Gabatarwa ga
Gudanar da Abinci da Drug reshe ne na sashen kiwon lafiya, ilimi da walwala na Amurka. A zahiri, FDA daidai take da ma'aikatar lafiya (mai alhakin amincewa da abinci na lafiya) da kuma hukumar kula da magunguna ta ƙasa (mai alhakin kula da lafiya). Amincewa da kwayoyi).Yana da alhakin maganin ƙasa, abinci, samfuran halittu, kayan kwalliya, likitan dabbobi, kayan aikin Yliao da samfuran bincike da sauran gudanarwa da aiki don karewa, haɓakawa da haɓaka lafiyar ƙasa, tabbatar da cewa tallace-tallacen kasuwancin Amurka na abinci, magunguna, kayan kwalliya da kayan aikin Yliao don aminci da ingancin jikin ɗan adam.Hukumar FDA ta magunguna, hukumar, ofishin likitan dabbobi, ofishin kiwon lafiya, ofishin kayayyakin nazarin halittu, kayan aikin Yliao da ofishin samar da bincike da cibiyoyin bincike na toxicology na kasa, cibiyoyin sarrafa ayyukan yanki, wato innings shida (wasu wallafe-wallafe kuma sun ce cibiyar shida), a cibiyar da cibiyoyin gudanarwa na yanki.
Iyakar da FDA
Kayayyakin likitanci
- X-ray diagnostic samfurin Yliao (yawan amfani, mai kyalli X - ray, CT, da dai sauransu) Tiya da sauran Laser kayan aiki da kayan aiki tare da Laser naúrar - Laser kayayyakin don dalilai na musamman (ciki har da nuni, kallo da kuma likita amfani) - uv kayan aikin warkewa (uv fitila da samfuran don Yliao) Sauran kayan aikin duban dan tayi don ba na jiki da kuma ganewar asali - microwave diathermy far da microwave jini hita - ultrasonic jiki far kayan aiki
Abubuwan da ke da alaƙa da takaddun shaida ETL
Ana buƙatar takaddun shaida na ETL don fitarwa zuwa Amurka da Kanada. Alamar ETL ta nuna cewa samfurin ya wuce gwajin amincewa na NRTL a Amurka da SCC a Kanada.Intertek yana ɗaya daga cikin ƙananan takaddun shaida da OSHA da SCC suka gane. Shenzhen anbo yana da dangantaka ta kud da kud da Intertek, wanda zai iya taimaka wa samfuran ku samun takardar shedar ETL da kuma samar da cikakkun ayyuka.Tsarin alamar ETL daidai yake da alamar UL ko CSA kuma ya cika ka'idodin aminci masu dacewa. Samun alamar sunan ETL don samfurin yana nufin yana ya cika mafi ƙarancin buƙatun ka'idodin aminci na samfur. Bugu da ƙari, alamar ETL kuma tana nuna cewa wurin samar da masana'anta ya dace da wasu ƙayyadaddun buƙatun buƙatun, kuma yana nazarin binciken binciken masana'anta na yau da kullun don tabbatar da daidaito.ETL ta kasance kusan sama da 100. shekaru.Haruffa uku ETL gajeru ne don Lab ɗin Gwajin Lantarki wanda mai ƙirƙira Mista Edison ya kafa a 1896.ETL yana wakiltar sabbin abubuwa, masu tasiri, masu zaman kansu.nt da kuma buɗe gwajin samfuri da ƙwarewa mai wadata.ETLus takaddun shaida (mu kaɗai, ba c): takaddun shaida na cETL (kawai c, ba mu) Takaddun shaida (C kawai, babu mu): Takaddun shaida na cETLus (kawai c, ba mu) Idan kuna da duka biyun, kuna samun sau 4 a shekara.
Kayan lantarki tare da ionizing radiation
-- Nunin TV da bidiyo a yanayin nunin CRT
Samfuran lantarki tare da radiyo marasa ionizing
Microwave tanda, fitilar rana da samfuran fitilar rana (rana) samfuran Laser na wayar hannu ta hannu gami da nunin Laser, Laser, nunin Laser tare da samfuran naúrar Laser (CD player, DVD, cd-rom, firintocin laser, da sauransu), Tsaro da samfuran ceto - harsashi mai kariya na kayan aikin X-ray (kamar tsarin duba X-ray, tsarin hoton X-ray, tsarin duba tsaro na X-ray, tsarin duba kaya na X-ray)
Masana'antu da samfuran bincike
Laser kayan aikin da Laser instrumentsnon-yliao bincike X-ray kayan aiki-radiofrequency da microwaves kayayyakin (mara microwave tanda) wadanda ba bincike da kuma warkewa duban dan tayi productsfda yana da nau'i biyu na dokoki don abinci, kwayoyi, da na'urori: yarda da sanarwa.
Rarrabewar sarrafa samfuran likita
Daraja I irin wannan samfurin ba zai sami ɗan haɗari ga mai amfani ba, ƙira yawanci ya fi sauƙi fiye da matakin aji II da na III, kamar 47% enemas Yliao samfuran suna cikin wannan matakin, 95% daga cikinsu ba sa buƙatar tsarin gudanarwa na aji II. Mafi yawan kayayyakin Yliao na aji II ne, na ajin II ne wanda ya kai kashi 43%, kamar keken guragu na lantarki da mata masu juna biyu ke bayarwa matakin III wannan matakin na kayayyakin yawanci ana amfani da shi don kula da shi ko kuma rayuwarsa, amfani da shi na iya haifar da lahani ko cutar da mutane. , kamar: saka cardiac pacing nono implants, da dai sauransu, tare da 10% na Yliao kayayyakin sun kasance a matakin III na aji na I, 95% na wanda ke kebe Yliao kayan aiki management, ba ya bukatar rike da sanarwar kafin kayayyakin a kasuwa. (sanarwa) ko lasisi (bayani) amma ga masana'antun a cikin ƙa'idodin rajista na hukumar FDA, suna lissafin manyan samfuran wannan nau'in gudanarwa kamar stethoscope na wucin gadi, ma'aunin zafin jiki na mercury, aiwatar da zama, da sauransu.
Gabatarwa zuwa takaddun shaida na FDA na samfuran lantarki-sakin radiation (marasa makaman nukiliya).
Yawancin sarrafa FDA da aka shigo da shi a cikin Amurka masu yin kayan abinci da magunguna sun san kayan shafawa Yliao kayan aikin hukuma mai iko, amma wani lokacin mutane da yawa suna sakaci da sakin na'urorin lantarki (radiation na fitar da samfurin) yana ɗaya daga cikin ƙayyadaddun samfurin FDA misali f saki. na tushen radiation tushen kayayyakin lantarki na kanto na biyar na FEDERAL FOOD DRUG AND COSMETIC ACT (542-531 FEDERAL FOOD, DrUG, AND COSMETIC ACT, wanda ake kira FD&
C) sakin abin da ake kira radiation na samfuran lantarki, gami da eriya ta TV tare da kayan aikin X-ray na bincike na allo da samfuran microwave ko Laser (kamar cd-rom da ƙirar laser (laser pointer)) da galibi samfurin lantarki ba za a bayyana shi azaman kayan aikin saki na Yliao ba, amma idan masana'anta ko masu rarrabawa sun yi iƙirarin yin aikin Yliao tare da samfurin, samfurin kuma zai bi FDA game da ƙayyadaddun kayan aikin Yliao na ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun dokokin majalisa na fitarwa na samfuran lantarki ta amfani da irin wannan. samfurori, babban dalilin shine don hana tasirin masu amfani da lafiyar jiki
Kayayyakin da ke da alaƙa da Laser, alal misali, manyan abubuwan fitar da kayayyaki na kasar Sin suna buƙatar dacewa da ƙayyadaddun FDA da sauran samfuran da ke ɗauke da injin gani shima yana cikin ƙayyadaddun bayanai, kamar kwamfutar littafin rubutu dangane da cd-rom, FDA bisa ga bayanin. Girman radiation ya kasu kashi hudu, masu amfani na yau da kullum don amfani da Laser Optical Drive ya ƙunshi mutane da yawa suna cikin ƙananan haɗari na farko (class 1) kafin farkon fil din mei, masu aiki dole ne su bi FDA da wadannan tanadi: 1 kai. teburin sanarwa;
2. Rijistar samfur;
3 matakan gwaji;
4. Rahoton Samfura;
Rahoton Shekara-shekara;
Za a aika da rahoton shekara-shekara zuwa ga FDA a ranar 1 ga Satumba kowace shekara.Idan ba a sabunta rahoton akai-akai ba, hukumar kwastam za ta ci gaba da tsare samfurin a lokacin izinin kwastam.
7 bayanai masu alaƙa;
Sharuɗɗa akan alamun gargaɗi
Tsarin takaddun shaida na FDA
1. Kwafin lasisin mutum na kamfani a cikin matakin shiri; Kwafin lasisin samarwa (tsaftar muhalli) da takardar shaidar cancanta;2.Karɓa da ƙaddamar da takaddun fassarar Ingilishi na DMF (babban takaddar magani) da SOP (tsarin aiki daidai) ga wakili;3.Binciken kayan DMF;FDA za ta bita a hankali tare da bincika masana'anta a wurin don bincika ko rubuce-rubucen DMF na gaske ne; Idan FDA ba ta sami wani kuskuren abu ba kuma ta yi la'akari da cewa ya cika buƙatun, za ta ba da shawarar shirin dubawa kafin amincewa.4. Binciken FDA.Idan akwai shakka, jami'in zai ba da fom 483 (shawarwari don gyarawa).Idan matsalar ta yi tsanani, jami'in ba zai ba da fom 483 (5) ba. Tambayoyin da ba su bayyana ba ga mai gabatar da kara za a yi bayani da tabbatar da su.
