... CE Certification Kuvhiya kumeso mask (F-Y1-A Type IIR FDA510k) vagadziri uye vatengesi |BDAC
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Kuvhiya kumeso mask (F-Y1-A Type IIR FDA510k)

Muenzaniso: F-Y1-A Rudzi IIR FDA510k
Style: Flat type
Kupfeka mhando: Kurembera nzeve
Vavha: Hapana
Filtration level: BFE98, Type IIR
Ruvara: Bhuruu
Executive mwero: EN14683-2019+AC:2019, FDA 510k
Packaging yakatarwa: 50pcs / bhegi, 2000pcs/CTN


Product Detail

Information

RUDZIDZO RWEKUWEDZERA

Kuumbwa kwezvinhu
Sefa system yakagadzirwa uye yakaturikidzana nepamusoro 25g isiri-yakarukwa, yechipiri layer 25g BFE99 yekusefa zvinhu, yemukati layer 25g isina-kurukwa.

Chikamu chekushandisa
Inoshandiswa kuvhara muromo, mhino uye shaya yemushandisi, uye inopa chipingamupinyi chemuviri kudzivirira kutapurirana kwakananga kwepathogenic microorganisms, mvura yemuviri, zvimedu, nezvimwe.

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  • Zvakapfuura:
  • Zvinotevera:

  • F-Y1-A Type IIR FDA 510k inoedzwa neBacterial Filtration Efficiency (BFE) uye Differential Pressure (Delta P), kupisa kwemachira embatya, Latex Particle Challenge, Synthetic Blood Penetration Resistance.

    Bacterial Filtration Efficiency (BFE) uye Differential Pressure (Delta P)
    Pfupiso: Iyo BFE bvunzo inoitwa kuti itarise kusefa kwezvinyorwa zvebvunzo nekuenzanisa kuverenga kwebhakitiriya kukwira kumusoro kwechinyorwa chebvunzo kune huwandu hwehutachiona kuzasi.Kumiswa kweStaphylococcus aureus kwakaitwa aerosolized uchishandisa nebulizer uye yakaunzwa kuchinyorwa chebvunzo pachiyero chekuyerera chisingaperi uye yakagadziriswa mhepo.Dambudziko rekutumira rakachengetwa pa 1.7 - 3.0 x 103 colony forming units (CFU) ine chidimbu chekukura (MPS) che 3.0 ± 0.3 μm.Iwo aerosols akadhonzwa kuburikidza nenhanhatu-nhanho, inogoneka particle, Andersen sampler yekuunganidza.Iyi nzira yekuyedza inoenderana neASTM F2101-19 uye EN 14683:2019, Annex B.
    Muedzo weDelta P unoitwa kuti utarise kufema kwezvinyorwa zvebvunzo nekuyera kusiyanisa kwemhepo kudzvanywa kumativi ese echinyorwa chebvunzo uchishandisa manometer, pamwero wekuyerera nguva dzose.Iyo Delta P bvunzo inoenderana neEN 14683: 2019, Annex C uye ASTM F2100-19.
    Yese nzira yekuyedza yekugamuchira maitiro akazadzikiswa.Kuyedzwa kwakaitwa mukuteerana neUS FDA yakanaka yekugadzira tsika (GMP) mirau 21 CFR Zvikamu 210, 211 uye 820.

    Kupisa kwezvipfeko zvembatya
    Iyi nzira yakaitwa kuongorora kupisa kwembatya dzembatya dzakajeka nekuyera kureruka kwekudzima uye nekumhanya kwekupararira kwemurazvo.Iyo parameter yenguva inoshandiswa kuparadzanisa zvinhu mumakirasi akasiyana, nekudaro zvichibatsira mukutonga kwejira rakakodzera kune zvipfeko uye zvekudzivirira zvipfeko zvinhu.Maitiro ekuyedza akaitwa zvinoenderana nenzira yekuyedza yakatsanangurwa mu16 CFR Chikamu 1610 (a) Nhanho yekutanga - kuyedza mumamiriro ekutanga.Nhanho 2 - Kugadziridza uye kuyedzwa mushure mekugadzirisa hakuna kuitwa.Yese nzira yekuyedza yekugamuchira maitiro akazadzikiswa.Kuyedzwa kwakaitwa mukuteerana neUS FDA yakanaka yekugadzira tsika (GMP) mirau 21 CFR Zvikamu 210, 211 uye 820.

    Latex Particle Dambudziko
    Pfupiso: Maitiro aya akaitwa kuti aongorore kusashanda kwechidimbu chefiltration performance (PFE) yechinyorwa chebvunzo.Monodispersed polystyrene latex spheres (PSL) yakave nebulized (atomized), yakaomeswa, uye yakapfuura nemubvunzo chinyorwa.Zvimedu zvakapfuura nechinyorwa chekuyedza zvakaverengerwa pachishandiswa laser particle counter.
    Kuverenga kweminiti imwe chete kwakaitwa, paine chinyorwa chekuyedza muhurongwa.Kuverengera kweminiti imwe chete yekudzora yakaitwa, pasina chinyorwa chekuyedza muhurongwa, isati yatanga uye yapera chinyorwa chega chega chebvunzo uye maverengero akaitwa pakati.Kudzora kuverenga kwakaitwa kuona avhareji yenhamba yezvimedu zvakaunzwa kuchinyorwa chebvunzo.Iko kusefa kwakanaka kwakaverengerwa uchishandisa nhamba yezvimedu zvinopinda muchinyorwa chebvunzo zvichienzaniswa neavhareji yehutongi hwekutonga.
    Maitirwo acho akashandisa nzira yekutanga kusefa yakatsanangurwa muASTM F2299, pamwe nezvimwe zvinosiya;kunyanya nzira yacho yakabatanidza dambudziko risiri reurere.Mukushandisa chaiko, zvimedu zvinotakura mutero, saka dambudziko iri rinomiririra mamiriro echisikigo.Iyo isina-neutralized aerosol inotsanangurwa zvakare mugwaro reFDA rekutungamira pamasiki ekuvhiya kumeso.Yese nzira yekuyedza yekugamuchira maitiro akazadzikiswa.Kuyedzwa kwakaitwa mukuteerana neUS FDA yakanaka yekugadzira tsika (GMP) mirau 21 CFR Zvikamu 210, 211 uye 820.

    Synthetic Ropa Kupinza Kupikisa
    Pfupiso: Iyi nzira yakaitwa kuti iongorore masks ekuvhiya uye mamwe marudzi ezvipfeko zvekudzivirira zvakagadzirirwa kudzivirira kubva pakupinda kwemvura.Chinangwa chemaitiro aya ndechekuteedzera chipfapfaidzo che arterial uye kuongorora kushanda kwechinyorwa chebvunzo mukudzivirira mushandisi kubva pakusangana neropa uye dzimwe mvura dzemuviri.Nharaunda kubva painotarirwa nzvimbo kusvika kumuromo wecannula ndeye 30.5 cm.Vhoriyamu yekuyedza ye2 mL yeropa rekugadzira yakashandiswa pachishandiswa nzira yekunangisa ndiro.
    Iyi nzira yekuyedza yakagadzirwa kuti ienderane neASTM F1862 uye ISO 22609 (sezvinorehwa muEN 14683:2019 uye AS4381:2015) kunze kwekutevera: ISO 22609 inoda kuti kuyedzwa kuitwe munzvimbo ine tembiricha ye21 ± 5°C. uye humwe hunyoro hwe85 ± 10%.Pane kudaro, kuyedzwa kwakaitwa munzvimbo dzakatenderedza mukati meminiti imwe chete yekubviswa kubva mukamuri yezvakatipoteredza inobatwa pane iwo ma parameter.
    Yese nzira yekuyedza yekugamuchira maitiro akazadzikiswa.Kuyedzwa kwakaitwa mukuteerana neUS FDA yakanaka yekugadzira tsika (GMP) mirau 21 CFR Zvikamu 210, 211 uye 820.

    Mask yekumeso yekurapa (inozivikanwawo sekuvhiya kana maitiro mask) chishandiso chekurapa chinovhara muromo, mhino uye chirebvu chinovimbisa chipingamupinyi chinodzikamisa shanduko yeanotapukira pakati pevashandi vechipatara nemurwere.Iwo anoshandiswa nevashandi vehutano kudzivirira madonhwe makuru ekufema uye splashes kubva pamuromo uye pamhino yeanopfeka uye kubatsira kuderedza uye / kana kudzora patsime kupararira kwemadonhwe makuru ekufema kubva kumunhu akapfeka kumeso.Masks ekumeso ekurapa anokurudzirwa, zvakare, senzira yekudzora sosi kune vanhu vane zviratidzo kuitira kudzivirira kupararira kwemadonhwe ekufema anogadzirwa nekukosora kana kuhotsira.Iko kushandiswa kwemasks ekurapa sekudzora sosi kwakaratidzwa kuderedza kuburitswa kwemadonhwe ekufema anotakura hutachiona hwekufema.

    Iko kuongororwa kwekuenderana kwemask yekuvhiya muUSA kwakavakirwa, pakati pezvimwe, pane zvinotevera zviyero uye zvinoenderana nezvinodiwa:

    ● Fluid Resistance Performance Test maererano neASTM F1862 neropa rekugadzira: Muedzo unofungidzirwa kuti wakapfuura maererano nehuwandu hwekumanikidza (80, 120 kana 160 mmHg) kana zvishoma 29 kubva ku32 samples yakapfuura muedzo pane imwe dzvinyiriro yakatarwa.Uyu muedzo unogona kuenzaniswa neSplash Resistance Pressure bvunzo inotsanangurwa mu EN 14683: 2019;

    ● Bacterial Filtration Efficiency test maererano neASTM F2101: muedzo unofungidzirwa kuti wakapfuura kana BFE iri ≥98%;mhedzisiro yebvunzo iyi inofananidzwa nemhedzisiro yeBFE bvunzo yakaitwa maererano EN 14683:2019;

    ● Differential Pressure (Delta P) bvunzo maererano neMIL-M-36954C: bvunzo inofungidzirwa yakapfuura kana mutsauko wekumanikidza ΔP wakaderera pane 5 mmH2O / cm2.Mhedzisiro yemuyedzo uyu inofananidzwa nemhedzisiro yekusiyanisa kudzvanywa bvunzo yakaitwa maererano ne EN 14683: 2019

    ● Biocompatibility evaluation yakaitwa maererano neISO 10993-1: 2018 "Biological evaluation yemishonga yezvokurapa Kuongorora uye kuongororwa mukati mekugadzirisa njodzi".Mask yekuvhiya yechiso inogona kuiswa muchikamu chepamusoro chekurapa chinosangana neganda kuburikidza neashoma-kubata (A, isingasviki maawa makumi maviri nemana) kana kubata kwenguva refu (maawa makumi maviri nemana kusvika kumazuva makumi matatu) uchifunga nezvekuwedzera kwekushandisa.Zvinoenderana nechikamu ichi, iyo biological endpoints inofanirwa kuongororwa ndeye cytotoxicity, irritation uye sensitization pamwe chete nemakemikari hunhu senzvimbo yekutanga kuongororwa.