Kev ntsuas kev ua kom tsis muaj menyuam kom ruaj khov ntawm cov ntaub ntawv yuav tsum muaj kev ntsuam xyuas dav dav nrog kev ntsuas nrawm, kev sim ntev -, thiab kuaj cov kab mob microbial, nrog rau kev hloov pauv ntawm lub cev, tshuaj, thiab cov khoom lom. Cov kev ntsuam xyuas tshwj xeeb yog raws li hauv qab no:
1. Kev faib tawm thiab kev ua raws li cov qauv kev ntsuas kev ruaj ntseg
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Hom kev xeem |
Cov xwm txheej ua |
Lub hom phiaj |
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Kev ntsuas nrawm |
40℃± 2 degree, 75% RH ± 5%, rau 3-6 lub hlis |
Simulates cov txheej txheem kev laus nyob rau hauv ntev - lub sij hawm cia, sai sai kwv yees lub neej txee. |
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Ntev -Tsev Kawm Ntawv |
25℃± 2 degree, 60% RH ± 10%, npog tag nrho lub txee lub neej ntawm cov khoom |
Tiag tiag qhia txog kev ruaj ntseg ntawm cov khoom nyob rau hauv ib txwm cia tej yam kev mob. |
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Kev Ntsuas Lub Teeb Irradiation |
Lub teeb siv 4500lx ± 500lx, rau 10 hnub |
Ntsuas qhov kev pheej hmoo degradation ntawm cov ntaub ntawv photosensitive. |
Raws li "Stability Evaluation Methods for Disinfectants" (GB/T 38499-2020), tag nrho cov kev ntsuam xyuas yuav tsum tau siv cov khoom ntim ua ntej kom ntseeg tau tias cov txiaj ntsig kev xeem sawv cev rau lub khw muag khoom tiag tiag.
2. Cov ntsuas ntsuas tseem ceeb
Kev hloov pauv hauv Cov Ntsiab Lus Tseem Ceeb: Tus nqi khaws cia ntawm cov khoom xyaw ua ntej thiab tom qab ua kom tsis muaj menyuam yog txiav txim siab siv txoj hauv kev xws li siab -kev ua haujlwm ua kua chromatography (HPLC). Qhov txo qis yuav tsum yog<10%.
Kev hloov pauv hauv Microbial Killing Ability: Cov kev sim sib tw yog ua los ntawm cov qauv ntawm Staphylococcus aureus, Escherichia coli, thiab Candida albicans los xyuas seb qhov ua kom tsis muaj menyuam puas ua tau raws li cov qauv.
Kev hloov ntawm lub cev muaj zog: Saib xyuas qhov txawv txav ntawm cov xim, tsw, nag lossis daus, thiab cov ntsiav tshuaj zoo li.
Kev Nyab Xeeb Kev Nyab Xeeb: Tshawb xyuas cov khoom tsim kev puas tsuaj tom qab ua kom tsis muaj menyuam, xws li ethylene oxide residue lossis bisphenol A nag lossis daus.
Kev ntsuam xyuas microbiological yog txoj kev ncaj ncees thiab raug tshaj plaws. Cov qib ntawm kev txo cov colony raug soj ntsuam los ntawm kev kuaj thiab kab lis kev cai los txiav txim seb cov tshuaj tua kab mob.
3. Kev ntsuam xyuas cov khoom hloov tau raws li cov txheej txheem tshwj xeeb sterilization
Gamma Ray Sterilization: Cov ntaub ntawv raug rau cov koob tshuaj ntawm 25-50 kGy. Kev hloov pauv ntawm lub zog txhua yam, pob tshab, thiab biocompatibility tom qab irradiation raug kuaj.
Ethylene oxide (EO) sterilization: Ua kom pom tseeb ntawm cov khoom siv adsorption thiab desorption muaj peev xwm rau EO roj kom tsis txhob muaj ntau dhau.
Siab -kub thiab siab -siab ua kom tsis muaj menyuam: Ntsuas seb cov khoom puas deforms, delaminates, los yog degrades nyob rau hauv tej yam kev mob ntawm 121℃thiab 15 psi.
Kev pom zoo: Rau cov khoom siv kho mob tseem ceeb, ntau qhov kev ntsuas kev ua kom tsis muaj menyuam (piv txwv li, 5-10 zaug) yuav tsum ua kom simulate rov siv cov xwm txheej.
4. Daim ntawv pov thawj thiab kev ua raws cai: Yuav tsum dhau qhov kev pov thawj thoob ntiaj teb xws li ISO 11137 (kua hluav taws xob sterilization) thiab ISO 11135 (EO sterilization).
Kev kho mob- cov ntaub ntawv qib yuav tsum tau ua raws li ISO 10993 biocompatibility thiab FDA USP Class VI certification.
Muab tag nrho COA (Certificate of Analysis) thiab MSDS (Material Safety Data Sheet) kom paub meej txog kev taug qab.
