Shanghai JPS Medical Co., Ltd.

I-Sterilization Biological Indicators

Incazelo emfushane:

I-Steam Sterilization Biological Indicators (BIs) ngamadivayisi asetshenziselwa ukuqinisekisa nokuqapha ukusebenza kwezinqubo zokuvala inzalo yesitimu. Ziqukethe ama-microorganisms amelana kakhulu, ngokuvamile izinhlamvu zebhaktheriya, ezisetshenziselwa ukuhlola ukuthi umjikelezo wokubulala amagciwane uzibulale ngempumelelo zonke izinhlobo zempilo yamagciwane, okuhlanganisa nezinhlobo ezimelana kakhulu.

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

Inani labantu: 10^6 Spores/umthwali

Isikhathi Sokufunda: 20 min, 1 hr, 3 hr, 24 hr

Imithethonqubo: ISO13485:2016/NS-EN ISO13485:2016 ISO11138-1:2017; ISO11138-3:2017; ISO 11138-8:2021


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Imikhiqizo

I-PRDUCTS ISIKHATHI INDLELA
Izinkomba Zebhayoloji Yokubamba Inzalo Ye-Steam (UItra Super Rapid Readout) 20 min JPE020
Izinkomba Zebhayoloji Ze-Sterilization (I-Super Rapid Readout) 1 ihora JPE060
Izinkomba Zebhayoloji Zokuvala I-Sterilization (Ukufunda Ngokushesha) 3 amahora JPE180
I-Sterilization Biological Indicators 24 amahora JPE144
I-Sterilization Biological Indicators amahora 48 JPE288

Izingxenye Ezibalulekile

Ama-Microorganisms:

Ama-BI aqukethe izinhlamvu zamabhaktheriya amelana nokushisa, ngokuvamile i-Geobacillus stearothermophilus, aziwa ngokumelana kwawo okuphezulu nokuvalwa komusi.

Lezi zinhlamvu ngokuvamile zomiswa phezu kwesithwali, njengephepha noma imvilophu yengilazi.

Inkampani yenethiwekhi:

Ama-spores asetshenziswa ezintweni ezithwalayo ezifakwa ngaphakathi kwemvilophu yokuzivikela noma ibhodlela.

Inkampani yenethiwekhi ivumela ukuphatha kalula kanye nokuchayeka okungaguquki kuzimo zokuvala inzalo.

Ukupakisha Okuyinhloko:

Ama-BI ambozwe ngezinto ezivikela izinhlamvu ngesikhathi sokuphatha nokusebenzisa kodwa ezivumela isitimu ukuba singene phakathi nomjikelezo wokuvala inzalo.

Ukupakishwa kuvame ukuklanywa ukuthi kungeneke ngesitimu kodwa kungabi ukungcola okuvela endaweni.

Ukusetshenziswa

Ukubekwa:

Ama-BI abekwe ezindaweni ezingaphakathi kwesibulala-magciwane lapho ukungena kwesitimu kulindeleke ukuthi kube yinselele enkulu. Lokhu kuvame ukufaka indawo emaphakathi yamaphakethe, imithwalo eminyene, noma izindawo eziqhelile ukusuka endaweni yokufaka isitimu.

Izinkomba eziningi zingasetshenziswa ezindaweni ezihlukene ukuze kuqinisekiswe ukusatshalaliswa kwesitimu okufanayo.

Umjikelezo Wokuvula Inzalo:

Isibulala-magciwane siqhutshwa ngomjikelezo ojwayelekile, ngokuvamile ku-121°C (250°F) imizuzu engu-15 noma ku-134°C (273°F) imizuzu engu-3, ​​ngaphansi kwengcindezi.

Ama-BI abhekene nezimo ezifanayo nezinto ezihlanzwa amagciwane.

Ukufukamela:

Ngemva komjikelezo wokuvala inzalo, ama-BI ayasuswa futhi afakwe ekufukameleni ukuze kunqunywe ukuthi noma yiziphi izinhlamvu ezisindile kule nqubo.

Ukufukamela kuvame ukwenzeka ezingeni lokushisa elithile elivumela ukukhula kwento ephilayo yokuhlola (isb, 55-60°C ku-Geobacillus stearothermophilus) isikhathi esimisiwe, ngokuvamile amahora angu-24-48.

Imiphumela yokufunda:

Ngemva kokufukamela, ama-BI ahlolelwa izimpawu zokukhula kwamagciwane. Akukho ukukhula okubonisa ukuthi inqubo yokuvala inzalo yayisebenza kahle ekubulaleni izinhlamvu, kuyilapho ukukhula kubonisa ukwehluleka.

Imiphumela ingaboniswa ngokushintsha kombala phakathi nendawo ezungeze izinhlamvu noma nge-turbidity, kuye ngedizayini ethile ye-BI.

Isicelo

Izibhedlela:

Isetshenziselwa ukuvala amathuluzi okuhlinza, ama-drapes, nezinye izinsiza zokwelapha eminyangweni emaphakathi yokuvala inzalo kanye namagumbi okuhlinza.

Imitholampilo Yamazinyo:

Ilungele ukubulala amathuluzi wamazinyo namathuluzi, iqinisekisa ukuthi apakishwe ngokuphephile futhi alungele ukusetshenziswa.

Imitholampilo yezilwane:

Isetshenziselwa ukuvala amathuluzi nempahla yezilwane, ukugcina inhlanzeko nokuphepha ekunakekelweni kwezilwane.

Amalabhorethri:

Iqinisekisa ukuthi impahla yaselabhorethri nezinto zokwakha ziyavalwa futhi azingcolisi, kubalulekile ekuhlolweni nasekucwaningeni okunembile.

Imitholampilo yeziguli ezingaphandle:

Isetshenziselwa amathuluzi okubulala amagciwane asetshenziswa ezinqubweni zokuhlinzwa ezincane kanye nokwelashwa, ukuqinisekisa ukuphepha kwesiguli kanye nokulawulwa kokutheleleka.

Izikhungo zokuhlinza i-Ambulatory:

Inikeza indlela ethembekile yokubulala amathuluzi okuhlinza kanye nempahla, esekela izinqubo zokuhlinza eziphumelelayo neziphephile.

Imitholampilo yasezindaweni:

Iwusizo ezikhungweni zezokwelapha ezihambayo nezesikhashana kumathuluzi okubulala amagciwane kanye nokugcina izimo eziyinyumba ezindaweni eziyinselele.

Ukubaluleka

Ukuqinisekisa Nokuqapha:

Ama-BI ahlinzeka ngendlela eqondile nethembekile yokuqinisekisa ukusebenza kahle kwezinqubo zokuvala inzalo yesitimu.

Basiza ukuqinisekisa ukuthi zonke izingxenye zomthwalo ovalelwe amagciwane zifinyelele izimo ezidingekayo ukuze kutholakale ubunyumba.

Ukuthobela Umthetho:

Ukusetshenziswa kwama-BI ngokuvamile kudingwa ngamazinga okulawula nemihlahlandlela (isb, ISO 11138, ANSI/AAMI ST79) ukuze kuqinisekiswe futhi kuqashwe izinqubo zokuvala inzalo.

Ama-BI ayingxenye ebalulekile yezinhlelo zokuqinisekisa ikhwalithi ezilungiselelweni zokunakekelwa kwezempilo, eziqinisekisa ukuphepha kwesiguli.

Ukuqinisekisa ikhwalithi:

Ukusebenzisa njalo ama-BI kusiza ukugcina amazinga aphezulu okulawula ukutheleleka ngokunikeza ukuqinisekiswa okuqhubekayo kokusebenza kwesibulala-magciwane.

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

Izinhlobo Zezinkomba Zebhayoloji

Izinkomba Zebhayoloji Ezizimele (ama-SCBI):

Lokhu kufaka phakathi i-spore carrier, indawo yokukhula, kanye nesistimu ye-incubation eyunithi eyodwa.

Ngemva kokuchayeka emjikelezweni wokuvala inzalo, i-SCBI ingenziwa isebenze futhi ifakwe ngqo ngaphandle kokuphatha okwengeziwe.

Izinkomba Zebhayoloji Yendabuko:

Lokhu kuvame ukuhlanganisa umucu we-spore ongaphakathi kwemvilophu yengilazi okufanele idluliselwe endaweni yokukhula ngemva komjikelezo wokuvala inzalo.

Ukufukamela nokutolika kwemiphumela kudinga izinyathelo ezengeziwe uma kuqhathaniswa nama-SCBI.


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