Kev Kho Mob vs Tsis yog-Kev Kho Mob Tsis yog-Cov khoom lag luam hauv EU
Qib Kev Kho Mob (Lub ntsej muag, lub kaus mom, khau npog, ris tsho)
Kev cai: EU Medical Device RegulationMDR 2017/745(Class I/Is).
Txuj: TS EN 14683(Qhov ncauj qhov ntswg: Hom I / II / IIR);TS EN 13795(gowns/caps/shoe covers)European Commission.
Kos npe: CE 0000(4-tus lej ceeb toom lub cev yog tias tsis muaj menyuam); sau npe "Medical Device"/"Surgical".
Kev ua tau zoo:
Qhov ncauj qhov ntswg:BFE Ntau dua lossis sib npaug li 95% (Hom I); BFE Ntau dua lossis sib npaug li 98% (Hom II / IIR, txaws-resistant)European Commission.
Hnav khaub ncaws / Caps / Khau Npog: Dej tsis kam, thaiv kev ua haujlwm, kev xaiv tsis muaj menyuam.
Npaj siv: Cov chaw kho mob (tsev kho mob, chaw kho mob, phais) European Commission.
Tsis yog- Qib Kho Mob (Civil/Industrial Use)
Kev cai: PPE Txoj Cai EU 2016/425(rau kev tiv thaiv plua plav / paug) lossis kev nyab xeeb dav dav (tsis muaj ntaub ntawv kho mob).
Txuj: TS EN 149(PPE lub tshuab ua pa: FFP1/2/3); tsis muaj tus qauv kho mob rau cov tsis yog-cov kaus mom / npog.
Kos npe: CE(tsis muaj 4-tus lej NB rau kev tshaj tawm tus kheej); sau npe "Civil Use"/"Industrial Hygiene".
Kev ua tau zoo: Tsis muaj kev kho mob -qeb kab mob / dej thaiv; yooj yim plua plav / av tiv thaiv.
EU Customs Clearance Requirements
Rau Kev Kho Mob - Cov Khoom Qib
CE Marking: Yam yuav tsum tau ua (Class I: tus kheej- tshaj tawm; Class Is/sterile: Ceeb Toom Certificate Certificate).
Cov ntaub ntawv Technical: Tag nrho cov ntaub ntawv (tsim, kev soj ntsuam kev pheej hmoo, cov ntawv xeem, IFU).
Tus Neeg Sawv Cev Tso Cai (EC Rep): EU-raws li kev sib cuag rau cov tsis yog-EU manufacturers.
Kev Sau Npe EUDAMED: UDI (Unique Device Identification) rau traceability.
ISO 13485 Kev Tswj Xyuas Kev Lag Luam: Daim ntawv pov thawj kev tswj xyuas zoo (yuav tsum tau muaj cov khoom tsis muaj menyuam).
Cov ntaub ntawv kev lis kev cai: Bill of Lading, Commercial Invoice, Packing List, CE Certificate, DoC.
Rau Tsis yog-Kev Kho Mob- Cov Khoom Qib
CE Marking: Rau PPE (EN 149): Daim ntawv pov thawj lub cev ceeb toom; rau kev tu cev yooj yim: tus kheej- tshaj tawm.
Cov ntawv xeem: Pov thawj ntawm kev ua raws li cov qauv tsim nyog (xws li EN 149 rau FFP lub qhov ncauj qhov ntswg).
Kev sau npe: Clear "Tsis yog{0}}Kev kho mob"/"Kev siv pej xeem" nqe lus; tsis muaj ntaub ntawv kho mob yuam kev.
Cov ntaub ntawv kev lis kev cai: Bill of Lading, Commercial Invoice, Packing List, CE DoC/Certificate.
