Shanghai JPS Medical Co., Ltd.

I-Formaldehyde Sterilization Biological Indicator

Incazelo emfushane:

I-Formaldehyde Sterilization Biological Indicators zingamathuluzi abalulekile okuqinisekisa ukusebenza kahle kwezinqubo zokuvala inzalo ezisekelwe ku-formaldehyde. Ngokusebenzisa izinhlamvu zebhaktheriya ezimelana kakhulu, zinikeza indlela eqinile nethembekile yokuqinisekisa ukuthi izimo zokuvala inzalo zanele ukuzuza ubunyumba obuphelele, ngaleyo ndlela kuqinisekiswe ukuphepha nokusebenza kahle kwezinto ezibulala amagciwane.

Inqubo: Formaldehyde

I-Microorganism: I-Geobacillus stearothermophilus(ATCCR@ 7953)

Inani labantu: 10^6 Spores/umthwali

Isikhathi Sokufunda: Amaminithi angu-20, ihora elingu-1

Imithethonqubo: ISO13485:2016/NS-EN ISO13485:2016

ISO 11138-1:2017; Isaziso se-Bl Premarket[510(k)], Iziphakamiso, ezikhishwe ngo-Okthoba 4, 2007


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Imikhiqizo

I-PRDUCTS ISIKHATHI INDLELA
Inkomba Yebhayoloji ye-Formaldehyde Sterilization (Ukufunda Okusheshayo Okusheshayo) 20 min JPE020
I-Formaldehyde Sterilization Biological Indicator (Super Rapid Readout) 1 ihora JPE060
I-Formaldehyde Sterilization Biological Indicator 24 amahora JPE144
I-Formaldehyde Sterilization Biological Indicator amahora 48 JPE288

Izingxenye Ezibalulekile

Ama-Microorganisms:

Izinkomba zebhayoloji ziqukethe izinhlamvu zamagciwane amelana kakhulu, njenge-Bacillus atrophaeus noma i-Geobacillus stearothermophilus.

Lezi zinhlamvu zikhethelwa ukumelana kwazo okwaziwayo ne-formaldehyde, okuzenza zilungele ukuqinisekisa inqubo yokuvala inzalo.

Inkampani yenethiwekhi:

Ama-spores asetshenziswa ezintweni ezithwalayo, njengephepha noma i-stainless steel disc.

Isithwali sibekwe ngaphakathi kwephakeji elivikelayo elivumela ukuthi i-sterilant ingene kodwa ivikele ama-spores ekungcoleni kwemvelo.

Ukupakisha Okuyinhloko:

Inkomba yebhayoloji ivalelwe ezintweni eziqinisekisa ukuthi ingaphathwa kalula futhi ibekwe ngaphakathi komthwalo wokuvala inzalo.

Iphakheji iklanyelwe ukuthi ikwazi ukungena kugesi we-formaldehyde kuyilapho igcina ubuqotho benkomba yezinto eziphilayo.

Ukusetshenziswa

Ukubekwa:

Izinkomba zebhayoloji zibekwe ezindaweni eziyinselele ngaphakathi komthwalo obulala amagciwane, njengendawo emaphakathi yamaphakethe noma ezindaweni lapho ukungena kwe-formaldehyde kulindeleke ukuthi kube nzima kakhulu.

Izinkomba eziningi zingasetshenziswa ezindaweni ezihlukene ukuze kuqinisekiswe ukusatshalaliswa okufanayo kwe-sterilant.

Umjikelezo Wokuvula Inzalo:

Isibulala-magciwane siqhutshwa ngomjikelezo waso ojwayelekile, ngokuvamile ohlanganisa ukuhlangana okulawulwayo kwegesi ye-formaldehyde ezingeni lokushisa elithile kanye nomswakama isikhathi esithile.

Izinkomba zivezwa ezimeni ezifanayo nezinto ezihlanzwa amagciwane.

Ukufukamela:

Ngemuva komjikelezo wokuvala inzalo, izinkomba zebhayoloji ziyasuswa futhi zifakwe ngaphansi kwezimo ezivumayo ukukhula kwento ephilayo yokuhlola.

Izikhathi zokufukamela ngokuvamile zisukela emahoreni angama-24 kuye kwangama-48, kuye ngama-microorganisms athile asetshenzisiwe.

Imiphumela yokufunda:

Ngemva kokufukamela, izinkomba ziyahlolwa ukuze kutholwe izimpawu zokukhula kwamagciwane.

Akukho ukukhula okubonisa ukuthi inqubo yokuvala inzalo ibisebenza ngempumelelo ekubulaleni izinhlamvu, kuyilapho ukukhula kukhombisa ukwehluleka kokuvala inzalo.

Ukubaluleka

Ukuqinisekisa Nokuqapha:

Izinkomba zezinto eziphilayo zihlinzeka ngendlela enokwethenjelwa neqondileukuqinisekisa ukusebenza kahle kwezinqubo zokuvala inzalo ye-formaldehyde.

Baqinisekisa ukuthi imingcele yokuvala inzalo (isikhathi, izinga lokushisa, ukugxila kwe-formaldehyde, nomswakama) yanele ukuze kuzuzwe ubunyumba.

Ukuthobela Umthetho:

Ukusetshenziswa kwezinkomba zebhayoloji kuvame ukudingwa ngamazinga okulawula nemihlahlandlela (njengaleyo evela ku-ISO kanye ne-ANSI/AAMI) ukuze kuqinisekiswe futhi kuqashwe izinqubo zokuvala inzalo.

Ama-BI ayingxenye ebalulekile yezinhlelo zokuqinisekisa ikhwalithi kuzilungiselelo ezidinga ubunyumba obuqinile, njengezikhungo zokunakekelwa kwempilo kanye nokukhiqizwa kwemithi.

Ukuqinisekisa ikhwalithi:

Ukusetshenziswa njalo kwezinkomba zebhayoloji kusiza ekugcineni amazinga aphezulu okulawula ukutheleleka kanye nokuphepha kwesiguli ngokunikeza ukuqinisekiswa okuqhubekayo kokusebenza kwesibulala-magciwane.

Ziyingxenye yohlelo olubanzi lokuqapha ukuvala inzalo okungase kuhlanganise izinkomba zamakhemikhali kanye nemishini yokuqapha ngokomzimba.

Izinhlobo Zezinkomba Zezinto Eziphilayo Ze-Formaldehyde Sterilization

Izinkomba Zebhayoloji Ezizimele (ama-SCBI):

Lezi zinkomba zifaka i-spore carrier, i-groove medium, kanye nohlelo lokufukamela endaweni eyodwa.

Ngemuva kokuchayeka kumjikelezo wokuvalwa kokuvalwa, ama-SCBI angenziwa asebenze futhi afakwe ngqo ngaphandle kokuphatha okwengeziwe.

Izinkomba Zebhayoloji Yendabuko:

Ngokuvamile kuhlanganisa umucu we-spore ngaphakathi kwemvilophu yengilazi noma ibhodlela.

Lezi zinkomba zidinga ukudluliselwa endaweni yokukhula ngemva komjikelezo wokuvala inzalo ukuze kufakwe incubation kanye nokuchazwa kwemiphumela.


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