Iyo yekupedzisira gwara kutarisana nemasks uye N95 Respirators muhutano hwehutano - Zhongxing

Munyika yekuchengetedzeka kwekurapa, zvinhu zvishoma zvakaita seyakakosha asi zvakaoma sechiso mask. Kubva pane yakapusa Surgical Mask kune yakakosha Chekufemesa chinonzi n95, kunzwisisa izvo nuances hakusi kwekungotevedzera - ndezvekudzivirira hupenyu. Senge maneja wekutakura, iwe uri pamitsetse yekumberi yekukohwa, uye sarudzo dzaunoita dzaunoita dzakananga pane vese varwere uye nezveutano nyanzvi. Ichi chinyorwa ndezvenyu. SaAllen, mugadziri ane makore gumi emakore emakore echiitiko ichigadzira anoregedza zviripo zvekushandisa zvemisika yepasirese seUSA uye Europe, ini ndoda kucheka kuburikidza nekuvhiringidzika. Isu tichaongorora zvakasiyana mhando dzemasks, tsvaga iwo mirau, uye ipa ruzivo rwekuita kuti ndikubatsire iwe sosi nechivimbo. Ichi hachisi chinyorwa chimwe chete; Iko kutarisa kuseri kwejira kubva pamaonero efekitori, yakagadzirirwa kupindura mibvunzo yako yakawanda yekumanikidza.

Ndeipi musiyano chaiwo pakati pekuvhiya mask uye n95 kufema?

Pakutanga kutarisa, a Surgical Mask uye Chekufemesa chinonzi n95 Zvingaite sezvakaita, asi mabasa avo, zvigadzirwa, uye zvinoshandiswa zvinoshandiswa pasi. A Surgical Mask yakasununguka-yakakodzera, kuraswa mudziyo unogadzira a chipinganidzo chemuviri pakati pemuromo nemhino dze Wearer uye zvinogona kusvibiswa munzvimbo yepamoyo. Chinangwa chayo chikuru ndechekuvhara yakakura-chikamu kudonha kutapurirana, kunge splashes kana kupfira, kuchengetedza vamwe kubva kumapundu ekufema. Masokisi ekuvhiya anogadzirwa yemucheka usiri-hwakatwaswa uye hunowanzoshandiswa munzvimbo dzakasarudzika panguva dzekurapa maitiro ekurapa kuti chengetedza zvese zviri zviviri murwere uye hutano hwehutano kubva ku kuchinjisa microorganisms, mvura yemuviri, uye zivisa zvinhu. Nekudaro, nekuda kwekusununguka kwakakodzera, pane kazhinji a gap pakati pe Edges yeMask uye kumeso, zvinoreva kuti hazvipe kudzivirirwa kwakazara kubva mukunyepedzera zvidiki Airborne zvimedu.


FFP2 Mask 5 Ply

An Chekufemesa chinonzi n95, kune rumwe rutivi, ndi kuferefeta Dziviriro mudziyo wakagadzirirwa kuzadzisa chaizvo kuvhara kumeso kwechiso uye inoshanda zvakanyanya Filt of Airborne zvimedu. "N95" dhizaini zvinoreva kuti kana uchinge wangwarira kuyedza, iyo kufema zvidhinha zvinokwana kuita 95 muzana yezvidiki zvikuru (0,3 micron) bvunzo zvimedu. Izvi zvinoita Chekufemesa chinonzi n95 Inoshanda pamusoro pezvese zvidiki nezvidimbu zvidiki. Kusiyana ne Surgical Mask, an Chekufemesa chinonzi n95 yakagadzirirwa kusimbisa zvakanyanya kumeso, kumanikidza inhaled uye yakafemerwa mhepo kuti ipfuure kuburikidza Filter zvinhu. Ichi chisimbiso chakasimba chakakosha pakubata kwayo. Nekuda kweizvi, zvinoonekwa zvinodzivirira zvekudzivirira pachako (Ppe) yakagadzirirwa yaishandiswa kuchengetedza the the Wearer kubva pakufumurwa kukuvadza mhepogeborne zvikamu.

Kuiisa zviri nyore, a Surgical Mask inodzivirira nharaunda kubva the the Wearer, nepo Chekufemesa chinonzi n95 inodzivirira iyo Wearer kubva nharaunda. Semaneja wekutengesa, kunzwisisa uyu mutsauko ndiyo yekutanga nhanho mukuona yako nzvimbo inopiwa nemhando chaiyo ye mask yebasa racho chairo. Iwe haungashandise maitiro akapusa mask Munguva yeAerosol-Gadzira maitiro, uye haudi kudhura N95 Kumushanyi anofamba achifamba pasi pehoro. Kugadzira sarudzo chaiyo inogadzirisa kuchengetedzeka uye kurova kunodhura zvinobudirira.

Masvosve ekurapa anodzorwa sei mumamiriro akasiyana ehutano?

Mutemo we Masks Medical chinhu chinonetsa chinokanganisa murwere uye kuchengetedza kuchengetedzeka, uye inosiyana zvakanyanya zvichienderana nerudzi rwe mask uye kuronga. Mu U.S., iyo yekudya uye zvinodhaka kutonga (FDA) uye iyo National Institute yekuchengetedza basa uye hutano (Nihs), chikamu che CDC, ndiwo miviri yekutanga iyo dzora zvigadzirwa izvi. Iyo isiriyo-tsika inogona kuvhiringidza, asi inovimbisa kuti imwe neimwe mask inosangana yakatarwa maitiro emabasa ekushandisa kwayo. Zvekutakura basa, izvi hazvingori tepi tsvuku; Icho chevimbiso yako yemhando uye yakachengeteka.

Masokisi ekuvhiya, semuenzaniso, zvinodzorwa ne FDA sekirasi II II Medical Acomputer. Ivo vanofanirwa kusangana chaizvo zvinodiwa Fluid Barrier Dziviriro uye Filt kushanda. The the FDATsanangudzo pasi 21 CFR 878.4040 inotsigira zviyero izvi Kurapa maitiro masks. Ivo vanoedzwa pazvinhu zvakaita sehutachiona hwehutachiona hwekubudirira (BFE) Izvi zvinovimbisa mask inogona kutsungirira splashes yeropa kana zvimwe zvinhu zvinotapukira panguva yekuita. A mask ndiko Fda-yakajekeswa inokupa chivimbo chekuti yakaongororwa nekuda kwekuchengetedza uye kushanda kwekushandisa mune a hutano hwekugara. Aya ndiwo marudzi emwero inoraswa 3-ply yekurapa kumeso masks ine nzeve-loops Izvo zvakakosha kuti uve nehurombo hwevarwere nekutadza kudzora.

Kucheka Kwemasupfeke Zvakatarisana (Ffrs), senge N95s, zvinodzorwa zvakasiyana. Kana ivo vakaitirwa general indasitiri yekushandisa (sekuvaka), ivo vanopfuura Nihs pasi 42 CFR Part 84. Nihs Miedzo uye inobvumikisa kuti aya anofembera anosangana zvishoma zvishoma nezvishoma uye zvivakwa zvekuvaka. Nekudaro, kana Chekufemesa chinonzi n95 inoitirwa kushandiswa mune a hutano hwekugara kuchengetedza kubva patchborne pathogens, inofanira kuita zvinodiwa zvose zviri zviviri Nihs uye FDA. Izvi zvisimbiso zvezvinhu zviviri zvinozivikanwa se Kuvhiya N95 Respirators. Ivo vanopa kuchengetedzwa kwekufema kwe N95 uye kudzivirirwa kwemvura kwemvura kwe Surgical Mask.

Iwe unogona kutsanangura iyo nioms uye fda mabasa mukubvumidzwa kweMask?

Kunzwisisa izvo zvakasarudzika zvimiro zve Nihs uye FDA iri paramount ye chero maneja wekutengesa anoongorora kufema. Funga nezvavo sevaviri vanyanzvi hunyanzvi vanoona chigadzirwa chakachengeteka uye chinoshanda kubva kumakona maviri akasiyana. Iyo National Institute for Kuchengetedzwa kwebasa uye hutano (Nihs) is agency yekutsvagisa yakatarisana nekuchengetedza mushandi. Basa rayo rekutanga pamusoro pespirishors ndeyekuyedza uye kusimbisa kuti vanosangana zvakanyanya, Filt, uye maitiro ekuita. Paunoona a Nihs kubvumidzwa pane Chekufemesa chinonzi n95, zvinoreva kuti mask yakave yakayedzwa yakaedzwa kuti ive nechokwadi chekuti mafirita kunze kwe95% yezvisikwa zvisina mafuta emhepo. Chitupa ichi chiri chekuchengetedza mushandi-mune ino kesi, the nezveutano nyanzvi.

Iyo yekudya uye zvinodhaka kutonga (FDA), kune rumwe rutivi, inodzora Masks Medical uye zvishandiso zvekuona kuti zvakachengeteka uye zvinoshanda kune hutano hweveruzhinji. For a Surgical Mask kana a Kuvhiya N95 kufema, the FDAKufarira kuri mukushandisa kwayo sechinhu chekurapa. The the FDA Ongorora zvigadzirwa izvi kuburikidza ne Premarket Kuzivisa [510 (k)] Kuzviisa pasi kuti uone kana vakachengeteka kuti vashandiswe mune zvekurapa Care Zvirongwa. The the FDA" The the FDABasa ndere dzora the the mask Sechivimbiso chekudzivirira kubva kune splashes, chinonamira, uye yakakura-yezvinhu zvidhinha, izvo zvinorema panguva yekuvhiya Maitiro ekudzivirira vese vari murwere uye murwere.

Saka, kupfupisa:

  • Nihs Inoruramisa iyo kufemaKugona kuita Filter mhepo yemhepo yekuchengetedza iyo Wearer.
  • FDA inojekesa a Surgical Mask kana Kuvhiya N95 kufema yekushandisa kwayo seyorapwa chishandiso, kutarisa pane kugona kwayo kuita se Fluid barrier.

Indasitiri yakajairwa Chekufemesa chinonzi n95 Zvinodiwa chete Nihs kubvumidzwa. Asi a Kuvhiya N95 kufema zvinodiwa zvose zviri zviviri Nihs Kubvumidzwa kweKukuru Kwazvo Kwekugona uye FDA kujekeswa kwekushandisa kwayo seyakaomarara-inodzivirira chishandiso chekuvhiya. Semutengi, kana iwe uchida a kufema yekamuri yekuvhiya kana mamwe marongero ane njodzi yekuwonekwa kwemvura, iwe unofanirwa kutsvaga a mask izvo zvine zvese zviri zviviri zvinyorwa.


Chiremba wekuvhiya kumeso kumeso

Nei yakakodzera yakakodzera kuti ienderane neN95 kufema?

An Chekufemesa chinonzi n95 inongoita seyisingacherechedze chisimbiso chavo. Nepo Filter Media yakagadzirirwa kuvhara kanokwana kuita 95% yezvidimbu, iyi yakakwirira mwero wekudzivirira yakadzivirirwa zvachose kana mhepo inogona kubuda Edges yeMask. Uyu ndiwo musiyano wakanyanya kukosha pakati pe kufema uye chiyero kumeso kumeso. A Surgical Mask inodhonzera zvakasununguka pamusoro pechiso, asi a Chekufemesa chinonzi n95 injinjini for a kuvhara kumeso kwechiso. Pasina iyi yakasungwa chisimbiso, mweya wakasvibiswa ichatevera nzira yekudzivisa kushoma, kupfuura iyo Filter uye kupinda mudura rekufema kwazvo kuburikidza ne gap. Izvi zvinoregedza chinangwa chaicho chekupfeka yakakwira-filtration kufema.

Kuzadzisa a yakakodzera kukwana inosanganisira matanho akati wandei. Kutanga, kufema Inofanirwa kuve yakakodzera saizi uye chimiro chechiso chemushandisi. Haasi zviso zvese zvakafanana, ndosaka vazhinji vagadziri vanopa mhando dzakasiyana uye saizi. Chechipiri, Wearer inofanira kudzidziswa nzira yekuisa zvakanaka uye kubvisa iyo mask. Izvi zvinosanganisira kukotama iyo mhino yekuenderana nebhiriji ye mhino nemuromo nharaunda uye simbisa tambo dzakamira zvakanaka. Pakupedzisira, nekuti Basa shandisa mu U.S., OSHA inoda vashandi kuti vapfuure bvunzo yakakodzera. Iyi nzira yakasarudzika iyo inotarisa yekukanda ichitenderedza chisimbiso. Zvinhu zvakaita chivi bvudzi inogona kukanganisa chisimbiso, ichiita bvunzo yakakodzera kuti isingagoneke uye kuisirwa iyo kufema zvisingabatsiri.

Semunhu wekutakura, mutoro wako unotambanudza kupfuura kungotenga N95s. Zviri pamusoro pekusimbisa sangano rako rine chirongwa chakazara chekudzivirira chedziviriro. Izvi zvinoreva kupa zvakasiyana kufema Models kuti vagare vakasiyana kumeso mazvimiro uye kutsigira iyo inodiwa kudzidziswa uye yakakodzera-kuyedza protocol. Zvakachipa Chekufemesa chinonzi n95 Izvo hazvina kukodzera chero munhu asiri mutongo; Kuchiva. Kukurukurirana nemutengesi wako nezve akasiyana-siyana ehukuru uye maumbirwo aunopa chinhu chakakosha chekugadzira ruzivo rwunoziva. Mugadziri akavimbika anofanirwa kuve akakwanisa kudzikisira zvirevo uye kutsigira yako nzvimbo yekuyera yakakodzera.

Chii chinonzi kuvhiya n95 vanofonera uye vanodiwa rini?

A Kuvhiya N95 kufema ndiyo hybrid champion ye Masks Medical, kupa yakakwirira mwero wekudzivirira mukuda Health Care Zvirongwa. Inosanganisa maitiro eyero Chekufemesa chinonzi n95 neiyo a Surgical Mask. Izvi zvinoreva kuti hazvingopi chete Niichi Dziviriro yekufema-inotenderwa kubva pamhepo yemhepo asi iri zvakare Fda-yakajekeswa se Kirasi II Chiremba mudziyo wekuramba kupokana nekuputika kwemvura. Funga nezvazvo se N95 Kupfeka mvura yekunaya. Yakagadzirirwa chengetedza zvese zviri zviviri murwere uye iyo Healthcare nyanzvi (Hcp) panguva yemaitiro ipo kune njodzi yakanyanya yezviuru zvemhepo nemhepo uye splashes kana sprays yeropa uye mvura yemuviri.

Izvi zvidimbu-zvinangwa zvinodonha zvakananga Yakagadzirirwa kushandiswa Munzvimbo dzinogara nadzo uye dziviriro kubva pamhepo nemvura nemvura zviri nyore. Izvi zvinosanganisira nzvimbo dzekushanda, madhipatimendi emazambirisheni panguva dzekutambudzika, uye panguva dzekugadzira maAerosol pane varwere vane chirwere chinozivikanwa kana chinofungidzirwa kuti chakadai, chakadai sekutakura kana bronchoscopy. The the Kupararira kweCavid-19 yakaunza kukosha kwe Kuvhiya N95 Kupinda mukutarisa kwakapinza, sezvazvakaitwa nekudzivirirwa kwakazara kubva kune hutachiona hwakatapurwa kuburikidza nemadonhwe ese uye madonhwe. The the Fluid barrier kana kufambira mberi kwesimba yeaya masks yakaedzwa yakaedzwa kuti ive nechokwadi chekuti vanopa nhoo yakavimbika.

Kana uchisvibisa, zvakakanganisika kuti uone kuti a mask yakatengeswa se "Kuvhiya N95"Inosimbiswa zvechokwadi nezvose zviri zviviri Nihs uye FDA. Iwe unofanirwa kukwanisa kuwana a Nihs nhamba yekubvumidza pane kufema pachayo (i.e., tc-84a-xxxx) uye simbisa yajekeswa ne FDA pasi Chigadzirwa Code Msh. Kushanda nemutengesi anoonekera anokwanisa kupa zvinyorwa izvi pasina kuzeza hazvitaurwe. Nepo idzi dzinobvunda dzinodhura zvakanyanya, ivo chinhu chakakosha Ppe Mune njodzi-yakawanda Care Zvirongwa, uye kukanganisika pamhando yavo haisi sarudzo.

Ko mavharuvhu edenga pane yekufema inokonzeresa kuchengeteka mune imwe kiriniki mamiriro?

MaVhezheni eLefalation pane kufema chinhu chakagadzirirwa kunyaradza, asi vane zvizere zvizere zvekushandisa mune a hutano hwekugara. A valve iri nzira imwe-inobhururuka inovhura kana iyo Wearer Inofema, ichibvumira kudziya, nyoro mweya kupukunyuka nyore nyore. Izvi zvinoita kufema Kunyanya kugadzikana kupfeka kwenguva yakareba uye kuderedza kupisa kwemukati mukati mask. Kune vashandi vekushanda kwemaindasitiri, sevari mukuvaka kana kugadzira, ichi chinhu chinoshamisa. Nekudaro, muchimiro chekurapa, kunyanya nekuda kweSosi kutonga, zvakafanana valve inova dambudziko rakakura.

Nyaya ndeyekuti Kupfeka vharuvhu Inobvumira madhiri emurwere asina kujairika ekudzingwa zvakananga munharaunda. Nepo valve haikanganisi kuchengetedzwa kwemunhu akapfeka kufema, Izvo zvinoregedza chinangwa cheMask mukudzivirira iyo Wearer kubva mukuparadzira hutachiona kune vamwe. Mundima isina kusimba kana kana uchiitira hanya nevarwere veNeunocomputer, iyi inzvimbo isingagamuchiriki. Munguva ye COVID 19 denda, iyo CDC zvakanyatso kukurudzirwa kuti ubve pakushandisa mafirita ne MaVhezheni eLefalation for sosi kutonga, sezvavanoita zvishoma kuti Batsira kuderedza kupararira kwehutachiona kubva pamunhu anotapukirwa.

Saka, nekuti zvinenge zvese Health Care Zvirongwa, Vanodonha na MaVhezheni eLefalation hazvina kukodzera. Kana iwe pfeka chiso mask muchipatara kana kiriniki, chinangwa chakapetwa kaviri: Zvidzivirire uye chengetedza avo vakakukomberedza. Kuvharirwa kufema Inongoita chete chinangwa chekutanga. Semutariri wekutakura, ichi chiitiko chinonyanya kukosha kuti utarise. Kunze kwekunge iwe uri kutenga kune chaiyo chaiyo Basa basa umo sosi yekudzora haisi kunetseka (iyo isingawanzo mukati nezveutano), iwe unofanirwa kugara wakasarudza N95s kana vamwe vanogonesa pasina a valve. Izvi zvinovimbisa kuti uri kupa Kudzivirirwa kuri nani nenzvimbo dzese dzekutarisira.


Mhando dzeMasks ekurapa

Chii chandinofanira kutarisa kana ndichiisa masokisi ekurapa kubva mhiri kwemakungwa?

Sourcing Masks Medical Kubva kumugadziri munyika yakaita seChina inogona kuve inobatsira chaizvo maererano nemutengo uye vhoriyamu, asi zvinoda kushingairira uye zano rakajeka. Semuridzi wefekitori, ndinotaura nevarume vekutakura senge zuva rega rega, uye ndinoziva zvaunonetseka. Iyo kiyi ndeyekufamba kupfuura mutengo uye tarisa pane kubatana uye kuongororwa. Kutanga uye kunyanya, kuda kujeka mugwaro. Mugadziri anokurumbira anokupa iwe pachako neiyo ISO 13485 Setifiketi FDA kunyoresa kana kunyoresa mavara. Usangobvisa izwi ravo; Bvunza magwaro uye uzive maitiro ekuvaratidza.

Chechipiri, kutaurirana ndizvo zvese. Imwe yemapepa makuru ekurwadziwa andinoita nezve kusarongeka kwekutaurirana. Iwe unoda mutengesi ane anotengesa, anotaurisa anotengesa, uye timu yekutsigira inonzwisisa zvinodiwa zvako zvehunyanzvi uye zvekudzora zvido. Vabvunze mibvunzo yakadzama nezve maitiro avo ekugadzira, mhando dzekudzora kwemhando, uye batch traceability masisitimu. Vanogona kukuudza chaizvo kuti ndeipi yakawanda yezvinhu zvakabikwa zvakapinda mukati mask Uri kutenga? Mumwe akanaka anogona. Iyi nhanho yeruzivo zvakare yakakosha kune kuronga kwezvinhu. Kurukura nguva dzinotungamira, kutumira sarudzo, uye marongero ekubhadhara kuti udzivise kunonoka uko kunogona kusiya nzvimbo yako ipfupi pane zvekushandisa.

Pakupedzisira, funga chibereko pachacho. Kumbira samples usati waisa yakakura kurongeka. Paunovagamuchira, tarisa kunaka. Tarisa maWelds pa nzeve, kunzwa kwe Frabhible machira, uye kutendeka kweiyo mhino. Enzanisa ne mask Iwe unoziva uye kuvimba. Zvinonzwa kuti zvinonakidza here? Pane chero chinoshamisa chinoshamisa here? Izvi zvidiki zvidiki zvinogona kuve zviratidzo zvemhando yakakura kudzora nyaya. Kunobva kumhiri kwemakungwa ndekwekuvaka kuvimba. Mubatanidzwa uko mativi ese maviri anobatsirwa kubva kujekesi, mhando, uye kutaurirana pachena. Kunyangwe iwe uri kutsvaga Yakakwirira-mhando yekuzviparadzanisa kana iri nyore kumeso kumeso, idzi nheyo dzekushingairira kwekushingaira nguva dzose.

Ko iyo yakajairwa-19 sei matanda emahombekombe akachinja sei mamiriro emasokisi akatarisana?

The the COVID 19 PANemic yaive chiitiko chechibvumirano chakanangana nekunzwisisa kwepasirese uye kushandiswa kwe kumeso kumeso. Pamberi pa2020, mune dzimwe nyika dzakawanda dzekuMadokero, mask-akapfekwa hwaigara Health Care Zvirongwa. Iyo panicemic yakashandurwa iyo mask kuita chiratidzo che Ubiquitous yehutano hweveruzhinji uye mutoro wemagariro, wakapfekwa na General veruzhinji zuva nezuva. Kuda kusingaenzaniswi uku kwakagadzira nzvimbo huru yepasi rose yekutengesa keteni Zvekuita nharo dzekutakura, musika wacho wakava mhirizhonga yemamiriro ekunze etsva mutsva (Kn95, Ffp2), zvisina kujairika vatengesi, uye zvigadzirwa zvekunyepedzera.

Imwe yeanonyanya kufambiswa yaive yekutarisa pane sosi kutonga. Iyo yekutanga yehutano hwehutano hwehutano hwakava hwakavapo mask Yakanga isiri kungotongwirira pachedu, asi nezvekudzivirira nharaunda. Izvi zvakakwidzidzira kukosha kwechinguvana jira mask kana maitiro mask Mukuderedza iyo Kupararira kweCavid-19. The the CDC uye mamwe masangano ehutano akaburitswa nedzidzo dzakatsanangurwa pamabatiro aungaita pfeka chiso kufukidza zvinobudirira, kusanganisira kurudziro kuna kuvandudza kukwana yekuvhiya uye machira emachira Nekunyepa loops kana kushandisa mask fitter. Iyo Pandemtic yakapihwa mwero mask, asi zvakare yakasika ruzivo gap izvo zvakasiya vatengi vazhinji uye kunyange vamwe nyanzvi dzinovhiringidzwa nezve mhando dzakasiyana dzemasks.

Kubva pakugadzira uye kutenga maonero, denda rakamanikidza dzidziso yekukurumidza. Takaona emergency exprgency mvumo (euas) kubva ku FDA kubvumira kushandiswa kwevasiri-vechinyakare mafadomita, se Kn95 kubva kuChina, mukati nezveutano Zvirongwa kana N95s dzaishoma. Izvi zvakajekesa kukosha kwekunzwisisa zviyero zvepasi rose. Izvo zvakasimbisawo kuda kwakasimba kwekusimba kwekugovera ketani yeketeni. Dambudziko rakatidzidzisa kuti kuvimba neyakawana chero nzvimbo kana dunhu rine njodzi uye kuti kuve nehukama hukama nevadzidzi vakavimbika, vakasarudzika vagadziri vanokosha. Nhaka ye COVID 19 musika unoziva zvakanyanya, unonzwisisika, uye zvakanyanya kudikanwa kwemhando uye pachena mune izvo Ppe.

Machira emachira kana standard maitiro emasiki akakodzera kugadzirira hutano?

Kukodzera kwe a jira mask kana maitiro akajairwa mask zvinoenderana zvachose pane chaiyo basa uye huwandu hwengozi mukati me Hutano hwekuchengeta. A jira mask inonyanya kuve sosi yekudzora chishandiso che General veruzhinji. Nepo a zvakanaka-zvakakodzera jira mask inogona Batsira kuderedza kubviswa kwemadonhwe ekufema kubva ku Wearer, inopa dziviriro huru kune Wearer kubva pakubvunzurudza zvidimbu zvakanaka kana maAerosols. Nechikonzero ichi, machira emachira anowanzoonekwa seisina kukwana kwekushandiswa kwekiriniki nehutano hwehutano hwevanopa hanya pamurwere. Ivo vanoshaya kutambudzika Filt uye fluid kurwisa zviyero zvinodiwa Masks Medical.

Maitiro akajairika Masks Medical, iri mhando ye Surgical Mask, inhau dzakasiyana. Ivo vane nzvimbo mukati nezveutano. Izvi kuraswa masks ari FDA-Defirongwa uye yakagadzirirwa kupa chipinganidzo kubva kumadonhwe uye splashes. Ivo vakakodzera zvakakwana kune dzakasiyana siyana mabasa, senge general bvunzo, kutakura kwemurombo, uye kushandisa munzvimbo dzinozivikanwa dzechipatara kusimudzira kuronga. Ivo vanopa chiyero chakanaka chekudzivirira uye nekufema kwemamiriro ezvinhu akaderera-njodzi. Nekudaro, ivo vari kwete a kufema. Ivo havaumbe chisimbiso chakasimba uye havapi chengetedzo yakavimbika pamusoro pekufemerwa madiki madiki emhepo.

Naizvozvo, mutemo wechigunwe kuenderana ne mask kune njodzi.

  • Jira rejasi: Kwete kwekushandiswa kwekiriniki neHCPS.
  • Procedure / Surgical Mask: Yakanakira nzvimbo yekudzora uye kuchengetedzwa kubva kune madonhwe mumamiriro akaderera-njodzi mamiriro emamiriro ezvinhu. Yakakosha pakuchengetedza varwere kubva kune vanopa vabati panguva yemaitiro asina tsvina.
  • Chekufemesa chinonzi n95: Inodiwa kuti udzivirirwe kubva pamhepo yemhepo, kunyanya panguva dzekugadzira maAerosol.

Kuti uwane maneja wekutengesa, izvi zvinoreva kuchengetedza hesipi yekutsvaira. Iwe unoda yakavimbika yekugovera yemhando yepamusoro Chirevo chekuvhiya kumeso masks pakushandiswa kwemazuva ese, padivi pechitoro che Nihs- N95 Respirators kune zviitiko zvine njodzi zvakanyanya. Zviri zvekuve nechishandiso chakaringana chebasa kuti uve nechokwadi kutevedzera uye kuchengetedzwa.

Navigating Certification: Chii chinonzi iso, CE, uye FDA zvinoreva chaizvo kune yako mask kutenga?

Kune maneja wekutakura, zvitupa ndezvekuvimba kwako. Iwo chiratidzo chechinangwa chekuti chigadzirwa chinosangana nemitemo yakatarwa. Ngatipwanyei vanozivikanwa kwazvo, iwe wauchasangana naye kana uchisvika Masks Medical.

Iso 13485 ndiyo nzira yepasi rese yeiyo mhando yemhando yemhando system yekugadzira mudziyo wekugadzira. Kana fekitori senge mine iso Haisi chitupa chigadzirwa; Icho chitupa chechiratidzo. Inokuudza iwe mugadziri ane masisitimu ari munzvimbo yekugadzirwa, kugadzirwa, kuongororwa, uye kutangisa njodzi. Uku ndiko kuvimbisa kwako kwehupamhi kwemunhu anokwanisa uye kuvimbika kune zvese zvigadzirwa, kubva a kumeso kumeso kune zvimwe zvinhu zvakaoma senge Kurapa kwekurapa kunobatanidza machubhu.

CE Makaing Chiratidzo chechiratidzo chinoratidza kuenderana nehutano, kuchengeteka, uye zvakaringana zvidziviriro zvigadzirwa zvinotengeswa mukati meEuropean Economic nharaunda (eea). For a Surgical Mask kana kufema. Iyo inosungirwa pasipoti yezvigadzirwa ichipinda iyo EU musika. Kwemutengi weUS-based, nepo asiri chirevo chakananga, chinoshanda sechiratidzo chakasimba chekuti mugadziri anogadzira kuenderana neyekumusoro mitezo yenyika.

Pakupedzisira, iyo FDA (Chikafu uye Drug Administration) inodzora Masks Medical MuUnited States. Sezvatakakurukura, masokisi ekuvhiya vanoonekwa Kirasi II Zvishandiso Zvekurapa uye Kuda FDA clearance, kazhinji kuburikidza ne510 (k) Premarket Kuzivisa. Maitiro aya anoratidza kuti chishandiso chakadai chakachengeteka uye chinoshanda seyakagashika nemutemo chishandiso chisiri pasi pekutenderwa kwekutanga. Nekuti Kuvhiya N95 Respirators, vanoda zvese zviri zviviri Nihs kubvumidzwa uye FDA clearance. Kuratidza kuti mutengesi FDA Kunyoresa uye chigadzirwa clearance inhanho isingabatsiri mune yako yakakodzera maitiro ekuita. Mutengesi akavimbika anogovera nhamba dzadzo dzekunyoresa uye 510 (k) mavara ekukumbira pakukumbira. These certifications are your shield against poor quality and regulatory non-compliance.

Chimiro Surgical Mask N95 Resppirator (Industrial) Kuvhiya N95 kufema
Chinangwa Chekutanga Fluid Barrier, Tsime Kudzora Kuparadzanisa Filtration kune Wearer Zvese zvipfeko zvinokanganisa uye filt
Kukwana Zvakasununguka-zvakakodzera Chisimbiso chakasimba-chakakodzera Chisimbiso chakasimba-chakakodzera
Filt Inovhara madonhwe makuru MaFilters ≥95% yeAirborne Scastle MaFilters ≥95% yeAirborne Scastle
Kubhururuka Kukwira kukwira kutenderedza mativi Low Laakage Kana Yakakodzera-Yakaedzwa Low Laakage Kana Yakakodzera-Yakaedzwa
Mutemo weUS FDA (21 CFR 878.4040) Nihs (42 CFR Part 84) Nihs uye FDA
Fluid kuramba Hongu (Kuedzwa na ASTM nzira) Aihwa Hongu (FDA Akacheneswa)
Shandisa kesi General murwere kutarisirwa, kuvhiyiwa Kuvaka, Kugadzira Maitiro Eorosol

Key kutoraya kuyeuka

Paunenge uchifambisa nyika yakaoma yezvokurapa mask uye kufema Kubata, chengetedza izvi zvakakosha pfungwa mupfungwa:

  • Basa rinotaura fomu: A Surgical Mask Inodzivirira Vamwe kubva the the Wearer nekuvharira madonhwe. An Chekufemesa chinonzi n95 inodzivirira iyo Wearer kubva nharaunda nekupusha kwemhepo yemhepo.
  • Fit zvinhu zvese zvekufema: An Chekufemesa chinonzi n95 isingabatsiri pasina chisimbiso chakasimba. A yakakodzera kukwana, Vakasarudzika nemuyedzo wakakodzera, unokosha kuzadzisa iyo yakavimbiswa mwero wekudzivirira.
  • Ziva Vako Varidzi Vako: MuUS, FDA anozvidza masokisi ekuvhiya sekushandisa kwekurapa, nepo Nihs Inoruramisa mashandiro emufession yefespirators. Kuvhiya N95s inofanira kusangana nezviyero zvevaviri.
  • Mavari ndezvekunyaradza, kwete makiriniki: Vanopanduka na MaVhezheni eLefalation chengetedza Wearer asi kwete avo vakavakomberedza. Ivo kazhinji havana kukodzera Health Care Zvirongwa Kunobva kupi kudzora kwakakosha.
  • Simbisa, usavimbe: Kana uchisvika pasirese, kudiwa uye kusimbisa certificificifieds saOso 13485, CE Maka Maka, uye FDA clearance. Partner nevatengesi vanoongorora vanotsauka vanotungamira kunaka uye kutaurirana.
  • Batanidza iyo mask kune njodzi: Shandisa nzira yakasviba. Stock Standard Masks Medical Zvekushandiswa kwakawanda uye kuchengetedza N95 Respirators Kuti uwane patsva, maitiro eAerosol kuti ave nechokwadi chekuchengetedza uye kubata zvinodhura zvinobudirira.

Kutumira Nguva: Jul-23-2025
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