Haufinyane tjena, TÜV SÜD China Group (eo ho tloha mona e tla bitswa "TÜV SÜD") e netefaditse direkoto tsa elektroniki le ditshaeno tsa elektroniki tsa sistimi ya taolo ya naetrojene ya metsi ya Haier Biomedical ho ya ka ditlhoko tsa FDA 21 CFR Karolo ya 11. Ditharollo tse leshome le metso e tsheletseng tsa dihlahiswa, tse ntshetsweng pele ka boikemelo ke Haier Biomedical, di fuwe tlaleho ya ho latela melao ya TÜV SÜD, ho kenyeletswa le letoto la Smartand Biobank.
Ho fumana setifikeiti sa FDA 21 CFR Karolo ea 11 ho bolela hore lirekoto tsa elektroniki le li-signature tsa sistimi ea tsamaiso ea LN₂ ea Haier Biomedical li fihlela maemo a botšepehi, botšepehi, lekunutu le ho sala morao, ka hona ho netefatsa boleng ba data le ts'ireletso. Sena se tla potlakisa ho amoheloa ha litharollo tsa sistimi ea polokelo ea naetrojene e metsi mebarakeng e kang US le Europe, ho tšehetsa katoloso ea machaba ea Haier Biomedical.
Ka ho fumana setifikeiti sa FDA, sistimi ea taolo ea naetrojene e metsi ea HB e qalile leeto le lecha la ho etsa hore na e be ea machabeng
TÜV SÜD, moetapele oa lefats'e oa liteko le setifikeiti sa mokha oa boraro, o lula a shebane le ho fana ka tšehetso ea botsebi ea ho latela melao ho pholletsa le liindasteri, ho thusa likhoebo ho lula li ikamahanya le melaoana e ntseng e fetoha. Karolo ea 11 e tloaelehileng ea FDA 21 CFR e fanoeng ke US Food and Drug Administration (FDA), e fana ka lirekoto tsa elektroniki phello e tšoanang ea molao joalo ka lirekoto tse ngotsoeng le li-saeno, ho netefatsa bonnete le ts'epo ea data ea elektroniki. Tekanyetso ena e sebetsa ho mekhatlo e sebelisang lirekoto tsa elektroniki le li-saeno meriana ea biopharmaceuticals, lisebelisoa tsa bongaka le indasteri ea lijo.
Ho tloha ha e phatlalatsoa, tekanyetso ena e se e amohetsoe haholo lefatšeng ka bophara, eseng feela ke lik'hamphani tsa meriana tsa Amerika, lipetlele, litsi tsa lipatlisiso le lilaboratori, empa hape le ke Europe le Asia. Bakeng sa lik'hamphani tse itšetlehileng ka lirekoto tsa elektroniki le lipontšo, ho latela litlhoko tsa FDA 21 CFR Karolo ea 11 ho bohlokoa bakeng sa katoloso e tsitsitseng ea machabeng, ho netefatsa ho latela melaoana ea FDA le maemo a bophelo bo botle le polokeho a amehang.
Sistimi ea taolo ea naetrojene ea metsi ea Haier Biomedical ea CryoBio ha e le hantle ke "boko bo bohlale" bakeng sa lijana tsa naetrojene ea metsi. E fetola mehloli ea sampole hore e be mehloli ea data, ka data e mengata e hlahlojoang, e rekotiloeng, le ho bolokoa ka nako ea sebele, e lemosang ka lintho tse sa tloaelehang. E boetse e na le litekanyo tse ikemetseng tse habeli tsa maemo a mocheso le a metsi, hammoho le tsamaiso ea maemo a ts'ebetso ea basebetsi. Ho phaella moo, e boetse e fana ka taolo ea pono ea lisampole bakeng sa phihlello e potlakileng. Basebelisi ba ka fetola pakeng tsa mekhoa ea letsoho, ea mohato oa khase, le ea mohato oa metsi ka ho tobetsa hanngoe, e ntlafatsang bokhoni. Ho feta moo, sistimi e hokahana le sethala sa tlhaiso-leseling ea sampole ea IoT le BIMS, e nolofalletsang khokahano e se nang sekoli har'a basebetsi, lisebelisoa le lisampole. Sena se fana ka boiphihlelo ba saense, bo tloaelehileng, bo bolokehileng le bo sebetsang ba polokelo ea mocheso o tlase haholo.
Haier Biomedical e hlahisitse tharollo e felletseng ea polokelo ea naetrojene ea metsi e loketseng libaka tsohle le likarolo tsa bophahamo, e shebane le litlhoko tse fapaneng tsa taolo ea polokelo ea sampole ea cryogenic. Tharollo e akaretsa maemo a fapaneng, ho kenyeletsoa bongaka, laboratori, polokelo ea mocheso o tlase, letoto la baeloji, le letoto la lipalangoang tsa baeloji, 'me e fa basebelisi boiphihlelo ba ts'ebetso e felletseng ho kenyeletsoa moralo oa boenjiniere, polokelo ea sampole, ho fumana sampole, ho tsamaisa sampole le tsamaiso ea sampole.
Ka ho latela maemo a FDA 21 CFR Karolo ea 11, sistimi ea taolo ea naetrojene ea metsi ea CryoBio ea Haier Biomedical e netefalitsoe bakeng sa bonnete ba lits'oaiso tsa rona tsa elektroniki le botšepehi ba lirekoto tsa rona tsa elektroniki. Setifikeiti sena sa ho latela melao se ntlafalitse tlholisano ea mantlha ea Haier Biomedical lefapheng la litharollo tsa polokelo ea naetrojene ea metsi, se potlakisa katoloso ea lets'oao mebarakeng ea lefats'e.
Potlakisa phetoho ea machaba ho hohela basebelisi, le ho ntlafatsa tlholisano ea limmaraka tsa lefats'e
Haier Biomedical esale e khomarela leano la machaba, e ntse e khothaletsa tsamaiso ea "marang-rang + ea sebaka" ka makhetlo a mabeli. Ka nako e ts'oanang, re ntse re tsoela pele ho matlafatsa nts'etsopele ea litsamaiso tsa 'maraka ho tobana le basebelisi, re ntlafatsa litharollo tsa rona tsa maemo a fapaneng mabapi le tšebelisano-'moho, ho iketsetsa le ho fana ka litšebeletso.
Ha e tsepamisitse maikutlo ho theheng boiphihlelo bo botle ka ho fetisisa ba mosebelisi, Haier Biomedical e matlafatsa ho etsa hore thepa e fumanehe sebakeng sa heno ka ho theha lihlopha le litsamaiso tsa lehae ho arabela ka potlako litlhoko tsa mosebelisi. Qetellong ea 2023, Haier Biomedical e se e na le marang-rang a kabo ea kantle ho naha a balekane ba fetang 800, e sebelisane le bafani ba litšebeletso ba fetang 500 ba kamora thekiso. Ho sa le joalo, re thehile sistimi ea boiphihlelo le setsi sa koetliso, e shebaneng le United Arab Emirates, Nigeria le United Kingdom, le sistimi ea polokelo le setsi sa thepa e fumanehang Netherlands le United States. Re tebisitse ho etsa hore thepa e fumanehe sebakeng sa heno UK 'me butle-butle re ntse re pheta mohlala ona lefatšeng ka bophara, re ntse re matlafatsa sistimi ea rona ea' maraka oa kantle ho naha.
Haier Biomedical e boetse e potlakisa katoloso ea lihlahisoa tse ncha, ho kenyeletsoa lisebelisoa tsa laboratori, lisebelisoa tse sebelisoang, le likhemisi tse bohlale, e leng se ntlafatsang tlholisano ea litharollo tsa rona tsa maemo. Bakeng sa basebelisi ba mahlale a bophelo, li-centrifuge tsa rona li entse tsoelo-pele Europe le Amerika, li-dryer tsa rona tsa ho hatsetsa li fumane liodara tsa pele Asia, 'me likhabinete tsa rona tsa polokeho ea likokoana-hloko li kene' marakeng oa Europe Bochabela. Ho sa le joalo, lisebelisoa tsa rona tsa laboratori li se li fihletsoe le ho phetoa Asia, Amerika Leboea le Europe. Bakeng sa litsi tsa bongaka, ntle le litharollo tsa ente ea letsatsi, lihatsetsi tsa meriana, li-unit tsa polokelo ea mali le lisebelisoa tse sebelisoang le tsona li ntse li hola ka potlako. Ka tšebelisano e tsoelang pele le mekhatlo ea machaba, Haier Biomedical e fana ka lits'ebeletso ho kenyeletsoa kaho ea laboratori, liteko tsa tikoloho le ho bolaea likokoana-hloko, ho theha menyetla e mecha ea kholo.
Qetellong ea 2023, mehlala e fetang 400 ea Haier Biomedical e se e fumane setifikeiti mose ho maoatle, 'me e se e rometsoe ka katleho mererong e mengata e meholo Zimbabwe, Democratic Republic of Congo, Ethiopia le Liberia, hammoho le projeke ea China-Africa Union Centers of Disease Control (CDC), e bontšang ntlafatso ea ts'ebetso ea phano. Lihlahisoa le litharollo tsa rona li se li amohetsoe haholo linaheng le libakeng tse fetang 150. Ka nako e ts'oanang, re bolokile tšebelisano-'moho ea nako e telele le mekhatlo ea machaba e fetang 60, ho kenyeletsoa Mokhatlo oa Lefatše oa Bophelo (WHO) le UNICEF.
Ho fumana setifikeiti sa FDA 21 CFR Karolo ea 11 ke ntlha ea bohlokoa bakeng sa Haier Biomedical ha re ntse re tsepamisitse maikutlo boqaping leetong la rona la katoloso ea lefats'e. E boetse e bontša boitlamo ba rona ba ho fihlela litlhoko tsa basebelisi ka boqapi. Ha re sheba pele, Haier Biomedical e tla tsoela pele ka mokhoa oa rona oa boqapi o shebaneng le basebelisi, e ntšetsa pele ho kenngoa ha rona ha maano a lefats'e ho pholletsa le libaka, liteishene le mekhahlelo ea lihlahisoa. Ka ho totobatsa boqapi ba lehae, re ikemiselitse ho hlahloba limmaraka tsa machaba ka bohlale.
Nako ea poso: Phupu-15-2024
