Isihloko seMeta:Iisuti zoKhuseleko ezilahlwayo zokusetyenziswa kwimizi-mveliso nakwizonyango | Umenzi wePPE oqinisekisiweyo

Inkcazo yeMeta:Fumanisa iindlela ezintsha kunye nemigangatho yeesuti zokuzikhusela ezilahlwayo eMelika naseYurophu. I-PPE ephefumlayo, eqinisekisiweyo, nenokwenziwa ngokwezifiso evela kwiFujian Yunge Medical Co., Ltd.

1. Imfuno ekhulayo yeIisuti zokukhusela ezilahlwayo

Kwiinyanga ezintathu ezidlulileyo, uphando lwehlabathi jikelele malunga“Iingubo zokugquma ezilahlwayo”, “Impahla yokukhusela kwimizi-mveliso”kunye"Iisuti eziqinisekisiweyo ze-EN14126"ziye zanda ngokuthe chu kulo lonke elaseMelika, eJamani, eFransi nase-UK.
Olu nyuko lubonisa imigangatho yokhuseleko ephezulu kwindawo yokusebenza, iimfuno zolawulo losulelo eziqinileyo, kunye nokutshintshela kwizinto ezilula neziphefumlayo ukuze umsebenzisi akhululeke ngakumbi.

I-Fujian Yunge Medical Co., Ltd. — eseXiamen, eTshayina — ngumvelisi ochwephesha we-izixhobo zokukhusela ezingalukwangaIisuti zethu zokuzikhusela ezingasetyenziswayo zisetyenziswa kakhuluukhathalelo lwempilo, iilebhu, amagumbi okucoca, izityalo zeekhemikhali, kunye namashishini okulungisa ukutya.

2. Yintoni Eyona Ikhathalelwe Ngabathengi e-US nase-EU

Ngokweendlela zamva nje zokukhangela kuGoogle, abathengi be-B2B bagxile kwiimpawu eziphambili zemveliso:

• Ukuphefumla kunye nentuthuzelo:Izinto ezilula nezingena kumanzi zinciphisa uxinzelelo lobushushu ngexesha lokutshintshana ixesha elide.

• Uzinzo:Umdla kwilaphu elingalukwanga elinokusetyenziswa kwakhona okanye elinobuhlobo nokusingqongileyo uyaqhubeka nokukhula.

• Ukhuseleko oluQinisekisiweyo:Abathengi baya bekhangela ngakumbiEN14126, EN13795kunyeInqanaba lesi-3–4 le-AAMIiziqinisekiso.

• Ukwenziwa ngokwezifiso:Iinketho ze-OEM/ODM kunye nokupakishwa okwenzelwe wena ngabasasazi.

• Ukuthembeka kobonelelo ngobuninzi:Umthamo wemveliso ozinzileyo kunye namaxesha amafutshane okufumana isibonelelo abalulekile ekukhetheni ababoneleli.

3. Imigangatho ephambili kunye neziqinisekiso

Imarike yaseYurophu (i-EU)

• EN 14126:Ukhuseleko kwiintsholongwane ezibangela izifo (ezibalulekileyo kunyango nasekusetyenzisweni kwelebhu).

• EN 13795:Imigangatho yeengubo zotyando kunye neengubo zokwaleka, ezisetyenziswa kakhulu kwiinkonzo zonyango.

• Isiqinisekiso se-CE:Iyimfuneko ekungenisweni nasekuthengisweni kwePPE ngaphakathi kwiManyano yaseYurophu.

IMarike yase-United States (e-US)

• Amanqanaba 1–4 e-AAMI PB70:Ichaza amanqanaba okusebenza kokuthintela ulwelo kwiingubo zokwahlukanisa kunye neengubo zokugquma.

• Ubhaliso lwe-FDA:Kufuneka kwiimpahla zokukhusela zonyango ezithengiswa kwicandelo lezempilo.

• I-ASTM F1670/F1671:Iindlela zovavanyo eziqhelekileyo zokuvavanya igazi elenziweyo kunye nokungena kwentsholongwane.

Iingubo zethu zokugquma ezingasetyenziswayo kunye neengubo zokuzigcina zodwa ziyahlangabezana nale migangatho yamazwe ngamazwe, zibonelelazombini ukhuseleko oluthuthuzelayo noluqinisekisiweyo.

4. Iimpawu zeMveliso Abathengi Abazifunayo

Ngokusekelwe kwidatha yophendlo lwakutshanje, ezona mpawu zidumileyo zesuti yokuzikhusela ziquka:

• Ilaphu elingelolukiweyo elinomoya omncinci elinomoya omncinci ukuze likwazi ukumelana nolwelo

• I-hood ethambileyo, ii-cuffs, kunye namaqatha okugquma umzimba wonke

• Iziphu engaphambili eneflegi yesaqhwithi ukuthintela ungcoliseko

• Ukutywinwa komthungo ukuze kubekho ukhuseleko oluphezulu

• Ifumaneka kwi40–65gsm, ifanelekile ukusetyenziswa kwezonyango nakwimizi-mveliso

• Umbala, ilogo, kunye nobungakanani obukhethiweyo

Ezi mpawu ziqinisekisa ukuba iisuti zethu zokuzikhusela zifanelekileukuphathwa kweekhemikhali, ukulungiswa kokutya, ukugcinwa kwegumbi lokucoca, kunye nokwahlukaniswa kwezonyangoiindawo ezingqongileyo.

5. Kutheni Ukhetha iFujian Yunge Medical Co., Ltd.

I-Fujian Yunge Medical Co., Ltd. ibigxile kakhulu kwi-i-spunlace kunye nezinto zokukhusela ezingalukwangaukusukela ngo-2017.
Asingomenzi nje kuphela kodwa sikwangumnikezeli wezisombululo, sinikezelaInkxaso ye-R&D, imveliso eyenziwe ngokwezifiso, kunye neenkonzo zokuthumela ngaphandle ngobuninzi.

Iingenelo zethu:

• Amaxabiso ngqo avela kufektringolawulo olungqongqo lomgangatho

• UkuthobelaImigangatho ye-EN kunye ne-AAMI

• Ukuhanjiswa okukhawulezayo kunye ne-MOQ eguquguqukayo

• I-OEM/ODMyamkelwe kubasasazi behlabathi

6. Qhagamshelana Nathi

Ukuba ujonge iumthengisi othembekileyo weesuti zokuzikhusela ezilahlwayoNgeemfuno zakho zempilo, zoshishino, okanye zorhwebo, nceda uqhagamshelane nathi:

I-Fujian Yunge Medical Co., Ltd.
I-imeyile: lita@fjxmmx.com
I-WhatsApp:+86 18350284997
Indawo: Xiamen, Fujian, China

Silangazelela ukubonelelaimpahla yokukhusela eqinisekisiweyo, ephefumlayo, nehlala ixesha elideukuxhasa ishishini lakho kulo lonke elaseYurophu nase-United States.