Mw'isi ya none, gusobanukirwa nibikoresho byo kurinda umuntu byingenzi kuruta mbere hose. Kubashinzwe amasoko nka Mark Thompson muri USA, humura amafaranga menshi yubuvuzi bwiza ni ngombwa. Iyi ngingo ihatira cyane muburyo bwihariye bwa 3-ply dispower disks, hamwe no kwibanda cyane ku kamaro ka Fda Icyemezo, kubaga Ibipimo, nibikorwa bituma a Urwego 3 mask amahitamo yizewe. Tuzasesengura iyubakwa, inyungu, nibintu bikomeye tugomba gusuzuma mugihe wowe buy cyangwa gutumiza Ibi bintu by'ingenzi. Aka gatabo gafite intego yo gutanga neza, ingamba amakuru Kugufasha gufata ibyemezo byuzuye, ushimangire umutekano n'imibereho myiza yabashinyaguzi kuri ibi bicuruzwa. Nkuko Allen, uwabikoze aturuka mu Bushinwa afite imirongo irindwi yumusaruro, ndumva interricies yo kubyara ubuziranenge mask Ibicuruzwa n'akamaro ko gukorera mu mucyo kubakiriya ba B2B.
Ni ubuhe bwoko bwa 3-ply dispox?
Wigeze wibaza igitera a 3-ply disk Ingirakamaro? Ijambo "3-ryo ubwaryo ryerekeza ku bikoresho bitatu bitandukanye bya ibikoresho byakoreshejwe mu kubaka. Ibi bice mubisanzwe bikozwe mubitambaro bidahemerewe, byatoranijwe kubiranga byihariye bigira uruhare muri mask'Imikorere rusange. Igice cyo hanze gikunze kuba kirwanya amazi, gitanga umurongo wambere wingabo zibangamira amashanyarazi cyangwa ibitonyanga. Igice cyimbere, cyicaye ku ruhu, mubisanzwe ni ukugira isuku kandi kigaragara, utezimbere ihumure kuba wambaye mugihe cyagutse.
Amarozi, akenshi, akenshi iri hagati ya 3-ply dissoble mumaso. Iyi shingiro ni iyambere gukanda Hagati, isanzwe ikozwe muri umwenda wuzuye polypropylene. Byateganijwe gukorana ikibazo, harimo bagiteri nibindi ikirere ibice. Ingufu muribi 3 Ibice byemeza ko mask itanga uburimbane bwa Kurinda, guhumeka, no guhumurizwa, kubigira intandaro mubintu byo kwivuza ndetse no gukoresha rusange. Kubwumwuga, gusobanukirwa niyi zuba shingiro nintambwe yambere yo gusuzuma ireme ry'ubushobozi ibicuruzwa.
Ibi IJAMBO RY'UMWANYA byateguwe kugirango bikoreshwe rimwe kugirango babungabunge isuku no gukora neza. Ongera usabe birashobora guteshuka ku mico yabo yo gukingira kandi birashoboka ko byanduye. Biturutse mu bitaro n'amavuriro ku bihe bya buri munsi bisaba igice cy'inyongera cya Kurinda, the 3-Ply mask yahindutse igikoresho cyingenzi. Ni ngombwa kuri kugura Ibi bintu biva mu masoko yizewe kugirango bakemure ibiteganijwe.
Kuki "3-ply" ikintu cyingenzi cyo gushakisha muburyo bwa mask yo mumaso?
Igenamigambi rya "3-Plly" rirenze umubare; Ni ikimenyetso cyibanze cya a isura ya mask'Ibishobora gukora neza nka a bariyeri. Buri umwe muri 3 ibice muri a 3-Ply mask ikora intego itandukanye, ikorera hamwe kugirango itange inkinzo yuzuye ugereranije na masike hamwe nibice bike. Kurugero, uruhindi mask irashobora gutanga bike Kurinda, mugihe 2-ply mask itezimbere kuri ibyo, ariko 3-Ply Kubaka bizwi cyane nkibisanzwe kugirango unshuro nziza gukanda no guhumeka muri Byashoboka masike.
The itandukaniro Mu rwego rwo kurengera ni ngombwa. Urwego rwo hanze rwa a 3-PLY nabi mask ni ngombwa kugirango dusubiremo amazi, nk'ibitonyanga byubuhumekero. Igice cyo hagati, nkuko byavuzwe, ni akayunguruzo. Igice cy'imbere cyibanze ku ihumure no guhiga ahantu heza mu mwuka wambaye, kubuza Uwiteka mask Kuva kuba utose kandi ntibyoroshye cyane. Iki cyerekezo cyumviyeho cyemeza ko mask irashobora gushungura neza ibice mugihe bisigaye bifatika kugirango wambare. Iyo ubonye a Ibisobanuro by'ibicuruzwa Kugaragaza "3-ply," byerekana urwego runaka rwo kubaka rwagenewe imikorere myiza.
Nkumupfumu, ndashobora kukubwira ko gukora ubuziranenge 3-Ply mask bikubiyemo guhitamo witonze ibikoresho n'iteraniro ryiza. Ubusugire bwa buri gice nuburyo bahujwe hamwe bigira ingaruka muri rusange gukanda gukora neza no kuramba bya mask. Kubantu bakunda Mark Thompson, bafite ireme ryiza, gusobanukirwa ko "3-ply" bisobanura urwego runaka rwibishushanyo ni ngombwa mugihe cyo gusuzuma ibishya ibicuruzwa cyangwa utanga isoko. Ntabwo ari umubare wibice byose, ahubwo nicyo ibyo bice kora birashoboka mubijyanye no kurinda.
Niki cyemezo cya FDA bisobanura iki kuri masike yo mumaso?
Iyo ubonye "FDA YEMEJWE"cyangwa, neza," fda yemerewe "cyangwa" FDA yemerewe "bifitanye isano IJAMBO RY'UMWANYA, bivuze ubuyobozi bwibiyobyabwenge na Ibiyobyabwenge hamwe nubuyobozi bwibiyobyabwenge byasuzumye ibicuruzwa Kugirango bihuze ibisabwa byihariye kugirango umutekano nibikorwa. The Fda ugira uruhare runini mu kugenzura ibikoresho byo kwivuza muri Amerika, kandi masike yo kubaga kugwa muri iki cyiciro. Ubugenzuzi ntabwo ari kashe yoroshye ya rubber; Harimo inzira aho abakora bagomba gutanga ibimenyetso byerekana ko ibyabo mask ikora nkuko byateganijwe.
Kuri a mask yo kubaga, Fda ibisobanuro mubisanzwe bisobanura ibicuruzwa yipimishije ibintu nkibice bya bagiteri bifite akamaro (BFE), ibice byubafirize neza (PFE), kurwanya amazi, gutwika, na biocompat. Ibi bigeragezo kwemeza mask itanga bihagije bariyeri, irinda amaduka y'amazi ashobora kunduza, kandi afite umutekano kuri kwambara kurwanya uruhu. Iyi ikomeye gusubiramo inzira itanga abaguzi kwizera ko the mask Bagura birashoboka kubidukikije. Niyo mpamvu abayobozi bashinzwe amasoko kubitaro n'amavuriro bishyira imbere ibicuruzwa hamwe Fda ibyangombwa.
Ni ngombwa kumva ko ibipfukisho byose byo mumaso bigengwa na Fda muri ubwo buryo. Kurugero, igifuniko cyigituba gikubiyemo gukoreshwa rusange mubisanzwe ntukeneye Fda Ongera usubiremo keretse basabye ubuvuzi bwihariye. Ariko, kuri 3-Ply dispos Kwangizwa nubuvuzi, cyangwa byumwihariko nkuko kubaga masike, kubahiriza hamwe Fda Amabwiriza nigipimo cyingenzi cyubwiza no kwizerwa. Nkumutanga, gutanga neza amakuru hafi Fda Imiterere ningirakamaro yo kubaka ikizere nabakiriya nka Mariko.
Byose ni masike ya pldas 3 yemewe? Itandukaniro rikomeye.
Iyi ni ingingo isanzwe yo kwitiranya ibintu: oya, ntabwo aribyose 3-Ply dispos ni Fda byemejwe cyangwa byahanaguwe. Ingingo ya "3-Plly" yerekeza ku kubaka Uwiteka mask - umubare wibice. Mugihe iyi ari ikintu cyiza, ntabwo gihita gisobanura mask yujuje ibipimo ngenderwaho bisabwa na Fda kubuvuzi cyangwa kubaga Koresha. Hari ingenzi itandukaniro hagati yintego rusange 3-Ply mask na an Fda-clered mask yo kubaga.
Benshi 3-Ply dispos Byakozwe kandi bigurishwa kugirango bikoreshe rusange cyangwa nkibipfukisho byo kurinda muburyo butari bwo buvuzi. Ibi birashobora gutanga urwego rwibintu gukanda ariko ntibishobora kuba byararenze kwipimisha amazi Kurwanya, Imikorere Yihariye (nka BEFE NA PFE ku rwego rwo mu mutwe), cyangwa biocompdatisholity Fda-clered masike yo kubaga kora. The Fda yibanda kugenzurwa na masike igenewe gukoreshwa muburyo bwubuzima cyangwa ibyo kora ibirego by'ubuvuzi.
Kubwibyo, mugihe amasuka ahitiramo ibitaro, amavuriro, cyangwa ibidukikije byose aho ushinzwe ubuvuzi Kurinda ni ngombwa, gusa ushakisha "3-ply" ntabwo bihagije. Ugomba gushakisha byumwihariko ibimenyetso byerekana ko Uwiteka ibicuruzwa bya mask ni Fda yahanaguwe cyangwa yemerewe gukoreshwa mubuvuzi. Gukoresha NTIBISANZWE 3-Ply mask Mubihe bisaba a kubaga cyangwa Urwego 3 mask yashoboraga guhungabanya umutekano. Kubaguzi B2B, kugenzura ibi Fda Imiterere nintambwe ikomeye muburyo bwo gutanga amasoko kugirango babeho buy a ibicuruzwa nibyo Birakwiye kubwintego yagenewe. Aha niho gufatanya Abakora ibikoresho byubuvuzi bazwi nka Zhongxing ihinduka ingenzi.
Nigute nshobora kugenzura amakuru ya FDA kuri 3-ply disk ya mask?
Kugenzura FDA kuri a 3-ply disk pack ni intambwe ikomeye yo kwemeza ko ubonye ubuvuzi bwemewe ibicuruzwa. Abakora ibicuruzwa hamwe nabaguzi bagomba gukora ibi amakuru byoroshye irahari. Kimwe mu mwanya wa mbere wo kureba ni ugupfukirana ibicuruzwa ubwabyo cyangwa ibicuruzwa. Fda-clered masike yo kubaga akenshi harimo ibisobanuro nkizina ryabakora, nimero yo kwiyandikisha, rimwe na rimwe Kode y'ibicuruzwa bya FDA.
Kuri cheque yuzuye, cyane cyane kuri nini Amabwiriza, urashobora kugerageza gukoresha Fda'Ububiko rusange. The Fda ikomeza ubumuga nko kwiyandikisha no kwiyandikisha ibikoresho. Mugihe uyobora ibi bishobora rimwe na rimwe gutoroshye kubakoresha nyuma yumukoresha, utanga isoko agomba kuba ashobora gutanga ibisobanuro byabo biyandikishije, bishobora noneho kwambukiranya. Kubaza utanga isoko mu buryo butaziguye inyandiko zishyigikira ibyabo Fda ibirego ni imyitozo isanzwe kandi isabwa. Ibi birashobora kubamo kopi ya 510 (k) ibaruwa isobanutse niba bishoboka, cyangwa kwiyandikisha mukigo amakuru.
Nka nyiri uruganda, i (Allen) gusobanukirwa n'akamaro ko gukorera mu mucyo. Dutanga abakiriya bacu, nka Mark Thompson, hamwe nibyangombwa byose bikenewe kugirango twemeze kubahiriza ibyacu mask Ibicuruzwa, harimo na kimwe Fda-Ibihe byahinduwe cyangwa kwiyandikisha kubicuruzwa byohereza hanze muri Amerika. Ntutindiganye kubisaba; Utanga inguzanyo yemewe 3-Ply dispos bizaba bitegurira kubisangiza. Uyu munyanga ufasha kwirinda impimbano cyangwa ibicuruzwa bitujuje ubuziranenge no kubyemeza ko ari umutekano kugura.
Ni ubuhe rwego rwa ASTM kuri masike yo kubaga (Urwego rwa 1, 2, 3)?
Birenze jenerali Fda Gukemura Gukoresha Ubuvuzi, masike yo kubaga bakunze gushyira mu kaga n'inzego z'imikorere byasobanuwe na ASTM mpuzamahanga (yahoze ari umuryango wa Amerika yo kugerageza n'ibikoresho). Ibi bipimo - Astm F2100 - Kugaragaza Ibisabwa byimikorere ya mask yubuvuzi, fasha abakoresha guhitamo urwego rukwiye rwa Kurinda. Hariho inzego eshatu zingenzi: Urwego 1, Urwego 2, na Urwego 3 rwo kubaga masike.
- ASTM urwego 1 masike byateguwe kubihe bitoroshye. Batanga urwego rwibanze rwa amazi Kurwanya no kwishyiriraho gukanda. Ibi birakwiriye inzira aho habaye ibyago bike byo gutera cyangwa aeroliya.
- ASTM Urwego Masike 2 tanga inzitizi igereranije. Bafite hejuru amazi Kurwanya kandi byiza gukanda (BFe na pfe) kuruta urwego 1. Ibi nibyiza kubikorwa hamwe nubushobozi buciriritse bwo guhura nibitekerezo na aerosol.
- ASTM urwego 3 masike Tanga urwego rwohejuru rwo kurinda hagati masike yo kubaga. Batanga ntarengwa amazi Kurwanya n'inzego zo hejuru za bagiteri no kwicogora gukanda. Ibi birasabwa inzira aho hari ibyago byinshi byo guhura namazi menshi, spray, cyangwa aerotol.
Gusobanukirwa izi nzego za Astm ni ngombwa mugihe uhitamo a 3-Ply Stiyal Mask. Niba ishyirahamwe ryanyu risaba gukomera Kurinda, guhitamo a Urwego 3 mask akenshi ni amahitamo meza. Gupakira cyangwa Ibisobanuro by'ibicuruzwa kuko masike nkiyi igomba kuvuga neza urwego rwa ASTM. Mugihe muganira ku bisabwa hamwe nuwabitanze, sobanura urwego rwifuzwa rufasha kwemeza ko wakiriye neza ibicuruzwa kubyo ukeneye. Ibi kugereranya ni ngombwa kubidukikije.
Kurenga FDA: Ni ibihe bipimo birerekana nkwiye gusuzuma mask 3-yuzuye?
Mugihe Fda Kwemeza na Astm F2100 kubahiriza nibyingenzi masike yo kubaga yagenewe isoko rya Amerika, hari ibindi bipimo byiza ko abaguzi bashishoza nka Mark Thompson bagomba gusubiramo. Ku bicuruzwa byagurishijwe mu Burayi, ikimenyetso cya CE ni ngombwa, cyerekana ko ubuzima, umutekano, umutekano, n'imitunganyirize. Ikindi cyemezo gikomeye cyo gushakisha ni iso 13485. Iki gipimo cyerekana ibisabwa muri sisitemu yo gucunga ubuziranenge aho umuryango ugomba kwerekana ubushobozi bwayo bwo gutanga ibikoresho byubuvuzi bihurira Umukiriya n'ibisabwa bisabwa.
Ubwiza bwibikoresho bikoreshwa muri 3-Ply mask Kandi ubwubatsi bwarwo nabyo bifite akamaro. Shakisha masike yakozwe nubunini buhebuje, icyiciro cyo kuvura kitari cyo. The Amatwi igomba kuba ifatanye neza, nyamara neza bihagije kuri yo kwambara. Ibyiza mask bizagaragaza kandi ikibazo izuru Igice gishobora guhindurwa kugirango ukore umutekano bikwiye hejuru ya umunwa n'amazuru, kugabanya icyuho aho ibice byikirere bishobora kwinjira cyangwa guhunga. Ihumure rusange no guhumeka, ndetse no muri a Urwego 3 mask, ni ngombwa kubakoresha.
Hanyuma, izina no gukorera mu mucyo wawe ni urufunguzo. Nka Allen, uhagarariye Zhongxing, uruganda rufite imirongo 7 yumusaruro, twishimiye kwiyemeza kwiyemeza gutumanaho neza kandi bwuguruye. Turashishikariza abaguzi kubaza gahunda zacu zo gutunganya, ingamba zo kugenzura ubuziranenge, hamwe na batch clatique. Utanga isoko yizewe azaba yiteguye gutanga ibisobanuro birambuye Amakuru yibicuruzwa, raporo, n'icyemezo. Ubu buryo bworoshye bwo gusuzuma a 3-Ply mask kandi utanga isoko afasha kwemeza ko ushora imari muri a ibicuruzwa Ibyo ntabwo byubahiriza gusa ahubwo binagira akamaro kandi byizewe. Dutanga ibintu bitandukanye Amaso meza yubuvuzi Nukuzuza aya mahame.
Ni irihe tandukaniro riri mu kurindwa: Isura 3-yambaye mask na ubundi bwoko bwa mask?
Gusobanukirwa itandukaniro in Kurinda zitangwa n'ibinyuranye mask Ubwoko ni ngombwa kugirango uhitemo kimwe mubihe byose. Bisanzwe 3-ply dissoble mumaso, cyane cyane a mask yo kubaga, itanga impirimbanyi nziza ya Kurinda no guhumeka ibintu byinshi. Ibikorwa byambere bikora nka a bariyeri Kurinda uwambaye kwirukana ibitonyanga byinshi byubuhumekero no gutanga bimwe Kurinda Kurwanya amasuka no kurya kubandi.
Iyo ugereranije a 3-ply disk ku mwenda woroshye mask, the itandukaniro ni. Mugihe masike yimyenda irashobora gufasha kugabanya ikwirakwizwa ryibitonyanga byuwambaye, muri rusange batanga hepfo gukanda gukora neza kubice bito no kubura ibizamini byangiza kandi amazi Kurwanya Ubuvuzi bwo kubaga ubwaburo. Masike yambaye imyenda ibereye ikoreshwa rusange mu ruhame mu bidukikije bidafite ibyago bike ariko ntibisabwa uburyohe bwubuzima aho urwego rwo hejuru rwa Kurinda birakenewe.
Ku rundi ruhande rwa specrum ni N95 cyangwa FFP2. Ibi byashizweho kugirango bikore ikimenyetso gifatanye mumaso no kuyungurura byibuze 95% (kuri N95) ya mato mato cyane (micron) ikirere ibice. Batanga urwego rwohejuru rwubuhumekero Kurinda kuruta bisanzwe 3-Ply Stiyake, cyane cyane kurwanya aerosol nziza. Ariko, bakeneye kwipimisha neza kandi birashobora kuba byiza cyane kuri yo kwambara. A 3-Ply Stiyal Mask, cyane cyane ASTM Urwego 3 mask, akenshi uhitamo abanyamwuga wubuzima mu bihe bidahuye na kashe yuzuye ya N95 ariko biracyasaba akamaro Kurinda inzitizi na gukanda. Kubakeneye kuzunguruka hejuru, bashakisha amahitamo nka FFP2 masike yo hejuru hejuru Birashobora gufatwa nkibintu byihariye bigira ingaruka nyinshi, bidafite ubwicanyi niba ibihume bigaragazwa.
Nigute wambara neza no kujugunya mask ya 3 yubahwa kugirango imikorere minini?
Ndetse no hejuru 3-Ply Fask Mask ntazatanga ikintu cyiza Kurinda Niba bidashaje kandi biteguye neza. Imikoreshereze ikwiye ni urufunguzo. Mbere yo kwambara a mask, menya neza ko amaboko yawe afite isuku - koresha isabune n'amazi cyangwa isuku ishingiye ku nzoga. Iyo ufashe mask, kugenzura amarira cyangwa ibyangiritse. O mask neza; Mubisanzwe, uruhande rwamabara ruhuye, na stalic strip cyangwa stiffer iri hejuru kugirango ihuze nawe izuru. Umutekano Amatwi ya Elastike Muzengurutse ugutwi, cyangwa guhambira inyuma umutwe wawe, bitewe nuburyo. Urufunguzo, kubumba izuru kugeza kumiterere yikiraro cyawe no gukurura hepfo ya mask hasi kugirango utwikire umunwa n'amazuru Byuzuye, kwemeza igituba bikwiye udafite icyuho.
A mask yatanzwe igenewe gukoreshwa rimwe. Ugomba gusimbuza ibyawe 3-ply disk Niba bihindutse, byanduye, cyangwa byangiritse, cyangwa nyuma yigihe kirekire cya kwambara (Mubisanzwe amasaha make, cyangwa nkubuyobozi bwakazi). Irinde gukoraho imbere ya mask Mugihe wambaye, nkuko bishobora kwanduzwa. Niba ubikora, uhite ufata amaboko.
Igihe nikigera cyo gukuraho mask, kora ukemura gusa Amatwi cyangwa amasano - ntukore kumbere ya mask. Guta ibyakoreshejwe mask ako kanya mu binini bifunze. Nyuma yo guta, fungura amaboko neza. Gukurikiza izi ntambwe bifasha kugwiza imikorere ya 3-Ply dispos Kandi kugabanya ibyago byo kwanduza, kubungabunga Kurinda Yashizweho kugirango itange iramenyekana byuzuye. Ibi ni ngombwa cyane mukuru abakoresha muburyo bwabigize umwuga.
Gutererana ubuziranenge-ubuziranenge, FDA yujuje ibyangombwa 3-ply itesha agaciro: inama kubaguzi.
Kubashinzwe amasoko nka Mark Thompson, humura ubuziranenge-ubuziranenge, Fda kubahiriza 3-Ply dispos bisaba umwete, cyane cyane iyo ushyizwe hejuru Amabwiriza. Intambwe yambere nugushaka cyane vet ishobora gutanga. Ntukarebe gusa kubiciro kuri ipaki; Reba izina ryabatanga isoko, ubushobozi bwo gukora, no kubahiriza amahame yubuziranenge. Saba ibisobanuro birambuye Ibicuruzwa, harimo ibikoresho byakoreshejwe, urwego rwa ASTM (niba bishoboka masike yo kubaga), nibimenyetso bya Fda kwemererwa cyangwa kwiyandikisha.
Iyo witeguye buy, saba abashobora kubaza ibibazo bikomeye. Baza uburyo bwo kugenzura ubuziranenge bwabo bwose. Nkuko Allen kuva Zhongxing, nakiriye ibi bibazo. Kurugero, ugomba kubaza:
- Impamyabumenyi: Gusaba kopi ya Fda Inyandiko, Iso 13485 ibyemezo, IC Raporo y'ibizamini (urugero, BFE, PFE, imyigaragambyo y'amazi).
- Ikirahuri: Irashobora gutanga a ipaki ya masike gusubira mubikorwa byayo nibikoresho fatizo? Ibi ni ngombwa kubwubwishingizi bwiza.
- Ubushobozi bwo gutanga umusaruro & kuyobora ibihe: Sobanukirwa nubushobozi bwabo bwo kuzuza ibisabwa kandi biteganijwe kohereza igihe.
- Isubiramo ry'icyitegererezo: Mbere yo gushyira binini gutumiza, saba ingero kuri gusubiramo Ubwiza, bikwiye, no guhumurizwa na 3-ply dissoble mumaso.
Kuyobora International kohereza n'ibikoresho ni ikindi kintu cyingenzi cya kugura inzira. Muganire ku nkomoko, uburyo bwo kohereza bwatoranijwe, hamwe nuburyo bwo gukuraho gasutamo hamwe nuwabitanze. Menya neza ko ibyangombwa byose biri mu rwego rwo gukumira gutinda. Gufatanya numufasha wubunararibonye wumva amabwiriza yohereza hanze mubihugu nka USA birashobora gutuma iyi nzira yoroshye. Gushora igihe mugushakisha utanga isoko yizewe kubwawe Byashobokaga Ubuvuzi bwa Mask Mask Sterile Ikeneye izishyura mubijyanye nibicuruzwa, kubahiriza, no gutanga isoko. Wibuke kugenzura niba kugabanyirizwa kode ni irahari kubyo kugura byinshi.
Igihe cya nyuma: Gicurasi-13-2025