Ubuyobozi buhebuje bwo guhangana na masike na N95 bahujwe mubuvuzi - Zhongxing

Mw'isi yo gutanga amasoko yubuvuzi, ibintu bike nibyingenzi nyamara bigoye nko mumaso mask. Kuva byoroshye mask yo kubaga Kuri Byihariye N95, gusobanukirwa nugence ntabwo ari iyubahirizwa gusa - ni ukurengera ubuzima. Nkumuyobozi ushinzwe amasoko, uri kumurongo wimbere wikureba, kandi ibyemezo ufata bifite ingaruka zitaziguye kubarwayi bombi ndetse Ubuvuzi abanyamwuga. Aka gatabo ni ibyawe. Nkuko Allen, uwabikoze hamwe nuburambe bwimyaka icumi atanga umusaruro wabigenewe ku masoko yisi yose nka Amerika n'Uburayi, ndashaka guca mu rujijo. Tuzasesengura ibitandukanye ubwoko bwa masike, decode amategeko, kandi utange ubushishozi bukoreshwa kugirango bigufashe isoko ufite ikizere. Ibi ntabwo ari ikindi kintu; Nukureba umwenda uturuka ku ruganda, rwagenewe gusubiza ibibazo byawe byo gukanda.

Ni irihe tandukaniro nyaryo riri hagati ya mask yo kubaga na N95?

Urebye, a mask yo kubaga na an N95 Birasa nkaho bisa, ariko imikorere yabo, ibishushanyo, nibyo bigenwa ni isi itandukanye. A mask yo kubaga ni ikintu gikwiriye, Byashoboka igikoresho gikora a Inzitizi z'umubiri hagati yumunwa nizuru rya waarer n'abashobora kwanduza ahantu hitowe. Intego yacyo yibanze ni uguhagarika igice kinini ibitonyanga Kwanduza, nk'amasuka cyangwa abakura, kurinda abandi imyuka y'ubuhumekero. Masike yo kubaga irakozwe y'ibitambara bidafite imbaraga kandi akenshi bikoreshwa mubidukikije mugihe cyo kwivuza kuri Kurinda umurwayi hamwe numwuga wubuzima kuva kuri Ihererekanyabubasha, amazi yumubiri, na ibikoresho. Ariko, kubera ubudahwema, akenshi a icyuho hagati ya impande za mask Isura, bivuze ko idatanga uburinzi bwuzuye guhumeka guto ikirere ibice.

An N95Ku rundi ruhande, ni a Ubuhumekero igikoresho cyo kurinda cyagenewe kugera kuri byinshi Gufunga isura nziza kandi neza cyane gukanda ya ikirere ibice. Igenamigambi rya "N95 risobanura ko mugihe umaze kwipimisha witonze, the guhumeka guhagarika byibuze 95 ku ijana bya micron nto cyane (micron) ibizamini. Ibi bikora N95 ingirakamaro kurwanya ibice binini kandi bito. Bitandukanye na mask yo kubaga, an N95 yashizweho kugirango ashyire hejuru mumaso, guhatira umwuka uhumeka kandi uhujwe kugirango unyure Akayunguruzo ibikoresho. Iki kimenyetso gifatanye ningirakamaro kugirango imikorere yayo. Kubera iyo mpamvu, bifatwa nkibikoresho byo kurinda umuntu (Ppe) igamije Byakoreshejwe Kuri Kurinda the waarer kuva kumugaragaro kugeza kumwanya wangiza.

Kubishyira gusa, a mask yo kubaga irinda ibidukikije Kuva the waarer, mugihe an N95 irinda Uwiteka waarer Kuva ibidukikije. Nkumuyobozi ushinzwe amasoko, gusobanukirwa nintambwe yambere yo kwemeza ko ikigo cyawe gitangwa nubwoko bwiza bwa mask kubikorwa byiza. Ntabwo wakoresha inzira yoroshye mask Mugihe cya Aerosil-Kubyaza, kandi ntushobora gukenera N95 Kuko umushyitsi agenda muri koridoro. Guhitamo neza uburyo bworoshye umutekano no gukoresha amafaranga neza.

Nigute Masks yubuvuzi igengwa muburyo butandukanye bwo kwita kubuzima?

Amabwiriza ya maskes ni ikintu gikomeye kigira ingaruka zitaziguye n'umutekano n'umutekano utanga, kandi biratandukanye bitewe cyane n'ubwoko bwa mask na gushiraho. Muri U.S., Ubuyobozi n'ibiyobyabwenge (Fda) hamwe n'ikigo cy'igihugu gishinzwe umutekano w'akazi n'ubuzima (Niosh), igice cya CDC, ni imibiri yambere kugenzura Ibicuruzwa. Ni sisitemu ebyiri ishobora kuba urujijo, ariko ireba ko buri mask ahura nibipimo byihariye byo gukoresha. Ku bijyanye no gutanga amasoko, iyi ntabwo ari kaseti itukura gusa; Ni ibyiringiro byawe byubwiza n'umutekano.

Masike yo kubaga, kurugero, bigengwa na Fda Nkuko ibikoresho byubuvuzi bya II. Bagomba kuba bujuje ibisabwa byihariye Kurinda amazi na gukanda gukora neza. The FdaAmafaranga agenga 21 CFR 878.400 yerekana ibipimo byibi Amaske yo kwivuza. Bageragejwe kubintu nkibishishwa bya bagiteri neza (BFE), ibice bikwirakwira neza (PFE), kurwanya amazi, nubusa. Ibi bireba mask irashobora kwihanganira amaraso cyangwa ibindi bikoresho byanduza mugihe runaka. A mask nibyo FDA-YASOHOTSE iguha icyizere ko cyasubiwemo umutekano no gukora neza kugirango ukoreshe muri a Igenamiterere ry'ubuzima. Ubu ni ubwoko bwibisanzwe Byashobokaga masike yubuvuzi bwamabaneza hamwe n'amatwi ibyo ni ngombwa mu kwihanganira ubuvuzi rusange no kurwanya indwara.

Gushungura Impuruspiece (Ffrs), nka N95s, bagengwa ukundi. Niba bagenewe inganda rusange zikoresha (nkibwubatsi), baragenzurwa na Niosh munsi 42 CFR igice cya 84. Niosh Ibizamini kandi byemeza ko abo bakurahura bahura nuburinganire no kubaka. Ariko, iyo an N95 igenewe gukoreshwa muri a Igenamiterere ry'ubuzima Kurinda indwara ya airborne, igomba kuba yujuje ibisabwa byombi Niosh na Fda. Ibi bikoresho byemejwe bizwi nka Kubaga N95 Ibisubizo. Batanga uburinzi bwa an N95 no kurinda amazi ya fluid kuri mask yo kubaga.

Urashobora gusobanura uruhare rwa Niosh na FDA mubyemerwa na mask?

Gusobanukirwa inshingano zitandukanye za Niosh na Fda ni umwanya munini wumuyobozi ushinzwe amasoko akusanya uburiganya kurinda ubuhumekero. Bitekerezeho nkuko inzobere ebyiri zitandukanye zemeza ko ibicuruzwa bifite umutekano kandi bifite akamaro kuva ibice bibiri bitandukanye. Ikigo cy'igihugu gishinzwe Umutekano wumwuga nubuzima (Niosh) Ese ikigo cy'ubushakashatsi cyibanze ku mutekano w'abakozi. Uruhare rwabanjirije Urubanza rwarwo rujyanye no kugerageza no kwemeza ko bahuye nubwubatsi bukomeye, gukanda, n'imikorere. Iyo ubonye a Niosh kwemerwa kuri an N95, bivuze ko mask yageragejwe cyane kugirango yemeze ko yanduza byibuze 95% yububiko bwa oily. Iri tegeko ni ryerekeye kurengera umukozi - muriki gihe, the Ubuvuzi umwuga.

Ubuyobozi bwibiryo n'Ibiyobyabwenge (Fda), kurundi ruhande, agenga maskes nibikoresho kugirango barebe ko bafite umutekano kandi bafite akamaro kubuzima rusange. Kuri a mask yo kubaga cyangwa a Kubaga N95 Wowe, the Fda'Inyungu ni mugukoresha nkigikoresho cyubuvuzi. The Fda gusubiramo ibi bicuruzwa binyuze kuri a Kumenyesha Premariket [510 (k)] Kugandukira kumenya niba bafite umutekano wo gukoresha mubuvuzi Igenamiterere. The Fda'Clear Cleaction yibanze ku miterere nk'ubutayu bwo kurwanya amazi, biocompaTubitekerezo (kwemeza ibikoresho ntibizarakaza uruhu), kandi ari umuriro. The FdaUruhare ni kugenzura the mask Nka bariyeri yo kurinda amasuka, abakurambere, hamwe nibitonyanga binini, bikaba bikomeye mugihe cyo kubaga inzira zo kurinda Umurwayi nuwabitanga.

Rero, muri make:

• Niosh yemeza Uwiteka guhumekaUbushobozi bwo Akayunguruzo Ibice byo mu kirere kugirango birinde waarer.
• Fda Gukuraho a mask yo kubaga cyangwa Kubaga N95 Wowe kugirango akoreshwe nkigikoresho cyubuvuzi, yibanda kubushobozi bwayo bwo gukora nka a inzitizi y'amazi.

Inganda zisanzwe N95 Gukenera gusa Niosh kwemerwa. Ariko a Kubaga N95 Wowe ibikenewe byombi Niosh kwemerwa kubijyanye n'ubushobozi bwayo na Fda Kwemeza kubikoresha nkibikoresho byo kubaga amazi. Nkumuguzi, niba ukeneye a guhumeka kucyumba cyo gukora cyangwa ibindi bikoresho bifite ibyago byo guhura namazi, ugomba gushakisha a mask ibyo bifite ibyangombwa byombi.

Kuki bikwiye cyane kunegura kubahumeka n95?

An N95 ni byiza nkigifuniko cyacyo. Mugihe Akayunguruzo Itangazamakuru ryashizweho kugirango rihagarike byibuze 95% yibice, uru rwego rwo hejuru rwangiritse rwose niba umwuka ushobora kuzenguruka impande za mask. Nibintu bimwe byingenzi bitandukanye hagati ya a guhumeka n'ubusanzwe isura ya mask. A mask yo kubaga drape iruhutse mumaso, ariko an N95 ni pometero kuri a Gufunga isura nziza. Hatariho iyi kashe ifatanye, umwuka wanduye uzakurikira inzira yibura, urenga Akayunguruzo kandi winjire muri zone yo guhumeka neza binyuze muri icyuho. Ibi bihakana intego nyine yo kwambara hejuru guhumeka.

Kugera kuri a bikwiye bikubiyemo intambwe nyinshi. Ubwa mbere, the guhumeka igomba kuba ingano ikwiye mumaso yumukoresha. Ntabwo amasura yose ari amwe, niyo mpamvu abakora benshi batanze moderi nubunini butandukanye. Kabiri, the waarer igomba gutozwa uburyo bwo gushira neza no gukuramo mask. Ibi birimo kunama isebanya kugirango uhuze n'ikiraro cya izuru n'umunwa agace no kwemeza imisatsi birahagaze neza. Amaherezo, kuri akazi Koresha muri U.S., Osha arasaba abakozi gutsinda ikizamini cyiza. Ubu ni uburyo busanzwe bugenzura kumeneka hafi ya kashe. Ibintu nka umusatsi wo mumaso irashobora kubangamira kashe, gukora ikizamini kidashoboka kandi gitanga guhumeka Ntakora.

Nkumuyobozi ushinzwe amasoko, inshingano zawe zikaba zirenze kugura gusa N95s. Nukwemeza ko umuryango wawe ufite gahunda yuzuye yubusambanyi. Ibi bivuze gutanga Bitandukanye guhumeka Icyitegererezo cyo Kwakira Inzego zitandukanye zo mumaso no gushyigikira amahugurwa akenewe hamwe na protocole ishimishije. Bihendutse N95 Ibyo ntibihuye numuntu ntabwo ari impaka; ni inshingano. Gushyikirana nuwabitanze kubyerekeye ubunini nuburyo butanga nigice cyingenzi cyo kugura neza. Uruganda rwizewe rugomba gushobora gutanga ibisobanuro birambuye no gushyigikira gahunda yo kwipimisha.

Ni ubuhe buryo bwo kubaga N95 mu buhumekero kandi nibikenewe ryari?

A Kubaga N95 Wowe ni nyampinga wa Hybrid wa maskes, tanga urwego rwohejuru rwo kurengera Igenamiterere ry'ubuzima. Ihuza ibiranga bisanzwe N95 hamwe n'iya a mask yo kubaga. Ibi bivuze ko idatanga gusa iriosh-yemewe kurinda ubuhubwe bwa niosh kuri aircorne yindege ariko nanone FDA-YASOHOTSE nka a Icyiciro II Igikoresho cyubuvuzi kugirango kirwanya kwinjira. Tekereza nka an N95 kwambara imvura. Yashizweho Kurinda umurwayi n'abigize umwuga w'ubuzima (HCP) Mugihe cyinzira aho hari ibyago byinshi byo mu kirere no kumeneka cyangwa gutera amaraso kandi amazi yumubiri.

Izi mbaraga zibiri zigamije bigenewe gukoreshwa Mubidukikije aho harwaga no kurinda umwuka hamwe namazi aribyingenzi. Ibi birimo ibyumba byo gukora, amashami yihutirwa mugihe cya Cauma, no mugihe cya Aerosol-ibiza ku barwayi bafite indwara zizwi cyangwa ukekwaho kugwa cyangwa Bronchoscopi. The Gukwirakwiza Covid-19 yazanye akamaro ka Kubaga N95 Intumbero ityaye, kuko yatanze uburinzi bwuzuye kuri virusi yandura ibitonyanga byombi na aerosol. The Inzitizi ya fluid cyangwa Filtration Efficy Muri ayo masike ageragezwa cyane kugirango barebe ko batanga ingabo yizewe.

Iyo hutse, ni ngombwa kugenzura ko a mask Kwangizwa nka A "Kubaga N95"ni byemewe rwose na byombi Niosh na Fda. Ugomba gushobora kubona a Niosh Umubare wemewe kuri guhumeka ubwayo (urugero, TC-84A-XXXX) hanyuma wemeze ko yakuweho na Fda munsi Kode y'ibicuruzwa MSH. Gukorana numuntu utanga umucyo ushobora gutanga iyi nyandiko nta gushidikanya ko atabiganiraho. Mugihe aba bazutse bahenze cyane, ni igice cyingenzi cya Ppe Mu kaga Igenamiterere, kandi uteshuka ku miterere yabo ntabwo ari amahitamo.

Ikiranga cyo guhumeka kumuhubuhumetswe neza mumutekano muburyo bwa clinical?

Impumuro nziza kuri a guhumeka ni ikintu cyagenewe guhumurizwa, ariko bifite ingaruka zikomeye kugirango zikoreshwe muri a Igenamiterere ry'ubuzima. A valve ni uburyo bumwe bwo gufungura iyo waarer guhumeka, kwemerera umwuka ususurutse, uhumura neza guhunga byoroshye. Ibi bikora guhumeka byoroshye kwambara igihe kirekire kandi bigabanya ubushyuhe imbere muri mask. Ku bakozi b'inganda, nk'abo mu kubaka cyangwa gukora, iyi ni ikintu cyiza. Ariko, mubuvuzi, cyane cyane kubigenzura isoko, kimwe valve ihinduka ikibazo gikomeye.

Ikibazo nuko Umumbunganya Emerera ibitonyanga byubuhumekero biterwa no kwirukanwa mubidukikije. Mugihe valve ntabwo iteshuka kurinda umuntu wambaye Uwiteka guhumeka, ihakana rwose intego ya mask mugukumira Uwiteka waarer kuva gukwirakwiza mikorobe kubandi. Mu murima wijimye cyangwa mugihe wita kubarwayi ba imyumbati, iyi ni ingaruka zitemewe. Mu gihe cya Covid-19 icyorezo, The CDC byasabwe neza no gukoresha ibihumeka hamwe Impumuro nziza kubugenzuzi bwinkomoko, nkuko babikora bike fasha kugabanya Ikwirakwizwa rya virusi kumuntu wanduye.

Kubwibyo, kuri bose Igenamiterere ry'ubuzima, abahumeka hamwe Impumuro nziza ntibikwiye. Iyo wowe ambara isura mask Mu bitaro cyangwa ku ivuriro, intego ni ebyiri: Irinde kandi urinde abari hafi yawe. Indangagaciro guhumeka agera gusa intego yambere. Nkumuyobozi ushinzwe amasoko, iyi ni irambuye yo kureba. Keretse niba ugura neza akazi akazi aho kugenzura inkomoko ntabwo ari impungenge (zidasanzwe muri Ubuvuzi), ugomba guhora uhitamo N95s cyangwa abandi basubitswe hanze a valve. Ibi birabyemeza Kurinda neza kubidukikije byose.

Niki nkwiye gushakisha mugihe uhesanzura masike yubuvuzi mumahanga?

Gutererana maskes Kuva ku wabikoze mu gihugu kimwe n'Ubushinwa birashobora kuba byiza cyane mubiciro nubunini, ariko bisaba umwete ningamba zisobanutse. Nka nyiri uruganda, mvugana nabashinzwe gutanga amasoko nkawe buri munsi, kandi nzi impungenge zawe. Icyangombwa ni ukurenga ku giciro no kwibanda kubufatanye no kugenzura. Mbere na mbere, icyifuzo cyo gukorera mu mucyo. Uruganda ruzwi ruzaguha icyemezo cya AD 13485 (kubikoresho byo gucunga neza ibikoresho byubuvuzi), GC biranga inyandiko (kubijyanye n'amasoko y'i Burayi), kandi ari ngombwa Fda kwiyandikisha cyangwa inzandiko zisobanutse. Ntukabifate gusa ijambo ryayo; Baza inyandiko kandi umenye kubigenzura.

Icya kabiri, itumanaho ni byose. Imwe mu ngingo nini zo kubabara ndumva ni itumanaho ridacogora. Ukeneye utanga isoko ufite itsinda ryitabira, ryicyongereza rivuga ryumva ibyangombwa bya tekiniki no kugena. Baza ibibazo birambuye kubyerekeye umusaruro wabo, kugenzura ubuziranenge, hamwe na sisitemu yo gukurura. Barashobora kukubwira neza ibikoresho byinshi bibi byagiye muri mask ugura? Umufatanyabikorwa mwiza arashobora. Uru rwego rwibisobanuro narwo rukomeye kubigena igenamigambi ryindi. Muganire ku kigero, amahitamo yo kohereza, no kwishyura hejuru kugirango wirinde gutinda bishobora kuva mu kigo cyawe gito.

Hanyuma, suzuma ibicuruzwa ubwabyo. Gusaba ingero mbere yo gushyira gahunda nini. Iyo wakiriye, suzuma ubuziranenge. Reba urugamba kuri Gutanga Amatwi, kumva Uwiteka Imyenda yo kumena, n'ubunyangamugayo bw'izuru. Gereranya na a mask Urabizi no kwizera. Yumva ko ari ibicucu? Hoba hariho impumuro idasanzwe? Ibisobanuro bito birashobora kwerekana ibibazo binini byo kugenzura ubuziranenge. Gutererana mumahanga ni ukubaka kwiringira. Nubufatanye aho impande zombi zungukirwa nubwumvikane, ubuziranenge, no gutumanaho kumugaragaro. Waba ushaka Imyambarire yo hejuru yo kwigunga cyangwa byoroshye isura ya mask, aya mahame yumunyamwete ukwiye burigihe arakurikizwa.

Nigute Covise-19 Pandemic yahinduye imiterere ya masike yo mumaso?

The Covid-19 Icyorezo cyari ikintu cyashize cyo kwamamaza gisanzwe ko gusobanukirwa kwisi yose no gukoresha isura ya mask. Mbere ya 2020, mu bihugu byinshi by'iburengerazuba, mask-kusanya ahanini hafungiwe Igenamiterere ry'ubuzima. Icyorezo cyahindutse mask mu kimenyetso cyiza cyubuzima rusange ninshingano zimibereho, yambarwa na Rusange buri munsi. Iyi icyifuzo kitigeze kibaho cyashizeho ikibazo kinini cyisi yisi yose, igaragaza intege nke kandi ikaganisha ku kwiyongera mu mikorere mishya, yemewe n'uburiganya. Ku bijyanye no gutanga amasoko, isoko ryabaye ahantu hahanamye kwumutungo mushya (KN95, Ffp2), abatanga isoko ritaremerwa, nibicuruzwa byiganano.

Imwe mu mpinduka zikomeye ni intego yo kugenzura inkomoko. Ubutumwa bwubuzima bwibanze bwabaye bwambaye a mask ntabwo yari kurindwa ku giti cye, ahubwo yari yerekeye kurengera abaturage. Ibi byazamuye akamaro ko noroshye mask cyangwa inzira mask kugabanya Gukwirakwiza Covid-19. The CDC hamwe nizindi nzego zubuzima zatanga ubuyobozi burambuye kuburyo na ambara isura gutwikira neza, harimo ibyifuzo kuri Kunoza ibintu bikwiye yo kubaga kandi masike yambaye imyenda Mugukubita imigezi yo gutwi cyangwa gukoresha mask firter. Icyorezo cya defamic deficratied The mask, ariko kandi yaremye ubumenyi icyuho ibyo byasize abaguzi benshi ndetse nabanyamwuga bamwe bitiranyije kuri ubwoko butandukanye bwa masike.

Duhereye ku bijyanye no gutanga amasoko, icyorezo cyatumye ubwihindurize bwihuse. Twabonye uruhushya rwo gukora byihutirwa (EUAS) kuva Fda Kwemerera gukoresha ibihumeka bidasubirwaho, nka KN95 Kuva mu Bushinwa, muri Ubuvuzi igenamiterere iyo N95s bari bake. Ibi byagaragaje akamaro ko gusobanukirwa amahame mpuzamahanga. Yashimangiye kandi gukenera kunegura uruniko rukomeye. Ikibazo cyatwigishije ko kwishingikiriza ku nkomoko cyangwa akarere kamwe karushijeho guteza akaga kandi ko kuba yarashyizeho umubano hamwe nabakora ibize byizewe, byemewe ni ntagereranywa. Umurage wa Covid-19 ni isoko rizi cyane, ubushishozi, kandi busaba ubuziranenge no gukorera mu mucyo muriyo Ppe.

Ni masike yimyenda cyangwa masike isanzwe ibereye gushiraho ubuzima?

Igikwiye kuri a mask cyangwa uburyo busanzwe mask biterwa rwose kumurimo runaka hamwe nurwego rwibibazo muri Igenamiterere ry'ubuzima. A mask ni mubyukuri igikoresho cyo kugenzura isoko kuri Rusange. Mugihe a bikwiye mask irashobora fasha kugabanya gusohora ibitonyanga byubuhumekero biva muri waarer, itanga uburinzi buke kuri waarer kuva guhumeka ibintu byiza cyangwa aerotol. Kubera iyo mpamvu, masike yimyenda muri rusange ifatwa nkaho idahagije yo gukoresha amavuriro ninzobere mu buzima bashinzwe kwitabwaho. Babuze umugozi gukanda n'amazi yo kurwanya amazi asabwa maskes.

Uburyo busanzwe maskes, ni ubwoko bwa mask yo kubaga, ni inkuru itandukanye. Ni staple in Ubuvuzi. Ibi Byashoboka masike ni FDA kandi yagenewe gutanga inzitizi yo kugabanuka no kumeneka. Bikwiriye rwose imirimo itandukanye, nkibizamini rusange, gutwara abarwayi, no gukoresha ahantu hamwe nibice byo guteza imbere isoko. Batanga uburinganire bwiza bwo kurinda no guhumeka mu bihe bitoroshye. Ariko, ni ntabwo a guhumeka. Ntabwo bakora kashe ifatanye kandi ntibatanga uburinzi bwizewe bwo guhumeka indwara ntoya yo mu kirere.

Kubwibyo, amategeko yintoki ni uguhuza mask ku kaga.

• Mask yambaye imyenda: Ntabwo ari ugukoresha amavuriro na HCPS.
• Inzira / mask yo kubaga: Icyifuzo cyo kugenzura inkomoko no kurinda ibitonyanga muburyo buciriritse. Icyangombwa cyo kurinda abarwayi kuva ku myuka y'abatanga mugihe cyoroshye.
• N95 ihumeka: Birasabwa kurinda ibice byo mu kirere, cyane cyane mugihe cya Aerosisol-zibyaza.

Kubashinzwe gutanga amasoko, ibi bivuze gukomeza ibarura ryitabiri. Ukeneye itangwa ryizewe ryujuje ubuziranenge Ubuvuzi bwo kubaga ubwaburo kugirango ukoreshe burimunsi, kuruhande rwa Niosh--ibyemewe N95 Ibisubizo kubintu byingaruka nyinshi. Nibyerekeranye nigikoresho gikwiye kumurimo kugirango wemeze kubahiriza n'umutekano.

Icyemezo kigenda: ISO, CE, na FDA rwose bivuze kugura mask yawe?

Kubwumuyobozi wamasoko, ibyemezo nururimi rwawe rwo kwizerana. Nibimenyetso bifatika byerekana ko ibicuruzwa byujuje ibipimo byashyizweho. Reka dusenye ibintu bisanzwe uzahura mugihe ugana maskes.

ISO 13485 ni amahame mpuzamahanga yo gucunga ubuziranenge bwo gukora ibikoresho byubuvuzi. Iyo uruganda rumeze nkiso 13485 rwemewe, bivuze ko twerekanye ubushobozi bwacu bwo gutanga ibikoresho byubuvuzi duhora duhura nibisabwa kugenzura ibisabwa. Ntabwo ari icyemezo cyo gutanga ibicuruzwa; Nibyemezo. Irakubwira uwabikoze afite sisitemu ikomeye mu mwanya wo gushushanya, umusaruro, ibisobanuro, no gucunga ibyago. Ngiyo ibyiringiro byawe byingirakamaro kubushobozi bwabatanga isoko no kwiringirwa kubicuruzwa byose, kuva a isura ya mask kubintu byinshi bigoye nka Gusukura kwa muganga guhuza imiyoboro.

IC ni ikimenyetso cyerekana cyerekana ko guhuza ubuzima, umutekano, no kurengera ibidukikije kubicuruzwa byagurishijwe mu bukungu bw'Uburayi (EEA). Kuri a mask yo kubaga cyangwa guhumeka, Ikimenyetso CE GE bisobanura ko ibicuruzwa byasuzumwe kugirango byubahirije amabwiriza cyangwa amabwiriza agenga EU bireba cyangwa amabwiriza yubuvuzi cyangwa amabwiriza y'ibikoresho byo gukingira). Ni pasiporo iteganijwe kubicuruzwa binjiza isoko rya EU. Kubaguzi bishingiye kuri Amerika, mugihe atari ibintu bitaziguye, bikora nk'ibimenyetso bikomeye ko uwabikoze akurikiza amahame mpuzamahanga yo hejuru.

Hanyuma, Fda (Ubuyobozi bwibiyobyabwenge) kugenzura maskes muri Amerika. Nkuko twaganiriye, masike yo kubaga birasuzumwa Icyiciro II Ibikoresho byo kwa muganga no gusaba Fda Kwemeza, mubisanzwe binyuze kuri 510 (k) Kumenyesha Premariket. Iyi nzira irerekana ko igikoresho byibuze gifite umutekano kandi kigakora neza nkigikoresho cyo kugurisha byemewe n'amategeko kitagomba kwemezwa mbere. Kuri Kubaga N95 Ibisubizo, bakeneye byombi Niosh kwemerwa kandi Fda kwemererwa. Kugenzura uwatanze isoko Fda Kwiyandikisha no gutanga ibicuruzwa nintambwe idahwitse mu nzira yawe imwe. Utanga isoko yizewe azatanga nimero zabo zo kwiyandikisha na 510 (k) amabaruwa arambuye abisabwe. Izi mpamyabumenyi ni ingabo yawe yo kurwanya ubuziranenge nubugenzuzi butubahirizwa.

Urufunguzo rwibanze rwo kwibuka

Mugihe uyobora isi igoye yubuvuzi mask na guhumeka Amasoko, komeza izi ngingo zingenzi mubitekerezo:

• Imikorere itegeka ifishi: A mask yo kubaga arinda abandi Kuva the waarer mu guhagarika ibitonyanga. An N95 irinda Uwiteka waarer Kuva ibidukikije mukangurura ibice by'indege.
• Bikwiranye nibintu byose kubuhumekewe: An N95 ntabwo ari ingaruka zidafite kashe ifatanye. A bikwiye, yagenzuwe nibizamini bikwiye, ni ngombwa kugirango ugere ku rwego rwasezeranijwe.
• Menya Abagenzuzi bawe: Muri Amerika, the Fda kugenzura masike yo kubaga nk'ibikoresho byo kwivuza, mugihe Niosh kwemeza imikorere yuzuye ibihumeka. Kubaga n95s Ugomba kuzuza ibipimo bya byombi.
• Indangagaciro ni zo guhumurizwa, ntabwo ari amavuriro: Guhumeka hamwe Impumuro nziza kurinda waarer ariko ntabwo abari hafi yabo. Mubisanzwe ntibishoboka Igenamiterere ry'ubuzima aho kugenzura inkomoko ari ngombwa.
• Kugenzura, ntukizere: Mugihe ushakisha amasezerano mpuzamahanga, gusaba no kugenzura ibyemezo nka iso 13485, GC biranga, kandi Fda kwemererwa. Umufatanyabikorwa hamwe nabatanga mu mucyo bashyira imbere ubuziranenge n'itumanaho.
• Huza mask ku kaga: Koresha uburyo bwanditseho. Ibicuruzwa maskes Kubikoresha muri rusange no kubika N95 Ibisubizo Kubangamiye cyane, uburyo bwo kwibasideliya bwo kurinda umutekano no gucunga neza.