Imaski yobuso botyando (F-Y1-A Uhlobo lwe-IIR FDA510k)
Ukuqulunqwa kwezinto
Inkqubo yokucoca iyilwe kwaye yalekwe ngomphezulu 25g non-elukiweyo, umaleko wesibini 25g BFE99 impahla yokuhluza, umaleko wangaphakathi 25g non-elukiweyo.
Ubungakanani besicelo
Isetyenziselwa ukugubungela umlomo, impumlo kunye nomhlathi womsebenzisi, kwaye inika umqobo womzimba wokuthintela ukuhanjiswa ngokuthe ngqo kwe-microorganisms ye-pathogenic, ulwelo lomzimba, amasuntswana, njl.
I-F-Y1-A Uhlobo lwe-IIR FDA 510k luvavanywa ngokuSebenza kweBacterial Filtration (BFE) kunye neDifferential Pressure (Delta P), ukutsha kweempahla ezilukiweyo, iLatex Particle Challenge, iSynthetic Blood Penetration Resistance.
UkuSebenza ngokuFanelekileyo kweBacterial Filtration (BFE) kunye neDifferential Pressure (Delta P)
Isishwankathelo: Uvavanyo lwe-BFE lwenziwa ukumisela ukusebenza kakuhle kokucoca kwamanqaku ovavanyo ngokuthelekisa ukubala kolawulo lwebhaktheriya phezulu kwenqaku lovavanyo ukuya kwi-bacterial count downstream.Ukunqunyanyiswa kwe-Staphylococcus aureus kwafakwa i-aerosolized usebenzisa i-nebulizer kwaye ihanjiswe kwinqaku lokuvavanya kwinqanaba lokuhamba rhoqo kunye noxinzelelo lomoya olusisigxina.Ukunikezelwa komceli mngeni kwagcinwa kwi-1.7 - 3.0 x 103 ikholoni yokwenza iiyunithi (CFU) kunye nobukhulu be-particle (MPS) ye-3.0 ± 0.3 μm.I-aerosols yatsalwa kwinqanaba elithandathu, i-particle esebenzayo, i-Andersen sampler yokuqokelela.Le ndlela yovavanyo ihambelana ne-ASTM F2101-19 kunye ne-EN 14683:2019, iSihlomelo B.
Uvavanyo lwe-Delta P lwenziwa ukufumanisa ukuphefumla kwamanqaku okuvavanya ngokulinganisa ukuhluka koxinzelelo lomoya ngapha nangapha kwenqaku lokuvavanya usebenzisa i-manometer, kwinqanaba lokuhamba rhoqo.Uvavanyo lwe-Delta P luhambelana ne-EN 14683: 2019, iSihlomelo C kunye ne-ASTM F2100-19.
Zonke iindlela zokwamkelwa kovavanyo ziye zahlangatyezwa.Uvavanyo lwenziwe ngokuhambelana ne-US FDA yokwenziwa kakuhle kwemveliso (GMP) imimiselo 21 CFR Icandelo 210, 211 kunye ne-820.
Ukutsha kwempahla yempahla
Le nkqubo yenzelwe ukuvavanya ukutsha kwempahla yengubo ecacileyo ngokulinganisa ukukhululeka komlilo kunye nesantya sokusasazeka komlilo.Ipharamitha yexesha lisetyenziselwa ukwahlula izinto kwiiklasi ezahlukeneyo, ngaloo ndlela incedisa kwisigwebo sokufaneleka kwelaphu lempahla kunye nempahla yokukhusela.Inkqubo yokuvavanya yenziwa ngokuhambelana nendlela yokuvavanya echazwe kwi-16 CFR Icandelo le-1610 (a) Inyathelo 1 - ukuvavanya kwimeko yokuqala.Inyathelo lesi-2 – Ukuhlaziya nokuvavanya emva kokuhlaziywa akuzange kwenziwe.Zonke iindlela zokwamkelwa kovavanyo ziye zahlangatyezwa.Uvavanyo lwenziwe ngokuhambelana ne-US FDA yokwenziwa kakuhle kwemveliso (GMP) imimiselo 21 CFR Icandelo 210, 211 kunye ne-820.
Umngeni weLatex Particle
Isishwankathelo: Le nkqubo yenzelwe ukuvavanya ukusebenza kakuhle kokucoca i-particle (PFE) yenqaku lovavanyo.I-Monodispersed polystyrene latex spheres (PSL) yenziwe i-nebulized (i-atomized), yomiswa, kwaye yagqithiswa kwinqaku lovavanyo.Amasuntswana adlule kwinqaku lovavanyo abalwe kusetyenziswa i-laser particle counter.
Ubalo lomzuzu omnye lwenziwe, kunye nenqaku lovavanyo kwisistim.Ubalo lolawulo lomzuzu omnye lwenziwa, ngaphandle kwenqaku lovavanyo kwisistim, ngaphambi nasemva kwenqaku lovavanyo ngalinye kunye namanani aphakathi.Ubalo lolawulo lwenziwa ukumisela inani eliqhelekileyo lamasuntswana ahanjiswe kwinqaku lovavanyo.Ukusebenza kakuhle kokucoca kubalwe kusetyenziswa inani lamaqhekeza angena kwinqaku lovavanyo xa kuthelekiswa nomyinge wamaxabiso olawulo.
Inkqubo isebenzise indlela yokucoca i-particle esisiseko echazwe kwi-ASTM F2299, ngaphandle kwezinye izinto;ngokukodwa inkqubo ibandakanye umngeni ongathathi hlangothi.Ekusetyenzisweni kokwenyani, amasuntswana athwala umrhumo, ngaloo ndlela lo mngeni umele imeko yendalo engaphezulu.I-aerosol engakhethi cala ikwacacisiwe kuxwebhu lwesikhokelo se-FDA kwiimaski zobuso botyando.Zonke iindlela zokwamkelwa kovavanyo ziye zahlangatyezwa.Uvavanyo lwenziwe ngokuhambelana ne-US FDA yokwenziwa kakuhle kwemveliso (GMP) imimiselo 21 CFR Icandelo 210, 211 kunye ne-820.
I-Synthetic Blood Penetration Resistance
Isishwankathelo: Le nkqubo yenzelwe ukuvavanya iimaski zobuso botyando kunye nezinye iintlobo zempahla ekhuselayo eyilelwe ukukhusela ekungeneni kolwelo.Injongo yale nkqubo kukulinganisa isitshizi se-arterial kunye nokuvavanya ukusebenza kwenqaku lovavanyo ekukhuseleni umsebenzisi ekuvezweni okunokwenzeka kwegazi kunye nolunye ulwelo lomzimba.Umgama ukusuka kwindawo ekujoliswe kuyo ukuya kwincam ye-cannula yi-30.5 cm.Umthamo wovavanyo we-2 mL wegazi lokwenziwa lasetyenziswa kusetyenziswa indlela yepleyiti ekujoliswe kuyo.
Le ndlela yovavanyo yenzelwe ukuthobela i-ASTM F1862 kunye ne-ISO 22609 (njengoko kukhankanyiwe kwi-EN 14683:2019 kunye ne-AS4381: 2015) ngaphandle kokulandelayo: ISO 22609 ifuna ukuba uvavanyo lwenziwe kwindawo enobushushu obuyi-21 ± 5°C. kunye nokufuma okungama-85 ± 10%.Endaweni yoko, uvavanyo lwenziwa kwiimeko ze-ambient ngaphakathi komzuzu omnye wokususwa kwigumbi lokusingqongileyo eligcinwe kwezo parameters.
Zonke iindlela zokwamkelwa kovavanyo ziye zahlangatyezwa.Uvavanyo lwenziwe ngokuhambelana ne-US FDA yokwenziwa kakuhle kwemveliso (GMP) imimiselo 21 CFR Icandelo 210, 211 kunye ne-820.
Imaski yobuso bezonyango (ekwaziwa njengoqhaqho okanye imaski yenkqubo) sisixhobo sonyango esigquma umlomo, impumlo kunye nesilevu siqinisekisa umqobo othintela utshintsho lwe-arhente eyosulelayo phakathi kwabasebenzi basesibhedlele kunye nesigulana.Zisetyenziswa ngabasebenzi bezempilo ukunqanda amathontsi amakhulu okuphefumla kunye nokutshiza ekufikeni emlonyeni nasempumlweni yomntu onxibileyo kwaye bancede ukunciphisa kunye / okanye ukulawula kumthombo ukusasazeka kwamathontsi amakhulu okuphefumla kumntu onxibe imaski yobuso.Iimaski zobuso bezonyango ziyacetyiswa, ngokunjalo, njengendlela yokulawula umthombo kubantu abaneempawu ukuze kuthintelwe ukusasazeka kwamathontsi okuphefumla akhutshwa ngokukhohlela okanye ukuthimla.Ukusetyenziswa kweemaski zonyango njengolawulo lomthombo kubonakaliswe ukunciphisa ukukhutshwa kwamathontsi okuphefumla athwele iintsholongwane zokuphefumla.
Uvavanyo lokuthobela imaski yotyando e-USA lusekwe, phakathi kwezinye, phezu kwale migangatho ilandelayo kunye neemfuno ezinxulumeneyo:
● Uvavanyo lweNtsebenzo ye-Fluid Resistance Performance ngokwe-ASTM F1862 ngegazi lokwenziwa: Uvavanyo lucatshangelwa ngokugqithiswa ngokubhekiselele kwixabiso loxinzelelo (80, 120 okanye 160 mmHg) ukuba ubuncinane i-29 kwiisampuli ze-32 zidlula uvavanyo kwixinzelelo oluchaziweyo.Olu vavanyo lunokuthathwa njengokuthelekiswa novavanyo lwe-Splash Resistance Pressure echazwe kwi-EN 14683: 2019;
● Uvavanyo lwe-Bacterial Filtration Efficiency ngokwe-ASTM F2101: uvavanyo luthathwa njengeluphumelele ukuba i-BFE i-≥98%;iziphumo zolu vavanyo zithelekiswa neziphumo zovavanyo lwe-BFE olwenziwe ngokwe-EN 14683: 2019;
● Uvavanyo oluhlukeneyo loxinzelelo (i-Delta P) ngokwe-MIL-M-36954C: uvavanyo luthathwa njengolugqithisiweyo ukuba umahluko wexinzelelo ΔP ungaphantsi kwe-5 mmH2O / cm2.Iziphumo zolu vavanyo zithelekiseka neziphumo zovavanyo loxinzelelo olwahlukileyo olwenziwa ngokwe-EN 14683: 2019
● Uvavanyo lwe-Biocompatibility olwenziwa ngokwe-ISO 10993-1: 2018 "Uvavanyo lwe-biological lwezixhobo zonyango Uvavanyo kunye novavanyo ngaphakathi kwenkqubo yokulawula umngcipheko".Imaski yobuso botyando ingahlelwa njengesixhobo sonyango esingaphezulu esinxibelelana nolusu ngonxibelelwano olulinganiselweyo (A, ngaphantsi kweeyure ezingama-24) okanye ukunxibelelana ixesha elide (iiyure ezingama-24 ukuya kwiintsuku ezingama-30) kuthathelwa ingqalelo isicelo esongezelekayo.Ngolu luhlu, iziphelo zebhayoloji ekufuneka zivavanywe yi-cytotoxicity, ukucaphuka kunye nokwazisa kunye nokubonakaliswa kwemichiza njengendawo yokuqala yovavanyo.
