ndi Chitsimikizo cha CE Chigoba cha nkhope ya Opaleshoni (F-Y1-A Type IIR FDA510k) opanga ndi ogulitsa |BDAC
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Chigoba cha nkhope yopangira opaleshoni (F-Y1-A Type IIR FDA510k)

Chitsanzo: F-Y1-A Type IIR FDA510k
Mtundu: Mtundu wathyathyathya
Kuvala mtundu: Kulendewera khutu
Vavu: Palibe
Mulingo wosefera: BFE98, Type IIR
Mtundu: Blue
Muyezo waukulu: EN14683-2019+AC: 2019, FDA 510k
Kuyika kwake: 50pcs / thumba, 2000pcs/CTN


Tsatanetsatane wa Zamalonda

Zambiri

ZINA ZOWONJEZERA

Kapangidwe kazinthu
Zosefera dongosolo lakonzedwa ndi layered ndi pamwamba 25g sanali nsalu, wachiwiri wosanjikiza 25g BFE99 kusefera zakuthupi, mkati wosanjikiza 25g sanali nsalu.

Kuchuluka kwa ntchito
Amagwiritsidwa ntchito kuphimba pakamwa, mphuno ndi nsagwada za wogwiritsa ntchito, ndipo amapereka chotchinga chakuthupi kuti ateteze kufalikira kwa tizilombo toyambitsa matenda, madzi a m'thupi, particles, etc.

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  • Zam'mbuyo:
  • Ena:

  • F-Y1-A Type IIR FDA 510k imayesedwa ndi Bacterial Filtration Efficiency (BFE) ndi Differential Pressure (Delta P), kupsa kwa nsalu, Latex Particle Challenge, Synthetic Blood Penetration Resistance.

    Bacterial Filtration Efficiency (BFE) ndi Differential Pressure (Delta P)
    Mwachidule: Mayeso a BFE amachitidwa kuti adziwe kusefera bwino kwa zolemba zoyeserera poyerekeza kuchuluka kwa mabakiteriya owongolera kumtunda kwa nkhani yoyeserera ndi kuchuluka kwa mabakiteriya kumunsi kwamtsinje.Kuyimitsidwa kwa Staphylococcus aureus kunali aerosolized pogwiritsa ntchito nebulizer ndikuperekedwa ku nkhani yoyesera nthawi zonse komanso kuthamanga kwa mpweya.Kubweretsa zovutazo kunasungidwa pa 1.7 - 3.0 x 103 koloni kupanga mayunitsi (CFU) ndi kukula kwa tinthu (MPS) kwa 3.0 ± 0.3 μm.Ma aerosols adakokedwa kudzera mu magawo asanu ndi limodzi, tinthu tating'onoting'ono, Andersen sampler kuti atolere.Njira yoyeserayi ikugwirizana ndi ASTM F2101-19 ndi EN 14683:2019, Annex B.
    Mayeso a Delta P amachitidwa kuti adziwe kupuma kwa nkhani zoyesa poyesa kusinthasintha kwa mpweya kumbali zonse za nkhani yoyesera pogwiritsa ntchito manometer, pakuyenda kosalekeza.Mayeso a Delta P amagwirizana ndi EN 14683:2019, Annex C ndi ASTM F2100-19.
    Njira zonse zovomerezera njira zoyeserera zidakwaniritsidwa.Kuyesedwa kunachitika motsatira malamulo a US FDA Good Production Practice (GMP) 21 CFR Parts 210, 211 and 820.

    Kutentha kwa nsalu za zovala
    Njirayi inkachitidwa pofuna kuyesa kupsa kwa nsalu za nsalu zapamwamba poyesa kumasuka kwa kuyaka ndi liwiro la kufalikira kwa lawi.Gawo la nthawi limagwiritsidwa ntchito kulekanitsa zida m'makalasi osiyanasiyana, potero zimathandizira pakuwunika kwa nsalu zoyenera zovala ndi zovala zoteteza.Njira yoyesera idachitidwa molingana ndi njira yoyesera yomwe yafotokozedwa mu 16 CFR Gawo 1610 (a) Gawo 1 - kuyesa m'malo oyamba.Khwerero 2 - Kukonzanso ndikuyesa pambuyo pakukonzanso sikunachitike.Njira zonse zovomerezera njira zoyeserera zidakwaniritsidwa.Kuyesedwa kunachitika motsatira malamulo a US FDA Good Production Practice (GMP) 21 CFR Parts 210, 211 and 820.

    Latex Particle Challenge
    Chidule cha nkhaniyi: Njirayi idachitidwa kuti awunikire kusachita bwino kwa particle filtration (PFE) ya nkhani yoyeserera.Monodispersed polystyrene latex spheres (PSL) anali nebulized (atomized), zowumitsidwa, ndi kudutsa mu nkhani yoyesera.Tinthu tating'onoting'ono tomwe tidadutsa munkhani yoyesererayo tidalembedwa pogwiritsa ntchito kauntala ya tinthu ta laser.
    Kuwerengera kwa mphindi imodzi kunachitidwa, ndi nkhani yoyesera mu dongosolo.Kuwerengera kwa mphindi imodzi kunachitika, popanda nkhani yoyesera m'dongosolo, nkhani isanayambe kapena itatha ndipo mawerengedwewo adawerengedwa.Kuwerengera kunachitika kuti mudziwe kuchuluka kwa tinthu tating'onoting'ono toperekedwa ku nkhani yoyeserera.Kuchita bwino kwa kusefera kunawerengedwa pogwiritsa ntchito kuchuluka kwa tinthu tating'onoting'ono tolowa m'nkhani yoyeserera poyerekeza ndi kuchuluka kwa zinthu zowongolera.
    Njirayi idagwiritsa ntchito njira yosefera ya tinthu tating'ono yomwe tafotokoza mu ASTM F2299, kupatulapo zina;makamaka ndondomekoyi inali ndi vuto losalowerera ndale.Pogwiritsidwa ntchito kwenikweni, tinthu tating'onoting'ono timakhala ndi chiwongolero, motero vuto ili likuyimira chikhalidwe chachilengedwe.Aerosol yosalowerera ndale idafotokozedwanso mu chikalata chowongolera cha FDA pa masks amaso opangira opaleshoni.Njira zonse zovomerezera njira zoyeserera zidakwaniritsidwa.Kuyesedwa kunachitika motsatira malamulo a US FDA Good Production Practice (GMP) 21 CFR Parts 210, 211 and 820.

    Kukaniza Kulowa Mwazi Wopanga
    Chidule cha nkhaniyi: Njirayi idachitidwa pofuna kuyesa masks opangira opaleshoni ndi mitundu ina ya zovala zodzitetezera zomwe zimapangidwa kuti ziteteze ku kulowa kwa madzi.Cholinga cha njirayi ndikufanizira kutsitsi ndikuwunika mphamvu ya nkhani yoyeserera poteteza wogwiritsa ntchito kuti asavutike ndi magazi ndi madzi ena amthupi.Mtunda wochokera kudera lomwe mukufuna kupita kunsonga ya cannula ndi 30.5 cm.Voliyumu yoyesera ya 2 mL yamagazi opangidwa idagwiritsidwa ntchito pogwiritsa ntchito njira yolowera mbale.
    Njira yoyeserayi idapangidwa kuti igwirizane ndi ASTM F1862 ndi ISO 22609 (monga momwe zafotokozedwera mu EN 14683:2019 ndi AS4381:2015) kupatula izi: ISO 22609 imafuna kuti kuyezetsa kuchitidwe m'malo okhala ndi kutentha kwa 21 ± 5°C. ndi chinyezi chachibale cha 85 ± 10%.M'malo mwake, kuyezetsa kunachitika pamalo ozungulira mkati mwa mphindi imodzi kuchokera kuchipinda chachilengedwe chomwe chimasungidwa pazigawozo.
    Njira zonse zovomerezera njira zoyeserera zidakwaniritsidwa.Kuyesedwa kunachitika motsatira malamulo a US FDA Good Production Practice (GMP) 21 CFR Parts 210, 211 and 820.

    Chigoba chakumaso kwachipatala (chomwe chimatchedwanso kuti opaleshoni kapena chigoba) ndi chida chachipatala chomwe chimaphimba pakamwa, mphuno ndi chibwano chomwe chimatsimikizira chotchinga chomwe chimalepheretsa kusintha kwa wothandizira matenda pakati pa ogwira ntchito pachipatala ndi wodwalayo.Amagwiritsidwa ntchito ndi ogwira ntchito yazaumoyo kuti aletse madontho akulu opumira komanso kukwapula kuti asafike pakamwa ndi mphuno ya wovalayo ndikuthandizira kuchepetsa komanso / kapena kuwongolera komwe kumachokera kufalikira kwa madontho akulu opumira kuchokera kwa munthu wovala chophimba kumaso.Masks akumaso azachipatala amalimbikitsidwa, komanso, ngati njira yowongolera magwero kwa anthu omwe ali ndi zizindikiro kuti apewe kufalikira kwa madontho opumira omwe amapangidwa ndi kutsokomola kapena kuyetsemula.Kugwiritsa ntchito masks azachipatala monga kuwongolera magwero kwawonetsedwa kuti kumachepetsa kutuluka kwa madontho opumira omwe amanyamula ma virus opuma.

    Kuwunika kwa kugwirizana kwa chigoba cha opaleshoni ku USA kumakhazikika, pakati pa zina, pamiyezo iyi ndi zofunikira zokhudzana nazo:

    ● Fluid Resistance Performance Test molingana ndi ASTM F1862 ndi magazi opangidwa: Mayesowa amaonedwa kuti adadutsa pokhudzana ndi kupanikizika kwapadera (80, 120 kapena 160 mmHg) ngati osachepera 29 mwa 32 zitsanzo apambana mayeso pa kukakamiza kodziwika.Mayesowa amatha kuonedwa ngati ofanana ndi mayeso a Splash Resistance Pressure ofotokozedwa mu EN 14683: 2019;

    ● Mayeso a Bacterial Filtration Efficiency malinga ndi ASTM F2101: mayesowo amaonedwa kuti apambana ngati BFE ndi ≥98%;zotsatira za mayesowa zikufanana ndi zotsatira za mayeso a BFE opangidwa molingana ndi EN 14683:2019;

    ● Mayesero Osiyanasiyana (Delta P) malinga ndi MIL-M-36954C: mayesero amaonedwa kuti adutsa ngati kusiyana kwapakati ΔP kuli kochepa kuposa 5 mmH2O / cm2.Zotsatira za mayesowa zikufanana ndi zotsatira za mayeso osiyanitsira omwe amachitidwa molingana ndi EN 14683: 2019.

    ● Biocompatibility evaluation yochitidwa molingana ndi ISO 10993-1:2018 "Biological evaluation of Medical Device Evaluation and kuyesa mkati mwa njira yoyang'anira zoopsa".Chigoba cha nkhope yopangira opaleshoni chikhoza kugawidwa ngati chida chachipatala chokhudzana ndi khungu kudzera mu kulumikizana kochepa (A, osakwana maola 24) kapena kukhudzana kwanthawi yayitali (maola 24 mpaka masiku 30) poganizira kuchuluka kwa ntchito.Malinga ndi gululi, mathero achilengedwe omwe akuyenera kuyesedwa ndi cytotoxicity, irritation and sensitization pamodzi ndi mawonekedwe amankhwala monga poyambira pakuwunika.