Ngexesha lenkqubo yokujonga imihla ngemihla, kwafunyaniswa ukuba ukwakhiwa kwamagumbi acocekileyo kwamanye amashishini akwanelanga. Ngokusekelwe kwiingxaki ezahlukeneyo ezivela kwiinkqubo zemveliso kunye nokujonga abavelisi abaninzi bezixhobo zonyango, kucetyiswa ezi mfuno zilandelayo zokwakhiwa kwamagumbi acocekileyo, ngakumbi kumashishini ezixhobo zonyango ezicocekileyo.
1. Iimfuno zokukhetha indawo
(1). Xa ukhetha indawo yomzi-mveliso, kufuneka ucinge ukuba imeko yendalo kunye neemeko zococeko ezijikeleze indawo zilungile, ubuncinci akukho mithombo yongcoliseko lomoya okanye lwamanzi, kwaye kufuneka ibe kude neendlela eziphambili zezithuthi, iindawo zemithwalo, njl.njl.
(2). Iimfuno zendalo esingqongileyo kwindawo yefektri: Umhlaba kunye neendlela kwindawo yefektri kufuneka zigudileyo kwaye zingabi nathuli. Kucetyiswa ukunciphisa indawo yomhlaba obonakalayo ngokusebenzisa uhlaza okanye amanye amanyathelo okanye ukuthatha amanyathelo okulawula uthuli. Inkunkuma, izinto ezingasebenziyo, njl. akufuneki zigcinwe kwindawo evulekileyo. Ngamafutshane, imeko-bume yefektri akufuneki ibangele ungcoliseko kwimveliso yezixhobo zonyango ezicocekileyo.
(3). Uyilo lulonke lwendawo yefektri kufuneka lube nengqiqo: akufuneki lube nefuthe elibi kwindawo yemveliso yezixhobo zonyango ezicocekileyo, ingakumbi indawo ecocekileyo.
2. Iimfuneko zoyilo lwegumbi (indawo) elicocekileyo
Ezi zinto zilandelayo kufuneka ziqwalaselwe xa kuyilo lwegumbi elicocekileyo.
(1). Lungiselela ngokwenkqubo yemveliso. Inkqubo mayibe mfutshane kangangoko ukunciphisa izinga lokusebenzisana phakathi kwabantu nezilwanyana, kwaye kuqinisekiswe ukuhamba kwabantu kunye nempahla ngokufanelekileyo. Mayixhotyiswe ngegumbi elicocekileyo labasebenzi (igumbi lokugcina idyasi, igumbi lokuhlambela, igumbi elicocekileyo lempahla yokunxiba kunye negumbi le-buffer), igumbi elicocekileyo lezinto (igumbi lokuthengisa ngaphandle, igumbi le-buffer kunye nebhokisi yepasi). Ukongeza kumagumbi afunekayo kwiinkqubo zemveliso, kufuneka ixhotyiswe ngegumbi lempahla yococeko, igumbi lokuhlamba impahla, igumbi lokugcina impahla lexeshana, igumbi lokucoca izixhobo zesikhululo sokusebenzela, njl. Igumbi ngalinye lizimele kwelinye. Indawo yegumbi elicocekileyo kufuneka ihambelane nomlinganiselo wemveliso ngelixa iqinisekisa iimfuno ezisisiseko.
(2). Ngokwenqanaba lokucoceka komoya, ingabhalwa ngokwendlela abasebenzi abahamba ngayo, ukusuka kwesezantsi ukuya kwephezulu; indawo yokusebenzela isuka ngaphakathi ukuya ngaphandle, ukusuka phezulu ukuya kwesezantsi.
3. Akukho kungcoliswa okwenzekayo kwigumbi elinye elicocekileyo (indawo) okanye phakathi kwamagumbi acocekileyo akufutshane.
① Inkqubo yemveliso kunye nezinto ezikrwada aziyi kuchaphazela umgangatho wemveliso;
② Kukho iindlela zokuvala umoya okanye iindlela zokulwa nongcoliseko phakathi kwamagumbi acocekileyo (iindawo) amanqanaba ahlukeneyo, kwaye izinto zidluliselwa ngebhokisi yokungena.
4. Ubungakanani bomoya omtsha kwigumbi elicocekileyo kufuneka buthathe eli xabiso liphezulu lilandelayo: Ubungakanani bomoya omtsha ofunekayo ukuhlawula umthamo wokukhupha umoya ngaphakathi kunye nokugcina uxinzelelo oluhle lwangaphakathi; Ubungakanani bomoya omtsha xa kungekho mntu kwigumbi elicocekileyo kufuneka bube ngaphantsi kwe-40 m3/h.
5. Indawo nganye yegumbi elicocekileyo mayingabi ngaphantsi kweemitha ezi-4 zesikwere (ngaphandle kweepaseji, izixhobo kunye nezinye izinto) ukuqinisekisa indawo yokusebenza ekhuselekileyo.
6. Ii-reagents zokuxilonga kwi-in vitro kufuneka zihambelane neemfuno ze-"Implementation Rules for the Production of In Vitro Diagnostic Reagents (Trial)". Phakathi kwazo, imisebenzi yokucubungula i-serum engalunganga nelungileyo, iiplasmids okanye iimveliso zegazi kufuneka yenziwe kwindawo enobuncinci beklasi ye-10000, igcine uxinzelelo olungalunganga kwiindawo ezikufutshane okanye ihambelane neemfuno zokhuseleko.
7. Icala lomoya obuyayo, umoya ohambisayo kunye nemibhobho yamanzi kufuneka liphawulwe.
8. Iimfuno zobushushu kunye nokufuma
(1). Iyahambelana neemfuno zenkqubo yemveliso.
(2). Xa kungekho mfuneko ikhethekileyo yenkqubo yemveliso, ubushushu begumbi elicocekileyo (indawo) elinomgangatho wococeko lomoya weklasi ye-100000 okanye i-10000 kufuneka bube yi-20℃ ~ 24℃, kwaye umswakama ohambelanayo kufuneka ube yi-45% ~ 65%; umgangatho wococeko lomoya kufuneka ube yiklasi ye-100000 okanye i-3000000. Ubushushu begumbi elicocekileyo leklasi ye-10,000 (indawo) kufuneka bube yi-18°C ukuya kwi-26°C, kwaye umswakama ohambelanayo kufuneka ube yi-45% ukuya kwi-65%. Ukuba kukho iimfuno ezikhethekileyo, kufuneka zimiselwe ngokweemfuno zenkqubo.
(3). Ubushushu begumbi elicocekileyo labasebenzi bufanele bube yi-16°C ~ 20°C ebusika kunye ne-26°C ~ 30°C ehlotyeni.
(4). Izixhobo zokubeka esweni ezisetyenziswa rhoqo
I-Anemometer, ikhawuntara yamasuntswana othuli, imitha yobushushu kunye nokufuma, imitha yoxinzelelo lomahluko, njl.
(5). Iimfuneko zamagumbi ovavanyo angenazintsholongwane
Igumbi elicocekileyo kufuneka lixhotyiswe ngegumbi lokuvavanya ukungabi nazintsholongwane (elahlukileyo kwindawo yemveliso) elinenkqubo yokucoca umoya ezimeleyo, efunekayo ukuba ibe yiklasi ye-100 yasekuhlaleni phantsi kweemeko zeklasi ye-10000. Igumbi lokuvavanya ukungabi nazintsholongwane kufuneka liquke: igumbi elicocekileyo labasebenzi (igumbi lokugcina idyasi, igumbi lokuhlambela, igumbi elicocekileyo lempahla yokunxiba kunye negumbi le-buffer), igumbi elicocekileyo lezinto (igumbi le-buffer okanye ibhokisi yepasi), igumbi lokuhlola ukungabi nazintsholongwane, kunye negumbi lokulawula elilungileyo.
(6). Iingxelo zovavanyo lokusingqongileyo ezivela kwiiarhente zovavanyo zamaqela esithathu
Nika ingxelo yovavanyo lokusingqongileyo evela kwi-arhente yovavanyo yomntu wesithathu ofanelekileyo kungekapheli unyaka omnye. Ingxelo yovavanyo mayihambe nesicwangciso somgangatho esibonisa indawo yegumbi ngalinye.
① Okwangoku kukho izinto ezintandathu zovavanyo: ubushushu, ukufuma, umahluko kuxinzelelo, inani lotshintsho lomoya, inani lothuli, kunye nebhaktiriya yothuli.
② Iindawo ezivavanyiweyo zezi: Indawo yokusebenzela yokuvelisa: igumbi elicocekileyo labasebenzi; igumbi elicocekileyo lezinto; indawo yesiphatho; amagumbi afunekayo kwinkqubo yemveliso; igumbi lokucoca izixhobo kwindawo yokusebenzela, igumbi lempahla yococeko, igumbi lokuhlamba impahla, igumbi lokugcina impahla okwethutyana, njl.njl. Igumbi lokuvavanya ubudlolo.
(7). Ikhathalogu yeemveliso zezixhobo zonyango ezifuna ukuveliswa kwegumbi elicocekileyo. Izixhobo zonyango ezingeyongozi okanye izixhobo zefektri ezipakishwe enye ezifakelwe kwaye zifakwe kwimithambo yegazi kwaye zifuna ukucutshungulwa okulandelayo (njengokuzaliswa nokuvalwa, njl.njl.) kwindawo ecocekileyo yeklasi ye-100 phantsi kweklasi ye-10000. Ukucutshungulwa kwezinto, ukucocwa kokugqibela, ukuhlanganiswa, ukupakishwa kokuqala kunye nokuvalwa kunye nezinye iindawo zemveliso kufuneka zibe nenqanaba lococeko elingaphantsi kweklasi ye-10000.
Umzekelo
① Ukufakelwa kwemithambo yegazi: njengee-vascular stents, ii-valve zentliziyo, imithambo yegazi yokwenziwa, njl.
② Imithambo yegazi engenelelayo: ii-catheter ezahlukeneyo zangaphakathi kwemithambo yegazi, njl. Ezifana nee-catheter zemithambo ephakathi, iinkqubo zokuhambisa i-stent, njl.
③ Ukucubungula, ukucoca kokugqibela kunye nokudibanisa izixhobo zonyango ezicocekileyo okanye izixhobo zefektri ezifakwe kwizicubu zomntu kwaye ziqhagamshelwe ngqo okanye ngokungathanga ngqo kwigazi, umngxuma wethambo okanye indawo engeyoyamvelo (ngaphandle kokucoca). Indawo yokuqala yokupakisha kunye nokuvala kunye nezinye iindawo zemveliso kufuneka zibe nenqanaba lokucoceka elingaphantsi kweklasi ye-100000.
④ Izixhobo ezifakwe kwizicwili zomntu: ii-pacemakers, izixhobo zokuhambisa amayeza ezifakelwa phantsi kwesikhumba, amabele okwenziwa, njl.
⑤ Ukudibana ngqo negazi: isahluli se-plasma, isihluzi segazi, iiglavu zotyando, njl.njl.
⑥ Izixhobo ezidibana ngqo negazi: iiseti zokufaka igazi, iiseti zokufaka igazi, iinaliti ezifakwa kwimithambo yegazi, iityhubhu zokuqokelela igazi nge-vacuum, njl.njl.
⑦ Izixhobo zokuthintana kwamathambo: izixhobo ezifakwa ngaphakathi kwamathambo, amathambo okwenziwa, njl.
⑧ Ukucubungula, ukucoca okokugqibela, ukuhlanganisa, ukupakishwa kokuqala kunye nokuvalwa kwezixhobo zonyango ezicocekileyo okanye iindawo zefektri enye (ezingacocwanga) ezidibana nomphezulu owonakeleyo kunye neenwebu zomzimba womntu kufuneka zenziwe kwigumbi elicocekileyo elingaphantsi kweklasi 300000 (indawo).
Umzekelo
① Ukudibana nomphezulu owonzakeleyo: iibhanti zokutsha okanye zokubopha amanxeba, umqhaphu ofunxayo wezonyango, i-gauze efunxayo, izinto zotyando ezingasetyenziswayo ezingafunekiyo ezifana neephedi zotyando, iilokhwe zotyando, iimaski zonyango, njl.njl.
② Ukudibana ne-mucous membrane: i-catheter yomchamo ecocekileyo, i-tracheal intubation, isixhobo sangaphakathi kwesibeleko, i-human lubricant, njl.
③ Kwizinto zokupakisha eziphambili ezidibana ngqo nomphezulu wezixhobo zonyango ezicocekileyo kwaye zisetyenziswa ngaphandle kokucoca, umgangatho wococeko lwendalo yemveliso kufuneka umiselwe ngokuhambelana nemigaqo efanayo nenqanaba lococeko lwendalo yemveliso yemveliso ukuqinisekisa ukuba umgangatho wezinto zokupakisha eziphambili uhlangabezana neemfuno zezixhobo zonyango ezicocekileyo ezipakishiweyo, ukuba izinto zokupakisha zokuqala aziqhagamshelani ngqo nomphezulu wesixhobo sezonyango esicocekileyo, kufuneka ziveliswe kwigumbi elicocekileyo (indawo) elinommandla ongaphantsi kweklasi 300000.
Umzekelo
① Ukudibana ngqo: njengezinto zokuqala zokupakisha izixhobo zokufaka, amabele okwenziwa, ii-catheters, njl.
② Akukho kudibana ngqo: njengezinto zokuqala zokupakisha iiseti zokufaka, iiseti zokufaka igazi, iisirinji, njl.njl.
③ Izixhobo zonyango ezicocekileyo (kuquka izixhobo zonyango) ezifunekayo okanye ezicutshungulwayo kusetyenziswa iindlela zokusebenza ezingasetyhiliyo kufuneka ziveliswe kumagumbi acocekileyo eklasi ye-100 (indawo) asekuhlaleni aphantsi kweklasi ye-10000.
Umzekelo
① Ezifana nokuzaliswa kwezinto ezithintela ukugabha kwegazi kunye nezisombululo zokugcina igazi lisebenza kakuhle, kunye nokulungiswa nokuzaliswa kweemveliso zolwelo ezingenabungozi.
② Cinezela uze ubambe i-vascular stent uze ufake iyeza.
Ingxelo:
① Izixhobo zonyango ezingeyongozi ziquka izixhobo zonyango ezingenazo naziphi na iintsholongwane eziphilayo ngokusebenzisa iindlela zokubulala iintsholongwane okanye iindlela zokulungisa i-aseptic. Iteknoloji yokuvelisa enciphisa ungcoliseko kufuneka isetyenziswe ekuveliseni izixhobo zonyango ezingeyongozi ukuqinisekisa ukuba izixhobo zonyango azingcoliswanga okanye zinokuphelisa ungcoliseko ngempumelelo.
② Ukungazalisi: Imeko apho imveliso ingenazo iintsholongwane eziphilayo.
③ Ukubulala iintsholongwane: Inkqubo eqinisekisiweyo esetyenziselwa ukwenza imveliso ingabi nanto yakwenza neentsholongwane eziphilayo.
④ Ukulungiswa kwe-Aseptic: Ukulungiswa kweemveliso ze-Aseptic kunye nokuzaliswa kwemveliso ze-Aseptic kwindawo elawulwayo. Umoya, izixhobo, izixhobo kunye nabasebenzi bendalo bayalawulwa ukuze ungcoliseko lweentsholongwane kunye neenxalenye zilawulwe kumanqanaba amkelekileyo.
Izixhobo zonyango ezingeyontsholongwane: zibhekisa kuzo naziphi na izixhobo zonyango ezibhalwe "ezingeyontsholongwane".
⑤ Igumbi elicocekileyo kufuneka libe negumbi lezinto zokuhlamba impahla, igumbi lokuhlamba impahla, igumbi lokugcina impahla lexeshana, igumbi lokucoca izixhobo zesikhululo sokusebenza, njl.
Iimveliso eziveliswa phantsi kweemeko ezicociweyo zibhekisa kwiimveliso ezifuna ukungabi nazintsholongwane okanye ukubulawa kwezintsholongwane ukuze zisetyenziswe okokugqibela.
Ixesha lokuposa: Jan-30-2024