Vuba aha, Ubuvuzi bwa Haiyan KangyuanIgikoresho Co, Ltd. yatsinze neza ISO13485: 2016 ibyemezo byubuvuzi bwa sisitemu yubuyobozi bwiza.Isubiramo ryose rifata iminsi itatu,ryishimiye gahunda yo gucunga neza, kumenya inzira no gusesengura, inshingano zubuyobozi, gusuzuma imiyoborere, intego nziza, gusesengura amakuru, abakozi, ibikorwa remezo, inzira zijyanye n’abakiriya, igishushanyo mbonera n’iterambere, amasoko, umusaruro na serivisi hamwe nububiko, gucunga ibyago, inzira kugenzura, kugenzura sterisizione, gukurikirana, kumenya imiterere, kurinda ibicuruzwa, kugenzura no kugenzura ibikoresho byo gupima, kunyurwa kwabakiriya Ibitekerezo (harimo no gukemura ibibazo), sisitemu yo kuburira, ubugenzuzi bwimbere, kugenzura ibicuruzwa bidahuye, ingamba zo gukosora no gukumira, gusuzuma inyandiko tekinike, nibindi.

This ubugenzuzi, bwagenzuwe nitsinda rishinzwe ubugenzuzi ku rubuga, bwemeje ko inzira zose z’ubushakashatsi bw’ubuvuzi bwa Kangyuan n’iterambere, umusaruro n’igurisha bikorwa hakurikijwe ibivugwa mu nyandiko z’imicungire y’ubuziranenge, kandi birasabwa gutanga icyemezo.

Nka sisitemu yemewe yo gucunga ubuziranenge ku rwego mpuzamahanga ku nganda zikoreshwa mu buvuzi, igipimo gishya ISO13485: 2016 (sisitemu yo gucunga neza ibikoresho by’ubuvuzi ku bisabwa kugira ngo igenzurwe) yashyizwe ahagaragara ku mugaragaro ku ya 1 Werurwe 2016.Imiterere ya 2016 yuburyo bushya bwa ISO13485 yongeramo umubare munini wibikoresho byubuvuzi byubuvuzi bwiza, bujyanye nibisabwa n'amabwiriza amwe n'amwe y’ibikoresho by’ubuvuzi by’igihugu, ni uburyo bwo gucunga neza no kwandikisha amabwiriza no kugenzura neza.

Ubuvuzi bwa Kangyuan bwatsindiye impamyabumenyi ku nshuro ya gatatu, butagaragaza gusa kumenyekanisha byimazeyo ibicuruzwa bya Kangyuan n’imiryango mpuzamahanga y’ibipimo ngenderwaho, ahubwo binagaragaza ko hashyizweho ubuziranenge, ubuziranenge ndetse n’amahanga mu rwego rwo gucunga neza ubuvuzi bwa Kangyuan.

Kugeza ubu, Ubuvuzi bwa Kangyuan burimo gukora no muri Amerika FDA, EU MDR isaba ibyemezo ndetse nindi mirimo.Turizera ko ku nkunga ya “pass” nyinshi kandi nyinshi ku isi, Kangyuan azakwirakwiza ubwoko bwose bwa catheteri ya silicone, catheters, ubushyuhe bwa mask yo mu kirere, endoumuyoboro wa tracheal, gusweracatheter, umuyoboro wigifu, masike zitandukanye nibindi bicuruzwa bikoreshwa mubuvuzi kwisi, gukorera abarwayi benshi kwisi, no gufasha ibicuruzwa bikoreshwa mubuvuzi kuzamurwa byuzuye!