Mask yo mumaso yo kubaga (F-Y1-A Ubwoko IIR FDA510k)

F-Y1-A Ubwoko bwa IIR FDA 510k igeragezwa na Bacterial Filtration Efficiency (BFE) hamwe nigitutu gitandukanye (Delta P), gutwika imyenda yimyenda, Ikibazo cya Latex Particle Challenge, Synthetic Blood Penetration Resistance

Imikorere ya bacteri (BFE) hamwe nigitutu gitandukanye (Delta P)
Incamake: Ikizamini cya BFE kirakorwa kugirango hamenyekane uburyo bwo kuyungurura ibintu byikigereranyo ugereranije numubare wa bagiteri ugenzura hejuru yikigereranyo hamwe na bagiteri zibara hepfo.Ihagarikwa rya Staphylococcus aureus ryashyizwe mu kirere hakoreshejwe nebulizer hanyuma rishyikirizwa ingingo yikizamini ku muvuduko uhoraho no ku muvuduko ukabije w’ikirere.Gutanga imbogamizi byakomeje kuri 1.7 - 3.0 x 103 ibice bigize koloni (CFU) bifite ubunini buke (MPS) bwa 3.0 ± 0.3 μ m.Aerosole yashushanijwe binyuze mu byiciro bitandatu, bifatika, Andersen sampler yo gukusanya.Ubu buryo bwikizamini bwujuje ASTM F2101-19 na EN 14683: 2019, Umugereka B.
Ikizamini cya Delta P kirakorwa kugirango hamenyekane guhumeka kwingingo zipimwa mugupima umuvuduko wumwuka utandukanye kumpande zombi zingingo zipimishije ukoresheje manometero, kumuvuduko uhoraho.Ikizamini cya Delta P cyujuje EN 14683: 2019, Umugereka C na ASTM F2100-19.
Uburyo bwo gukora ibizamini byose byujujwe.Ikizamini cyakozwe hubahirijwe amabwiriza yo muri Amerika FDA yo gukora neza (GMP) 21 CFR Ibice 210, 211 na 820.

Gutwika imyenda y'imyenda
Ubu buryo bwakozwe kugirango hamenyekane umuriro w’imyenda isanzwe yimyenda yo gupima hifashishijwe uburyo bworoshye bwo gutwika n'umuvuduko wumuriro ukwirakwira.Ibipimo byigihe bikoreshwa mugutandukanya ibikoresho mubyiciro bitandukanye, bityo bigafasha mugucira urubanza imyenda ibereye imyenda nibikoresho byo gukingira.Uburyo bwikizamini bwakozwe hakurikijwe uburyo bwikizamini buvugwa muri 16 CFR Igice cya 1610 (a) Intambwe ya 1 - kwipimisha muburyo bwambere.Intambwe ya 2 - Kuvugurura no kugerageza nyuma yo kuvugurura ntibyakozwe.Uburyo bwo gukora ibizamini byose byujujwe.Ikizamini cyakozwe hubahirijwe amabwiriza yo muri Amerika FDA yo gukora neza (GMP) 21 CFR Ibice 210, 211 na 820.

Ikibazo cya Latex
Incamake: Ubu buryo bwakozwe kugirango hasuzumwe imikorere idashobora kubaho muyungurura (PFE) yingingo yikizamini.Monodispersed polystyrene latex spheres (PSL) yashizwemo (atomize), iruma, kandi inyura mu ngingo yikizamini.Ibice byanyuze mu ngingo yikizamini byabaruwe hifashishijwe icyuma cya laser.
Kubara umunota umwe byakozwe, hamwe ningingo yikizamini muri sisitemu.Igenzura ry'umunota umwe ryakozwe, nta ngingo yikizamini muri sisitemu, mbere na nyuma ya buri ngingo yikizamini kandi ibarwa yagereranijwe.Igenzura ryakozwe kugirango hamenyekane impuzandengo y'ibice byagejejwe ku ngingo yikizamini.Iyungurura imikorere yabazwe ikoresheje umubare wibice byinjira mu kizamini ugereranije nimpuzandengo yo kugenzura agaciro.
Uburyo bwakoresheje uburyo bwibanze bwo kuyungurura byasobanuwe muri ASTM F2299, usibye bimwe;byumwihariko inzira yarimo ikibazo kitabogamye.Mugukoresha nyabyo, ibice bitwara amafaranga, bityo iyi mbogamizi igereranya imiterere karemano.Aerosol idafite aho ibogamiye nayo isobanurwa mu nyandiko ya FDA yo kuyobora masike yo kubaga.Uburyo bwo gukora ibizamini byose byujujwe.Ikizamini cyakozwe hubahirijwe amabwiriza yo muri Amerika FDA yo gukora neza (GMP) 21 CFR Ibice 210, 211 na 820.

Synthetic Amaraso Yinjira Kurwanya
Incamake: Ubu buryo bwakozwe kugirango hasuzumwe isura yo kubaga hamwe nubundi bwoko bwimyenda ikingira igamije kurinda amazi.Intego yubu buryo ni ukwigana imiti ya arterial no gusuzuma akamaro k'ingingo yo kwipimisha mukurinda uyikoresha kwandura amaraso nandi mavuta yo mumubiri.Intera kuva kumwanya wateganijwe kugera hejuru yurumogi ni cm 30.5.Ingano yipimishije ya 2 mL yamaraso yubukorikori yakoreshejwe hakoreshejwe uburyo bwa plaque.
Ubu buryo bwikizamini bwateguwe kugirango hubahirizwe ASTM F1862 na ISO 22609 (nkuko bivugwa muri EN 14683: 2019 na AS4381: 2015) usibye ibi bikurikira: ISO 22609 isaba kwipimisha gukorerwa mubidukikije bifite ubushyuhe bwa 21 ± 5 ° C n'ubushuhe bugereranije bwa 85 ± 10%.Ahubwo, kwipimisha byakorewe mubihe bidukikije muminota umwe yo gukurwa mubyumba byibidukikije byakozwe kuri ibyo bipimo.
Uburyo bwo gukora ibizamini byose byujujwe.Ikizamini cyakozwe hubahirijwe amabwiriza yo muri Amerika FDA yo gukora neza (GMP) 21 CFR Ibice 210, 211 na 820.

Mask yo mumaso yubuvuzi (izwi kandi kubaga cyangwa kubaga mask) nigikoresho cyubuvuzi gitwikiriye umunwa, izuru n'akanwa byerekana inzitizi igabanya inzibacyuho yanduza abakozi banduye n’umurwayi.Bakoreshwa n'abakozi bashinzwe ubuzima kugirango babuze ibitonyanga binini byubuhumekero no gutemba kugera kumunwa nizuru ryuwambaye kandi bifasha kugabanya no / cyangwa kugenzura isoko ikwirakwizwa ryibitonyanga binini byubuhumekero kumuntu wambaye mask yo mumaso.Masike yo mumaso yubuvuzi irasabwa, kimwe, nkuburyo bwo kugenzura isoko kubantu bafite ibimenyetso hagamijwe gukumira ikwirakwizwa ryibitonyanga byubuhumekero biterwa no gukorora cyangwa kwitsamura.Gukoresha masike yubuvuzi nkigenzura ryamasoko byagaragaye ko bigabanya irekurwa ryibitonyanga byubuhumekero bitwara virusi zubuhumekero.

Isuzuma ryo guhuza mask yo kubaga muri Amerika rishingiye ku bindi bikurikira n'ibisabwa bijyanye:

Test Ikizamini cya Fluid Resistance Performance ukurikije ASTM F1862 hamwe namaraso yubukorikori: Ikizamini gifatwa nkicyatsinzwe kubijyanye nigiciro cyumuvuduko (80, 120 cyangwa 160 mmHg) niba byibuze 29 kuri 32 byatsinze ikizamini kumuvuduko runaka.Iki kizamini gishobora gufatwa nkigereranywa nikizamini cya Splash Resistance Pressure cyasobanuwe muri EN 14683: 2019;

Test Ikizamini cya bacteri Filtration Ikigereranyo ukurikije ASTM F2101: ikizamini gifatwa nkicyatsinzwe niba BFE ari ≥98%;ibisubizo by'iki kizamini biragereranywa n'ibisubizo bya BFE byakozwe ukurikije EN 14683: 2019;

Test Ikizamini gitandukanye (Delta P) ukurikije MIL-M-36954C: ikizamini gifatwa nkicyatsinzwe niba itandukaniro ryumuvuduko ΔP riri munsi ya 5 mmH2O / cm2.Ibisubizo by'iki kizamini biragereranywa n'ibisubizo by'ikizamini gitandukanye cyakozwe ukurikije EN 14683: 2019

Evaluation Isuzuma ryibinyabuzima ryakozwe hakurikijwe ISO 10993-1: 2018 “Isuzuma ryibinyabuzima ryibikoresho byubuvuzi Gusuzuma no kwipimisha muburyo bwo gucunga ibyago”.Maskike yo mumaso irashobora gushyirwa mubikorwa nkigikoresho cyubuvuzi cyo hejuru gihura nuruhu binyuze mumikoranire mike (A, munsi yamasaha 24) cyangwa kumara igihe kinini (amasaha 24 kugeza 30) urebye kubisaba.Ukurikije ibi byiciro, iherezo ryibinyabuzima bigomba gusuzumwa ni cytotoxicity, kurakara no gukangurira hamwe no kuranga imiti nkintangiriro yo gusuzuma