Imaski yobuso bokuhlinzwa (F-Y1-A Uhlobo lwe-IIR FDA510k) Isithombe Esifakiwe

Imaski yobuso bokuhlinzwa (F-Y1-A Uhlobo IIR FDA510k)

Imodeli: F-Y1-A Uhlobo IIR FDA510k
Isitayela: Uhlobo oluyisicaba
Uhlobo lokugqoka: Indlebe ilenga
I-Valve: Akukho
Izinga lokuhlunga: BFE98, Uhlobo IIR
Umbala: Oluhlaza okwesibhakabhaka
Izinga eliphezulu: EN14683-2019+AC:2019, FDA 510k
Ukucaciswa kokupakisha: 50pcs/bag, 2000pcs/CTN

Thumela i-imeyili kithi

Imininingwane Yomkhiqizo

Ulwazi

ULWAZI OLWENGEZIWE

Ukwakheka kwezinto
Uhlelo lokuhlunga luklanywe futhi lwendlalwe ngobuphezulu obungama-25g obungalukiwe, ungqimba lwesibili 25g BFE99 impahla yokuhlunga, ungqimba lwangaphakathi 25g olungalukiwe.

Ububanzi besicelo
Isetshenziselwa ukumboza umlomo, ikhala nomhlathi womsebenzisi, futhi inikeza umgoqo womzimba ukuvimbela ukudluliselwa okuqondile kwama-microorganisms e-pathogenic, uketshezi lomzimba, izinhlayiya, njll.

Okwedlule: Imaski yobuso bokuhlinzwa (F-Y3-A)

Olandelayo: Imaski yobuso bokuhlinzwa (F-Y1-A Uhlobo lwe-IIR)

I-F-Y1-A Uhlobo lwe-IIR FDA 510k ihlolwe ngokusebenza kahle kwe-Bacterial Filtration (BFE) kanye ne-Differential Pressure (Delta P), ukuvutha kwendwangu yezingubo, i-Latex Particle Challenge, Ukuphikiswa Kokwenziwa Kokungena Kwegazi

I-Bacterial Filtration Efficiency (BFE) kanye ne-Differential Pressure (Delta P)
Isifinyezo: Ukuhlolwa kwe-BFE kwenzelwa ukucacisa ukusebenza kahle kokuhlunga kwama-athikili okuhlola ngokuqhathanisa ukubala kokulawula amagciwane phezulu kwe-athikili yokuhlola nezibalo zebhaktheriya ezansi nomfula.Ukumiswa kwe-Staphylococcus aureus kwenziwa aerosolized kusetshenziswa i-nebulizer futhi kwalethwa esihlokweni sokuhlola ngesilinganiso sokugeleza esingaguquki kanye nomfutho womoya ongaguquki.Ukulethwa kwenselelo kwagcinwa ku-1.7 - 3.0 x 103 amayunithi okwenza ikholoni (CFU) enosayizi wezinhlayiyana omaphakathi (MPS) we-3.0 ± 0.3 μm.Ama-aerosols adwetshwe ngesiteji esiyisithupha, i-particle esebenzayo, isampula ye-Andersen ukuze iqoqwe.Le ndlela yokuhlola ihambisana ne-ASTM F2101-19 kanye ne-EN 14683:2019, Annex B.
Ukuhlolwa kwe-Delta P kwenziwa ukuze kutholwe ukuphefumla kwama-athikili okuhlola ngokulinganisa ingcindezi yomoya ehlukile kunoma yiluphi uhlangothi lwesihloko sokuhlola kusetshenziswa i-manometer, ngesilinganiso sokugeleza esingaguquki.Ukuhlolwa kwe-Delta P kuthobela i-EN 14683:2019, i-Annex C kanye ne-ASTM F2100-19.
Zonke izindlela zokwamukela izindlela zokuhlola zifinyelelwe.Ukuhlolwa kwenziwe ngokuhambisana nemithetho ye-US FDA good Production practice (GMP) 21 CFR Izingxenye 210, 211 kanye 820.

Ukuvutha kwezindwangu zokugqoka
Le nqubo yenzelwa ukuhlola ukuvutha kwezindwangu zezingubo ezingenalutho ngokulinganisa ukuthungela kalula kanye nesivinini sokusabalala komlilo.Ipharamitha yesikhathi isetshenziselwa ukuhlukanisa izinto zibe amakilasi ahlukene, ngaleyo ndlela kusize ekwahluleleni ukufaneleka kwendwangu yezimpahla zokugqoka kanye nempahla yokuvikela.Inqubo yokuhlola yenziwe ngokuhambisana nendlela yokuhlola echazwe ku-16 CFR Ingxenye 1610 (a) Isinyathelo 1 – ukuhlola esimweni sokuqala.Isinyathelo sesi-2 – Ukulungisa kabusha nokuhlola ngemva kokulungiswa kabusha akuzange kwenziwe.Zonke izindlela zokwamukela izindlela zokuhlola zifinyelelwe.Ukuhlolwa kwenziwe ngokuhambisana nemithetho ye-US FDA good Production practice (GMP) 21 CFR Izingxenye 210, 211 kanye 820.

I-Latex Particle Challenge
Isifinyezo: Le nqubo yenzelwa ukuhlola ukusebenza kahle kokuhlunga kwezinhlayiyana (PFE) kwe-athikili yokuhlola.I-Monodispersed polystyrene latex spheres (PSL) yenziwe i-nebulize (i-atomized), yomiswa, futhi yadlula ku-athikili yokuhlola.Izinhlayiya ezidlule esihlokweni sokuhlola zibalwe kusetshenziswa isibali sezinhlayiyana ze-laser.
Isibalo somzuzu owodwa senziwe, nesihloko sokuhlola ohlelweni.Isibalo sokulawula somzuzu owodwa senziwe, ngaphandle kwe-athikili yokuhlola kusistimu, ngaphambi nangemuva kwe-athikili yokuhlola ngayinye nokubala kulinganiselwe.Izibalo zokulawula zenziwe ukuze kunqunywe inombolo emaphakathi yezinhlayiya ezilethwe ku-athikili yokuhlola.Ukusebenza kahle kokuhlunga kubalwe kusetshenziswa inombolo yezinhlayiya ezingena ku-athikili yokuhlola uma kuqhathaniswa nesilinganiso samanani okulawula.
Inqubo isebenzisa indlela eyisisekelo yokuhlunga izinhlayiyana echazwe ku-ASTM F2299, ngaphandle kokunye okuhlukile;ikakhulukazi inqubo ihlanganise inselele engachemile.Ekusetshenzisweni kwangempela, izinhlayiya zithwala imali, ngaleyo ndlela le nselele imele isimo semvelo.I-aerosol engakhethi hlangothi nayo icaciswe embhalweni wokuqondisa we-FDA kumamaski obuso bokuhlinzwa.Zonke izindlela zokwamukela izindlela zokuhlola zifinyelelwe.Ukuhlolwa kwenziwe ngokuhambisana nemithetho ye-US FDA good Production practice (GMP) 21 CFR Izingxenye 210, 211 kanye 820.

I-Synthetic Blood Penetration Resistance
Isifinyezo: Le nqubo yenzelwa ukuhlola amamaski obuso okuhlinzwa nezinye izinhlobo zezinto zokuzivikela eziklanyelwe ukuvikela ekungeneni koketshezi.Injongo yale nqubo iwukulingisa isifutho se-arterial nokuhlola ukusebenza kahle kwe-athikili yokuhlola ekuvikeleni umsebenzisi ekuchayekeni okungenzeka egazini nolunye uketshezi lomzimba.Ibanga ukusuka endaweni okuqondiswe kuyo ukuya esihlokweni se-cannula ngu-30.5 cm.Ivolumu yokuhlola engu-2 mL yegazi lokwenziwa isetshenziswe kusetshenziswa indlela yepuleti lokukhomba.
Le ndlela yokuhlola yakhelwe ukuthobela i-ASTM F1862 ne-ISO 22609 (njengoba kubhekiselwe ku-EN 14683:2019 kanye ne-AS4381:2015) ngaphandle kwalokhu okulandelayo: I-ISO 22609 idinga ukuthi ukuhlolwa kwenziwe endaweni enezinga lokushisa elingu-21 ± 5°C. kanye nomswakama ohlobene ongu-85 ± 10%.Esikhundleni salokho, ukuhlolwa kwenziwe ezimeni ze-ambient ngaphakathi kweminithi elilodwa lokukhishwa egumbini lezemvelo eligcinwe kulawo mapharamitha.
Zonke izindlela zokwamukela izindlela zokuhlola zifinyelelwe.Ukuhlolwa kwenziwe ngokuhambisana nemithetho ye-US FDA good Production practice (GMP) 21 CFR Izingxenye 210, 211 kanye 820.

Imaski yobuso bezokwelapha (eyaziwa nangokuthi imaski yokuhlinzwa noma yenqubo) iyithuluzi lezokwelapha elivala umlomo, ikhala nesilevu eliqinisekisa umgoqo okhawulela uguquko lwe-ejenti ethelelanayo phakathi kwezisebenzi zesibhedlela nesiguli.Asetshenziswa ngabasebenzi bezokunakekelwa kwempilo ukuvimbela amaconsi amakhulu okuphefumula kanye nokuchaphaza ukuthi angafinyeleli emlonyeni nasekhaleni lomuntu oyigqokile futhi asize ukunciphisa kanye/noma ukulawula emthonjeni ukusabalala kwamaconsi amakhulu okuphefumula avela kumuntu ogqoke imaskhi yobuso.Kunconywa imaski yobuso bezokwelapha, njengendlela yokulawula umthombo kubantu abanezimpawu ukuze kuvinjelwe ukusabalala kwamaconsi okuphefumula akhiqizwa ukukhwehlela noma ukuthimula.Ukusetshenziswa kwemaski yezokwelapha njengokulawula umthombo kukhonjisiwe kunciphisa ukukhishwa kwamaconsi okuphefumula athwala amagciwane okuphefumula.

Ukuhlolwa kokuvumelana kwemaski okuhlinzwa e-USA kusekelwe, phakathi kokunye, phezu kwamazinga alandelayo nezimfuneko ezihlobene:

● Ukuhlolwa Kokusebenza Kokumelana Noketshezi ngokuya nge-ASTM F1862 enegazi lokwenziwa: Ukuhlolwa kuthathwa njengokuphasiswa maqondana nenani lokucindezela (80, 120 noma 160 mmHg) uma okungenani amasampula angama-29 kwangu-32 edlula isivivinyo ngomfutho othile.Lokhu kuhlolwa kungabhekwa njengokuqhathaniswa nokuhlolwa kwe-Splash Resistance Pressure okuchazwe ku-EN 14683:2019;

● Ukuhlolwa kwe-Bacterial Filtration Efficiency ngokusho kwe-ASTM F2101: ukuhlolwa kubhekwa njengephasile uma i-BFE ingu-≥98%;imiphumela yalokhu kuhlolwa iqhathaniswa nemiphumela yokuhlolwa kwe-BFE eyenziwe ngokuya nge-EN 14683:2019;

● Ukuhlolwa kwe-Differential Pressure (Delta P) ngokuya nge-MIL-M-36954C: ukuhlolwa kubhekwa njengephasile uma umehluko wengcindezi ΔP ungaphansi kuka-5 mmH2O/cm2.Imiphumela yalokhu kuhlolwa iqhathaniswa nemiphumela yokuhlolwa kwengcindezi ehlukile eyenziwe ngokuya nge-EN 14683:2019

● Ukuhlolwa kwe-Biocompatibility kwenziwa ngokuya nge-ISO 10993-1:2018 “Ukuhlolwa kwebhayoloji kwemishini yezokwelapha Ukuhlola nokuhlola ngaphakathi kwenqubo yokulawula ubungozi”.Imaski yobuso bokuhlinzwa ingase ihlukaniswe njengedivayisi yezokwelapha engaphezulu ethinta isikhumba ngokuxhumana okulinganiselwe (A, ngaphansi kwamahora angu-24) noma ukuthintana isikhathi eside (amahora angu-24 kuya ezinsukwini ezingu-30) kucatshangelwa uhlelo lokusebenza olwengeziwe.Ngokwalokhu kuhlukaniswa, iziphetho zebhayoloji okufanele zihlolwe i-cytotoxicity, ukucasuka kanye nokuzwela kanye nokuhlukaniswa kwamakhemikhali njengendawo yokuqala yokuhlola.