Kwihlabathi lanamhlanje, ukuqonda intsingiselo yezixhobo ezikhuselayo kubaluleke ngakumbi kunangaphambili. Kubaphathi abathengileyo njengoMark Thompson e-USA, ukufunyanwa kwezinto ezisemgangathweni ezisemgangathweni kunento ephambili. Eli nqaku lihlala lingene nzulu kwiisenti ze Imaski ye-3-ply dissocks, kugxilwe kakhulu ngokubaluleka kwe Fda isiqinisekiso, utyala Imigangatho, kunye nento eyenza Imaski ye-3 ukhetho oluthembekileyo. Siza kuphonononga ulwakhiwo, izibonelelo, kunye nezinto ezibalulekileyo ekufuneka ziqwalaselwe xa wena Thenga okanye iodolo ezi zinto zibalulekileyo. Esi sikhokelo sinenjongo yokubonelela ngokucacileyo, isenzo esisebenzayo Ulwazi Ukukunceda wenze izigqibo ezinolwazi, uqinisekisa ukhuseleko kunye nentlalo-ntle yabo baxhomekeke kwezi mveliso. Njenge-allen, umenzi ovela e-China nemigca yesixhenxe imveliso, ndiyayiqonda intswelo yokuvelisa umgangatho imaski iimveliso kunye nokubaluleka kokungafihlisi kwabathengi bam B2b.
Yintoni kanye kanye imaski ye-3-pily?
Ukhe wazibuza ukuba yintoni eyenza Imaski ye-3-pily Iyasebenza? Ibinzana elithi "i-3-ply" libhekisa kwizibonda ezintathu ezahlukeneyo zezinto ezisetyenziswayo kulwakhiwo lwayo. Ezi zixhobo ziqhele okwenziwa kwiilaphu ezingezizo ezilukiweyo, ezikhethwe kwiimpawu zabo ezithile ezinegalelo kwi imaskiUkusebenza ngokubanzi. I-ORDORT i-ORDER ihlala yenzelwe ukuba inganyangeki ibenzi, ibonelela ngomgca wokuqala wokuzikhusela ngokuchasene okanye kwiimpuphu. Ungqingo lwangaphakathi, oluhlala nxamnye nolusu, luhlala luthambile kwaye luhlala luthatheka-i-absur-therbarbler, ukuphucula intuthuzelo yomtheko ngexesha lokusetyenziswa okwandisiweyo.
Umlingo, nangona kunjalo, uhlala ulele kuluhlu oluphakathi kwe Imaski ye-3-pily imassi. Lo mlinganiso yeyona nto iphambili ukuthoba Iphakathi, idlalwa rhoqo kwilaphu le-volyproplene. I-Neener-ihlawulwe ukuba ikhuphe uluhlu oluqhelekileyo, kubandakanya i-bacteria kunye nezinye umoya amasuntswana. Ukudityaniswa kwezi 3 Ii-Disees ziqinisekisa ukuba imaski inika ibhalansi ye ukhuseleko, ukuphefumla, kunye nentuthuzelo, kuyenza ibe sisiqalo kwizicwangciso zonyango kunye nokusetyenziswa koluntu ngokubanzi. Iingcali zokuthengwa, ukuqonda oku kwakhiwa kwakhiwa linyathelo lokuqala ekuvavanyeni umgangatho wokubakho imveliso.
Ezi Imaski yobuso zenzelwe ukusetyenziswa okungatshatanga ukugcina ucoceko kunye nokusebenza kakuhle. Ukuhleba kunokulalanisa iimpawu zabo zokukhusela kwaye kunokubakho ukunyusa umngcipheko wongcoliseko. Kwizibhedlele nakwiikliniki kwiimeko zemihla ngemihla ezifuna umaleko ongezelelweyo we ukhuseleko, Imaski ye-3-Ply iye yaba sisixhobo esingathethekiyo. Kubalulekile ukuthenga Ezi zinto zivela kwimithombo ethembekileyo yokuqinisekisa ukuba bayahlangabezana nemigangatho elindelekileyo.
Kutheni le nto "i-3-ply" inqaku eliphambili lokujonga kwimveliso yobuso yemaski?
Indawo ye "-tly" ingaphezulu nje kwenani nje; Isalathiso esisisiseko se Imaski yobusoImpumelelo enokubakho njenge umqobo. Nganye nganye 3 iileyile kwi Imaski ye-3-Ply Isebenza injongo eyahlukileyo, esebenzisana ngokudibeneyo ukuba inike i-Shurness ebanzi ngokuthelekisa ngokuthelekisa imaski kunye nee-walers ezimbalwa. Umzekelo, i-on-Ply imaski inokubonelela ubuncinci ukhuseleko, ngelixa i-2-Ply imaski iphucula oko, kodwa I-3-Ply Ulwakhiwo lwamkelwa ngokubanzi njengomgangatho wokulinganisa okuhle kwe ukuthoba kunye nokuphefumla ngaphakathi ilahla Imaski.
I umahluko Kumanqanaba okhuselo kubalulekile. Umaleko wangaphandle we I-3-pily ilahlekile imaski kubalulekile ukuba uguquke ulwelo, njengamathontsi aphefumlayo. Umaleko ophakathi, njengoko kuchaziwe, sisihluzi esibalulekileyo. Ungqimba lwangaphakathi ugxininisa kwintuthuzelo kunye nokukhulisa umswakama kumphefumlo we-decer, ukuthintela i imaski Ukusuka ekubeni ungabizi kwaye ungathandeki ngokukhawuleza. Le ndlela yokuyila iqinisekisa ukuba imaski inokucoca ngokufanelekileyo amasuntswana ngelixa eseleyo ukunxiba. Xa ubona i Ingcaciso yeMveliso Ukuqaqambisa "3-Ply," ibonisa inqanaba elithile lokwakha elenzelwe ukusebenza kakuhle.
Njengomvelisi, ndingakuxelela ukuba yenza umgangatho Imaski ye-3-Ply kubandakanya ukukhetha ngononophelo lwezixhobo kunye nendibano echanekileyo. Ingqibelelo yomaleko ngamnye kunye nendlela ebot ngayo ichaphazela kakhulu ukuthoba Ukusebenza kakuhle kunye nokuqina kwe imaski. Ngomntu onjengathi uMarkon, onobuthathaka obuthandileyo, ukuqonda ukuba "3-ply" uphawula umgangatho othile woyilo lubalulekile xa kuvavanywa intsha imveliso okanye umthengisi. Ayisiyo malunga nenani leendawo, kodwa zeziphi ezona yenza kunokwenzeka ngokomgaqo wokhuselo.
Isatifikethi se-FDA sithetha ntoni kwiimaski zobuso ezilahlayo?
Xa ubona "I-FDA iqinisekisiwe"Okanye," i-FDA icocekile "okanye" i-FDA igunyazisiwe Imaski yobuso, oko kuthetha ukuba ulawulo lokutya lwe-U.S. imveliso Ukuqinisekisa ukuba ihlangabezana neemfuno ezithile zomthetho zokhuseleko kunye nokusebenza. I Fda Udlala indima ebalulekileyo enyamekelani izixhobo zonyango eUnited States, kwaye Imaski ye-subgical Ukuwa phantsi kolu luhlu. Lo ukongamela ayisiyisitampu esilula; Ibandakanya inkqubo apho abavelisi kufuneka banike ubungqina bokuba imaski yenza njengoko bekucwangcisiwe.
Ye imaski ye-sugical, Fda I-COORD iqhelekile ithetha imveliso Ivavanyiwe izinto ezinje nge-bacrinterration (BFE), ukusebenza kakuhle Ezi mvavanyo ziqinisekisa i imaski ibonelela ngokwaneleyo umqobo, zikhusela ngokuchasene ne-spolshes ezinokubangela ulwelo, kwaye zikhuselekile nxiba ngokuchasene nolusu. Le ngxilindi uphononongo Inkqubo inika abathengi abazithemba ukuba imaski Bathengwa kufanelekile kwiindawo zonyango. Yiyo le nto abaphathi bezibhedlele zeZibhedlele kunye neeklinikhi eziphambili eziphambili nge Fda iziqinisekiso.
Kubalulekile ukuba uqonde ukuba ayizizo zonke izigqubuthelo zeNYE zilawulwa ngu Fda ngendlela enye. Umzekelo, i-cloig ebusweni ebekwenzelwe ukusetyenziswa koluntu ngokubanzi ukuba ayifuni Fda uphononongo ngaphandle kokuba benza amabango onyango. Nangona kunjalo, kuba Imaski ye-3-ply dispos ithengisiwe ngeenjongo zonyango, okanye ngokukodwa njenge utyala Imaski, ukuthobela Fda Imigaqo luphawu oluphambili lomgangatho kunye nokuthembeka. Njengomthengisi, ukubonelela ngokucacileyo Ulwazi malunga Fda Isimo sibalulekile ekwenzeni ukuthembana nabathengi njengoMark.
Ngaba zonke iimaski ezi-3-pily zilahlekile i-FDA ivunyiwe? Umahluko obalulekileyo.
Le yindawo eqhelekileyo yokudideka: hayi, ayisiyo yonke Imaski ye-3-ply dispos zikhona Fda ivunyiwe okanye icinyiwe. Inqaku elithi "i-3-ply" libhekisa ekwakhiweni kwe imaski -Inani lezinto. Ngelixa le yinto elungileyo, ayithethi ngokuzenzekelayo imaski dibana nemigangatho yokusebenza engqongqo efunwa yi Fda ngonyango okanye utyala sebenzisa. Kukho into ebalulekileyo umahluko phakathi kwenjongo ngokubanzi Imaski ye-3-Ply kunye ne Fda-ubo imaski ye-sugical.
Ezininzi Imaski ye-3-ply dispos zenziwa kwaye zathengiswa ngokusetyenziswa ngokubanzi okanye njengezigubungela kwizimo ezikhuselekileyo kwezonyango. Ezi zinokubonelela ngesidanga ukuthoba Kodwa isenokungabi nakuqulunqwa uvavanyo olungqongqo ulwelo Ukuxhathisa, ukuqina okukhethekileyo okuqinisekileyo (njenge-BFA kunye ne-PFE kumanqanaba enqanaba lezonyango), okanye i-biompatise Fda-ubo Imaski ye-subgical yenza. I Fda ijolise esweni kwayo kwiimaski ezenzelwe ukusetyenziswa kuseto lwempilo okanye ezo yenza amabango ezonyango.
Ke ngoko, xa sifumana iimaski ezibhedlele, iiklinikhi, okanye nayiphi na imeko apho iBakala lezonyango ukhuseleko iyimfuneko, ifuna nje "i-3-ply" ayonelanga. Kufuneka ujonge ngokuthe ngqo kwimpawu zokuba Imveliso yeMask i Fda icinyiwe okanye igunyaziswe ukusetyenziswa kwezonyango. Sebenzisa ukungaqinisekisi Imaski ye-3-Ply Kwimeko efuna utyala okanye Imaski ye-3 inokuthobela ukhuseleko. Kubathengi be-B2B, ukuqinisekisa oku Fda Isimo linyathelo elibalulekileyo kwinkqubo yokuthenga ukuze uqiniseke ukuba Thenga a imveliso yiyo i kufanelekile ngenjongo yayo. Kulapho isebenzisana khona Abavelisi besixhobo sonyango esidumileyo esinjenge-Zhongxing ibalulekile.
Ndingaqinisekisa njani iinkcukacha ze-FDA yePakethi ye-3-ply disty pack?
Qinisekisa Ulwazi lwe-FDA ye Ipakethi ye-3-ply diskess ye-TOK linyathelo elibalulekileyo lokuqinisekisa ukuba ufumana impilo yezonyango imveliso. Abavelisi abadumileyo kunye nabasasazi kufuneka benze le nto Ulwazi ngokulula iyafumaneka. Enye yeendawo zokuqala zokujonga yinkqubo yemveliso ngokwayo okanye ilebheli yemveliso. Fda-ubo Imaski ye-subgical ihlala ibandakanya iinkcukacha ezinje ngomenzi womenzi, inombolo yobhaliso, kwaye ngamanye amaxesha Ikhowudi yemveliso ye-FDA.
Itshekhi echanekileyo ngakumbi, ngakumbi enkulu ii-odolo, ungazama ukusebenzisa i FdaUvimba woluntu. I Fda Gcina ugcino lwezixhobo ezinje ngobhaliso lokuBhala kunye nokudweliswa kwesixhobo sedatha. Ngelixa ezihamba ngamanye amaxesha zinokuba nzima kumsebenzisi wokugqibela, umthengisi kufuneka akwazi ukubonelela ngeenkcukacha zabo zobhaliso, ezinokuthi ziphikiseke. Ukucela umthengisi wakho ngqo kumaxwebhu axhasayo Fda Amabango ngumgangatho oqhelekileyo kwaye ucetyiswayo. Oku kunokubandakanya ikopi yeleta yazo ye-510 (k) yeleta ukuba iyasebenza, okanye ubhaliso lwendawo yabo Ulwazi.
Njengomnini-mveliso, i (i-allen) iyakuqonda ukubaluleka kokungafihli. Sinika abathengi bethu, njengoMarkopson, ngalo lonke amaxwebhu ayimfuneko ukuqinisekisa ukuthotyelwa kwethu imaski iimveliso, kubandakanya nayiphi na FdaUkuqinisekiswa okunxulumene okanye ubhaliso lweemveliso esithumela ngaphandle e-USA. Ungathandabuzi ukucela oku; Umthengisi osemthethweni webanga lezonyango Imaski ye-3-ply dispos Uya kulungela ukwabelana ngayo. Le ntsizi inceda ukuthintela ubuxoki okanye iimveliso ezingaphantsi kwaye ziqinisekisa ukuba usenza ikhuselekile ukuthenga.
Ngawaphi amanqanaba e-ASTM yeemaski zoNyango (iNqanaba 1, 2, 3)?
Ngaphezulu ngokubanzi Fda Imvume yokusetyenziswa kwezonyango, Imaski ye-subgical zihlala zihlelwa ngokwahlulahlulwahlulwahlulwahlulwa kwentsebenzo ezichazwe yi-ASTM yeHlabathi (eyayekade yaseMelika yoVavanyo lovavanyo kunye nezixhobo). Le migangatho - i-ASTM F2100-Chaza iimfuno zentsebenzo zonyango lwe-Masks, ukunceda abasebenzisi bakhetha inqanaba elifanelekileyo ukhuseleko. Kukho amanqanaba amathathu aphambili: Inqanaba 1, Inqanaba 2, kwaye Inqanaba le-3.
- I-ASTM yenqanaba le-1 zenzelwe iimeko zomngcipheko ophantsi. Banikezela ngenqanaba elisisiseko le ulwelo Ukuxhathisa kunye neMitha ukuthoba. Oku kufanelekile kwiinkqubo apho kukho umngcipheko ophantsi wokutshiza okanye ukuvezwa kwe-aerosol.
- I-ASTM yenqanaba 2 le-ASTM Nikeza umqobo ophakathi. Ziphezulu ulwelo Ukuchasana nokungcono ukuthoba (I-BFA ne-PFE) kune-Maskis 1 imaski. Ezi zilungele iinkqubo ezinokubakho ngokubonakalayo ekuvezeni ukutshiza kunye ne-aerosols.
- I-ASTM yenqanaba le-3 Nikeza elona nqanaba liphezulu lokukhuselwa phakathi Imaski ye-subgical. Babonelela kakhulu ulwelo Ukuxhathisa kunye namanqanaba aphezulu entsholongwane ukuthoba. Oku kuyacetyiswa kwiinkqubo apho kukho umngcipheko omkhulu wokuveza izixa ezibalulekileyo ze-fluid, ukutshiza, okanye ii-aerosols.
Ukuqonda la manqanaba e-ASTM kubalulekile xa ukhetha i Imaski ye-3-pily surgical. Ukuba umbutho wakho ufuna amandla ukhuseleko, ukukhetha i Imaski ye-3 ihlala ilukhetho olufanelekileyo. Ukupakishwa okanye Ingcaciso yeMveliso Ngeemaski ezinjalo kufuneka zichaze ngokucacileyo inqanaba le-ASTM. Xa uxoxa ngeemfuno kumthengisi, echaza inqanaba le-ASTM elifunayo inceda ekuqinisekiseni ukuba ufumana ichanekile imveliso ngeemfuno zakho. Le uthelekiso ibalulekile kwizimo zomngcipheko omkhulu.
Ngaphaya kwe-FDA: Zeziphi ezinye iizalathi ezisemgangathweni ekufuneka ndizihlole imaski ye-3-pily?
Ngelixa Fda Ukucocwa kunye ne-Astm F2100 Ukuthobela izinto Imaski ye-subgical Injongo yeNtengiso yase-US, kukho ezinye izikhombisi ezisemgangathweni ukuba abathengi abaqaqambileyo abafana noMarkopson kufuneka uphononongo. Ukufumana iimveliso ezithengiswe eYurophu, umamaki wase-CA ubalulekile, obonisa ukungqinelana nempilo, ukhuseleko, kunye nokukhusela imigangatho yokhuseleko lwendalo. Esinye isiqinisekiso esibalulekileyo sokujonga i-ISO 13485. Lo mgangatho ucacisa iimfuno zenkqubo yolawulo esemgangathweni apho umbutho kufuneka ubonise amandla onyango kunye neenkonzo ezinxulumene nazo ezidibana khona umthengi kunye neemfuno ezifanelekileyo zolawulo.
Umgangatho wezinto ezisetyenzisiweyo kwi Imaski ye-3-Ply kwaye ukwakhiwa kwalo kubaluleke kakhulu. Jonga iimaski ezenziwe ngendwangu ekumgangatho ophezulu, kwiBanga leMali leMali. I iindlebe kufuneka iqhotyoshelwe ngokukhuselekileyo, ukanti ukhululekile ngokwaneleyo nxiba. Entle imaski iya kubonisa ibala impumlo isiqwenga esinokulungiswa ukuze kudale ukhuselekile kufanelekile ngaphezulu kwe umlomo kunye nempumlo, ukunciphisa izithuba apho amasuntswana asebenza khona anokungena okanye abaleke. Intuthuzelo iyonke kunye nokuphefumla, nakwi Imaski ye-3, kubalulekile ukuthotyelwa komsebenzisi.
Okokugqibela, isidumo kunye nokungafihlisiyo kubathengisi bakho siphambili. Njenge-allen, emele i-zhongx, umzi-mveliso onemigca yemveliso yesi-7, sizingca malunga nokuzinikela kwethu kumgangatho osemgangathweni nonyango. Sikhuthaza abathengi ukuba babuze malunga neenkqubo zethu zokwenza, amanyathelo olawulo esemgangathweni, kunye nokulandelwa kwe-batch. Umthengisi othembekileyo uyakuvuma ukubonelela ngeenkcukacha Ulwazi ngeMveliso, iingxelo zovavanyo, kunye neziqinisekiso. Le ndlela igqibeleleyo yokuvavanya i Imaski ye-3-Ply kwaye umthengisi wayo unceda ekuqinisekiseni ukuba utyala imali kwi imveliso Ayingqinelani kuphela kodwa iyasebenza kwaye ithembekile kwaye ithembekile. Sinikezela ngeentlobo Umgangatho ophezulu wonyango masks ifikelela kule migangatho.
Yintoni umahluko wokukhuselwa: I-3-fris-i-3-pully ye-3-pulls yemaski ye-vs. Ezinye iintlobo zeMask?
Ukuqonda i umahluko ngaphakathi ukhuseleko Inikelwe ngokwahlukeneyo imaski Iindidi zibalulekile ekukhetheni enye efanelekileyo kuyo nayiphi na imeko enikiweyo. Umgangatho Imaski ye-3-pily imassi, ngakumbi a imaski ye-sugical, inika ibhalansi elungileyo ye ukhuseleko kunye nokuphefumla kwiimeko ezininzi. Ngokuyintloko isebenza njenge umqobo Ukuthintela i-Debler ekukhutsheni amachaphaza amakhulu okuphefumla kwaye unike abanye ukhuseleko ngokuchasene neebhulukhwe ezivela kwabanye.
Xa uthelekisa a Imaski ye-3-pily kwilaphu elilula imaski, umahluko iyabonakala. Ngelixa i-comps i-masks inokunceda ukunciphisa ukusasazeka kwamathontsi avela kumhlambi, banikezela ngamazantsi ukuthoba Ukusebenza kakuhle kwamasuntswana amancinci kwaye uswele uvavanyo oluluqilima kwaye ulwelo Ukuxhathisa Ubuso boNyango lweMicimbi yoNyango. I-Cloith masks zihlala zilungele ukusetyenziswa koluntu ngokubanzi kwimingcipheko esemngciphekweni kodwa azikhuthazwanga kuseto lwempilo apho amanqanaba aphezulu ukhuseleko ziyafuneka.
Kwelinye icala le-spectrum yi-N95 okanye i-FFP2 yokwabalana. Oku kwenzelwe ukwenza itywina eliqinileyo ebusweni kunye nokucoca ubuncinci i-95% (ye-N95) ye-N95) yencinci (0.3 microron) umoya amasuntswana. Banikezela ngenqanaba eliphezulu lokuphefumla ukhuseleko kunomgangatho Imaski ye-3-pily yoqhaqho, ngakumbi ngokuchasene ne-aerosols entle. Nangona kunjalo, bafuna uvavanyo olufanelekileyo kwaye banokukhululeka kakhulu nxiba. A Imaski ye-3-pily surgical, ngakumbi i-astm Imaski ye-3, ihlala iluhlobo olukhethiweyo kubasebenzi bezempilo kwiimeko ezingafuni itywina elipheleleyo le-N95 kodwa isafuna ukuba ibalulekile Ukhuseleko lomqobo kwaye ukuthoba. Kwabo bafuna ukuthotywa okuphezulu, ukuphonononga iindlela ezifana I-FFP2 imaski ye-flting inokuqwalaselwa ngemingcipheko ethile yomngcipheko omkhulu, ongenzi utyando ukuba ibonisiwe abaqhubi.
Unganxiba njani ngokufanelekileyo kwaye ulahle imaski ye-3-puly yobuso ye-sk
Nditsho elona nqanaba liphezulu I-3-puly yobuso seMaski ayizukubonelela kakuhle ukhuseleko Ukuba ayinxibi kwaye ilahlwe ngokuchanekileyo. Ukusetyenziswa ngokuchanekileyo kubalulekile. Ngaphambi kokufaka imaski, qinisekisa ukuba izandla zakho zicocekile-sebenzisa isepha kunye namanzi okanye isiphene sesandla esisekwe ngesandla. Xa uthatha i imaski, hlonipha naziphi na iinyembezi okanye ukonakala. I-orvey i imaski ngokuchanekileyo; Ngokwesiqhelo, icala elinemibala ebunjani, kwaye umtya wentsimbi okanye umda oqinileyo uphakathi ukuze uhambelane neyakho impumlo. Khusela i Iindlebe zokupheka ze-elastic ujikeleze iindlebe zakho, okanye ubophe ubuhlanga obusentlokweni yakho, kuxhomekeke kwisitayile. Ngobuqhetseba, wabumba isiqwenga sempumlo ukuya kwi-blorho yakho yempumlo kwaye utsala ezantsi kwe imaski phantsi ukugubungela kwakho umlomo kunye nempumlo ngokupheleleyo, ukuqinisekisa i-snug kufanelekile ngaphandle kwezithuba.
A imaski yokulahla yenzelwe ukusetyenziswa okungatshatanga. Kuya kufuneka uthathe indawo yakho Imaski ye-3-pily Ukuba iba ngumkhenkce, ungcolile, okanye owonakalisiweyo, okanye emva kwexesha elide le nxiba (Ngokwesiqhelo iiyure ezimbalwa, okanye ngokwesikhokelo sendawo zomsebenzi). Kulumkele ukuchukumisa umphambili we imaski Ngelixa inxibe, njengoko inokuba ingcolile. Ukuba wenjenjalo, coca izandla zakho kwangoko.
Xa ilixesha lokususa imaski, yenza njalo ngokuphatha kuphela iindlebe okanye ubudlelwane-musa ukuchukumisa umphambili we imaski. Lahla isetyenzisiwe imaski kwangoko kwi-bin evaliweyo. Emva kokuchithwa, ukucoca izandla zakho kwakhona kwakhona. Ukulandela la manyathelo kunceda ukwandisa ukusebenza kwe Imaski ye-3-ply dispos kwaye inciphise umngcipheko wokungcoliseka komnqamlezo, ukuqinisekisa i ukhuseleko Yenzelwe ukubonelela ifezekisiwe ngokupheleleyo. Oku kubaluleke kakhulu umntu omdala Abasebenzisi kwizicwangciso zobungcali.
Ukufumana imaski ephezulu, i-FDA ihambelana neemaski ezi-3 ze-3-pily zokulahla: Iingcebiso zabathengi.
Kubaphathi abathengileyo njengoMark Thompson, ukufumanisa umgangatho ophezulu, Fda uthobela Imaski ye-3-ply dispos Ifuna ukukhuthala, ngakumbi xa ibeka i-bulk ii-odolo. Inyathelo lokuqala kukungabikho kwabathengisi ngokucokisekileyo. Sukujonga nje ngexabiso ipakethe; Cinga ngodumo lomthengisi, amandla emveliso, kunye nokubambelela kwabo kwimigangatho esemgangathweni. Cela iinkcukacha Imveliso yemveliso, kubandakanya izixhobo ezisetyenzisiweyo, inqanaba le-ASTM (ukuba liyasebenza Imaski ye-subgical), kunye nobungqina be Fda ukucaciswa okanye ubhaliso.
Xa ukulungele Thenga, buza abavelisi abachaphazelekayo. Buza malunga neenkqubo zazo zolawulo lomgangatho kuyo yonke imveliso. Njengoko i-allen ivela eZhongDing, ndiyayifumana le mibuzo. Umzekelo, kuya kufuneka ubuze malunga:
- Izatifikethi: Cela ikopi ye Fda Amaxwebhu, i-ISO 13485 Izatifikethi, ukumakisha, kunye neengxelo zovavanyo ezifanelekileyo (
- Ukulandelela kweBatch: Ngaba umthengisi unokuyila ipakethe yemaski ebuyela kwi-batch yayo yemveliso kunye nezixhobo ezingafunekiyo? Oku kubalulekile kumgangatho wokuqinisekisa umgangatho.
- Ukuvelisa amandla kunye namaxesha akhokelayo: Qonda amandla abo okufezekisa iimfuno zakho zevolumu kwaye kulindeleke Ukuhambisa ngenqanawe amaxesha abekiweyo.
- Uphononongo lwesampulu: Ngaphambi kokubeka okukhulu iodolo, cela iisampulu ukuba uphononongo umgangatho, kufanelekile, nentuthuzelo ye Imaski ye-3-pily imassi.
Ukuhambahamba kwamanye amazwe Ukuhambisa ngenqanawe kwaye izinto zenye inkalo ephambili ye ukuthenga inkqubo. Xoxa nge-ACsms, iindlela zokuhambisa ezikhethiweyo, kunye neenkqubo zokucamngca ngeziko nomxhasi wakho. Qinisekisa ukuba onke amaxwebhu ukwenzela ukuthintela ukulibaziseka. Ukusebenzisana nomvelisi onamava oqondayo kwimigaqo yokuthumela kwelinye ilizwe kumazwe afana ne-USA angenza le nkqubo incinci. Ukutyala ixesha ekufumaneni umthengisi othembekileyo wakho Ukulahla iMaski yoNyango lweMaski Iimfuno ziya kuhlawula ngokwemigaqo yomgangatho wemveliso, ukuthotyelwa, kunye nokunikezelwa kozinzo. Khumbula ukukhangela ukuba isaphulelo ikhowudi i iyafumaneka ukuthenga okuthengiweyo.
IXESHA LOKUQALA: I-13 ukuya kwi-1325