Daim ntawv thov ntawm TPU tau raug xaiv los ntawm cov tuam txhab ua lag luam tshuaj, khoom noj qab haus huv, khoom siv hauv tsev kho mob, cov khoom siv biomedical, thiab cov cuab yeej tiv thaiv tus kheej (PPE) rau cov neeg ua haujlwm kho mob.
Hauv ntau lub khw, TPU tau txais kev pom zoo rau nws qhov kev ua tau zoo, tshwj xeeb tshaj yog nyob rau hauv kev kho mob. Nws muaj ntau yam kev siv, xws li cov khoom siv lub plawv thiab cov hnab plasma mus rau cov tsev pheeb suab cais hauv tsev kho mob.Nws lub zog siab, tsim kua muag tsis kam thiab cov yam ntxwv biocompatibility txuas ntxiv txhawb qhov tseem ceeb ntawm cov khoom lag luam tshiab hauv kev lag luam kho mob tag nrho.As cov ntawv thov tshiab txuas ntxiv mus. tshwm sim, tshwj xeeb tshaj yog cov chaw tsim khoom siv kho mob tau nquag txhawb kev lag luam nthuav dav ntawm cov ntawv thov uas muaj (xws li kev cais tawm los yog cov ntaub qhwv lub qhov txhab).
Tshwj xeeb tshaj yog, polyurethane muaj kev hwm rau nws qhov zoo hauv cov cheeb tsam hnyav no.Nyob rau hauv ib puag ncig kev kho mob, cov ntaub ntawv feem ntau yuav tsum tau txhuam los yog khoov rau ib leeg.Qhov tsis muaj zog ntawm TPU yuav ua rau cov ntaub ntawv no ua rau qaug zog lossis poob zog. .Txhim kho qhov ua tau zoo ntawm cov ntaub ntawv los ntawm TPU tau dhau los ua ib txoj hauv kev tseem ceeb los txhawb cov khoom tsim thiab kev tsim kho tshiab.
Nrog rau txoj kev loj hlob ntawm TPU kev lag luam ib xyoos ib zaug, nws txoj kev pib tsis yog ib qho nyuaj rau kev kho mob. Tus naj npawb ntawm TPU cov neeg muag khoom uas tuaj yeem ua tau raws li cov kev cai kho mob thiab muaj peev xwm ua tau raws li kev tsim khoom loj yog maj mam nce, tab sis cov khoom siv kho mob TPU tseem ceeb hauv khw tseem muaj tsawg. Lub ntsiab "txoj kev thaiv" yog: cov qauv ntawv pov thawj.Tam sim no, cov qauv ntawv pov thawj tseem ceeb yog cov hauv qab no:
1.EU Regulation 2017/745 (MDR): Raws li EU MDR txoj cai, txhua yam khoom siv kho mob muag hauv EU ua lag luam yuav tsum tau ua kom tau raws li kev soj ntsuam kev soj ntsuam tshiab, suav nrog cov kev cai rau cov khoom siv biocompatibility, tshuaj muaj pes tsawg leeg, traceability, thiab lwm yam. nyob rau hauv cov khoom siv kho mob, TPU yuav tsum tau mus dhau ntawm cov kev xeem thiab cov kev ntsuam xyuas los xyuas kom meej tias nws ua tau raws li cov cai ntawm MDR, uas yuav siv sij hawm thiab cov peev txheej.
2. ISO 10993: ISO 10993 yog tus qauv thoob ntiaj teb rau kev ntsuam xyuas biocompatibility, uas suav nrog cov khoom siv kuaj, xws li cytotoxicity, khaus tawv nqaij, ua xua, thiab lwm yam.Rau cov ntaub ntawv TPU, cov kev ntsuam xyuas biocompatibility tseem ceeb yuav tsum tau ua kom ntseeg tau tias lawv ua tau raws. Cov kev cai ntawm ISO 10993 los ua pov thawj lawv txoj kev nyab xeeb thiab kev lees paub hauv cov khoom siv kho mob.
3. FDA cov kev cai: US FDA nruj heev rau kev pom zoo thiab kev saib xyuas ntawm cov khoom siv kho mob.Rau TPU ua cov khoom siv hauv kev kho mob, nws yog ib qho tsim nyog yuav tsum xa daim ntawv thov kom ntxaws thiab ua cov kev ntsuam xyuas thiab cov kev ntsuam xyuas cuam tshuam los ua pov thawj tias nws muaj kev nyab xeeb thiab kev ua tau zoo ua tau raws li qhov xav tau ntawm FDA.
4. USP Qib VI yuav tsum: VI tsab ntawm USP (United States Pharmacopoeia) qhia cov kev cai rau cov ntaub ntawv yas nyob rau hauv kev sib cuag tshuaj, nrog rau cov yuav tsum tau rau extract kev soj ntsuam, cytotoxicity, thiab biocompatibility.As ib tug khoom siv rau kev kho mob, TPU yuav tsum tau raws li cov kev cai ntawm USP Qib VI kom ntseeg tau tias nws muaj kev nyab xeeb thiab ruaj khov hauv kev sib cuag tshuaj.