Mashin fuska na tiyata (F-Y1-A Nau'in IIR FDA510k)
Abun abun ciki
An tsara tsarin tacewa kuma an shimfiɗa shi ta saman 25g maras saka, Layer na biyu 25g BFE99 kayan tacewa, Layer na ciki 25g maras saka.
Iyakar aikace-aikace
Ana amfani da shi don rufe baki, hanci da muƙamuƙi na mai amfani, kuma yana ba da shinge na jiki don hana yaduwar ƙwayoyin cuta kai tsaye, ruwan jiki, barbashi, da dai sauransu.
F-Y1-A Nau'in IIR FDA 510k an gwada shi ta Kwayoyin Filtration Efficiency (BFE) da Bambance-bambancen Matsi (Delta P), flammability na tufafin tufafi, Latex Particle Challenge, Rubutun Jini Juriya
Ingantaccen Tacewar Kwayoyin cuta (BFE) da Matsalolin Daban-daban (Delta P)
Takaitawa: Ana yin gwajin BFE don tantance ingancin tacewa na labaran gwaji ta hanyar kwatanta ƙididdigar sarrafa ƙwayoyin cuta a saman labarin gwajin zuwa ƙididdigar ƙwayoyin cuta a ƙasa.An dakatar da dakatarwar Staphylococcus aureus ta amfani da nebulizer kuma an isar da shi zuwa labarin gwajin a madaidaicin magudanar ruwa da tsayayyen iska.An kiyaye isar da ƙalubalen a 1.7 - 3.0 x 103 raka'o'in kafa mulkin mallaka (CFU) tare da ma'anar ƙwayar ƙwayar cuta (MPS) na 3.0 ± 0.3 μm.An zana aerosols ta hanyar mataki shida, mai yiwuwa barbashi, Andersen sampler don tarawa.Wannan hanyar gwajin ta dace da ASTM F2101-19 da EN 14683:2019, Annex B.
Ana yin gwajin Delta P don tantance numfashin labaran gwaji ta hanyar auna matsi na iska daban-daban a kowane bangare na labarin gwajin ta hanyar amfani da manometer, a matsakaicin adadin kwarara.Gwajin Delta P ya dace da EN 14683: 2019, Annex C da ASTM F2100-19.
Dukkan sharuɗɗan karɓar hanyar gwaji an cika su.Anyi gwajin ne bisa yarda da ƙa'idodin masana'antu na FDA na Amurka (GMP) 21 CFR Parts 210, 211 da 820.
Flammability na kayan sakawa
Anyi wannan hanya don auna ƙonewar kayan sakawa na saman fili ta hanyar auna sauƙin ƙonewa da saurin yaduwar harshen wuta.Ana amfani da ma'auni na lokaci don raba kayan zuwa nau'o'i daban-daban, don haka taimakawa wajen yanke hukunci na dacewa da masana'anta don tufafi da kayan tufafi masu kariya.An yi aikin gwajin daidai da hanyar gwajin da aka tsara a cikin 16 CFR Sashe na 1610 (a) Mataki na 1 - gwaji a cikin asali.Mataki na 2 - Gyarawa da gwaji bayan gyara ba a yi ba.Dukkan sharuɗɗan karɓar hanyar gwaji an cika su.Anyi gwajin ne bisa yarda da ƙa'idodin masana'antu na FDA na Amurka (GMP) 21 CFR Parts 210, 211 da 820.
Kalubalen Barar Latex
Takaitawa: Anyi wannan hanya don kimanta ingancin tacewa mara amfani (PFE) na labarin gwajin.Monodispersed polystyrene latex spheres (PSL) an nebulized (atomized), bushe, da kuma wuce ta cikin labarin gwajin.Abubuwan da suka wuce ta labarin gwajin an ƙididdige su ta hanyar amfani da maƙallan leza.
An yi ƙidayar minti ɗaya, tare da labarin gwaji a cikin tsarin.An yi ƙidayar sarrafawa ta minti ɗaya, ba tare da labarin gwaji a cikin tsarin ba, kafin da bayan kowace labarin gwaji da ƙididdige ƙididdiga.An yi ƙididdige ƙididdiga don ƙayyade matsakaicin adadin barbashi da aka kawo zuwa labarin gwaji.An ƙididdige ingancin tacewa ta amfani da adadin barbashi masu shiga labarin gwajin idan aka kwatanta da matsakaicin ƙimar sarrafawa.
Hanyar ta yi amfani da ainihin hanyar tace abubuwan da aka bayyana a cikin ASTM F2299, tare da wasu keɓancewa;musamman tsarin ya ƙunshi ƙalubalen da ba ya tsaka tsaki.A cikin amfani na gaske, barbashi suna ɗaukar caji, don haka wannan ƙalubalen yana wakiltar ƙarin yanayi na halitta.An kuma ayyana aerosol ɗin da ba ya tsaka-tsaki a cikin takaddar jagora na FDA akan abin rufe fuska na tiyata.Dukkan sharuɗɗan karɓar hanyar gwaji an cika su.Anyi gwajin ne bisa yarda da ƙa'idodin masana'antu na FDA na Amurka (GMP) 21 CFR Sassan 210, 211 da 820.
Juriya Shiga Jini Na roba
Takaitawa: Anyi wannan hanya don kimanta abin rufe fuska na tiyata da sauran nau'ikan kayan kariya da aka tsara don kariya daga shigar ruwa.Manufar wannan hanya ita ce a kwaikwayi feshin jijiya da kuma kimanta tasirin labarin gwajin don kare mai amfani daga yiwuwar kamuwa da jini da sauran ruwan jiki.Nisa daga saman yankin da aka yi niyya zuwa saman cannula shine 30.5 cm.An yi amfani da ƙarar gwaji na 2 ml na jini na roba ta amfani da hanyar farantin karfe.
An tsara wannan hanyar gwajin don dacewa da ASTM F1862 da ISO 22609 (kamar yadda aka ambata a cikin EN 14683: 2019 da AS4381: 2015) ban da mai zuwa: ISO 22609 yana buƙatar gwaji a cikin yanayi mai zafin jiki na 21 ± 5 ° C. da kuma dangi zafi na 85 ± 10%.Madadin haka, an yi gwaji a yanayin yanayi a cikin minti ɗaya na cirewa daga ɗakin muhalli da aka gudanar a waɗannan sigogi.
Dukkan sharuɗɗan karɓar hanyar gwaji an cika su.Anyi gwajin ne bisa yarda da ƙa'idodin masana'antu na FDA na Amurka (GMP) 21 CFR Parts 210, 211 da 820.
Abin rufe fuska na likita (wanda kuma aka sani da tiyata ko abin rufe fuska) na'urar kiwon lafiya ce da ke rufe baki, hanci da haƙora da ke tabbatar da shingen da ke iyakance sauye-sauyen wakili mai kamuwa da cuta tsakanin ma'aikatan asibiti da majiyyaci.Ma'aikatan kiwon lafiya suna amfani da su don hana manyan ɗigon numfashi da fantsama daga isa baki da hancin mai sawa da kuma taimakawa ragewa da/ko sarrafa tushen yaduwar manyan digon numfashi daga mutumin da ke sanye da abin rufe fuska.Ana ba da shawarar abin rufe fuska na likitanci, haka kuma, a matsayin hanyar sarrafa tushen ga mutanen da ke da alamun bayyanar cututtuka don hana yaduwar digon numfashi da ake samu ta tari ko atishawa.Aiwatar da abin rufe fuska na likitanci a matsayin kulawar tushe an nuna yana rage sakin digon numfashi masu ɗauke da ƙwayoyin cuta na numfashi.
Ƙididdigar daidaito don abin rufe fuska na tiyata a Amurka ya dogara, a tsakanin wasu, bisa ƙa'idodi masu zuwa da buƙatu masu alaƙa:
● Gwajin Gwajin Juriya na Ruwa bisa ga ASTM F1862 tare da jini na roba: Ana ɗaukar gwajin wucewa dangane da ƙimar matsa lamba (80, 120 ko 160 mmHg) idan aƙalla 29 cikin samfuran 32 sun wuce gwajin a ƙayyadadden matsa lamba.Ana iya la'akari da wannan gwajin kamar kwatankwacin gwajin Matsi na Resistance Splash wanda aka kwatanta a cikin EN 14683: 2019;
● Gwajin Ingantacciyar Tacewar Kwayoyin cuta bisa ga ASTM F2101: ana ɗaukar gwajin wucewa idan BFE shine ≥98%;Sakamakon wannan gwajin ya yi daidai da sakamakon gwajin BFE da aka yi bisa ga EN 14683: 2019;
● Gwajin Daban Daban (Delta P) bisa ga MIL-M-36954C: an yi la'akari da gwajin wucewa idan bambancin matsa lamba ΔP ya kasance ƙasa da 5 mmH2O / cm2.Sakamakon wannan gwajin ya yi daidai da sakamakon gwajin gwaji na bambance-bambancen da aka yi bisa ga EN 14683: 2019
● Ƙimar biocompatibility da aka yi bisa ga ISO 10993-1: 2018 "Kimanin Halittu na Na'urorin Kiwon Lafiya da gwaji a cikin tsarin gudanar da haɗari".Za a iya rarraba abin rufe fuska a matsayin na'urar likita ta saman da ke hulɗa da fata ta hanyar iyakataccen lamba (A, ƙasa da sa'o'i 24) ko dogon lokaci (awanni 24 zuwa kwanaki 30) la'akari da aikace-aikacen tarawa.Dangane da wannan rarrabuwa, wuraren ƙarshen nazarin halittu da za a tantance su ne cytotoxicity, haushi da kuma hankali tare da yanayin sinadarai a matsayin farkon kima.
