Dab tsi yog Cov Qauv Rau Cov Khoom Siv Hauv Cov Khoom Siv Kho Mob Kho Mob?

Kev xaiv cov khoom siv kho mob kho mob yuav tsum ua raws li cov qauv kev lag luam nruj thiab cov lus qhia tshwj xeeb kom ntseeg tau tias cov neeg mob muaj kev nyab xeeb thiab kev kho mob zoo thaum ua tau raws li biocompatibility, durability, thiab kev ua haujlwm. Cov hauv qab no yog kev tshuaj xyuas raws li cov qauv hauv tebchaws tam sim no, cov kev cai thoob ntiaj teb, thiab kev siv tshuaj kho mob:

Biocompatibility Standards:Qhov tseem ceeb yuav tsum tau ua kom muaj kev nyab xeeb ntawm tib neeg kev sib cuag. Tag nrho cov ntaub ntawv uas tuaj rau hauv kev sib cuag ncaj qha lossis tsis ncaj nraim nrog tib neeg lub cev yuav tsum tau txais kev ntsuam xyuas biocompatibility kom tsis txhob muaj tshuaj lom, tsis haum tshuaj, lossis kev mob tshwm sim.

Cov qauv hauv tsev:

• YY/T 0285 Series: Lub hauv paus tseem ceeb rau kev kuaj biocompatibility ntawm cov cuab yeej kho mob hauv kuv lub tebchaws, suav nrog cov khoom kuaj xws li cytotoxicity, rhiab heev, khaus, mob toxicity, subchronic / chronic toxicity, implantation cov tshuaj tiv thaiv, thiab cov kev pheej hmoo ntawm cov khoom degradation.
• GB/T 16886 (sib npaug rau ISO 10993): Qhia tag nrho cov txheej txheem ntawm kev soj ntsuam lom ntawm cov khoom siv kho mob, yuav tsum tau ntsuas ntsuas raws li hom kev tiv tauj (sov, luv- cog cog, ntev- cog cog) thiab sijhawm.
• Cov Qauv Khoom Siv Tshwj Xeeb: Piv txwv li, ultra- siab molecular hnyav polyethylene (PE-UHMW) rau kev phais phais yuav tsum ua raws li GB/T 19701 kom ntseeg tau tias nws cov purity, tshauv cov ntsiab lus, thiab tensile zog raws li cov qauv.

International Standards:

• ISO 10993 Series: Cov txheej txheem thoob ntiaj teb tau txais kev pom zoo biocompatibility, nrog ntau cov qauv suav ua ke nrog nws.
• FDA thiab MDR Yuav Tsum Tau: Ob lub US FDA thiab EU MDR yuav tsum tau ua tiav cov ntaub ntawv biocompatibility, nrog rau cov kev cai nruj dua, tshwj xeeb tshaj yog rau cov khoom siv cog qoob loo ntev -.