Muva nje, i-Haiyan Kangyuan MedicalInsimbi I-Co., Ltd. yaphumelela ngempumelelo isitifiketi se-ISO13485:2016 sokuphathwa kwekhwalithi yedivayisi yezokwelapha.Ukubuyekezwa konke kuthatha izinsuku ezintathu,rokuhambisana nohlelo lokuphatha ikhwalithi, ukuhlonzwa kwenqubo nokuhlaziya, izibopho zokuphatha, ukubuyekezwa kokuphatha, izinjongo zekhwalithi, ukuhlaziywa kwedatha, izinsiza zabantu, ingqalasizinda, izinqubo eziphathelene namakhasimende, ukuklama nokuthuthukiswa, ukuthengwa kwempahla, ukukhiqizwa kanye nokuhlinzekwa kwesevisi nendawo yokugcina impahla, ukuphathwa kwezinhlekelele, inqubo ukuqinisekiswa, ukuvala inzalo, ukulandeleka, isimo sokuhlonza, ukuvikelwa komkhiqizo, ukuqapha nokulawula okokusebenza kokulinganisa, impendulo yokwaneliseka kwekhasimende (okuhlanganisa nokusingatha isikhalazo), uhlelo lokuxwayisa, ukucwaninga kwangaphakathi, ukulawulwa komkhiqizo okungavumelani, izinyathelo zokulungisa nezokuvimbela, ukubuyekezwa kombhalo wezobuchwepheshe, njll.

This ukucwaningwa kwamabhuku, okuqinisekiswe ithimba lokucwaningwa kwamabhuku esizeni, kuqinisekise ukuthi zonke izinqubo zocwaningo lwe-Kangyuan Medical kanye nentuthuko, ukukhiqizwa nokuthengisa kwenziwa ngokuhambisana nezinhlinzeko zemibhalo yesistimu yokuphatha ikhwalithi, futhi kunconywa ukuthi kukhishwe isitifiketi.

Njengendinganiso yesistimu yokuphatha ikhwalithi eyaziwa emhlabeni wonke yemboni yemishini yezokwelapha, indinganiso entsha ye-ISO13485:2016 (uhlelo lokuphatha ikhwalithi yedivayisi yezokwelapha yezidingo zokulawula) ikhishwe ngokusemthethweni ngomhla ka-1 Mashi 2016.Inguqulo yango-2016 yezinga elisha le-ISO13485 lengeza inani elikhulu lezinqubo ezihamba phambili zemboni yemishini yezokwelapha, ehambisana nezimfuneko zemithetho ethile yemishini yezokwelapha kazwelonke, iwuhlelo lokuphatha ikhwalithi kanye nokubhaliswa kokulawula nokuqondisa amazinga ahlanganiswe eduze kakhulu.

I-Kangyuan Medical yaphasisa isitifiketi okwesithathu, esingabonisi nje kuphela ukuqashelwa okuphelele kwemikhiqizo ye-Kangyuan yizinhlangano zamazinga omhlaba, kodwa futhi kuphawula ukumiswa okwengeziwe, ukumiswa kanye nokwenziwa kwamanye amazwe kwesistimu yokuphatha ikhwalithi yezokwelapha yase-Kangyuan.

Njengamanje, i-Kangyuan Medical nayo yenza i-US FDA, isicelo sesitifiketi se-EU MDR kanye nomunye umsebenzi.Sithemba ukuthi ngokwesekwa “okudlula” okukhulayo komhlaba wonke, i-Kangyuan izohlanganisa zonke izinhlobo zama-silicone catheter, ama-temperature catheter, i-laryngeal mask airway catheter, endoithubhu loqhoqhoqho, ukumuncai-catheter, ishubhu lesisu, imaski ehlukahlukene kanye neminye imikhiqizo yezokwelapha emhlabeni wonke, enikeza iziguli eziningi emhlabeni wonke, nokusiza imikhiqizo yezokwelapha ukuthi ithuthukiswe ngokuphelele!