Isixhobo Sokudluliswa Kweenkqubo Ezivaliweyo Zonyango Umfanekiso Obonakalayo

Isixhobo Sokudlulisa Isixhobo Sezonyango Esivaliweyo

Inkcazo emfutshane:

Isixhobo Sokudlulisa Isixhobo Esivaliweyo (CSTD) sisixhobo sokhuseleko sokuphatha iziyobisi esenzelwe ukuthintela ukuphuma kwamachiza ayingozi okanye umphunga kwindalo esingqongileyo kunye nokuthintela ungcoliseko lwendalo ukuba lungene kwinkqubo ngexesha lokulungiselela nokunika.

Thumela i-imeyile kuthi

Iinkcukacha zeMveliso

Iithegi zeMveliso

isixhobo sokudlulisa inkqubo evaliweyo (1)

isixhobo sokudlulisa inkqubo evaliweyo (3)

isixhobo sokudlulisa inkqubo evaliweyo (11)

Ukusetyenziswa kweSixhobo sokuDlulisa iNkqubo esiValiweyo

Kwiindawo zonyango—ingakumbi iikhemesti ze-oncology—ii-CSTD zisetyenziswa kakhulu xa kusetyenziswa amayeza ayingozi afana nee-chemotherapy agents. La mayeza anokuba yingozi kubasebenzi bezempilo ukuba abonakala nge-aerosols, ukuvuza, okanye ukuchitheka ngengozi.

Inkqubo eqhelekileyo ye-CSTD ibandakanya izinto ezifana nee-adapters ze-vial, ii-adapters zesirinji, ii-spikes zebhegi, kunye nemigca yokudlulisela edala indlela evaliweyo phakathi kwezikhongozeli zamayeza kunye nezixhobo zokuhambisa.

FUMANA IXABISO NGOKU

Inkcazo yemveliso yeIsixhobo Sokudlulisa Isistimu Esivaliweyo

Indlela evaliweyo: Igcina inkqubo ivaliwe ngexesha lokudluliselwa kweziyobisi.
Ukuthintela ukuvuza kunye ne-aerosol: Kunciphisa umngcipheko wokuvezwa kweziyobisi ezinobungozi.
Ukhuseleko lokusingqongileyo: Kuthintela izinto ezingcolisayo zangaphandle ukuba zingangeni kumalungiselelo eziyobisi angenazintsholongwane.
Ukuthobela imigangatho yokhuseleko: Kunceda amaziko ezempilo ukuba ahlangabezane nezikhokelo ezivela kwimibutho efana neNational Institute for Occupational Safety and Health kunye ne-United States Pharmacopeia (umz., USP <800>).

Izicelo eziqhelekileyo

Ukuhlanganiswa kwamayeza e-chemotherapy
Ukudluliselwa kwamayeza ayingozi ukusuka kwibhotile ukuya kwisirinji okanye kwibhegi ye-IV
Ukunikezelwa kwamayeza e-Oncology kwizibhedlele nakwiikliniki

Ulawulo:

I-MDR 2017/745
I-USA FDA 510K

Umgangatho:

EN ISO 13485 : 2016/AC: 2016 Inkqubo yolawulo lomgangatho wezixhobo zonyango ngokweemfuno zomthetho
I-EN ISO 14971: Izixhobo zonyango zika-2012 - Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135:2014 Izixhobo zonyango Ukucoca i-ethylene oxide Ukuqinisekiswa kunye nolawulo ngokubanzi
I-ISO 6009:2016 Iinaliti zokujova ezingafunekiyo nezilahlwayo Chonga ikhowudi yombala
I-ISO 7864:2016 Iinaliti zokujova ezingasetyenziswanga nezingenazintsholongwane
I-ISO 9626:2016 Iityhubhu zeenaliti zentsimbi engenasici zokwenza izixhobo zonyango

Iprofayile yeNkampani yeTeamstand

I-SHANGHAI TEAMSTAND CORPORATION ngumboneleli ophambili weemveliso zonyango kunye nezisombululo.

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