"Kwizixhobo zempilo nobuhle bokukhanya, uvavanyo olugunyazisiweyo aluyonto nje "yesiqinisekiso sokuthobela imithetho," kodwa luyisithembiso esibonakalayo sokhuseleko esinikezelwa kubasebenzisi kwihlabathi liphela."
Kutshanje, iimveliso zeMerican ziphumelele ngempumelelo uvavanyo oluqatha yi-SGS, umbutho wovavanyo owaziwayo kwihlabathi liphela, kwaye zifumene iziqinisekiso ezininzi ezigunyazisiweyo, kubandakanya ukhuseleko, iziqinisekiso ze-EMC, iziqinisekiso ze-FCC, kunye neengxelo zokuhambelana kwezinto eziphilayo. Oku akusebenzi nje njengobungqina obuqinileyo bokuba iimveliso zeMerican ziphakathi kweenkokheli zamazwe ngamazwe kukhuseleko, ukuthembeka, kunye nokuthobela imithetho, kodwa kubonisa nokuzibophelela kwayo okungagungqiyo ekubekeni phambili ukhuseleko lwabasebenzisi.
I-SGS, njengeyona nto iphambili kushishino lokuhlola nokuqinisekisa ngehlabathi, iyaziwa ngemigangatho yayo engqongqo. Ukukwazi kweMerican ukufumana uvavanyo oluphambili kunye neziqinisekiso ezininzi ngexesha elinye kubonisa impumelelo kwiindawo ezintathu ezibalulekileyo zokhuseleko lwemveliso, apho zonke izalathisi eziphambili zihlangabezana nemigangatho yamazwe ngamazwe!
Ukuchaneka nokuthembeka ngokwezinga lobungcali
Ngokuphathelele uvavanyo lokuthobela ukhuseleko, iMerican ilinganisa ngokuthe ngqo imigangatho yokhuseleko ephezulu yezixhobo zonyango kwaye ifumene ngempumelelo iingxelo ezininzi zovavanyo lokuthobela ukhuseleko, kuquka i-IEC60601-1, i-IEC60601-2-57, i-IEC62471, kunye ne-IEC60601-6.
Phakathi kwale migangatho, i-IEC60601-2-57, njengomgangatho wokhuseleko ozinikeleyo kwizixhobo ze-phototherapy yobuhle, ijongana nemingcipheko ethile yezixhobo ze-phototherapy, ezinje ngokhuseleko lwe-photobiological, ulawulo oluchanekileyo lwamandla okukhupha, kunye nolawulo lobushushu, imisela izikhokelo zokusetyenziswa ezidlula kakhulu imigangatho eqhelekileyo. I-Merican yoyise ngempumelelo imiqobo yokhuseleko ephezulu kakhulu eyenzelwe ngokukodwa izixhobo ze-phototherapy yobuhle, yakha isiseko sokhuseleko esikumgangatho wobungcali kwiimveliso zayo.
Ukuzibophelela okuqinileyo kukhuseleko olukumgangatho wezonyango.
Ngokuphathelele i-EMC (ukuhambelana kwe-electromagnetic), iMerican ikwasebenza kakuhle kakhulu, ifikelela kwinqanaba eliphambili kwimigangatho yezixhobo zonyango. Iphumelele ukufumana isiqinisekiso se-FCC esivela e-United States kunye nengxelo yovavanyo lwe-IEC60601-1-2 EMC, idala indawo yokusebenza ekhuselekileyo nethembekileyo kubasebenzisi.
Kubalulekile ukuqaphela ukuba ingxelo yovavanyo lwe-IEC60601-1-2 EMC ngumgangatho wokhuseleko onyanzelekileyo ekufuneka izixhobo zonyango ziwufikelele. Kwicandelo lobuhle be-optical, zimbalwa iinkampani ezihlangabezana nemigangatho yobungcali yokuhambelana kwe-electromagnetic kwinqanaba lezonyango, kwaye ukuthobela ngempumelelo kweMerican lo mgangatho kubonisa amandla ayo ophando nophuhliso oluqinileyo kunye nokulandela ngokungqongqo imigangatho yokhuseleko, eyakhiwe kwiminyaka eli-17 yokuzinikela kubuhle be-optical.
Ukuqinisekisa uxolo lwengqondo oluvela kumthombo.
Kwicandelo lokhuseleko lwebhayoloji, olunxulumene ngqo nempilo yomsebenzisi, iMerican ilandela umgangatho wamazwe ngamazwe we-ISO 10993. Zonke izixhobo zokunxibelelana kwiimveliso zayo ziphumelele uvavanyo olubalulekileyo lokhuseleko lwebhayoloji, kubandakanya uvavanyo lokukrala kolusu kunye novavanyo lokubonakalisa uvakalelo, ukuqinisekisa ukuba akukho kukrala kunye nokubonakalisa uvakalelo. Oku kuqinisekisa uxolo lwengqondo ukususela ekuqaleni kokusetyenziswa, ukuqinisekisa ukuba ukhathalelo lobuhle lwakhiwe ngenene kwisiseko sokhuseleko lwesayensi.
Ummeli waseMerican uthe, “Ukufumana iziqinisekiso ezininzi ezigunyazisiweyo kunye neemvume akupheleli nje ekuqapheleni umgangatho wethu, kodwa kuthetha ukuba iimveliso zaseMerican zinokumelana nokuhlolwa nokuqinisekiswa kwemigangatho yokhuseleko engqongqo kwihlabathi. Eli linyathelo elibalulekileyo kuphuhliso lwenkampani.”
KwiMerican, oku kubonisa ukugqitywa kwemizamo edlulileyo kunye nendawo yokuqala kwezibophelelo zethu zexesha elizayo, ukulinganisa amandla ethu okuvelisa izinto ezintsha kunye nemigangatho yomgangatho. Kwixesha elizayo, iMerican iza kusebenzisa oku njengomlinganiselo omtsha, iqhubeka nokuqinisa intsebenziswano yeqhinga kunye nemibutho yamazwe ngamazwe enegunya njenge-SGS, iguqula inkqubo yethu yokulawula umgangatho oqinileyo kunye nemigangatho yokhuseleko ejonge phambili, egubungela yonke inkqubo, ibe "yijini yokhuseleko" ethembekileyo kwimveliso nganye, idala amava aqinisekisayo kunye nexabiso elikhethekileyo kubasebenzisi behlabathi.
