisebe ihlukaniswe izigaba ezine, abathengi jikelele ukusebenzisa i-laser optical drive iqukethe eziningi ziyingxenye yengozi ephansi yesigaba sokuqala (ikilasi 1) ngaphambi kwe-pin mei yokuqala yokushayela, opharetha kufanele bahambisane ne-FDA lezi zinhlinzeko ezilandelayo: 1 self Ithebula lesimemezelo;
2. Ukubhaliswa komkhiqizo;
3 amazinga wokuhlola;
4. Imibiko yomkhiqizo;
Imibiko Yonyaka;
Umbiko wonyaka uzothunyelwa nge-imeyili ku-FDA ngoSepthemba 1 unyaka ngamunye.Uma umbiko ungabuyekezwa njalo, umkhiqizo uzoboshwa ngamasiko ngesikhathi sokukhishwa kwempahla.
7 amarekhodi ahlobene;
Izinhlinzeko ngezimpawu eziyisixwayiso
Inqubo yesitifiketi se-FDA
1. Ikhophi yelayisensi yomuntu osemthethweni webhizinisi esigabeni sokulungiselela;Ikhophi yelayisensi yokukhiqiza (izindlu zangasese) nesitifiketi seziqu;2.Yamukela futhi uhambise imibhalo yokuhumusha yesiNgisi ye-DMF(idokhumenti yezidakamizwa eyinhloko) kanye ne-SOP(inqubo yokusebenza evamile) kumenzeli;3.Ukubuyekezwa kwezinto ze-DMF;I-FDA izobuyekeza futhi ihlole imboni ngaso leso sikhathi ukuze ihlole ukuthi amadokhumenti abhaliwe e-DMF ayiqiniso yini; Uma i-FDA ingalitholi iphutha elibalulekile futhi icabanga ukuthi iyahlangabezana nezimfuneko, izophakamisa uhlelo lokuhlola ngaphambi kokugunyazwa.4. Ukuhlolwa kwe-FDA.Uma kunokungabaza, isikhulu sizonikeza ifomu 483 (isiphakamiso sokulungiswa).Uma inkinga inkulu, isikhulu ngeke silinikeze ifomu 483 (5).Imibuzo engacacile kumshushisi iyochazwa futhi ifakazelwe.
