Njengoko imfuno yehlabathi yezixhobo zonyango ezilahlayo ezikumgangatho ophezulu ziqhubeka zikhula, imibutho elawulayo eYurophu nase-United States iqinisa iimfuno zokuthotyelwa-ingakumbi kwiisirinji kunye nezinto ezisetyenziswayo zokuqokelela igazi. Ezi zixhobo zonyango zibalulekileyo ziphantsi koqwalaselo olukhulayo ngenxa yokusetyenziswa kwazo ngokubanzi kuxilongo, ugonyo, kunye nokhathalelo lwezigulane.
Kubavelisi, abarhwebi, kunye nabasasazi, ukuqonda le migangatho iphuhlayo ayikokuhlangabezana neemfuneko zomthetho-kubalulekile ekuqinisekiseni ukhuseleko lwemveliso, ukuphucula ukufikelela kwimarike, kunye nokwakha intembeko yexesha elide.
Ugxininiso olungqongqo kuKhuseleko nokulandeleka
Kuzo zombini i-European Union kunye ne-United States, ukhuseleko lwesigulane ngoyena mqhubi uphambili emva kweenguqu ezintsha zolawulo. Umzekelo, i-EU's Medical Device Regulation (MDR), ethathe indawo ye-MDD yangaphambili ngo-2021, igxininisa uvavanyo olubanzi lweklinikhi, uvavanyo lomngcipheko, kunye nokucupha emva kokuthengisa.
E-US, i-FDA's 21 CFR Part 820 (Quality System Regulation) iyaqhubeka ukusebenza njengesiseko semigangatho yokwenziwa. Nangona kunjalo, uhlaziyo oluzayo oluhambelana ne-ISO 13485 luya kubeka ugxininiso olunzima ekulandeleni kunye namaxwebhu-ingakumbi kwizixhobo zeClass II ezifana neesirinji kunye neetyhubhu zokuqokelela igazi.
Kuthetha ntoni oku kubaboneleli? Inqanaba ngalinye lekhonkco lokubonelela-ukususela ekukhethweni kwezinto ezikrwada ukuya kwipakethe-ngoku kufuneka lilandeleleke kwaye liqinisekise.
Ugxininiso kwi-Biocompatibility kunye noQinisekiso lweNzalo
Ngokunyuka kweenkxalabo malunga nokuphendula kwesigulana kunye nobungozi bosulelo, uvavanyo lwe-biocompatibility alusakhethi. Abalawuli baseYurophu nabase-US bafuna uvavanyo olunzulu phantsi kwemigangatho ye-ISO 10993 ukuqinisekisa ukuba izinto ezisetyenziswa kwiisirinji, iilancethi, kunye neetyhubhu zikhuselekile kunxibelelwano lwabantu.
Ukongeza, iinkqubo zokuvala inzala (ezifana ne-ethylene oxide okanye i-gamma irradiation) kufuneka zihlangabezane neemfuno zokuqinisekisa ezichazwe kwi-ISO 11135 okanye i-ISO 11137, ngokulandelelanayo. Uqinisekiso lokungazali lubaluleke kakhulu kwiimveliso ezizaliswe kwangaphambili okanye ezisetyenziswa ekuqokeleleni igazi ngokuthe ngqo.
Kubathengi bezonyango kunye nabarhwebi abavela kwamanye amazwe, oku kuthetha ukukhetha ababoneleli abanokubonelela ngeengxelo ezibhaliweyo zobunyumba kunye neenkqubo eziqinisekisiweyo kubaluleke kakhulu kunangaphambili.
I-Eco-Conscious Materials kunye neeMfuno zokuPakisha eziZinzileyo
Kwiminyaka yakutshanje, ukuzinza kuye kwasuka kumyalezo wokuthengisa ukuya kulindelo lolawulo. I-EU ikhuthaza ngenkuthalo ukunciphisa iiplastiki ezisetyenziselwa enye kunye nezinto ezinobungozi bokusingqongileyo. Nangona iimveliso zonyango zihlala zikhululekile ekuthintelweni, kukho uxinzelelo olukhulayo lokusebenzisa izinto ezinokuphinda zisetyenziswe okanye ezisekwe kwibhayoloji naphina apho kunokwenzeka.
Ngokukwanjalo, imakethi yase-US-ingakumbi phakathi kwenethiwekhi enkulu yokuthengwa kwezempilo-iya ivavanya iimveliso ngokusekwe kwindawo yazo yokusingqongileyo. Ukupakishwa okunciphisa inkunkuma, okanye izixhobo ezenziwe nge-BPA-free kunye ne-DEHP-free materials, ziba yinto eqhelekileyo.
Kubavelisi bezinto ezityiwayo zokuqokelela igazi kunye neesirinji, ukuziqhelanisa nolu lindelo akuyi kuhlangabezana nokuthotyelwa kuphela-kodwa kuya kwandisa ukukhuphisana.
Ukubaluleka kokuFakwa kweeleyibhile okuchanekileyo kunye nokuThotyelwa kwe-UDI
Izigqeba ezilawulayo ziyakuchitha ukuchaneka kweelebhile. I-EU MDR kunye ne-US FDA zombini zifuna ukuba iimveliso ziprinte ngokucacileyo i-Unique Device Identifiers (UDI), imihla yokuphelelwa, amanani ebhetshi, kunye nolwimi lwasekuhlaleni kwiimarike ezithengiswa kuzo.
Ukungaphumeleli ukuhlangabezana nale migangatho kunokubangela ukulibaziseka, ukukhumbula, okanye ukulahlekelwa ukufikelela kwimarike. Ukukhetha inkqubo yokupakisha kunye nokuleyibheli exhasa iimfuno zolawulo lokuleyibheli linyathelo elibalulekileyo ekuqinisekiseni ukusebenza ngokungenamagingxi-gingxi kokungenisa/ukuthumela ngaphandle.
ImiGaqo yokuHamba ngokuzithemba
Ukuhamba kwindawo yokulawula enzima eYurophu nase-US kufuna okungaphezulu nje kokuthotyelwa kwesiseko-kufuna ukulungiswa okusebenzayo, ukuqinisekiswa kwemveliso eqhubekayo, kunye nokuqwalasela ngokusondeleyo kwiimpawu ezivelayo.
Kubathengi, abarhwebi, kunye nababoneleli bezempilo ngokufanayo, ukuhlala unolwazi malunga nemimiselo yamva nje kwiisirinji kunye nezinto ezisetyenziswayo zokuqokelela igazi kubalulekile ukwenza izigqibo zobulumko.
Ngaba ujonge ukuqinisekisa ukuba iimveliso zakho zonyango ezilahlayo ziyahlangabezana nemigangatho yolawulo yehlabathi? Finyelela kwiSinomed namhlanje kwaye ujonge ukuba izisombululo zethu zikuxhasa njani ukuthotyelwa kwakho kunye neenjongo zomgangatho.
Ixesha lokuposa: Jun-23-2025
