Imaski Yezimbali VS. I-N95 Respirator: Umhlahlandlela we-FDA wemishini yokuzivikela komuntu kanye ne-filtration - zhongxing

Emhlabeni wokuthengwa kwezokwelapha, ukunemba kuyikho konke. Ochwepheshe njengoMark Thompson, umphathi wokuthengwa kwezibhedlela e-USA, amagama athi "isakaza, ""I-n95 respirator, "futhi"imaski yobuso"Bayingxenye ye-Daily Lexicon. Noma kunjalo, umehluko obucashile kepha obucayi phakathi kwabo, ikakhulukazi ngelensi ye Uhlobo lwe-fda, kungaba yinkimbinkimbi. Le khasi I-COVIAL-19 Public Health Emergency Ulethe lokhu kwahluka phambili, kwakha izikhukhula zemikhiqizo emisha, izimiso, nokudideka. Njengomenzi we okokuvikela komuntu okuvikelayo E-China, mina, u-Allen, sengihambise lezi zindawo zokulawula ukuhambisa amaklayenti kulo lonke elaseNyakatho Melika naseYurophu. Ukuqonda Uhlobo lwe-fdaIndima ye-ST ayisho nje ngokuhambisana; kumayelana nokuqinisekisa ukuphepha kwe Abasebenzi bezokunakekelwa kwempilo neziguli. Lo mhlahlandlela uzovusa umehluko phakathi kwe isakaza kanye a umdlaluvuzi, chaza i- Uhlobo lwe-fdaIgunya elilawulayo, futhi linikeze imininingwane ecacile oyidingayo ukuze uthole okulungile Ikhilongothobele nganoma yisiphi isimo.

Kuyiphi ngempela imaskhi yokuhlinzwa emehlweni e-FDA?

Ngokuya kwe- Uhlobo lwe-fda, a isakaza kuyinto efanelekile, elahlekile Idivayisi yezokwelapha lokho kwakha a Isithiyo esibonakalayo phakathi kwe umlomo nekhala womgqokeli kanye nokungcola okungenzeka endaweni esheshayo. Kungukuthi umkhiqizo ogqokwa ebusweni, kepha kubalulekile ukuqonda okuyisisekelo kwayo Ukusetshenziswa okuhlosiwe. A isakaza yakhelwe ukuvimba amaconsi amakhulu wezinhlakahla, ama-splashes, izithombo, noma i-splatter engaqukatha Amagciwane kanye namagciwane, ukuzivimba ekufinyeleleni ogqokile ekhaleni nomlomo.

Ngasikhathi sinye, a isakaza kuhloselwe ukuvikela abanye. Kuyasiza ukubamba owakho ogqokayo Ukuphefumula Kwenduna lapho bephefumula, bekhuluma, noma ukukhwehlela. Le ndima embaxambili yingakho ebalulekile ngesikhathi a Inqubo yezokwelapha. Kodwa-ke, ngenxa yokufaneleka kwayo okuvulekile, a isakaza ayibunzi uphawu oluqinile phakathi kwe imaski nobusweni bakho. Lokhu kusho ukuthi akuhlinzeki okufanayo Izinga lokuvikelwa ngokulwa nezinhlayiya ezincane ezingenazindiza njenge umdlaluvuzi. Le khasi Uhlobo lwe-fda ilawula le isakaza njenge- Idivayisi ye-Class II yezokwelapha, okusho ukuthi kufanele ihlangabezane namazinga okusebenza athile okuthengiswa ngokusemthethweni ku-U.S.

Ngabe kuhluke kanjani ngokuyisisekelo sokuphefumula kusuka kumaskandi okuhlinza?

Ngenkathi a isakaza kwakha umgoqo, a umdlaluvuzi ucezu lwe okokuvikela komuntu okuvikelayo yakhelwe ukuzokulungwa. Umehluko osemqoka ulele enhlosweni nasekuklameni kwawo. A umdlaluvuzi, njenge I-n95 respirator, kungenye ye Amadivayisi wokuvikela wokuphefumula yakhelwe ukulingana ngobuso, ukudala uphawu oluzungeze ekhaleni nomlomo. Nini igqoke kahle, lokhu kubhala kubumbeke umoya wakhipha umoya futhi wakhipha umoya wokuhlunga.

Umsebenzi oyinhloko we umdlaluvuzi kuya Vikela ogqokile kusuka ezinhlwini ezinobungozi ezinobungozi emoyeni. E-United States, la madivayisi ayahlolwa futhi aqinisekiswe yiNational Institute for Ukuphepha emsebenzini kanye nempilo (Niosh), ingxenye ye I-CDC, ngaphansi komthethonqubo I-42 CFR Ingxenye 84. The "I-N95"Ukuqokwa kukhombisa ukuthi umdlaluvuzi Kuhlunga okungenani ama-95% ezinhlayiya ezincanyana kakhulu (0.3 micron). Ngakho-ke, Umehluko phakathi kwamaski ahlinzayo futhi ama-respirators aqakathekile: a isakaza isithiyo samaconsi, ngenkathi a umdlaluvuzi isihlungi sezinhlayiya ezinomoya. Indinganiso isakaza akuyona into umdlaluvuzi.

Ngakho-ke, ingu-N95 Respirator idivaysi yezokwelapha elawulwa yi-FDA?

Leli yiphuzu elijwayelekile lokudideka, futhi impendulo inenhlonipho. Kakhulu I-N95 Ama-Rescurators enzelwe izilungiselelo zezimboni, njengokuthola ukwakhiwa, ukuvikela abasebenzi ngothuli nakwezinye izinhlayiya. Lokhu kufakazelwe yi-niosh kepha akubhekwa njenge Idivayisi yezokwelapha futhi ayilawulwa yi- Uhlobo lwe-fda.

Kodwa-ke, isigaba esikhethekile esikhethekile sikhona saziwa ngokuthi "Kuhlinzwa N95 Respirator. "Lolu hlobo lwe umdlaluvuzi ihlukile ngoba ibilokhu iqinisekiswe nguNiosh njenge I-n95 respirator futhi kusulwe yi- Uhlobo lwe-fda njenge- isakaza. Lokhu kusho a Kuhlinzwa N95 inikeza okungcono kakhulu emhlabeni wonke: Inikeza umoya ophakeme ukuhlukunyezwa kwe-filtration ukunciphisa Ukuvezwa njengezinga I-N95, na- Inikeza Ukuvikelwa okuvimbayo of a isakaza Ukuqapha ama-splashes namaphethelo. Lezi Kuhlinzwa N95 ama-respirators ihlose ukusetshenziswa phakathi kwa- Izilungiselelo Zokunakekelwa Kwempilo ezenziwa ngabasebenzi bezempilo Ngezinqubo ezingakhiqiza ama-aerosols, enikeza izinga eliphakeme kakhulu lokuvikelwa kokuphefumula kanye noketshezi olulodwa isivivu.

Kuyini "ubuso bokuvila ubuso" futhi kuvumelana kuphi?

Igama "Ubuso bokubopha bumboza" waba evame kakhulu ngesikhathi sobhubhane. Kubhekisa ku umkhiqizo ogqokwa ebusweni lokho kumboza ogqokile ekhaleni nomlomo Ngokuyinhloko ukulawulwa komthombo - okuwukuthi, ukuvikela owesithekale kabi ekusakazeni amaconsi abo okuphefumula. Lokhu kufaka imaski yendwangu nezinye izembozo zobuso ezilula.

Ngokungafani a isakaza, a ukumboza ubuso bembozo ngokuvamile akubhekwa njenge Idivayisi yezokwelapha ngu Uhlobo lwe-fda Ngaphandle kokuthi ilebula yayo iphakamisa izinjongo zokwelashwa. Le khasi Uhlobo lwe-fda Kukhishwe okuqondile ukuhola Kule mikhiqizo, ukucacisa ukuthi inqobo nje uma bengasenzi izicelo mayelana Izithiyo ze-fluid noma amazinga okusebenza kahle kwe-fieltration, babengeke babe ngaphansi kwemithetho eqinile efanayo ne isakaza. A ukumboza ubuso bembozo ihlinzeka ngesithiyo somzimba esincane futhi ayibhekwa Ikhilongothobele. Zenzelwe i- Abasebenzi abajwayelekile bokunakekela umphakathi kanye nezempilo Ezimweni ezingezona ezokwelapha, hhayi ukusetshenziswa ngesikhathi sokunakekelwa kweziguli noma izinqubo zokuhlinza.

I-FDA ihlukanisa kanjani futhi ilawule imaskhi yokuhlinzwa?

Le khasi I-FDA iyalawula a isakaza njenge- Idivayisi ye-Class II yezokwelapha, okubeka esigabeni esisezingeni eliphakathi. Ukumaketha ngokusemthethweni a isakaza Ku-U.S. Ngaphansi kwezimo ezijwayelekile, umenzi kufanele alethe i-510 (k) Isaziso se-Premarket ku Uhlobo lwe-fda. Lokhu kuhanjiswa kumele kube nobufakazi bokuthi okusha isivivu "okulingana kakhulu" ngokuphepha kanye nokusebenza ngempumelelo kudivayisi esevele isemakethe.

Njengengxenye yale nqubo, Uhlobo lwe-fda idinga idatha yokusebenza ukufakazela isivivuUkusebenza kahle. Imaski yokuhlinza futhi ihlolwe Ngezakhiwo ezimbalwa ezibalulekile:

• Ukumelana noketshezi: Kukala amandla ka isivivuUkwakhiwa kokunciphisa uketshezi kusuka ekuhambeni kokuqukethwe.
• Ukusebenza kwegciwane le-bacterial (BFE): Le khasi isivivuIkhono lokuhlunga amagciwane.
• Ukusebenza kahle kwe-Filtration (PFE): Le khasi degree of izinhlambazwa ngokumelene nezinhlayiya ezingaphansi kweMicron.
• Ukuphefumula (Delta P): Iqinisekisa isivivu ukhululekile ukugqoka futhi akuvimbi ngokweqile ukuphefumula.
• Ukuvutha: Le khasi isivivu kumele akhombise ukumelana kwelangabi.
  Lezi zindinganiso eziqinile ziqinisekisa ukuthi noma yini I-FDA-cleated imaski yokuhlinza hlinzeka ngokuthembekile Isithiyo esingokomzimba ku-fluids kanye nokubabaza Matter njengoba kufunwa.

Yini eyashintsha ngomthethonqubo we-FDA ngesikhathi esiphuthumayo sempilo yomphakathi ye-18?

Isidingo esingakaze sibonwe okokuvikela komuntu okuvikelayo Ngesikhathi sobhubhane kugqugquzele Uhlobo lwe-fda ukuthatha izinyathelo ezingavamile zokwandisa ukulethwa. Ukufeza lokhu, the I-FDA ikhiphe isambulela eua (Ukugunyazwa kokusetshenziswa okuphuthumayo) ye isakaza amamodeli ayengakaze athole inqubo yokuthola imvume engu-510 (k). Leli isambulela eua ngemaski yokuhlinza uvumele imaski ethile ukuthi isetshenziswe kuyo Izilungiselelo Zokunakekelwa Kwezempilo, inqobo nje uma behlangabezana nenqubo ebekiwe yokusebenza. Lokhu kungenye yezinto eziningana imishini yokuvikela umuntu euas kukhishwe.

Le khasi Uhlobo lwe-fda futhi kukhishwe i-euas ye ama-respirators we-covid-19, ukuvumela ukungenisa kanye Sebenzisa kuphela lezo zokuhlinza kanye nabahlukanisi abangavikeli ababengavunywa yi-niosh kodwa baboniswa ukufeza amazinga aqhathaniswa ne- I-N95. Lezi zinyathelo zazibucayi ukuvikela Abasebenzi bezempilo Lapho izimpahla zendabuko zaziyindlala. Kodwa-ke, kubalulekile ukukhumbula lokhu kugunyazwa kwakungesikhashana futhi kuboshwe ngqo ku I-COVIAL-19 Public Health Emergency. -Ma yini isakaza noma umdlaluvuzi Kumakethelwa ngaphansi kwe-EUA kubhekwa "Igunyazwe ukusetshenziswa okuphuthumayo, "hhayi" i-FDA-cleed "noma" ivunyelwe. "

Bonke bantu ama-jppiretors afanele abasebenzi bezokunakekelwa kwempilo?

Cha, futhi lokhu kungumehluko obalulekile wanoma yimuphi umthengi wezokwelapha. Indawo ejwayelekile yezimboni I-n95 respirator, ngenkathi enikeza okuhle kakhulu ukuzokulungwa, akulungile Izilungiselelo Zokunakekelwa Kwezempilo. Abaningi balaba bantu bokuphefumula bane-valve yokuphefumula - umbuthano omncane wepulasitiki ongaphambili we isivivu Lokho kwenza kube lula ukuphefumula. Ngenkathi ukhululekile, leli valve likhipha umoya ongakhangiswayo emvelweni, ehlula inhloso yokulawulwa komthombo emkhakheni oyinyumba.

A Kuhlinzwa N95 Respirator yakhelwe ngqo ukusetshenziswa kwabasebenzi bezempilo. Ayinayo i-valve yokuphefumula futhi, njengoba kushiwo, nayo isulwa yi- Uhlobo lwe-fda ngokumelana koketshezi. Ngakho-ke, ku Ukuhlelwa Kwezempilo, ikakhulukazi phakathi nezinqubo eziyinyumba noma lapho unakekela iziguli ezithathelanayo, okuwukuphela kwento efanele I-N95 a Kuhlinzwa N95 Respirator. Kusetshenziswa izimboni zezimboni I-n95 respirator kungahlehlisa imvelo oyinyumba kanye nokuphepha kweziguli.

Njengomthengi, yini okufanele ngiyibheke kumaski okuhlinza e-FDA?

Lapho ngithola i-a isakaza, Ukubheka ngalé kwezimangalo zokumaketha kubalulekile. Njengomenzi, sinikeza le datha kumakhasimende ethu ukukhombisa ukuthobela kanye nekhwalithi. Nakhu okufanele uqinisekise:

• I-510 (K) imvume: Cela Uhlobo lwe-fda 510 (k) inombolo ye-realeance ye isakaza. Lolu yiluphi ulwazi lomphakathi futhi lungaqinisekiswa ku Uhlobo lwe-fdaDatabase database.
• Amazinga we-ASTM F2100: Le khasi Uhlobo lwe-fda ibona i-ASTM F2100 Engabhalansi, ekhona Imaski Yenqubo na- Imaski yokuhlinza Ezingeni 1, 2, noma 3 ngokususelwa ekusebenzeni kwazo ezivivinyweni ezinhlanu ezibalulekile okukhulunywe ngazo ngaphambili. Izinga 3 isakaza inikeza okuphezulu kakhulu Izithiyo ze-fluid noma amazinga okusebenza kahle kwe-fieltration.
• Umkhiqizi odumile: Uzakwethu nomenzi onomlando wethrekhi yokukhiqiza Amadivayisi wezokwelapha awela ngaphakathi Uhlobo lwe-fda Imithetho. Funa izitifiketi njenge-ISO 13485, ephathelene nezinhlelo zokuphathwa kwekhwalithi yezokwelapha.

Ukuqinisekisa ukuthi umphakeli wakho anganikeza lobu bufakazi buqinisekisa ukuthi uthenga okusemthethweni isakaza enikeza ukuvikela abasebenzi bakho neziguli, njengekhwalithi yethu ephezulu Imaski yobuso bezokwelapha. -Kwethu Ukulahlwa kwe-3Ply Face Mask kungenye inketho ethembekile ehlangabezana namazinga ekhwalithi aqinile.

Ngingaqinisekisa kanjani uma imaskhi yokuhlinzwa noma i-respirator ivunyelwe yi-FDA?

Ukuqinisekisa ubuqiniso be- isivivu noma umdlaluvuzi isinyathelo esibucayi ekuthengeni ukugwema imikhiqizo yenkomba.

• Okwezimo zokuphefumula ze-niosh: Le khasi I-CDC' I-National National Protectory Laborator (NPPTL) igcina uhlu lwemishini eqinisekisiwe. Ungasesha lolu hlu ukuze uqinisekise uma a umdlaluvuzi, kufaka phakathi noma iyiphi I-N95 noma Kuhlinzwa N95 imodeli, ivunyelwe nguNiosh.
• Okwe-FDA-cleated masks sc ratch: Le khasi Uhlobo lwe-fdaI-database yesaziso yesaziso se-510 Ungasesha ngomenzi noma igama ledivayisi ukuthola imininingwane yemvume yokuthile isakaza.
• Okwamadivayisi ngaphansi kwe-EUA: Ngesikhathi esiphuthumayo, The Uhlobo lwe-fda Uhlu olugcinwe lwabo bonke Imaski Egunyaziwe kanye nama-respirator kwiwebhusayithi yawo. Lolu hlu oluchazwe luni Izinhlobo zamamaski okuhlinza bafakiwe ngaphansi kwe isambulela eua ngemaski yokuhlinza. Yize i-EUA isiphelile, lezi zinsolo zihlala ziyinkomba ewusizo.

Usebenzisa lezi zinsizakusebenza ezisemthethweni ukuphela kwendlela eqinisekile yokuqinisekisa ukuthi Imaski yokuhlinza kanye nabakwa-N95 Uthenga okusemthethweni. Umkhiqizo onjengethu Imaski ye-FFP2, ngenkathi kuhlangana namazinga aseYurophu, kukhombisa uhlobo lwekhwalithi futhi ukuzokulungwa ukusebenza okulindelwe kusuka kusemthethweni Ikhilongothobele.

Yiluphi uhlelo lwe-FDA oluphuthumayo lwe-masks kanye nama-respirators?

Njenge- Izimo eziphuthumayo zezempilo zomphakathi, the Uhlobo lwe-fda isuka kude nokuguquguquka kwe-euas futhi ibuyele ezinqubweni ezijwayelekile zokulawula. I-ejensi ishicilele a Uhlelo lokuguqula amadivayisi wezokwelapha phambilini lokho kwathengiswa ngaphansi kwe-EUA. Leli ukuhola ubeka umugqa wesikhathi nezidingo zabakhiqizi balezi Imaski yokuhlinza kanye nokuphefumula ukuhambisa ngendabuko Uhlobo lwe-fda imvume uma befisa ukuqhubeka nokuthengisa imikhiqizo yabo ku-U.S.

Lokhu kusho ukuthi iningi le isivivu na- umdlaluvuzi Imikhiqizo evele emakethe ngesikhathi sobhubhane izodinga ukudlula kwinqubo eyi-510 (K). Lolu shintsho lubalulekile ekuqinisekiseni ukuphepha kwesikhathi eside kanye nekhwalithi yokunikezwa kwe-U.S. okokuvikela komuntu okuvikelayo. Okweziphathi zokuthengwa kwempahla, kusho ukuthi uzodinga ukukhuthala ekuqinisekiseni abahlinzeki bakho balandela lokhu Uhlelo lokuguqula amadivayisi wezokwelapha futhi anganikeza ubufakazi bokuthi banazo okutholakele noma abasanda kutholwa Uhlobo lwe-fda imvume yanoma iyiphi isakaza. Imaka ukubuyela kumazinga aphezulu achaza Amadivayisi alawulwa yi-FDA.