Surgical Mask vs. N95 Respirator: FDE FILDE KUTI KUTI URI KUTI URI KUTI URI KUTI URI KUTI URI KUTI URI KUTI URI KUDZIVA

Munyika yekuviga kwekurapa, kunyatsojeka ndiko zvese. Kune nyanzvi dzakafanana nemako Thompson, maneja wokuropa wechipatara muUSA, mazwi "Surgical Mask, ""Chekufemesa chinonzi n95, "Uye"kumeso kumeso"Icho chikamu chezuva nezuva lexicon. Asi, izvo zvinoshamisa asi mutsauko wakashata pakati pavo, kunyanya kuburikidza ne lens ye FDA, inogona kuoma. The the Covid-19 19 hutano hwehutano hwekukurumidzira Akaunza misiyano iyi kumberi, ichigadzira mafashama ezvigadzirwa zvitsva, mirau, uye nyonganiso. Semugadziri we Zvishandiso Zvega Zvekudzivirira MuChina, ini, Allen, akafamba aya emasangano ekumanikidza kuti ape vatengi kuNorth America neEurope. Kunzwisisa FDAChiitiko hachisi chekungotevedzera mhosva; Zviri pamusoro pekusimbisa kuchengetedzwa kwe Hutano hwevashandi uye varwere. Iyi nhungamiro ichavhura misiyano pakati pe Surgical Mask uye a kufema, kujekesa FDA'SEGulatory Simba, uye ipa ruzivo rwakajeka iwe rwaunoda kusisira kurudyi Ppe chero mamiriro ezvinhu.

Chii chaizvo chinonzi masiki ekuvhiya mumaziso e fda?

Maererano ne FDA, a Surgical Mask yakasununguka-yakakodzera, inoraswa Medical mudziyo izvo zvinogadzira a chipinganidzo chemuviri pakati pe muromo nemhino yeanotya uye angangogona kumisikidzwa munzvimbo iri ipapo. Iri Chigadzirwa chakapfekwa pachiso, asi zvakakosha kuti unzwisise zvakanyanya Yakatarisirwa kushandiswa. A Surgical Mask yakagadzirirwa kuvhara yakakura-yezvinhu madonhwe, inoputika, inoputira, kana splatter iyo inogona kunge iine Virazi uye mabhakitiriya, ichivadzivirira kusvika kusvika kune vanopfeka mhino nemuromo.

Panguva imwe chete, a Surgical Mask inoitirwawo kuchengetedza vamwe. Iyo inobatsira kuteya uyo akapfeka vese Zvikamu zvekufema pavanofema, kutaura, kana kukosora. Ichi chikamu chechidiki ndechekuti nei vakakosha panguva ye Kurapa maitiro. Nekudaro, nekuda kwekusunungurwa kwayo, a Surgical Mask haina kuumba chisimbiso chakasimba pakati pe mask uye kumeso kwako. Izvi zvinoreva kuti hazvipe zvakafanana mwero wekudzivirira kupokana nehaling zvidiki mhepo yemhepo yemhepo se kufema. The the FDA anotonga Surgical Mask se Kirasi II Medical Chishandiso.

Kufema kwakasiyana sei kwakasiyana kubva kune mask yekuvhiya?

Nepo a Surgical Mask inogadzira chipinganidzo, a kufema chidimbu che Zvishandiso Zvega Zvekudzivirira Yakagadzirirwa Filt. Musiyano wakakosha unorara muchinangwa chayo uye dhizaini. A kufema, senge Chekufemesa chinonzi n95, ndeimwe ye kufema zvinodzivirira zvishandiso yakagadzirirwa kukwira kumusoro kumeso, ichigadzira chisimbiso chakakomberedza mhino nemuromo. Rini kupfeka zvakanaka, iyi yemazimbe emachira emagetsi uye mhepo yakawedzera kupfuudza kuburikidza nefaira.

Basa rekutanga re kufema ndeyekuti Dzivirira Anotya kubva pakubvunzesa ngozi yemhepo yemhepo. MuUnited States, izvi zvishandiso zvinoedzwa uye zvakasimbiswa neNational Institute for Kuchengetedzwa kwebasa uye hutano (Nioti), chikamu che CDC, pasi pemutemo 42 CFR Chikamu 84. The "N95"Kusanangurwa kunoratidza kuti kufema Mafirita kunze kanokwana 95% yezvidiki zvikuru (0,3 micron) bvunzo zvidimbu. Saka, the Misiyano pakati pekuvhiya masks uye vanofemera vakakosha: a Surgical Mask chipinganidzo chemadonhwe, nepo kufema iri firita yemhepo yemhepo. Chiyero Surgical Mask haisi a kufema.

Saka, its n95 kufema chiratidzo chekurapa chakarongwa neFDA?

Iyi inguva inowanzo nyonganiso, uye mhinduro ndeyechokwadi. Zvakanyanya N95 Vanoperekedza vakagadzirirwa maindasitiri marongero, akadai sekuvaka, kuchengetedza vashandi kubva kuguruva nezvimwe zvinhu. Izvi zvinosimbiswa neNihs asi hazvifungirwe a Medical mudziyo uye haina kutongwa ne FDA.

Nekudaro, chikamu chakakosha-chikamu chinozivikanwa se "Kuvhiya N95 kufema. "Rudzi urwu rwe kufema yakasarudzika nekuti yanga iri miviri yakasimbiswa neNihsh se Chekufemesa chinonzi n95 ndokujekeswa ne FDA se Surgical Mask. Izvi zvinoreva a Kuvhiya N95 inopa zvakanakisa zvenyika: Inopa iyo yepamusoro periorne chidimbu chekupedzisira kuderedza kuratidzwa senge chiyero N95, uye inopa iyo Fluid Barrier Dziviriro a Surgical Mask Kuchengetera kupaza splashes uye kupfira. Izvi Kuvhiya N95 Vanoperekedza Yakagadzirirwa kushandiswa mukati Hutano hwehutano marongero nehutano hwevashandi vehutano panguva yemaitiro anogona kuburitsa maAerosils, achipa iyo yepamusoro mwero wekufema uye fluid dziviriro mune imwe chete mask.

Chii chinonzi "chipinganidzo chechiso chekuvhara" uye chinopinda kupi?

Izwi iri "Chishamiso Chiso" yakajairika panguva ye dengic. Zvinoreva a Chigadzirwa chakapfekwa pachiso izvo zvinofukidza wapfeka mhino nemuromo Zvikurukuru kuti uwane kudzora - ndiko kuti, kudzivirira uyo anopfeka kubva mukuparadzira yavo yekufema madonhwe ekufema. Izvi zvinosanganisira machira emachira uye zvimwe zvakapfava kumeso.

Kusiyana ne Surgical Mask, a Chishamiso Chiso kazhinji haina kutariswa a Medical mudziyo na FDA kunze kwekunge zvanzika chayo zvichiratidza kuti ndezvekurapa zvinangwa. The the FDA yakapihwa yakatarwa Nhungamiro Nezvakagadzirwa izvi, kujekesa kuti chero bedzi vasina kuita zvekuti Fluid Barrier kana Filtration Kubudirira Matanho, ivo vaisazove pasi pemitemo yakafanana nemitemo yakafanana ne Surgical Mask. A Chishamiso Chiso inopa chishoma chemuviri chipingamupinyi uye hazvitariswe Ppe. Ivo vakaitirwa izvo vanhu vazhinji uye vane hutano vashandi vehutano mumakiriniki asina-echiriniki, kwete yekushandisa panguva yekutarisirwa murwere kana maitiro ekuvhiya.

FDA inoparadzanisa sei uye inotonga mask yekuvhiya?

The the FDA Anoremekedza a Surgical Mask se Kirasi II Medical Chishandiso, iyo inoisa iyo muchikamu chine mwero-chine njodzi. Kumusika zviri pamutemo a Surgical Mask muU.S. Pasi pemamiriro ezvinhu akajairika, mugadziri anofanira kuendesa 510 (k) Premarket Kuzivisa ku FDA. Uku kutumira kunofanirwa kuve neuchapupu hwekuti nyowani mask "zvakafanana" mukuchengetedza uye kushanda kune mudziyo watove pamusika.

Sechikamu cheichi chiitiko, iyo FDA inoda data rekuita kuratidza iyo maskKubudirira kushanda. Masokisi ekuvhiya anoedzwawo Kune akati wandei zvakakosha zvivakwa:

• Fluid kuramba: Inoyera kugona kwe maskKuvaka kuvakwa kuderedza mvura kubva pakufamba kuburikidza nezvinyorwa.
• Bacterial Filt Riltration Kubudirira (BFE): The the maskKukwanisa kushandura mabhakitiriya.
• Kuparadzanisa Filtoration Kubudirira (PFE): The the Dhigirii yezvikamu zvechikamu kupokana newe-micron zvidimbu.
• Kufema (delta p): Anofunga kuti mask yakagadzikana kupfeka uye haina kunyanyisa kudzora kufema.
• Kufa: The the mask anofanira kuratidza murazvo wekupokana.
  Izvi zviyero zvine simba zvinoona kuti chero Fda-yakajekeswa kuvhiya masks ipa yakavimbika chipingamupinyi chemuviri kusvika kumvura uye chidimbu nyaya sekurehwa.

Chii chakachinja nemutemo weFD panguva yekuchinja-19 kwehutano hweveruzhinji?

Chisati chamboitika Zvishandiso Zvega Zvekudzivirira Munguva yePandemic yakakurudzira iyo FDA kutora matanho anoshamisa kuti awedzere kuwanira. Kuzadzisa izvi, iyo FDA yakapihwa amburera eua (Emergency Shandisa Mvumo) ye Surgical Mask Models iyo isina kuiswa pasi pezve standard 510 (k) clearance maitiro. Izvi Umbrella eua for svutugadzike masks inobvumidzwa mamwe masks kuti ishandiswe mukati Healthcare Zvirongwa, chero vaisangana zvakataurwa maitiro ekuita. Iyi yaive imwe ye akati wandei Zvivakwa zvekudzivirira pachako euas yakapihwa.

The the FDA zvakare yakapihwa euas ye Vanoperekedzwa zveCavid-19, kubvumira kupinza uye Kushandisa kweiyo chete kuvhiya uye isiri-yekuvhiya yekuvhiya yakanga isiri niesh-inotenderwa asi yakaratidzwa kuti isangane zviyero zvakafanana ne N95. Aya matanho aive akaomeserwa nekuchengetedza hutano hwevashandi apo zvekushandisa zvetsika zvaive zvishoma. Nekudaro, zvakakosha kuti urangarira izvi mvumo zvaive zvenguva pfupi uye zvakasungwa zvakananga kune covid-19 19 hutano hwehutano hwekukurumidzira. Chero Surgical Mask kana kufema Kutengeswa pasi peEUU kwainzi "Yakatenderwa kushandiswa kwekukurumidza, "kwete" fda-yakajekeswa "kana" fda-yakatenderwa. "

Zvese zvimedu zveN95 zvakakodzera kune hutano hwevashandi vehutano?

Kwete, uye ichi chiitiko chakakosha chemutengi chero upi zvake. Indasitiri yakajairwa Chekufemesa chinonzi n95, nepo kupa zvakanakisa Filt, haina kunaka Health Care Zvirongwa. Vazhinji vevakadonhedza ava vane vharuvhu rekunyepedzera - denderedzwa repurasitiki repurasitiki pamberi pe mask izvo zvinoita kuti zvive nyore kufema. Nepo kugadzikana, iyi vharuvhu inoburitsa kufema kusina basa mumamiriro ezvinhu, kukunda chinangwa chekusimudzira simba mumunda usina kugadzikana.

A Kuvhiya N95 kufema yakagadzirwa chaizvo Shandisa nevashandi vehutano vehutano. Haina vhezheni yekuwedzera uye, sezvakataurwa, inojekeswa ne FDA zvekurwisa fluid. Saka, mune a Hutano hwekuchengeta, kunyanya panguva dzakashata kana kana dzichirarama varwere vanotapukira, izvo chete zvakakodzera N95 a Kuvhiya N95 kufema. Uchishandisa maindasitiri Chekufemesa chinonzi n95 inogona kukanganisa nzvimbo isina kusimba uye kuchengetedza murombo.

Semutengi, chii chandinofanira kutarisa muFDA-yakajekeswa masiki ekuvhiya?

Paunenge uchisvika a Surgical Mask, kutarisa kunze kwekushambadzira kwekutengesa kwakakosha. Semugadziri, tinopa data iri kune vatengi vedu kuratidza kutevedzera uye kunaka. Hechino chaunofanirwa kuratidza:

• 510 (k) clearance: Bvunza FDA 510 (k) kujekeswa nhamba ye Surgical Mask. Urwu ruzivo rwevanhu uye runogona kusimbiswa pane FDADatabase.
• ASTM F2100 mazinga: The the FDA inoziva iyo ASTM F2100 Standard, Ndeipi mitengo Procedure masks uye masokisi ekuvhiya padanho 1, 2, kana 3 zvichienderana nekuita kwavo mumuedzo mashanu anokosha ambotaurwa. Chikamu chechitatu Surgical Mask inopa yakakwirira kwazvo Fluid Barrier kana Filtration Kubudirira Matanho.
• Anokudzwa Mugadziri: Partner neanogadzira iyo ine rekodhi rekodhi yekugadzira zvishandiso zvekurapa zvinowira mukati FDA mitemo. Tarisa certification senge iso 13485, iyo ine chekuita nezvekurapa yemhando yemhando system.

Kuona kuti mutengesi wako anogona kupa ufakazi uhwu anovimbisa kuti uri kutenga zviri pamutemo Surgical Mask izvo zvinopa dziviriro tsvimbo yako nevarwere vanoda, senge yedu yakakwirira-mhando Chiremba wekuvhiya kumeso kumeso. Edu Inoraswa 3Ply yekurapa kumeso mask imwe yakasarudzika sarudzo inosangana nematanho emhando yepamusoro.

Ndingaite sei kuti ndionekwe kana maski ekuvhiya kana kufema anotenderwa neFDA?

Kuratidza kusarudzika kwe a mask kana kufema inhanho yakaoma mukuviga kuti udzivise zvigadzirwa zvekunyepedzera.

• YeNihosh-anotenderwa mafirita: The the CDCS National National Promise Technology Laboratory (NPPTL) inochengetedza yakasimbiswa zvinyorwa zvinyorwa. Iwe unogona kutsvaga iyi rondedzero kuratidza kana a kufema, kusanganisira chero N95 kana Kuvhiya N95 Model, is nosh-inotenderwa.
• Kune fda-yakajekeswa masokisi ekuvhiya. The the FDA'S 510 (K) Premarket Notification Database ndiyo yekutanga sosi. Iwe unogona kutsvaga nemugadziri kana zita remusi wekutsvaga iyo clearance madhiri eiyo chaiyo Surgical Mask.
• Zvemidziyo pasi peEua: Panguva yekukurumidzira, iyo FDA yakarongedzwa zvinyorwa zvevose Yakatenderwa kuvhiya masks uye anokona pawebsite yayo. Rondedzero idzi dzakataurwa kuti ndeipi Kuvhiya Mask Models dzakabatanidzwa pasi pe Umbrella eua for svutugadzike masks. Kunyangwe iyo eua iri kupera, aya machira anoramba ari chiitiko chinobatsira.

Kushandisa izvi zviwanikwa zvepamutemo ndiyo chete nzira yechokwadi yekusimbisa iyo Surgical Masks uye N95 Respirators urikutenga zviri pamutemo. Chigadzirwa senge chedu FFP2 Mask, vachiri kusangana nemaitiro eEurope, vanoratidzira mhando yemhando uye Filt kuita kunotarisirwa kubva kune zviri pamutemo Ppe.

Chii chinonzi FDA's post-emergency chirongwa che masks uye vanofona?

Se Veruzhinji Hutano Kwekukurumidzira Magumo, the FDA iri kufamba kure nekuchinjika kweEUAS uye kudzokera ku standard yekudzora maitiro. Iyo agency yakaburitsa a Shanduko yeTrans yeChirongwa chekurapa izvo zvakambotenderwa pasi pe eua. Izvi Nhungamiro inotsigira iyo nguva yenguva uye zvinodiwa kuti vagadziri vezvizvi masokisi ekuvhiya uye anodonhedza kuendesa kune yechinyakare FDA clearance kana vachishuva kuramba vachitengesa zvigadzirwa zvavo muU.S.

Izvi zvinoreva kuti vazhinji ve mask uye kufema Brands akaonekwa pamusika panguva yePandemic achafanirwa kuenda kuburikidza neakasimba 510 (k) maitiro. Shanduko iyi yakakosha kuti uve nechokwadi chekuchengetedza kwenguva refu uye mhando yeU.S. Supply of Zvishandiso Zvega Zvekudzivirira. Zvemabhaja ekutakura, zvinoreva kuti iwe uchafanirwa kushingairira mukuona kuti vatengesi vako vateveri izvi Shanduko yeTrans yeChirongwa chekurapa uye inogona kupa humbowo hwekuuya kwavo kana kutsvaga FDA clearances kune chero Surgical Mask. Iyo inorongedza kudzokera kune yakakwirira zviyero zvinotsanangura zvishandiso zvakatongwa neFDA.