Umbuzo wokuthi ingabe izinkundla zokunemba zegwadle ezisetshenziswa ngaphansi kwemishini yezokwelapha ebalulekile, njengezinsimbi zokuhlola ithuluzi lokuhlinza kanye nemishini yokuthwebula yokucaca okuphezulu, kufanele ihambisane namazinga athile emboni yezokwelapha ibaluleke kakhulu endaweni yanamuhla eqhutshwa ikhwalithi. Impendulo elula iwukuthi nakuba i-granite ngokwayo ngokuvamile “iyisisetshenziswa” noma “ingxenye esekelayo” futhi ingeyona idivayisi yezokwelapha, umkhiqizi wayo kufanele abambelele ezinhlelweni eziqinile zokuphatha ikhwalithi ukuze aqinisekise ukuthi ingxenye ihlangabezana namazinga okungaxoxiswana ngawo womkhiqizi wedivayisi yezokwelapha, ekugcineni asekele ukuphepha kwesiguli nokusebenza kahle kwedivayisi.
Umkhiqizi wedivayisi yezokwelapha usebenza ngaphansi kokuqondisa okuqinile, okubuswa ngokuyinhloko amazinga afana ne-ISO 13485 (I-Quality Management Systems for Medical Devices) kanye ne-US FDA Quality System Regulation (QSR), okuya ngokuya kuvumelana nohlaka lwe-ISO. Le mithethonqubo igunyaza uhlelo lokuphatha ikhwalithi oluqinile (i-QMS) oluqondisa yonke into kusukela ekuqinisekiseni ukwakheka nokulawulwa kwezingcuphe (ISO 14971) kuya ekulawuleni ukwenziwa kanye nokulandeleka.
Okubalulekile, isisekelo segwadle, kulo mongo, sisebenza njengendiza eyinkomba ye-metrology eyisisekelo. Indima yayo ukuhlinzeka ngesisekelo esingesona esikazibuthe, esizinzile ngokushisa, futhi esinyakaziswayo lapho imishini yezokwelapha enembayo ephezulu—njenge-CMM eqinisekisa ukufakelwa komgogodla noma uhlelo lwe-laser olulinganisa inzwa yokucabanga—ingasebenza ngaphakathi kokubekezelelana kwayo okucacisiwe. Noma yikuphi ukwehluleka ekunembeni, ukucaba, noma ukuzinza kwenkundla yegwadle kuhumusha ngokuqondile iphutha lokulinganisa noma ukukhukhuleka kokusebenza kudivayisi yezokwelapha ngokwayo.
Ngakho-ke, nakuba i-granite ingekho ngaphansi kokuhlolwa kwe-biocompatibility (ISO 10993) noma ukuqinisekiswa kokuvalwa inzalo njengethuluzi lokuhlinza, umphakeli wengxenye kufanele abonise ukuthobelana okugcwele nekhwalithi eyinhloko kanye namazinga e-metrology afunwa umkhakha. Kumkhiqizi ofana ne-ZHONGHUI Group (ZHHIMG®), lokhu kusho ukuhlinzeka ngezinkundla ezakhiwe futhi ezigunyazwe ukucaciswa kwe-metrology okwaziwayo emhlabeni jikelele njenge-ASME B89.3.7 noma i-DIN 876. Okubaluleke nakakhulu, uhlelo lokuphatha ikhwalithi yomphakeli we-granite kufanele luhambisane nezidingo ezifunwayo zeklayenti labo lesisekelo semboni yezokwelapha, okuvamise ukuhlanganisa ukuthi uhlelo lwe-ISO 9001 lufanele— I-ZHHIMG ibambe ngokuziqhenya eduze kwe-ISO 14001 ne-ISO 45001.
Ngaphezu kwalokho, isiqiniseko sangempela kulo mkhakha sidlulela nasekulandeleleni umkhondo. Yonke inkundla ye-ZHHIMG® Precision Granite iza nezitifiketi zokulinganisa ezilandeleka ku-National Metrology Institutes (NMI). Lawa maphepha afakazela ukuthi ukucaba kwesisekelo, ubuqotho, kanye ne-perpendicularity kukalwe kusetshenziswa okokusebenza okulinganiselwe, kwakha iketango elinganqamuki lokuqinisekisa elidingekayo ngaphansi kwensiza yezokwelapha i-QMS. Empeleni, nakuba inkundla ngokwayo ingenalo uphawu lwe-CE kudivayisi yezokwelapha, ikhono layo lokugcina ukunemba okuphezulu livumela okokugcina okokusebenza kwezokwelapha ukuthi kugcine ngokuzethemba izitifiketi zayo zezokwelapha neziqinisekiso zokusebenza.
Ukukhethwa kokuminyana okuphezulu, okokusebenza okuphezulu njenge-ZHHIMG® Black Granite kusekela futhi lokhu kuthobela okubalulekile. Izimfanelo zayo zangaphakathi—ukuminyana okuphezulu kokudambisa ukudlidliza okungcono kanye nokuzinza okuphakeme kokushisa—empeleni, izicaciso zobunjiniyela eziklanyelwe ukunciphisa ubungozi (imfuneko eyinhloko ye-ISO 14971) ngaphakathi kwemvilophu yokusebenza kwemishini yezokwelapha. Kubakhiqizi nabacwaningi emkhakheni wezokwelapha, ukukhetha iplatifomu ye-granite kumnikezeli oqinisekisiwe womhlaba wonke kanye nezibophezele ngekhwalithi efana ne-ZHHIMG akuyona nje izintandokazi; kuyisinyathelo esibalulekile ekususeni ubungozi kuyo yonke inqubo yokukhiqiza kanye nokulawulwa kwekhwalithi, ukuqinisekisa ukunemba okusindisa impilo komkhiqizo wokugcina wezokwelapha.
Isikhathi sokuthumela: Oct-22-2025