Intangiriro kuri
Ubuyobozi bushinzwe ibiryo nibiyobyabwenge nishami ryishami ry’ubuzima muri Amerika ry’ubuzima, uburezi n’imibereho myiza. Mu byukuri, FDA ihwanye na minisiteri y’ubuzima (ishinzwe kwemeza ibiryo by’ubuzima) hamwe n’ubuyobozi bw’igihugu gishinzwe ibiyobyabwenge (bishinzwe kwemeza ibiyobyabwenge) .Bishinzwe ubuvuzi bwigihugu, ibiryo, ibikomoka ku binyabuzima, amavuta yo kwisiga, ubuvuzi bwamatungo, ibikoresho bya Yliao nibicuruzwa byo kwisuzumisha hamwe nubundi buyobozi no gukora kurinda, guteza imbere no guteza imbere ubuzima bwigihugu, kwemeza ko kugurisha kwamerika muri Amerika kugurisha ibiryo, ubuvuzi, kwisiga nibikoresho bya Yliao kumutekano no gukora neza kumubiri wabantu.Ikigo cya FDA gishinzwe ibiyobyabwenge, ikigo, ibiro byubuvuzi bwamatungo, biro yubuzima, biro y’ibicuruzwa bikomoka ku binyabuzima, ibikoresho bya Yliao hamwe n’ibiro bishinzwe ubushakashatsi bw’uburozi hamwe n’ibigo by’ubushakashatsi by’uburozi, ibigo bishinzwe imirimo yo mu karere, ni ukuvuga inshuro esheshatu (ibitabo bimwe na bimwe bivuga ikigo cya gatandatu), a kigo n'inzego z'ubuyobozi bw'akarere.
Ingano ya FDA
Ibicuruzwa byubuvuzi
- X. ibikoresho byo kuvura (uv itara nibicuruzwa bya Yliao) Ibindi bikoresho bya ultrasound byubuvuzi byo kuvura no gupima umubiri - microwave diathermy therapy na microwave yamashanyarazi-- ibikoresho byo kuvura ultrasonic
Icyemezo cya ETL kijyanye nibirimo
Icyemezo cya ETL kirakenewe kugirango byoherezwe muri Amerika no muri Kanada.Ikimenyetso cya ETL cyerekana ko ibicuruzwa byatsinze ikizamini cya NRTL muri Amerika na SCC muri Kanada.Intertek nimwe mubigo bike byemewe na OSHA na SCC. Shenzhen anbo ifitanye umubano wa hafi na Intertek, ishobora gufasha ibicuruzwa byawe kubona ibyemezo bya ETL no gutanga serivisi zuzuye.Kumenyekanisha ibimenyetso bya ETL bihwanye na UL cyangwa CSA kandi byujuje ubuziranenge bwumutekano. Kugira ibendera ryizina rya ETL kubicuruzwa bivuze ko aribyo yujuje ibyangombwa bisabwa byibuze byumutekano wibicuruzwa. Byongeye kandi, ikirango cya ETL cyerekana kandi ko aho uruganda rukora ibicuruzwa byujuje ibyangombwa bisabwa, kandi rukiga ubugenzuzi buri gihe bwo kugenzura uruganda kugirango habeho guhuza.ETL imaze hafi 100 imyaka. Inyuguti eshatu ETL ni ngufi kuri Laboratoire Yamashanyarazi yashinzwe nuwabihimbye Bwana Edison mumwaka wa 1896.ETL ihagarariye udushya, imbaraga, independent no gufungura igeragezwa ryibicuruzwa nuburambe bukize.Icyemezo cya Lus (gusa twe, nta c): icyemezo cya cETL (gusa c, oya natwe): icyemezo cya CETLus (gusa c, oya natwe): icyemezo cya cETLus (gusa c, oya natwe): cETLus Icyemezo (gusa c, oya twe): cETLus icyemezo (gusa c, oya twe) Niba ufite byombi, ubona inshuro 4 mumwaka.
Ibicuruzwa bya elegitoronike hamwe nimirasire ya ionizing
- TV na videwo yerekana muburyo bwa CRT
Ibicuruzwa bya elegitoronike hamwe nimirasire idafite ionizing
Ifuru ya Microwave, itara ryizuba nibicuruzwa byamatara yizuba (izuba) byambaye ubusa-bigendanwa bya terefone igendanwa-laser Harimo kwerekana laser, laser, kwerekana laser hamwe nibicuruzwa bya laser (CD ikinisha, DVD, cd-rom, printer ya laser, nibindi.), Umutekano n'ibicuruzwa byo gutabara-igikonoshwa gikingira ibikoresho bya X-ray (nka sisitemu yo kugenzura X-ray, sisitemu yo gufata amashusho ya X-ray, sisitemu yo kugenzura umutekano wa X-ray, sisitemu yo kugenzura imizigo X-ray)
Ibicuruzwa byinganda nubushakashatsi
Ibikoresho bya lazeri nibikoresho bya lasernon-yliao kwisuzumisha ibikoresho bya X-ray-radiofrequency nibicuruzwa bya microwave (itanura rya microwave) ibicuruzwa bidasuzumwa kandi bivura ultrasound ibicuruzwafda bifite ubwoko bubiri bwamabwiriza agenga ibiryo, ibiyobyabwenge, nibikoresho: kwemeza no kubimenyesha
Ibyiciro byo gucunga imiti
Icyiciro cya I ubu bwoko bwibicuruzwa bizagira ingaruka nke kubakoresha, igishushanyo gisanzwe cyoroshye kurwego rwa II na III, nka 47% enemas Yliao ibicuruzwa biri mururu rwego, 95% muribyo ntibakeneye amabwiriza yo kuyobora icyiciro cya II ibicuruzwa byinshi bya Yliao nibyiciro bya II, nibicuruzwa byo mucyiciro cya II bingana na 43%, nkibimuga byabamugaye batwite batwite batanga urwego rwa III urwego rwibicuruzwa rusanzwe rukoreshwa mukubungabunga cyangwa ubuzima bwe, mugukoresha birashobora guteza ingaruka mbi cyangwa kugirira nabi abantu . .
Intangiriro kuri FDA icyemezo cyibicuruzwa bikoresha imirasire (bitari kirimbuzi)
Benshi mubuyobozi bwa FDA butumizwa muri Reta zunzubumwe zamerika abarya ibiryo nibiyobyabwenge bazi kwisiga ibikoresho bya Yliao byubuyobozi bubifitiye ububasha, ariko rimwe na rimwe abantu benshi birengagiza irekurwa rya elegitoroniki yimirasire (imirasire isohora ibicuruzwa) nikimwe mubicuruzwa bisobanurwa na FDA bisanzwe f gusohora y'imirasire yibicuruzwa bya elegitoronike kuri canto ya gatanu YUBUYOBE BWA FEDERAL N'IBIKORWA BYA COSMETIC (542-531 FEDERAL FOOD, DRUG, NA COSMETIC ACT, byitwa FD &
C) kurekura ibyo bita imirasire yibicuruzwa bya elegitoronike, harimo na antenne ya TV hamwe na ecran ikoresha X-ray isuzuma ibikoresho bya X-ray nibikoresho bya microwave cyangwa laser (nka cd-rom na laser designator (laser pointer)) kandi byinshi ibicuruzwa bya elegitoronike ntibizamenyekana nkibikoresho bya Yliao bisohora imirasire, ariko niba uwabikoze cyangwa uwabitanze avuga ko Yliao ikorana nibicuruzwa, ibicuruzwa kandi igomba kubahiriza FDA kubyerekeranye nibikoresho bya Yliao byerekana amategeko ya kongere asobanura imirasire yibicuruzwa bya elegitoronike ukoresheje ibyo ibicuruzwa, impamvu nyamukuru nukurinda abaguzi ingaruka kubuzima
Ibicuruzwa bifitanye isano na Laser, kurugero, ibicuruzwa byingenzi byoherezwa mubushinwa bigomba guhuza nibisobanuro bya FDA nibindi bicuruzwa birimo disiki ya optique nabyo biri mubisobanuro, nka mudasobwa ya ikaye mubijyanye na cd-rom, FDA ukurikije ingano yimirasire igabanijwemo ibyiciro bine, abakoresha muri rusange gukoresha disiki ya laser optique irimo byinshi mubyago byo hasi yicyiciro cya mbere (icyiciro cya 1) mbere yimodoka ya mbere pin mei, abashoramari bagomba kubahiriza FDA ingingo zikurikira: 1 wenyine imbonerahamwe;
2. Kwandikisha ibicuruzwa;
Ibipimo 3 by'ibizamini;
4. Raporo y'ibicuruzwa;
Raporo y'umwaka;
Raporo y'umwaka yoherezwa muri FDA ku ya 1 Nzeri buri mwaka.Niba raporo idasubirwamo buri gihe, ibicuruzwa bizafungwa na gasutamo mugihe cyo gutumiza gasutamo.
Inyandiko 7 zijyanye;
Ingingo ku bimenyetso byo kuburira
Uburyo bwo kwemeza FDA
1. Kopi yimpushya zemewe namasosiyete mugihe cyo kwitegura; Kopi yumusaruro (isuku) nicyemezo cyimpamyabumenyi; 2.Emera kandi utange inyandiko yicyongereza ya DMF (inyandiko nyamukuru yibiyobyabwenge) na SOP (progaramu isanzwe ikora) kubakozi; 3.Gusubiramo ibikoresho bya DMF;FDA igomba gusuzuma neza no kugenzura uruganda aho hantu kugirango irebe niba inyandiko za DMF zanditse ari ukuri; Niba FDA itabonye ikosa ryibintu kandi ikabona ko yujuje ibisabwa, igomba gutanga gahunda yo kugenzura mbere yo kubyemeza.4. Igenzura rya FDA.Niba hari ugushidikanya, umuyobozi azatanga urupapuro 483 (icyifuzo cyo gukosora).Niba ikibazo gikomeye, umuyobozi ntazatanga urupapuro rwa 483 (5) .Ibibazo bidasobanutse neza umushinjacyaha bizasobanurwa kandi bigaragare
