Kwimeko yanamhlanje yokhathalelo lwempilo, ukufikelela okuqinisekileyo kwi I-Community eNcinci yeHlabathi yinto enkulu. Ukusuka kwelona lilula I-Cotton Swabs ukubaluleka I-gauze yezonyangoEzi zinto zidlala indima ebalulekileyo kwinkathalo yesigulana nolawulo losulelo. Eli nqaku libonisa umhlaba we Izinto zokugcina zonyango ezilahlekileyo, ephakamisa ukubaluleka komgangatho, ukuthobela, kunye nokufumana iqabane elifanelekileyo lokwenza. Nokuba ungumphathi wemveliso yesibhedlele, umhambisi wonyango, okanye umlawuli weklinikhi, ukuqonda imeko ye I-Healthy Healds Iqhosha lokubonelela ngononophelo lwezigulana ezifanelekileyo.
Kutheni le nto izidumbulu zinokuchitheka zibalulekile kwimpilo yanamhlanje?
Ukunyuka kwe I-Community eNcinci yeHlabathi Unoguquko lwempilo yempilo, ephucula kakhulu ukhuseleko lwezigulana kunye nolawulo losulelo. Khawufane ucinge ihlabathi apho Ikotoni yezonyango kwaye I-Gauze Bandeges Kwakhiwa kwakhona-umngcipheko wokungcoliseka komnqamlezo kuya kuba kukhulu kakhulu. Sebenzisa iimveliso zonyango olunye njenge Iibhola zekotoni, iintlobo ezahlukeneyo ze I-gauze yezonyango, kwaye Imaski yobuso Nikeza umqobo omtsha, onesidima kwisigulana ngasinye, ukunciphisa kakhulu ukusasazeka kosulelo.
Ukusuka kwisenzo esilula sokucoca inxeba nge I-Stele Gauze Swab kwiinkqubo ezintsonkothileyo ezifuna I-Subrical Shoures ngeenaliti, Ukuchikwa kwezinto kubalulekile. Cinga ngokusetyenziswa kwe I-Nasal Osnurnus cannulas Ngenkxaso yokuphefumla - uyilo lokusetyenziswa kwesigulana olunye lubalulekile kucoceko. Ngokufanayo, Amaphepha ebhedi yezonyango kwaye I-caps ezonyango Igalelo kwindalo esicocekileyo, ekhuselekileyo. Ukulula kunye nokhuseleko olunikezelweyo Izinto zokugcina zonyango ezilahlekileyo Vumela oochwephesha bempilo ukuze bagxile kukhathalelo lwezigulana ngaphandle komthwalo ongezelelweyo weenkqubo ze-steigration ezingqongqo kwezi zinto ziqhelekileyo. Oku kusebenza kakuhle kuhambelana nokugcina iindleko ekuhambeni kwexesha, ngaphandle kokuthenga okuphindaphindiweyo.
Zeziphi iintlobo zokuthengisa ezilahlekileyo zonyango ezikhoyo?
Uluhlu lwe I-Community eNcinci yeHlabathi Ngaba inkulu, inyamekele iimfuno ezahlukeneyo kuzo zonke iintlobo zonyango ezahlukeneyo. Njengomntu ophambili umzi-mveliso Imigca yesixhenxe lemveliso, thina, thingging, sinike ukhetho olupheleleyo, kubandakanya:
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Iimveliso zekotoni zonyango: Eli nqanaba libandakanya izinto ezibalulekileyo Ikotoni yezonyango, Iibhola zekotoni, kwaye I-Cotton Swabs. Bethu Ikotoni yezonyango ifunyenwe ngenxa yokuzithemba kwayo kwaye icocekile, ilungele izicelo ezahlukeneyo.
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Iimveliso zeGauze: Sinika uluhlu olubanzi lwe I-gauze yezonyango, kubandakanya I-Gauze Bandeges, I-Gauze Roll, kwaye I-Gauze Swabs. Bethu I-Gauze Bandeges ziyafumaneka kwiisayizi ezahlukeneyo kunye nezixhobo ukuze zihambelane neemfuno zenxeba ezahlukeneyo.
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I-Cotton yamazinyo I-Cotton: Yenzelwe ngokukhethekileyo iinkqubo zamazinyo, bethu I-Cotton yamazinyo Nikeza i-absorby ebalaseleyo kwaye iyafumaneka kubungakanani ohlukeneyo.
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I-Noploven Inhleys: Eli luhlu libandakanya izinto zokulawula usulelo olubalulekileyo I-Propoloys egadayo / amaphepha esidiliya, ubuso beMaski (kubandakanya bethu Ubuso bonyango), Ukuhlukaniswa, Amaphepha ebhedi yezonyango (Jonga wethu Iphepha lokulala lonyango), I-caps ezonyango, isihlangu sigubungela, kwaye I-rogical gowns.
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Unonophelo lokuphefumla: Sinikezela ngeemveliso zenkxaso yokuphefumla enjenge I-Nasal Osnurnus cannulas (Jonga wethu ioksijini yeoksijini ye-nasal), I-Ibilizer i-Masks, kunye neMaski yeOxygen.
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Izinto zoqhaqho: Izinto zethu zokuhlinzwa zibandakanya Ukukhupha iityhubhu, I-Blades ye-Scalpels, I-Subrical Shoures ngeenaliti (jonga yethu I-Sterle Suture ngenaliti), kwaye I-Yankeuer Hardles.
Olu candelo lemveliso olubanzi lwemveliso luqinisekisa ukuba ababoneleli bezempilo banokuqulatha inxenye ebalulekileyo yezixhobo zabo ezibalulekileyo kumthombo omnye, onokuthenjwa.
Ukuqinisekisa umgangatho: Yintoni eyenza ukuba kungabinakho ukungabi natyala?
Kuba I-Community eNcinci yeHlabathi, umgangatho awukhona. Izixhobo ezisetyenzisiweyo, inkqubo yokwenziwa, kunye nokubambelela kwimilinganiselo yazo zonke izinto ezibalulekileyo. Iimveliso ezinokuthenjwa ziqala nge Izixhobo ezikumgangatho ophakathi. Umzekelo, bethu Ikotoni yezonyango Kukhethwe ubunyulu bayo kunye nokufumana i-arsity, ukuqinisekisa ukuba ihlangabezana neemfuno ezinqabileyo zokusetyenziswa kwezonyango. Ngokufanayo, amalaphu asetyenziswa kwithu I-nonphove ihlahleni njenge Ukuhlukaniswa kwaye ubuso beMaski zikhethwe kwipropathi yabo yomqobo kunye nokuphefumla.
Ukungasebenziyo yinye inkxalabo enkulu kakhulu Izinto zokugcina zonyango ezilahlekileyo. Izinto ezinje I-Subrical Shoures ngeenaliti, I-Stele Gauze Swabs, kwaye iintlobo ezithile ze I-Gauze Roll Kufuneka ungenise iinkqubo zokuziqhelanisa nezixhobo ezingqongqo ukuphelisa i-microorganisms. Siqinisekisa ukuba iimveliso zethu zeziyolo zifezekisa imigangatho eyaziwayo, zibonelela ngokuzithemba kukhuseleko lwabo. Ukuthobela Imigaqo yezonyango kunye neZiqinisekiso Itestamente yokuzibophelela komenzi kumgangatho. Ukuthathwa kweziqinisekiso ezifana ne-ISO 13485 kubonisa ukuba inkqubo yethu yolawulo yomgangatho idibana nemigangatho yehlabathi yezixhobo zonyango. Ngapha koko, kuxhomekeka kwimakethi ekujoliswe kuyo, ukuthotyelwa kwe-DAMakisha okanye imigaqo yelizwe kubalulekile ekuqinisekiseni ukwamkelwa kwemveliso kunye nokhuseleko. Iimpawu ezifana nokukhetha i-hypoallergenic yemveliso ethile inika izigulana ezinobuntu, zibonisa ukubaluleka kokukhetha kunye neenkqubo zemveliso. Ekugqibeleni, intsebenzo eyomeleleyo nenokuthenjwa lulindelo oluphambili. A Iqela le-Gauze Bandege kufuneka ikhuseleke inxeba, kwaye a ioksijini yeoksijini ye-nasal kufuneka ihambise ioksijini ngokuthembekileyo.
I-Stele vs. engeyiyo i-non-en
Umahluko phakathi kwe-suble kunye ne-stele Izinto zokugcina zonyango ezilahlekileyo ibalulekile kwaye ixhomekeke ngokupheleleyo kwisicelo esijongwayo. Iimveliso ze-Stele zisebenza ngenkqubo yokuqinisekiswa kweSterilizal yokuphelisa zonke iintlobo zobomi bentsholongwane, ukuqinisekisa ukuba zikhuselekile ukuba zisetyenziswe ngokudibana ngqo namanxeba avulekileyo okanye ngexesha lenkqubo engahlambulukanga. Imizekelo ibandakanya I-Stele Gauze Swabs isetyenziselwe ukucoca, I-Subrical Shoures ngeenaliti, kwaye ezithile I-Gauze Roll yenzelwe ukupakisha amanxeba. Ukusebenzisa izinto ezizezimali kwezi meko kubalulekile ukuthintela usulelo lwendawo kunye nezinye iingxaki.
Engagungqi I-Community eNcinci yeHlabathiKwakwelinye icala, zenziwa kwiindawo ezilawulwayo kodwa azizange zenzeke. Ezi mveliso zilungele izicelo apho umngcipheko wokosuleleka usezantsi okanye apho ulusu luhlala khona. Imizekelo ibandakanya Iibhola zekotoni isetyenziselwa ukusebenzisa amayeza aphezulu, Amaphepha ebhedi yezonyango, I-caps ezonyango, kwaye isihlangu sigubungela. Ngelixa ingeyiyo ingozi, ezi zinto zisafaka igalelo ekugcineni imeko ecocekileyo. Isigqibo sokusebenzisa i-STREEL EKUFUNDISELELAYO IIMPAWU ZOKUGQIBELA njenge I-Gauze Bandeges ihlala ixhomekeke kubungakanani kunye nobume benxeba. I-abrarions encinci, i-non-guile inokwenzeka, ngelixa i-sueze inyanzelekile ukuba ibe ngamanxeba. Ukuqonda olu mahluko kubalulekile kubaphathi bezempilo kunye nabasebenzi beklinikhi ukuqinisekisa ukuba iimveliso ezifanelekileyo zisetyenziselwa imeko nganye.
Xa ukhunjulwa I-Community eNcinci yeHlabathi, ukuqonda kunye nokuqinisekisa ukungqinisisa okufanelekileyo kubaluleke kakhulu ekuqinisekiseni ukhuseleko lwemveliso kunye nokuthotyelwa kweMigaqo. Ezi kuqiniselelo zisebenza njengokuqinisekiswa ngokuzimeleyo ukuba umenzi unamathele kwimigangatho esekwe kunye nezokhuseleko.
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ISO 13485: Lo ngumgangatho owamkelweyo kwihlabathi jikelele ochaza iimfuno zenkqubo yolawulo lomgangatho (QMS) ekhethekileyo kwishishini lezonyango. Umenzi ophethe isiqinisekiso se-ISO 13485, njengoZhongs, ubonakalisa ukuzibophelela ekuhlanganiseni umthengi rhoqo kunye neemfuno zolawulo lwezixhobo zonyango. Oku kusebenza kuluhlu olubanzi lweemveliso, ukusuka Ikotoni yezonyango ukubaleka Izinto zoqhaqho.
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Makisha: Kwimveliso ezithengiswa kwingingqi yezoqoqosho yaseYurophu (EEA), umahluko we-CE unyanzelekile kwizixhobo ezininzi zonyango, kubandakanya I-Community eNcinci yeHlabathi. IMaki SE CE ibonisa ukuba imveliso ihlangabezana neemfuno ezibalulekileyo kwimiyalelo echaphazelekayo yaseYurophu. Umzekelo, wethu Imaski yobuso kwaye Ukuhlukaniswa Injongo yemakethi yaseYurophu ithwala uMark Mark.
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Imvume ye-FDA (yentengiso yase-US): Ngelixa bekungasoloko kunyanzelekile ukuba kufuneke kuzo zonke iiklasi zezonyango (ezinokuthengiswa ezinokuchitheka okungenasiphelo phantsi), ukuqonda iimfuno zomthetho ze-FDA kubalulekile kubathengisi abajolise kwimakethi yase-US. Ezinye iimveliso zinokufuna iSaziso sePhepha lePhepha lePhepha lePhepha lePhepha lePhepha leMpahla (510 (k) imvume).
Ngaphandle kweziqinisekiso ezikhulu, imigaqo ethile yelizwe inokufaka isicelo. Umzekelo, i-Australia ineemfuno zalo zolawulo lwezinto zexabiso lempahla (i-TGA). Njenge B2b Umthengi ngaphandle kwiNdawo eyahlukeneyo kubandakanya i-USA, amantla Emelika, IYurophu, kwaye Ostreliya, siqinisekisa ukuba iimveliso zethu ziyahambelana nemigaqo eyimfuneko kwimakethi nganye yethagethi. Abathathi-nxaxheba njengoMark Thompson e-USA, eqinisekisa ukuba I-gauze yezonyango, I-SURGIL SURT, kwaye ezinye izinto ezithengiweyo zihlangabezane nemigangatho efanelekileyo yeyona nto iphambili. Ukuqinisekisa ngeziqinisekiso zinika intembelo kwi Umgangatho wemveliso kunye nendalo ye Izinto zonyango.
Izibonelelo zokusebenzisana nomvelisi wesixhobo sonyango ngqo eTshayina?
Ukusebenzisana ngqo nomvelisi wesixhobo sonyango e-China, njengakowethu umzi-mveliso, Zhongking, inika izibonelelo ezibalulekileyo, ngakumbi ngokweendleko zokusebenza kunye nokulawulwa kwenkqubo yemveliso. Ukufunyanwa ngokuthe ngqo kuphelisa amaphepha-mvume, anokubakho kwixabiso lokukhuphisana Ikotoni yezonyango, I-Gauze Bandeges, I-nonphove ihlahleni, kunye nezinye I-Healthy Healds.
Ukusebenza ngqo ne umzi-mveliso ikwabonelela ngendlela engafunekiyo kunye nolawulo lwemveliso ** yemveliso
IXESHA LOKUQALA: UJAN-03-2025