Shanghai JPS Medical Co., Ltd.

I-Ethylene Oxide Sterilization Biological Indicator

Inkcazelo emfutshane:

I-Ethylene Oxide Sterilization Biological Izalathisi zizixhobo ezibalulekileyo zokuqinisekisa ukuphumelela kweenkqubo ze-EtO sterilization. Ngokusebenzisa iintsholongwane zebhaktiriya ezixhathisa kakhulu, zibonelela ngendlela eyomeleleyo nethembekileyo yokuqinisekisa ukuba iimeko zokuvala inzala ziyahlangatyezwa, zibe negalelo kulawulo olusebenzayo losulelo kunye nokuthotyelwa kwemithetho.

Inkqubo: Ethylene oxide

IMicroorganism: Bacillus atrophaeus(ATCCR@ 9372)

Abemi: 10^6 Spores/carrier

Ixesha lokufunda: 3 hr, 24 Hr, 48 hr

Imimiselo: ISO13485:2016/NS-EN ISO13485:2016ISO 11138-1:2017; ISO 11138-2:2017; ISO 11138-8:2021


Iinkcukacha zeMveliso

Iithegi zeMveliso

Iimveliso

IMISEBENZI IXESHA UMZEKELO
I-Ethylene Oxide Sterilization Biological Indicator (Ukufunda ngokukhawuleza) Iiyure ezi-3 JPE180
I-Ethylene Oxide Sterilization Biological Indicator Iiyure ezingama-48 JPE288

Amacandelo Angundoqo

Iintsholongwane:

Ii-BIs zinembewu yeebhaktheriya ezixhathisa kakhulu, iBacillus atrophaeus okanye iGeobacillus stearothermophilus.

Ezi spores zikhethelwe ukuxhathisa kwazo okwaziwayo kwi-ethylene oxide, zizenza zilungele ukuqinisekiswa kwenkqubo yokuvala inzala.

Umthwali:

I-spores isetyenziswe kwizinto ezithwala njengephepha, i-disc yensimbi engenasici, okanye i-plastic strip.

Umthwali uvalelwe kwiphakheji ekhuselayo evumela ukuba i-EtO igesi ingene ngelixa igcina ingqibelelo ye-spores.

Ukupakishwa okuPhambili:

Ii-BIs zifakwe kwizinto eziqinisekisa ukuba zinokuphathwa ngokulula kwaye zibekwe ngaphakathi komthwalo wokuvalwa inzala.

Ukupakishwa kwenzelwe ukuba kungeneke kwirhasi ye-ethylene oxide kodwa kungangenwa kungcoliseko oluvela kwindalo esingqongileyo.

Ukusetyenziswa

Ukubekwa:

Ii-BIs zibekwe kwiindawo ezingaphakathi kwegumbi lokubulala iintsholongwane apho ukungena kwerhasi kulindeleke ukuba kube ngumngeni omkhulu, njengendawo esembindini wepakethi eshinyeneyo okanye izixhobo ezingaphakathi ezintsonkothileyo.

Iimpawu ezininzi zihlala zisetyenziswa kwiindawo ezahlukeneyo zokuqinisekisa ukuhanjiswa kwegesi efanayo.

Umjikelo woNzala:

Isibulali-ntsholongwane siqhutywa ngomjikelo oqhelekileyo, oquka irhasi ye-EtO kwiindawo ezithile, amaqondo obushushu, kunye namanqanaba okufuma kangangexesha elimiselweyo.

Ii-BIs zisesichengeni seemeko ezifanayo nezo zicocwayo.

Ukuqanduselwa:

Emva komjikelo wokuvala inzala, ii-BIs ziyasuswa kwaye zifakwe phantsi kweemeko ezilungele ukukhula kwento ephilayo yovavanyo (umzekelo, i-37°C ye-Bacillus atrophaeus).

Ixesha lokufukamela lidla ngokuhlala phakathi kweeyure ezingama-24 ukuya kwezingama-48.

Iziphumo zokuFunda:

Emva kokufukanyiswa, ii-BIs zivavanyelwa iimpawu zokukhula kweentsholongwane. Akukho kukhula kubonisa ukuba inkqubo yokuvala inzala ibisebenza ngempumelelo ekubulaleni iimbewu, ngelixa ukukhula kubonisa ukusilela.

Iziphumo zingabonakaliswa ngokutshintsha kombala kwindlela yokukhula okanye ngokubhuqa.

Ukubaluleka

Ukuqinisekiswa kunye nokuBeka iliso:

Ii-BIs zibonelela ngeyona ndlela ithembekileyo nethe ngqo yokuqinisekisa ukusebenza kweenkqubo zokuvalwa kwe-EtO.

Banceda ekuqinisekiseni ukuba zonke iindawo zomthwalo ovalwe inzala zifikelele kwiimeko eziyimfuneko ukuze kuphunyezwe inzala.

Ukuthotyelwa koMgaqo:

Ukusetyenziswa kwee-BIs kudla ngokufunwa yimigangatho elawulayo kunye nezikhokelo (umz., ISO 11135, ANSI/AAMI ST41) ukuqinisekisa kunye nokubeka iliso kwiinkqubo zokuvala inzala.

Ii-BIs ziyinxalenye ebalulekileyo yeenkqubo zoqinisekiso lomgangatho kukhathalelo lwempilo kunye nezicwangciso zemizi-mveliso, eziqinisekisa ukhuseleko lwesigulane kunye nabathengi.

Ukuqinisekisa umgangatho:

Ukusetyenziswa rhoqo kwee-BIs kunceda ukugcina imigangatho ephezulu yolawulo losulelo ngokubonelela ngesiqinisekiso esiqhubekayo sokusebenza kwesibulala-ntsholongwane.

Ziyinxalenye yenkqubo yokubeka iliso ebanzi yokuvala inzala enokuthi iquke izikhombisi zeekhemikhali kunye nezixhobo zokubeka iliso ezibonakalayo.

Iintlobo ze-Ethylene Oxide Sterilization Biological Indicators

Izalathisi zeBhayoloji eziZiqulathe ngokwazo (SCBIs):

Ezi ziquka umthwali we spore, i medium growth, kunye ne-incubation system kwiyunithi enye.

Emva kokuvezwa kumjikelezo wokuvala inzala, i-SCBI inokuvulwa kwaye ifakwe ngokuthe ngqo ngaphandle kokuphatha okongeziweyo.

Iimpawu zebhayoloji yesiNtu:

Ezi ngokuqhelekileyo ziquka i-spore strip ngaphakathi kwemvulophu yeglasi okanye ivial.

Ezi zifuna utshintshelo kwindawo yokukhula emva komjikelo wokuvala incubation kunye nokutolikwa kweziphumo.

Izinto eziluncedo zokuSebenzisa ii-BI kwi-EtO Sterilization

Uvakalelo oluPhezulu:

Ii-BI zibhaqa ubukho bembewu yebhaktiriya exhathisa kakhulu, ibonelela ngovavanyo olungqongqo lwenkqubo yokuvala inzala.

Uqinisekiso oluBanzi:

Ii-BIs ziqinisekisa yonke inkqubo yokuvala inzala, kubandakanywa ukungena kwerhasi, ixesha lokuvezwa, ubushushu, kunye nokufuma.

Ingqinisekiso yoKhuseleko:

Baqinisekisa ukuba iimveliso ezizintsholongwane zikhuselekile ukuba zingasetyenziswa, azinantsholongwane.


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