Haufinyane tjena, Haiyan Kangyuan MedicalSeletsa Co., Ltd. e fetisitse ka katleho ISO13485: 2016 setifikeiti sa tsamaiso ea boleng ba sesebelisoa sa bongaka.Tlhahlobo eohle e nka matsatsi a mararo,re khahliloe ke sistimi ea taolo ea boleng, boitsebahatso le tlhahlobo ea ts'ebetso, boikarabello ba botsamaisi, tlhahlobo ea botsamaisi, lipheo tsa boleng, tlhahlobo ea data, lisebelisoa tsa batho, litšebeletso tsa motheo, lits'ebetso tse amanang le bareki, moralo le nts'etsopele, theko, tlhahiso le litšebeletso le polokelo, taolo ea likotsi, ts'ebetso. netefatso, netefatso ea ho thibela likokoana-hloko, ho latelloa, boemo ba boitsebahatso, ts'ireletso ea sehlahisoa, tlhokomelo le taolo ea lisebelisoa, khotsofalo ea bareki (ho kenyeletsoa le ho sebetsana le litletlebo), sistimi ea temoso, tlhahlobo ea ka hare, taolo ea sehlahisoa e sa lumellaneng, mehato ea tokiso le thibelo, tlhahlobo ea litokomane tsa tekheniki, jj.

This tlhahlobo, e netefalitsoeng ke sehlopha sa liphuputso setšeng, e tiisitse hore lits'ebetso tsohle tsa Kangyuan Medical lipatlisiso le nts'etsopele, tlhahiso le thekiso li etsoa ho latela lipehelo tsa litokomane tsa tsamaiso ea boleng, 'me ho kgothaletswa ho fana ka setifikeiti.

E le tekanyetso ea tsamaiso ea boleng bo amohelehang lefatšeng ka bophara bakeng sa indasteri ea lisebelisoa tsa bongaka, tekanyetso e ncha ea ISO13485: 2016 (sistimi ea taolo ea boleng ba lisebelisoa tsa bongaka bakeng sa litlhoko tsa taolo) e lokollotsoe ka molao ka la 1 Hlakubele 2016.Phetolelo ea 2016 ea maemo a macha a ISO13485 e eketsa palo e kholo ea mekhoa e metle ea indasteri ea lisebelisoa tsa bongaka, e tsamaellanang le litlhoko tsa melaoana e meng ea naha ea lisebelisoa tsa bongaka, ke sistimi ea taolo ea boleng le ngoliso ea taolo le taolo ea litekanyetso tse kopaneng haholoanyane.

Kangyuan Medical e fetisitse setifikeiti ka lekhetlo la boraro, e seng feela ho bonts'a kananelo e felletseng ea lihlahisoa tsa Kangyuan ke mekhatlo ea maemo a machabeng, empa e boetse e tšoaea maemo a holimo, maemo le machaba a tsamaiso ea boleng ba bongaka ba Kangyuan.

Hajoale, Kangyuan Medical e boetse e etsa US FDA, kopo ea setifikeiti sa EU MDR le mosebetsi o mong.Re tšepa hore ka tšehetso ea "pass" e ntseng e eketseha ea lefats'e, Kangyuan e tla koahela mefuta eohle ea li-catheter tsa silicone, li-catheter tsa mocheso, laryngeal mask airway catheter, endotracheal tube, ho monyacatheter, tube ea mala, limaske tse fapaneng le lihlahisoa tse ling tse ka jeoang tsa bongaka lefatšeng ka bophara, li sebeletsa bakuli ba bangata lefats'eng ka bophara, le ho thusa lihlahisoa tsa lisebelisoa tsa bongaka hore li ntlafatsoe ka botlalo!