Chiyambi cha
Ulamuliro wa Chakudya ndi Mankhwala ndi nthambi ya dipatimenti ya zaumoyo ku United States yazaumoyo, maphunziro ndi chisamaliro. Kunena zowona, a FDA ndi ofanana ndi unduna wa zaumoyo (omwe uli ndi udindo wovomereza chakudya chaumoyo) ndi kayendetsedwe ka mankhwala mdziko (omwe ali ndi udindo wowongolera). chivomerezo cha mankhwala).Ili ndi udindo wa mankhwala dziko, chakudya, kwachilengedwenso mankhwala, zodzoladzola, Chowona Zanyama, Yliao zipangizo ndi mankhwala matenda ndi kasamalidwe ena ndi ntchito kuteteza, kulimbikitsa ndi kusintha thanzi dziko, kuonetsetsa kuti American msika malonda a chakudya, mankhwala, zodzoladzola ndi zida Yliao chitetezo ndi mphamvu ya thupi la munthu.Ulamuliro wa mankhwala a FDA, bungwe, ofesi yachipatala cha Chowona Zanyama, ofesi yazaumoyo, ofesi yazachilengedwe, zida za Yliao ndi diagnostics Bureau ndi National toxicology Research Center, mabungwe oyang'anira ntchito m'chigawo, omwe ndi ma innings asanu ndi limodzi (zofalitsa zina zimanenanso malo asanu ndi limodzi), a pakati ndi mabungwe oyang'anira dera.
Chiwerengero cha FDA
Zamankhwala
- X-ray diagnostic Yliao product (ntchito zambiri, fluorescent X - ray, CT, etc.)Opaleshoni ndi zida zina za laser ndi zida zokhala ndi laser unit-- mankhwala a laser pazolinga zapadera (kuphatikiza mawonetsedwe, kuyang'ana ndi kugwiritsa ntchito mankhwala)- uv zida zochizira (nyali ya UV ndi zinthu za Yliao)Zida zina zamankhwala zopangira ma ultrasound pazamankhwala osagwiritsa ntchito thupi komanso kuzindikira -- microwave diathermy therapy ndi microwave blood heater-- ultrasonic physical therapy equipment
Zogwirizana ndi certification ya ETL
Satifiketi ya ETL ndiyofunikira kuti itumizidwe ku United States ndi Canada.Chizindikiro cha ETL chikuwonetsa kuti malondawa adapambana mayeso ovomerezeka a NRTL ku United States ndi SCC ku Canada.Intertek ndi amodzi mwa mabungwe ochepa otsimikizira omwe amazindikiridwa ndi OSHA ndi SCC. Shenzhen anbo ali ndi ubale wapamtima ndi EUROLAB, womwe ungathandize malonda anu kupeza chiphaso cha ETL ndikupereka chithandizo chokwanira.Kuzindikiritsa chizindikiro cha ETL ndikofanana ndi chizindikiro cha UL kapena CSA ndipo kumakwaniritsa zofunikira zachitetezo. wakwaniritsa zofunikira zochepa pamiyezo yachitetezo chazinthu.Kuphatikiza apo, logo ya ETL ikuwonetsanso kuti malo opangira opanga amakwaniritsa zofunikira zina, ndipo amawerengera zowunikira pafupipafupi zamafakitale kuti zitsimikizire kuti consistency.ETL yakhala ikupitilira zaka 100. zaka.Zilembo zitatu za ETL ndi zazifupi za Electrical Testing Labs zomwe zinakhazikitsidwa ndi woyambitsa Bambo Edison mu 1896.ETL imayimira luso, mphamvu, zodziimira.nt ndi kuyesa kotseguka kwazinthu ndi zokumana nazo zambiri.ETLus certification (ife tokha, palibe c) : cETL certification (okha c, palibe ife) : certification cETlus (okha c, no ife) : certification cETlus (kokha c, palibe ife) : cETlus chiphaso (chokha c, palibe ife) : certification cETlus (chokha c, palibe ife)Ngati muli nazo zonse, mumapeza ka 4 pachaka.
Zida zamagetsi zokhala ndi ma ionizing radiation
- Zowonetsera pa TV ndi makanema mumayendedwe a CRT
Zamagetsi zamagetsi zopanda ionizing radiation
Ovuni ya Microwave, nyale zadzuwa ndi zinthu zopangira nyali zadzuwa (dzuwa) zinthu zopanda mafoni-laser zam'manja kuphatikiza cholozera cha laser, laser, chiwonetsero cha laser chokhala ndi zida za laser unit (CD player, DVD, cd-rom, laser printers, etc.),Safety ndi zopulumutsira - chipolopolo choteteza cha zida za X-ray (monga makina owunikira ma X-ray, makina ojambulira ma X-ray, makina owunikira chitetezo cha X-ray, makina oyendera katundu wa X-ray)
Zamakampani ndi kafukufuku
Zida za laser ndi zida za lasernon-yliao diagnostic X-ray zida-radiofrequency ndi mankhwala a mayikirowevu (mavuni osakhala mayikirowevu) sanali matenda ndi achire ultrasound productsfda ali mitundu iwiri ya malamulo chakudya, mankhwala, ndi zipangizo: chivomerezo ndi zidziwitso.
Gulu la kasamalidwe ka mankhwala
Kalasi I mtundu uwu wa mankhwala adzakhala ndi ngozi pang'ono kwa wosuta, kamangidwe kawirikawiri mosavuta kuposa kalasi II ndi III mlingo, monga 47% enemas Yliao mankhwala ali mlingo uwu, 95% a iwo safuna malamulo kasamalidwe kalasi II zambiri Yliao mankhwala ndi kalasi II, ndi kalasi II mankhwala mlandu 43%, monga chikuku magetsi amayi apakati amapereka mlingo III mlingo uwu wa mankhwala nthawi zambiri ntchito kusunga kapena moyo wake, ntchito zingayambitse mavuto kapena kuvulaza anthu. , monga: kuyika ma implants a mtima pacing pachifuwa, ndi zina zotero, ndi 10% ya mankhwala a Yliao ali a msinkhu wa III wa kalasi yoyamba, 95% yomwe ili yosamalidwa kasamalidwe ka zipangizo za Yliao, sikutanthauza kulengeza malonda pamsika. (chidziwitso) kapena laisensi (chilolezo) koma kwa opanga muzolembera za bungwe la FDA, amalemba zinthu zazikuluzikulu zamtunduwu monga stethoscope yochita kupanga, mercury thermometer, sit implement, etc.
Kuyamba kwa certification ya FDA yamagetsi otulutsa ma radiation (osakhala a nyukiliya).
Ambiri mwa kasamalidwe kake ka kunja kwa FDA ku United States FOOD AND DRUG opanga amadziwa zodzikongoletsera zida za Yliao zaulamuliro woyenerera, koma nthawi zina anthu ambiri amanyalanyaza kutulutsidwa kwa zida zamagetsi (radiation emitting mankhwala) ndi imodzi mwazinthu zomwe zidafotokozedwa m'madipatimenti FDA muyezo f kumasulidwa. gwero la radiation la zinthu zamagetsi la canto lachisanu la FEDERAL FOOD DRUG AND COSMETIC ACT (542-531 FEDERAL FOOD, DRUG, AND COSMETIC ACT, yotchedwa FD&
C) kutulutsidwa kwa zomwe zimatchedwa ma radiation azinthu zamagetsi, kuphatikiza mlongoti wa pa TV wokhala ndi zida zowunikira X-ray ndi zida za microwave kapena laser (monga cd-rom ndi laser designator (laser pointer)) ndi ambiri a mankhwala amagetsi sangadziwike ngati Yliao kumasulidwa zida radiation, koma ngati wopanga kapena wogawa ananena kuti Yliao ntchito ndi mankhwala, mankhwala ndi kutsatira FDA za Yliao zipangizo mfundo za congressional malamulo specifications kumasulidwa ma radiation a zinthu zamagetsi pogwiritsa ntchito zimenezi. mankhwala, chifukwa chachikulu ndi kuteteza ogula zimakhudza thanzi
Zogulitsa zokhudzana ndi laser, mwachitsanzo, zinthu zazikulu zaku China zomwe zimatumiza kunja zimayenera kugwirizana ndi zomwe FDA idalemba ndi zinthu zina zomwe zili ndi optical drive zilinso mwatsatanetsatane, monga makompyuta apakompyuta potengera cd-rom, FDA molingana ndi kukula kwa ma radiation agawidwa m'magulu anayi, ogula ambiri kuti agwiritse ntchito laser optical drive ali ndi ambiri omwe ali pachiwopsezo chochepa cha kalasi yoyamba (kalasi 1) isanachitike pini yoyamba ya mei, oyendetsa ayenera kutsatira FDA zotsatirazi: 1 kudzikonda tebulo lachidziwitso;
2. Kulembetsa katundu;
3 mayeso miyezo;
4. Malipoti a Zamalonda;
Malipoti apachaka;
Lipoti lapachaka lidzatumizidwa ku FDA pa Seputembara 1 chaka chilichonse.Ngati lipotilo silinasinthidwe nthawi zonse, katunduyo amamangidwa ndi miyambo panthawi yachilolezo.
7 zolemba zogwirizana;
Zopereka pa zizindikiro zochenjeza
FDA certification ndondomeko
1. Kope la chiphaso cha munthu wovomerezeka pakampani panthawi yokonzekera;Chilolezo chakupanga (ukhondo) ndi satifiketi yakuyeneretsedwa;2.Landirani ndikupereka zikalata zomasulira m'Chingerezi za DMF(chikalata chachikulu chamankhwala) ndi SOP(njira yoyendetsera ntchito) kwa wothandizira;3.Kubwereza kwa zida za DMF;A FDA aziwunika mosamala ndikuwunika fakitale pomwepo kuti awone ngati zolembedwa za DMF ndizowona; Ngati FDA sipeza cholakwika chilichonse ndipo ikuwona kuti ikukwaniritsa zofunikira, idzapereka dongosolo loyendera chisanadze.4. Kuwunika kwa FDA.Ngati pali chikaiko, mkuluyo apereke fomu 483 (pempho lokonzanso).Ngati vuto ndi lalikulu, wogwira ntchitoyo sapereka fomu 483 (5). Mafunso osamveka bwino kwa wosuma mlandu afotokozedwe ndi kutsimikiziridwa.
