Shanghai JPS Medical Co., Ltd.

Isalathisi se-Formaldehyde Sterilization

Inkcazelo emfutshane:

Izalathi zebhayoloji ze-Formaldehyde Sterilization zizixhobo ezibalulekileyo zokuqinisekisa ukusebenza kweenkqubo zokuvala inzala esekwe kwi-formaldehyde. Ngokusebenzisa iintsholongwane zebhaktiriya ezixhathisa kakhulu, zibonelela ngendlela eyomeleleyo nethembekileyo yokuqinisekisa ukuba iimeko zokuvala inzala zanele ukufezekisa ubunyumba obupheleleyo, ngaloo ndlela iqinisekisa ukhuseleko kunye nokusebenza kakuhle kwezinto ezintsholongwane.

Inkqubo: Formaldehyde

IMicroorganism: Geobacillus stearothermophilus(ATCCR@7953)

Abemi: 10^6 Spores/carrier

Ixesha lokuFunda: Imizuzu engama-20, iyure eyi-1

Imigaqo: ISO13485:2016/NS-EN ISO13485:2016

ISO 11138-1: 2017; Isaziso se-Bl Premarket[510(k)], Izingeniso, ezikhutshwe ngo-Oktobha 4, 2007


Iinkcukacha zeMveliso

Iithegi zeMveliso

Iimveliso

IMISEBENZI IXESHA UMZEKELO
I-Formaldehyde Sterilization Biological Indicator (Ukufunda okuKhawulezayo okuPhezulu) 20min JPE020
Isalathisi sebhayoloji ye-Formaldehyde Sterilization (UkuFunda okuKhawulezayo) Iyure e-1 JPE060
Isalathisi se-Formaldehyde Sterilization Iiyure ezingama-24 JPE144
Isalathisi se-Formaldehyde Sterilization Iiyure ezingama-48 JPE288

Amacandelo Angundoqo

Iintsholongwane:

Izalathi zebhayoloji zinembewu yeebhaktheriya ezixhathisa kakhulu, ezifana neBacillus atrophaeus okanye iGeobacillus stearothermophilus.

Ezi spores zikhethelwe ukuxhathisa kwazo okwaziwayo kwi-formaldehyde, nto leyo ezenza zilungele ukuqinisekiswa kwenkqubo yokuvala inzala.

Umthwali:

I-spores isetyenziswe kwizinto ezithwalayo, ezifana nephepha okanye i-disc yensimbi engenasici.

Umthwali ubekwe ngaphakathi kwepakethe yokukhusela evumela ukuba i-sterilant ingene kodwa ikhusela i-spores ekungcoleni kwendalo.

Ukupakishwa okuPhambili:

Isalathisi sebhayoloji sivalelwe kwizinto eziqinisekisa ukuba zinokuphathwa ngokulula kwaye zibekwe ngaphakathi komthwalo wokubulala inzala.

Ukupakishwa kwenzelwe ukuba kungene igesi ye-formaldehyde ngelixa igcina ingqibelelo yesalathisi sebhayoloji.

Ukusetyenziswa

Ukubekwa:

Iimpawu zebhayoloji zibekwe kwiindawo ezicela umngeni ngaphakathi komthwalo wokucoca, njengasembindini weepakethi okanye kwiindawo apho ukungena kwe-formaldehyde kulindeleke ukuba kube yeyona nto inzima kakhulu.

Iimpawu ezininzi zingasetyenziswa kwiindawo ezahlukeneyo ukuqinisekisa ukuhanjiswa okufanayo kwe-sterilant.

Umjikelo woNzala:

Isibulali-ntsholongwane siqhutywa kumjikelo waso oqhelekileyo, oquka ukulawulwa kwerhasi ye-formaldehyde kubushushu obuthile kunye nokufuma kangangexesha elithile.

Izalathi zisesichengeni seemeko ezifanayo nezo zicocwayo.

Ukuqanduselwa:

Emva komjikelezo wokuvala inzala, izikhombisi zebhayoloji ziyasuswa kwaye zifakwe phantsi kweemeko ezilungele ukukhula kovavanyo.

Amaxesha okufukamela ngokuqhelekileyo aqala kwiiyure ezingama-24 ukuya kwezingama-48, kuxhomekeke kwiintsholongwane ezithile ezisetyenzisiweyo.

Iziphumo zokuFunda:

Emva kokufukamela, izikhombisi zivavanyelwa iimpawu zokukhula kwe-microbial.

Akukho kukhula kubonisa ukuba inkqubo yokuvala inzala ibisebenza ngempumelelo ekubulaleni iimbewu, ngelixa ukukhula kubonisa ukusilela kokuvala inzala.

Ukubaluleka

Ukuqinisekiswa kunye nokuBeka iliso:

Izalathi zebhayoloji zibonelela ngeyona ndlela ithembekileyo nethe ngqoukuqinisekisa ukusebenza kakuhle kweenkqubo zokuvala inzala ye-formaldehyde.

Baqinisekisa ukuba iiparamitha zokuvala inzala (ixesha, ubushushu, ukuxinana kwe-formaldehyde, kunye nokufuma) zanele ukufezekisa ubunyumba.

Ukuthotyelwa koMgaqo:

Ukusetyenziswa kwezalathi zebhayoloji kudla ngokufunwa yimigangatho yolawulo kunye nezikhokelo (ezifana nezo zivela kwi-ISO kunye ne-ANSI/AAMI) ukuze kuqinisekiswe kwaye kubekwe iliso kwiinkqubo zokuvala inzala.

Ii-BIs ziyinxalenye ebalulekileyo yeenkqubo zoqinisekiso lomgangatho kwiisetingi ezifuna inzala engqongqo, efana nezibonelelo zonyango kunye nokuveliswa kwamayeza.

Ukuqinisekisa umgangatho:

Ukusetyenziswa rhoqo kwezalathi zebhayoloji kunceda ukugcina imigangatho ephezulu yolawulo losulelo kunye nokhuseleko lwesigulane ngokubonelela ngokuqinisekiswa okuqhubekayo kokusebenza kwe-sterilizer.

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

Iindidi ze-Formaldehyde Sterilization Biological Indicators

Izalathisi zeBhayoloji eziZiqulathe ngokwazo (SCBIs):

Ezi zalathi zibandakanya i-spore carrier, ukukhula phakathi, kunye ne-incubation system kwiyunithi enye.

Emva kokuvezwa kumjikelo wokuvala inzala, ii-SCBI zinokuvulwa kwaye zifakwe ngokuthe ngqo ngaphandle kokuphatha okongeziweyo.

Iimpawu zebhayoloji yesiNtu:

Ngokuqhelekileyo ziquka i-spore strip ngaphakathi kwemvulophu yeglasi okanye ivial.

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


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