Ngabe i-FDA iyawagunyaza amathangi okugcina
Kwadalwa ngo Ngokwamukisa
Ingabe i-FDA igunyaza amathangi okugcina?
Ukungaqondi kahle okuvamile ukuthi i-FDA yaseMelika 'igunyaza' ithangi lokugcina eliphelile ngendlela umnyango wezakhiwo ogunyaza ngayo isakhiwo. Ayikwenzi lokho. I-FDA ilawula izinto ezithinta ukudla - i-coating, i-sealant, ama-gaskets, ama-fittings - ngaphansi kwe-Federal Food, Drug, and Cosmetic Act kanye nemithethonqubo yokuqalisa efana ne-21 CFR. Ithangi 'lihambisana ne-FDA' lapho zonke izingxenye ezithinta ukudla zenziwe ngezinto ezigunyaziwe, ezilinganiselwe ngokufanele, hhayi lapho umkhumbi ohlanganisiwe uphethe isitembu se-FDA.
I-Shijiazhuang Zhengzhong Technology Co., Ltd. (Center Enamel) ihlinzeka ngamathangi izinto zawo ezithinta ukudla ezikhethwa ngokuhambisana nohlaka lwe-FDA yaseMelika, futhi inikeza izitatimende zokuhambisana ezisebenzayo zalezo zinto esikhundleni sokusho ukuthi ithangi lonke ligunyazwe yi-FDA okungekho.
1. I-FDA Ilawula Izinto, Hhayi Izakhiwo Ezihlanganisiwe
Uhlelo lwe-FDA lokuthinta ukudla lugunyaza izinto - isibonelo, uhlelo lwe-resin ekusembozweni ngaphansi kwe-21 CFR 175.300 - futhi lubeka imingcele kulokho okungangena ekudleni. Asikho isitifiketi se-FDA sethangi eliqediwe eliboshiwe. Ukuhambisana kuboniswa ingxenye nengxenye: i-enamel noma i-polymer lining, isivalo, ama-gaskets kanye nezinto zangaphakathi zidinga ukufaneleka ngaphansi kohlaka. Ithangi elihlanganisiwe liyahambisana ngoba izingxenye zalo ziyahambisana, hhayi ngoba ithangi lagunyazwa njengeyunithi.
· Akukho Kugunyazwa Kwezinga Lethangi: I-FDA ayiqinisekisi amathangi aqediwe.
· Kusekelwe Ezingxenyeni: Into ngayinye ethinta ukudla ihlolwa ngokwehlukile.
· 21 CFR 175.300: Ilawula izinto zokugqoka ezinama-resin nama-polymer ezithinta ukudla.
· Imikhawulo Yokufuduka: Izinto ezigunyaziwe zinemikhawulo yokukhipha noma yokufuduka.
· Ukuthobela Kuyaboniswa: Ngokwesimo sezinto, hhayi isitembu somkhumbi.
2. Okusho 'Ukuhambisana ne-FDA' Ngokwenzayo
Ethangini, ukuhambisana ne-FDA kusho ukuthi izingxenye ezimanzi zenziwe ngezinto ezigunyazwe ukuthintana nokudla futhi zisetshenziswa ngaphakathi kwemikhawulo yazo. Ethangini lengilazi elihlanganiswe nensimbi, lokho kuyindlela ye-enamel nesivalo sokuhlanganisa; ethangini lensimbi engagqwali, i-alloy namanye ama-gasket; ethangini lensimbi eline-coating, uhlelo lwe-coating. Umhlinzeki othi 'ithangi eligunyazwe yi-FDA' usebenzisa isifinyezo noma udlula emkhawulweni, futhi umthengi kufanele acele ubufakazi bezinto ezisetshenzisiwe.
· Izingxenye Ezimanzi: I-enamel, isivalo, ama-gasket nezingxenye zokuxhuma kufanele kuhambisane.
· Ngaphakathi Kwemikhawulo: Izinto kufanele zisetshenziswe ngendlela egunyaziwe, hhayi nje ukuqanjwa amagama.
· Ingozi Yesifinyezo: 'Ithangi eligunyazwe yi-FDA' alichazi kahle.
· Cela Ubufakazi: Cela izitatimende zokuhambisana nezinga lezinto.
· I-Alloy Ibalulekile: Ngisho ne-stainless idinga izinga elifanele nokuqedwa.
3. Ukubhaliswa, Ukufakwa Ohlwini kanye Nalokho Okufanele Ukucela
Izikhungo ezikhiqiza, ezicubungula noma ezipakisha ukudla zingabhalisa ne-FDA, kodwa lokho ukubhaliswa kwesikhungo, hhayi ukugunyazwa komkhiqizo, futhi akusebenzi ethangini njengomkhiqizo. Lokho umthengi okufanele akucela isitatimende sokuhambisana nokuthinta ukudla kwengxenye ngayinye emanzi, esho umthetho nokwakheka okuqondile, kanye nokuqinisekiswa kwanoma yikuphi ukubhaliswa kwesikhungo okuhambisana nochungechunge lokuhlinzeka.
· Ukubhaliswa Kwesikhungo: Kusebenza ezikhungweni zokudla, hhayi emathangini njengemikhiqizo.
· Akusona Isigunyazo Somkhiqizo: Ukubhaliswa akusona isitifiketi sethangi.
· Cela Izitatimende: Cela ubufakazi bokuthobela kwezinga lezingxenye.
· Shono Ifomula: Iresiphi eqondile kufanele ibhekiselwe kuyo.
· Gcina Amarekhodi: Izitatimende zezingxenye zihamba nefayela lethangi.
Ipharamitha yokuklama | Inani elijwayelekile noma ibanga | Kungani kubalulekile |
Ububanzi be-FDA | Izinto ezithinta ukudla | Hhayi amathangi aqediwe |
21 CFR 175.300 | Ama-coatings okuthintana nokudla | Ibeke imikhawulo yokukhishwa |
Uhlobo lobufakazi | Izitatimende zezingxenye | Ifomula eqanjiwe kanye nemikhawulo |
Ukubhaliswa kwesikhungo | Izindawo zokudla | Akusona isitifiketi somkhiqizo |
Izingxenye ezimanzi | I-coating, i-sealant, ama-gaskets, izinto zokuxhuma | Ngayinye kufanele ihambisane |
Umkhawulo okufanele uhlolwe | 'Ithangi elivunywe yi-FDA' akucaci kahle | Dinga ubufakazi bezinga lengxenye |
Isimangalo | Okusho ngempela kona | Okufanele ukucela | Isixwayiso |
Ithangi eligunyazwe yi-FDA | Akukho into enjalo; izingxenye ziyalawulwa | Izitatimende zokuhambisana nezingxenye | Isimangalo 'sokugunyazwa' sezinga lethangi |
Kuhambisana ne-FDA | Izingxenye ezimanzi zihlangabezana ne-21 CFR | Izinto eziqanjwe ngamagama nemikhawulo | Akukho bufakazi obusekelayo |
Izinga lokudla | Kuhlangabezana nomthetho wokuthinta ukudla | Umthetho nokwakheka | Ilebula engacacile kuphela |
Ibhaliswe ne-FDA | Isikhungo, hhayi umkhiqizo | Ukubhaliswa kwesikhungo uma kufanele | Isigunyazo somkhiqizo esisobala |
Isiqinisekiso Sobunjiniyela Nosekelo Lwephrojekthi
Ithangi ngalinye elilethwa yiShijiazhuang Zhengzhong Technology Co., Ltd. (Center Enamel) lakhiwe ngokuhambisana ne-AWWA D103-09 kanye ne-EN 1090 ngokuqinisekiswa kwe-finite element yomthwalo wegobongo, uphahla kanye ne-nozzle, lincibilikiswa ku-820-930°C ngaphansi kokulawulwa kwe-ISO 9001 ne-ISO 45001, lihlolwa nge-holiday test ku-1500 V kuyo yonke indawo engaphezulu, futhi lihlanganiswa ngamabhawodi e-Grade 8.8 kanye ne-sealant eqinisekiswe umkhiqizi. Amathangi athinta ukudla anikezwa nobufakazi bokuhambisana kwezinga lezingxenye ngaphansi kohlaka lwe-U.S. FDA - i-enamel noma i-coating kanye ne-sealant zibiziwe futhi zingaphakathi kwemikhawulo - izitatimende ezifanele zilethwa kanye namarekhodi ethangi, futhi umklamo wesakhiwo wenziwa ngokwekhodi esebenzayo.
I-FDA ayigunyazi amathangi okugcina aphelele; igunyaza izinto ezithinta ukudla eziqukethwe kuwo. Ithangi lihambisana ne-FDA lapho zonke izingxenye ezimanzi - ukumboza, isivalo, amagaskethi, izinto zokuxhuma - zihlangabezana ne-21 CFR, okuboniswa izitatimende zezinga lezinto kunokuba kube isitembu somkhumbi.
Imibuzo Evame Ukubuzwa (FAQ)
Ingabe ithangi lingadayiswa njengeligunyazwe yi-FDA?
Ngokuqinile, cha - i-FDA ayigunyazi amathangi aqediwe. Umhlinzeki angafaka isicelo esifanele kuphela sokuthi izingxenye ezithinta ukudla zihambisana nohlaka lwe-FDA. Uma isilinganiso sithi 'ithangi eligunyazwe yi-FDA', cela ubufakazi bezinga lezingxenye; ulimi olunembile lubalulekile ekuhlolweni nasekungenisweni.
Ingabe insimbi engagqwali idinga isitifiketi se-FDA?
I-Stainless 304 noma i-316L ngokuvamile ibonwa njengokufanele ukuthintana nokudla, kodwa ukuhambisana kukhonjiswa ngezinga, ukuqedwa kanye nanoma yimaphi ama-gaskets noma ama-coatings asetshenzisiwe, hhayi isitifiketi sezinga lethangi. Emsebenzini wokudla okunamandla noma okufudumele, i-alloy ethile kanye nesimo sendawo kufanele kuqinisekiswe.
Ingabe ukubhaliswa kwesikhungo kwanele ukukhombisa ukuhambisana?
Cha. Ukubhaliswa kwesikhungo kumayelana nesikhungo sokudla, hhayi umkhiqizo. Akukutsheli lutho mayelana nokuthi i-coating noma i-sealant yethangi iyahambisana yini ne-21 CFR. Izitatimende zokuhambisana kwezinto ziwubufakazi obalulekile.
Ingabe ithangi lingenzelwa imithetho yokuthintana nokudla yase-U.S.?
Yebo. Udonga kanye ne-sealant kungakhethwa futhi kubhalwe phansi ngokuhambisana ne-21 CFR yemakethe yase-U.S., nezitatimende zokuhambisana kwezingxenye zilethwa ekunikezelweni kanye nokulandelwa kokwakheka okungafinyeleleka kumaphaneli anikeziwe.
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