Umvaqo wasezulwini wezempilo ubalulekile kakhulu ekwakhiweni ngokuphelele kwemithetho, ikakhulu xa kufakiwe ukwakha izixhobo zokulungisa ubomi. Isikhangeli samagejha ephambili sezigcawu somlomo sihamba ngemithetho eziphathelene kakhulu ukuze siciniseke ubomi bomntu nesiphumo sesigaba. Le manje akhethekile ayingxaki ukulandela imithetho eziphambili yokuhlela ubomi okuthunyelwa kuwo yonke into, kusukela ekukhetheni izinto ziye kusapho lokugcina. Ubuncinci bezigcawu ephambili zomlomo kumelwe abe ngamandla amanani okulawula ubomi okuyinxalenye yesimo sezifundo zasezulwini njengoko ayihlenze indlela yokuzala izinto ngendlela efanelekileyo.
ISO 13485 Inqanawa Yemfundo Yophando Lwesixhobo Sokubophephela
Umbuso Wokwakha Izixhobo Zempilo Ngokugcwele
ISO 13485 isikhungo sesibophelo sendawo yonke enobulungiswa yokwenza izixhobo zokuthutha kumzimba. Le ndlela ejwayelekileyo yokuphatha ubunzima ibhekise ekhathazekileyo kizidingo ezithile zokwenza izixhobo zempilo, ihlenze ukuthi wonke umfaniso wokwakha uphumelele kiziviko eziphambene ngezivikelo. Le ndlela ifaka imfanelo yokudizayina, ukuphatha izilingo, nokuphila kwendlela yokuphucula okudingekayo ukugcina ubunzima obubangelene bokuba yisiprodo.
Ukusebenzisa ISO 13485 kufuna ukudokolavala ngendlela yonke yezindlela zokwakha, kuqala kumqondo wokudizayina uze kube yisiprodo esigcweleyo. Kufuneka indawo yokwenza izixhobo zokuthutha kumzimba ibe nenkulumo epholile ngokukhethwa kwebhodi, ukulondoloza kwamakhadi okufinyelela, nokuthiwe ngezivikelo. Le zidingo zihlenze ukuthi ngaphandle kokuchaza okuchazwe ngaphambi komxholo osetyenzisiwe ekwakheni izixhobo zokuthutha kufanele nezidingo zokuphepha nokusebenza kwesiprodo esigcine.
Imibhalo fanye neenzame zoqikelelo
Izidingo zodokumenti kanye ne-ISO 13485 ziyaphakama ngaphezu kokugcina amabhuku. Kumele wonke umphakathi wamanzi e-orthopedic trauma ugcine amabhuku abalulekile okugcina ubukhona bomfanekiso obulandelana ngezindlela ukusuka ekwenzweni kuya kumkhiqizo wesiphetho. Lokhu kufaka phakathi amabhuku abalulekile, amakhadi okulinganisa kwezixhobo zokulinga, nokuchazwa kwemfundo ethembisa ukuba inkqubo iphila ngokuvamile.
Ukubaluleka kwe-traceability kuthathwa indima ebalulekile uma kusebenziswa nezinto ezifakwayo ezithintela izifo, lapho ubuhle bendalo yomuntu ihlose ukwazi ukubala kanye nokubuyisela ngokushesha izinto ezingavamile. Izikhungo zezimali zamandla zisebenzisa izinhlelo zedatha ezihlelekile ukugcina lezi zimpendulo, ukuze kube khona inkinobeko yokuphendula ngokushesha uma kukhona iziproblemi zebhodolo noma imibuzo yezemthetho.
Isimo se-FDA 21 CFR Part 820
Izidingo Zokwenza Ngokulungileyo
Ukulawula kukaFDA 21 CFR Umugqa 820, okwaziwa ngokujulile njengeKulawula Kwesimo Sezinga, kumele imithetho engcono yokwenza izinto ngokuphathelene nendalo yezixwayiso zomedical eMasenikeni. Injini yezixwayiso zeorthopedic trauma ifuneka ibonise ukuthi ihlanzele konke lokhu kulinganiselwe ngokuphelele. Lokhu kulawula kufakela konke okuhlobene nokwakha izinto, kusukela ekulawuleni kwebhizinisi nekuthengiselana kuze kube khona ukwakha nokulawula umsebenzi.
Okulawulwa kwabizini ngaphansi kuka820 kumelisa ukuthi abayenza babeme indlela eyenzakalelayo yokuguqula izidingo zomsebenzisi kuvingelelo ephawulekayo yeziphazamiso. Lokhu kufaka phakathi ukwenza imbizo yebhizinisi, ukubonakalisa nokwakha izinqubomgomo, nakuba ngufile yesiphazamiso. Kuzixwayiso ze-trauma, lokhu kulawula kuyisikhathi esibalulekile ngoba isiseko sasekhaya siyaneleke kakhulu futhi kudinga ukusebenza ngokucophelela emehlweni yekhono.
Ukukhiqizwa Nezimali Zokuxhumana
Izimfuneko zokuphatha kubekiwe ngu-Part 820 ihlinza ukuthi ngalinye isikhangiso sangaphandle sokuphatha izimoto zokugcina kwemipofu lilindeleke kakhulu imisebenzi yokwakha. Lezi zimfuneko kufaka phakathi izibonelo ezibhalwe nezindlela zokwakha, ukulungiselela kwegcine, nokulandela kwebhubhu, ubunzima, nokuhlukahluka kwezimali. Kufanele kube khona ulandeleko oluphathelene nobunzima, ubunzima, nokuhlanjulwa kwezimali ukuze kugobekwe ukungena kwezinto ezingcono noma ukulahlekelwa kwemali engcono.
Ukulungiswa kwegcine kuyinxenye ebalulekile futhi yokuqinisekisa ukuthi i-Part 820 ilandelwa. Abawetha kumele bafakaze ukuthi imisebenzi yawo yokwakha iyaphinda-phinda iphumelela emathilweni ayitholile. Lokhu kufaka phakathi ukucophelela iqiniso lokufakwa, iqiniso lokusebenza, nokulungiswa kwezikhathi zonke zezixhobo zokwakha nezindlela eziphathelene kakhulu.
Imigomo Yezimali Nokuchaza Kwesimo Sebiyokomphimethe
Ukukhetha Kwemali Engu-Medical Grade
Ukukhetha kwemithwalo efanayo kusisisekelo sobuchwepheshe besiseko samanzi abakhethiweyo. Kumele kuthuthwe imithwalo ephathele ngemigaqo yesifundo esigcwele, kubandakanywe imigaqo yokuthuthukisa, ukukhuseleka kwe-corrosion, nokwezimalo zezimali. I-grades ze-stainless steel njenge-316LVM nasekwalokhu kwe-titanium kusetyenziswa kakubi ngoba zinobuchwepheshe obuhle nokwezimalo zezimali.
Kumele kutholakale i-Documentation yokuthuthukisa yemithwalo ngalinye ukhupha kwebuthwalo, ekhombisa ubuchwepheshe bokuchazwa ngokugcwele kwebuchwepheshe bokuchazwa ngokugcwele kwebuthwalo. Lezi zikhabhishi ziqinisekisa ukuthi imithwalo ihlangene nemigaqo evela ngaphambi kokungena kwezimali. Izinhloso zokuhlola ngapheshe zihlola ukuthi imithwalo elitholile litholakala nezikhathi zokuthuthukisa.
Izinqumo zokuthuthukisa ukuthuthukisa
Ukuhlaziywa kwebiocompatibility ngokwesimo se-ISO 10993 kusivikela ukuthi izixhobo zotsholwa zilungile ekuxhaseni ngeyiphasenthi. Kumele kwenziwe ukulondoloza okubanzi yezinhlelo zokuhlaziywa kwabonakude, kufaka phakathi ukuhlaziywa kwebhodhi, amavivino ethuvinuko, nokulinganisa kwebhubhu yokuphathelana. Lezi zikhathi zihlaziywa iziphumo ezimbi ezingaba khona ngexesha lenketho.
Indlela yokuqala yesilinganiso siqala ngokulinganisa ngokugcwele ubunzima bokuxhasa kwayiphasenthi. Kwizixhobo zotsholwa eziphambuka ngokukhawuleza ne-tissue, iintsoloko ezithile zihlanganisa ukuhlaziywa kwebhubhu yokuphathelana nokuphendula kwegunya. Abayebenza kumele bakhusele imibhalo epheleleyo yazo zonke iziphumo zokuhlaziywa kwabiocompatibility njengenxalenye yezinteto zakho zokulungiswa.
Ukulungiswa Kwesitshalo Kunye Nempahla Yemeko
Imithetho Yokulima Isitshalo
Ukuchithwa kwezinhlela kuyisimo esibalulekile sokulinganiso ngaso sonke isikhalo sezigaba zokulima. Izindlela ezihlukene eziphathelene nokuchithwa kuzo ziphathekile ukuchithwa ngevapeli, ukuchithwa nge-ethylene oxide, ne-ukuchithwa nge-radiation gamma. Inhlalo ngalunye kwezi zindlela kudinga izibonelo ezithile zokuthiwe ukuthi inkinga yokuchithwa iyafika ku-10^-6, okusho ukuthi usizo lwe-microorganism ethile ekhona ukuphila emva kokuchithwa kuyindodana engu-1 ku-1000000.
Ukubonakala kwesibonelo sokuchithwa ngevapeli kufaka phakathi ukwenza izibonelo ze-biological indicator zisetshenziselwa i-Geobacillus stearothermophilus spores, abanelise indlela yokungena kwezimali. Lezi zibonelo kumele zibonise ukuthi inkinga yokuchithwa iyafika njalo kuwo wonke amandla okuchithwa. Izibonelo zokulinganisa ubude bezulu zihlinze ubude bethulwane kuyo yonke indawo yesikhumba sokuchithwa.
Izidingo Zokupakiwa Ngokuchithwa
Amathuluzi okupaka izixhobo zokulungisa izikhala kufuneka azilindele ukulungileyo kuqalekile xa kusabalalisa ixesha lokugcina nokuthengwa. Kufuneka indawo yokwenza izixhobo zokulungisa izikhala ziboneke amathuluzi okupaka nokuphatha kwemisebenzi ngokwemigaqo ye-ASTM ne-ISO. Lokhu kufaka phakathi ukucwangcisa imfundo yekati xa ixesha likhula ukuze kubonakale ukuthinta kwegama lapho ixesha elizolungiswa.
Izinhlelo zomkhwebulelo wokulungileyo zisetyenziswa ngokuvamile iphere ethunjwe, izinto ezingenakho umgca, noma iplastic films ezenzelela ukungena kwesayithi ngelishwa kungavikeli ukungena kwemicrobial. Imisebenzi yokuphatha kwegama kudinga ukubonakaliswa ukuze kuthintele isilinganiso sesiphumo nesimilo. Izibonelo zokuhlola ziphawula ukuthi wonke amagama afanele kuthole kakhulu kumathuba aphumelelayo ngaphambi kokuphumayo.
Ukulawula Isimo kunye Nezimali Ze-Cleanroom
Imigaqo Yodidi Lwe-Cleanroom
Amathuba wokwakha kwi-factory yezixhumanisi zokulungisa izifo ze-trauma kumele achuphele imikhuba yokuhlukunyezela ukuze akhuphele ukulahlekwa kwezixhumanisi zokugula. Imikhuba ye-ISO 14644 ichaza izigaba zocingo oluncane ngokuthi kungaba yini umkhawulo wokwahlukana kwamaphethini okuvikela amandla. Ukukhiqiza kwizixhumanisi ezinjalo kumele kube nezigaba 100,000 (ISO 8) noma kahle kangako emsebenzini wokudala nokupaka.
Imithombo yokulandela umoya ihlinzekela ubomi bomoya, ubomi bomphumela womthambo, nokuhlanjelwa kwegazi kumathuba okukhathaleloko ekukhathaleleni. Izinkcazo zokubala izinto eziphakeme zibala ububi bomoya, kodwa ukususa isampula somphumulo kuchazela ukusebenza kwezinyathelo zokucima nokuhlupha. Lezi zindlela zokulandela zenza idatha eyichaza ukusebenza kwezinqumo zokulandela umoya.
Ukufundisa Abantu Basebenzayo Nezinyathelo Zokuzipaka
Abasebenzi basebhungu bakhombisa umthombo mkhulu wokulahlekwa kwezinto ezihlukileyo ekwakhiweni kwezixhobo zemedical. Kufuneka isikolo esihlinzekileyo sendawo yokwenza izixhobo zomlambo ngaphandle sisebenzise izifundo ezipheleleyo eziqukethe indlela eyiyo yokuzidlanga, imithetho yentselela kumashwama, kunye neenguqulelo zokuziphatha kwindawo ehlinyelwayo. Izahlulo ezenziwa ngokuthe ngqo ziyafuneka zenzeke ukuthi bonke abantu baye naqhaza olufunekayo.
Imithetho yokuzidlanga iqela elikhulu lezixhobo zokuphatheka, kubandakanywa iinethi zamagxuma, iimaski zentsimbi, iiglovu ezilungileyo, kunye nezigaba ezifana nekamva yomphakathi. Imithetho yokungena kunye nokuphuma kwizindlu ezipheleleyo kufuneka ihlawulwe ngokucacileyo ukuze kugcinwe ubuhlwempu kususwa. Iintonga zamanqwelo kunye neemathe adibeneyo ajolisa izinto ezingenakho phantsi kwabantu kunye nezixhobo qala ngenxa yokungena kwindawo ephathwayo.
Imibuzo Evame Ukubuzwa
Ziziphi iimpendulo ezisemgangathweni ezibophephela ukwenza izixhobo zomlambo ngaphandle
Imitholampilo ekhethweni kwimvume iyasondla ku-ISO 13485 yokuphatha izinhlelo zokhweba, FDA 21 CFR Part 820 ngendlela efanelekileyo yokwakha, ISO 10993 ukulungiselela kwebiocompatibility, ne-ISO 14644 emakhelweni ephelele. Ngaphezu koko, indawo yokwakha yezixhumanisi zomculo wezibindi kufuneka ishamele ku-ISO 11137 ukuthi kuswelelwe ukulungiswa nokukhanya, nakuba izimiso eziyinkimbini ze-ASTM ngezici zomthelela nokuxhumana komthetho.
Ukukhetha umthelela kubangaphi kumqondo wamatholampilo?
Ukukhetha umthelela kubangela ngqo imisebenzi, ubomi obude, nokhuseleko komsisa. Indawo yokwakha yezixhumanisi zomculo wezibindi kufuneka ikhetha amathelela enenjalo efanayo, engavilengi futhi engabikho biocompatibility. Amathelela ahlelwe ngu-316LVM stainless steel namakhilomitha we-titanium, angayeni ingqikithi eyinhle ye-strength-to-weight futhi abonakale ngqo biocompatibility profiles kumsebenzi wasekhaya.
Ububi bukanjani okulungiswa kokulahlekelwa kuzindlela zokwakha?
Ukuthiyeswa kwebonakude kusivikela ukuthi zonke izixhumanisi zezilonda zifinyeleza amandla okuthiyeswa okudingekayo ngaphambi kokusetshenziswa kwezokwelapha. Kumele kwenziwa imbono ebalulekile emfukweni wemfuko wemzimba wokwenza izixhumanisi zezilonda ukuthola ukuthi izindlela zokuthiyeswa ziqinisekile ngokuphathelene ukuthi zihlinze ngokuphathelene ngokuphathelene. Lokhu kufaka phakathi iziviko zezinhloso zokubonakude, ukulungiselela kwegcina, nokuphatha okuphathelene okuvikela ukuthi izindlela ziqinisekile ngokuphathelene.
Kungani amandla wendawo abalulekile kumvelo wemzimba wokwenza izixhumanisi zezilonda
Amandla wendawo avikela ukulahlekwa okungakho kuthinta ukuthiyeswa koma umsebenzi wemzimba. Amakhanda okwenza kumele akhokhele amandla okuhlakwa okuchazwe ngu-ISO 14644, ngokulungiselela okuphathelene kwegcina elilizayo, ukuhlakwa kwegcina, kanye nokulungiselela kwabantu. Le mandla kabaluleke kakhulu ekugcineni ubumnandi bomkhiqizo kanye nokuvikela ubomi bempilo yempilo yezokwelapha.
