• lab-217043_1280

Sero fekitari zvinodiwa kuti mbishi zvinhu

Muviri uye makemikari nharaunda, zvinovaka muviri uye tsika midziyo ndizvo zvitatu zvakakosha zvesero tsika.Pane zvinhu zvakawanda zvinokanganisa kukura kwesero, pakati pezvingave izvo zvigadzirwa zvesero fekitariine zvikamu izvo zvisingafadzi kukura kwesero zvakare chinhu chakakosha.

The United States Pharmacopeia Medical Materials classification kirasi 6, kubva USP kirasi I kusvika USP kirasi VI, USP kirasi VI riri giredhi yepamusorosoro.Zvinoenderana neUSP-NF general rules, mapurasitiki akaiswa mu vivo biological reaction bvunzo anozoiswa mumhando dzakatarwa epurasitiki epurasitiki mamakisi.Chinangwa chebvunzo ndechekuona iyo biocompatibility yezvigadzirwa zvepurasitiki uye kukodzera kwavo kwemidziyo yekurapa, maimplants uye mamwe masisitimu.

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Iyo mbishi yefekitori yesero ndeye polystyrene uye API inosangana neUSP Kirasi VI chiyero.Plastiki yakaverengerwa sepurasitiki yechitanhatu yekurapa muUnited States zvinoreva kuti bvunzo dzakakwana uye dzakasimba dzakatangwa.Us Medical Materials Level 6 ndiyo yave chiyero chegoridhe kumarudzi ese ezvokurapa-giredhi zvigadzirwa uye sarudzo yemhando yepamusoro yevagadziri vemidziyo yekurapa.Zvinhu zvekuyedzwa zvaisanganisira systemic toxicity test (mbeva), intradermal reaction test (tsuro) uye implantation test (tsuro).

Chete polystyrene mbishi zvinhu zvakaedzwa kusangana nezvinodiwa zveUSP kirasi VI zvinogona kushandiswa mukatisero fekitariproduction.Pamusoro pezvo, midziyo yemhando yemasero inoda kuburitswa mumusangano weC-class yekucheneswa, zvinoenderana ne ISO13485 yemhando yekutonga system zvinodiwa, kunyatso kudzora kunaka kwechigadzirwa kubva mukuita kwekugadzira, kuve nechokwadi chiyero chakakodzera chezvigadzirwa zvakapedzwa.


Nguva yekutumira: Zvita-30-2022