Amalebula e-UDI angakwazi ukuhlonza amadivaysi ezokwelapha ngokusatshalaliswa kwawo kanye nokusetshenziswa kwawo.Umnqamulajuqu wokumaka Ikilasi 1 namadivayisi angafakwanga ohlwini luyeza maduze.
Ukuze kuthuthukiswe ukulandeleka kwemishini yezokwelapha, i-FDA isungule uhlelo lwe-UDI futhi yalusebenzisa ngezigaba eziqala ngo-2014. Nakuba i-ejensi yahlehlisa ukuthobela i-UDI ku-Class I kanye namadivayisi angekho esigabeni kuze kube uSepthemba 2022, ukuthobela ngokugcwele kwe-Class II kanye ne-Class III kanye imishini yezokwelapha efakelwayo okwamanje idinga ukusekela ukuphila kanye nemishini esekela ukuphila.
Amasistimu e-UDI adinga ukusetshenziswa kwezihlonzi zedivayisi ezihlukile ukumaka izinsiza zezokwelapha kukho kokubili okungafundwa umuntu (umbhalo ongenalutho) kanye namafomu afundeka ngomshini kusetshenziswa ubuchwepheshe bokuhlonza okuzenzakalelayo kanye nokuthwebula idatha (AIDC).Lezi zihlonzi kufanele zivele kulebula nasemaphaketheni, futhi ngezinye izikhathi kudivayisi ngokwayo.
Amakhodi afundeka abantu nemishini akhiqizwe (ngokuhamba kwewashi ukusuka ekhoneni elingaphezulu kwesokunxele) iphrinta ye-inkjet eshisayo, umshini wokuphrinta we-thermal transfer overprinting (TTO) kanye ne-UV laser [Isithombe ngenhlonipho ye-Videojet]
Amasistimu wokumaka nge-laser avame ukusetshenziselwa ukuphrinta nokumaka ngokuqondile emishinini yezokwelapha ngoba angakhiqiza amakhodi ahlala njalo kumapulasitiki amaningi aqinile, ingilazi, nezinsimbi.Ubuchwepheshe obungcono kakhulu bokuphrinta nokumaka bohlelo olunikeziwe buncike ezintweni ezihlanganisa i-substrate yokupakisha, ukuhlanganiswa kwemishini, isivinini sokukhiqiza, nezidingo zekhodi.
Ake sibhekisise izinketho zokupakisha ezidumile zemishini yezokwelapha: I-DuPont Tyvek namaphepha ezokwelapha afanayo.
I-Tyvek yenziwe ngemicu ye-polyethylene (HDPE) enhle kakhulu futhi eqhubekayo.Ngenxa yokumelana nezinyembezi, ukuqina, ukuphefumula, umgoqo we-microbial kanye nokuhambisana nezindlela zokuvala inzalo, iyinto ethandwayo yokupakisha idivayisi yezokwelapha.Izitayela ezihlukahlukene ze-Tyvek zihlangabezana namandla emishini nezimfuneko zokusebenza zokuvikela zokupakishwa kwezokwelapha.Izinto ezisetshenziswayo zenziwa zibe yizikhwama, izikhwama kanye nezivalo ze-form-fill-seal.
Ngenxa yokuthungwa kweTyvek nezici eziyingqayizivele, ukukhetha ubuchwepheshe bokuphrinta amakhodi e-UDI kuyo kudinga ukucatshangelwa ngokucophelela.Ngokuya ngezilungiselelo zomugqa wokukhiqiza, izidingo zejubane kanye nohlobo lweTyvek olukhethiwe, ubuchwepheshe obuthathu obuhlukene bokunyathelisa nokumaka bunganikeza amakhodi ahambisanayo e-UDI womuntu nomshini afundekayo.
I-inkjet eshisayo ubuchwepheshe bokuphrinta obungathintani nabo obungasebenzisa oyinki abathile abasuselwe ku-solvent nabasuselwe emanzini ukuphrinta ngesivinini esikhulu, nokucaca okuphezulu ku-Tyvek 1073B, 1059B, 2Fs, kanye ne-40L.Imibhobho eminingi ye-cartridge yephrinta iphusha amaconsi kayinki ukuze akhiqize amakhodi anokulungiswa okuphezulu.
Amakhanda amaningi okuphrinta e-inkjet ashisayo angafakwa kukhoyili yomshini we-thermoforming futhi abekwe ngaphambi kokuvalwa kokushisa ukuze aphrinte ikhodi kukhoyili yekhava.Ikhanda lokuphrinta lidlula kuwebhu ukuze lifake amaphakheji amaningi kuyilapho lifanisa izinga lenkomba kuphasi eyodwa.Lawa masistimu asekela ulwazi lomsebenzi oluvela kusizindalwazi sangaphandle nezikena zebhakhodi eziphathwa ngesandla.
Ngosizo lobuchwepheshe be-TTO, ikhanda lokuphrinta elilawulwa ngedijithali lincibilikisa uyinki okuribhoni ngokuqondile ku-Tyvek ukuze uphrinte amakhodi anokulungiswa okuphezulu nombhalo wezinhlamvu nezinombolo.Abakhiqizi bangakwazi ukuhlanganisa amaphrinta e-TTO emigqeni yokupakisha eshintshashintshayo enyakazayo enyakazayo enyakazayo esheshayo neshesha kakhulu.Amaribhoni athile enziwe ngengxube ye-wax ne-resin anokunamathela okuhle kakhulu, ukuqhathanisa nokumelana nokukhanya ku-Tyvek 1059B, 2Fs kanye ne-40L.
Umgomo wokusebenza kwe-laser ye-ultraviolet ukugxila nokulawula umsebe wokukhanya kwe-ultraviolet ngochungechunge lwezibuko ezincane ukuze kukhiqizwe amamaki anomehluko aphezulu, anikeze amamaki amahle kakhulu ku-Tyvek 2F.Ubude begagasi be-ultraviolet belaser bukhiqiza ushintsho lombala ngokusabela kwe-photochemical kwento ngaphandle kokulimaza into.Lobu buchwepheshe be-laser abudingi izinto ezisebenzisekayo ezifana noyinki noma iribhoni.
Lapho ukhetha ubuchwepheshe bokuphrinta noma bokumaka ukuze usize ukuhlangabezana nezimfuneko zekhodi ye-UDI, ukusetshenziswa, ukutshalwa kwezimali, kanye nezindleko zokusebenza zokusebenza kwakho yizo zonke izici okudingeka zicatshangelwe.Izinga lokushisa nomswakama nakho kuthinta ukusebenza kwephrinta noma i-laser, ngakho-ke kufanele uhlole ukupakishwa kwakho nemikhiqizo ngokuya ngendawo okuzungezile ukuze usize ukucacisa isixazululo esingcono kakhulu.
Kungakhathaliseki ukuthi ukhetha i-inkjet eshisayo, ukudluliswa kwe-thermal noma ubuchwepheshe be-laser ye-UV, umhlinzeki wesisombululo sekhodi onolwazi angakuqondisa ekukhetheni ubuchwepheshe obungcono kakhulu bokubhala ngekhodi kwe-UDI ekufakweni kwe-Tyvek.Bangakwazi futhi ukuhlonza nokusebenzisa isofthiwe yokuphatha idatha eyinkimbinkimbi ukuze ikusize uhlangabezane nekhodi ye-UDI nezimfuneko zokulandeleka.
Imibono evezwe kulokhu okuthunyelwe kwebhulogi ingeyombhali kuphela futhi ayibonisi imibono ye-Medical Design and Outsourcing noma abasebenzi bayo.
Ukubhaliswa kwedizayini yezokwelapha kanye nokukhishwa kwemisebenzi.Beka uphawu lokubekisa, yabelana futhi uhlanganyele namajenali wobunjiniyela bedizayini yezokwelapha namuhla.
I-DeviceTalks iyingxoxo phakathi kwabaholi bezobuchwepheshe bezokwelapha.Izehlakalo, ama-podcasts, ama-webinars, kanye nokushintshana komuntu ngamunye kwemibono nemininingwane.
Umagazini webhizinisi wemishini yezokwelapha.I-MassDevice iyiphephabhuku lebhizinisi lezindaba zedivayisi yezokwelapha elixoxa indaba yamadivayisi asindisa ukuphila.
Isikhathi sokuthumela: Dec-14-2021