Ku bijyanye no gupakira ibiryo n'ibikoresho, icyemezo cyo mu rwego rw'ibiribwa ni ngombwa kugira ngo umutekano n'ubwiza bw'ibicuruzwa dukoresha.Ibikoresho bibiri bikunze gukoreshwa mubicuruzwa byo mu rwego rwibiribwa ni silicone na plastike, byombi bifite ibyemezo bitandukanye bituma umutekano uhura nibiryo.Muri iki kiganiro, tuzasesengura ibyemezo bitandukanye bya silicone yo mu rwego rwa ibiryo na plastike, itandukaniro ryayo nikoreshwa.
Icyemezo cya silicone yo mu rwego rwibiryo:
- Icyemezo cya LFGB: Iki cyemezo gisabwa mu Muryango w’ubumwe bw’ibihugu by’Uburayi, byerekana ko ibikoresho bya silicone byujuje ibisabwa n'amategeko y’ibiribwa, ubuzima n’umutekano.Ibicuruzwa bya silicone byemejwe na LFGB bifite umutekano kugirango uhure neza nibiryo.Hariho uburyo butandukanye bwo gupima ibyemezo bya LFGB, harimo ibintu byimuka, ibyuma biremereye, impumuro nziza hamwe no gupima uburyohe.
- Icyemezo cya FDA: FDA (Ikigo gishinzwe ibiryo n'ibiyobyabwenge) ni ikigo ngenzuramikorere muri Amerika cyita ku mutekano no gukora neza mu biribwa, ibiyobyabwenge n'ibikoresho by'ubuvuzi.Ibicuruzwa bya silicone byemewe na FDA bifatwa nkumutekano kugirango bikoreshwe mubikorwa byo guhuza ibiryo.Uburyo bwo kwemeza FDA busuzuma ibikoresho bya silicone kubigize imiti, imiterere yumubiri, nibindi bintu kugirango byemeze gukoresha ibiryo.
- Icyemezo cya Medical Grade Silicone Icyemezo: Iki cyemezo cyerekana ko ibikoresho bya silicone byujuje ubuziranenge bwa USP Icyiciro cya VI na ISO 10993 kugirango biocompatibilité.Ubuvuzi bwa silicone yo mu rwego rwubuvuzi nayo ikwiranye no gusaba ibiryo kuko iba biocompatable na sterile.Ubuvuzi bwa silicone ikoreshwa mubuvuzi kandiibikomoka ku buvuzibityo rero akaba agomba kubahiriza amahame akomeye yumutekano.
Icyemezo cya Plastike Icyemezo:
- Icyemezo cya PET na HDPE: Polyethylene terephthalate (PET) na polyethylene yuzuye (HDPE) nubwoko bubiri bwa plastike bukoreshwa mubipfunyika ibiryo no mubikoresho.Ibikoresho byombi byemewe na FDA kugirango bihuze ibiryo kandi bifatwa nkumutekano mukoresha mubiribwa n'ibinyobwa.
- PP, PVC, Polystirene, Polyethylene, Polyakarubone na Nylon Icyemezo: Izi plastiki nazo zemewe na FDA zo guhuza ibiryo.Ariko, bafite urwego rutandukanye rwumutekano no guhuza no gukoresha ibiryo.Kurugero, polystirene ntabwo isabwa ibiryo bishyushye cyangwa amazi bitewe nubushyuhe buke bwayo, mugihe polyethylene ikwiranye nubushyuhe n'ubushyuhe.
- Icyemezo cya LFGB: Kimwe na silicone, plastike yo mu rwego rwibiryo irashobora kandi kugira icyemezo cya LFGB kizakoreshwa muri EU.LFGB yemewe ya plastike yapimwe kandi isanga ifite umutekano mukoresha mubisabwa byo guhuza ibiryo.
Itandukaniro nyamukuru hagati yibi byemezo ni ibipimo byabo byo kwipimisha nibisabwa.Kurugero, gahunda yo kwemeza FDA ya silicone isuzuma ingaruka yibintu ku biribwa ndetse n’ingaruka zishobora guterwa n’imiti y’imiti, mu gihe icyemezo cya silicone yo mu rwego rw’ubuvuzi cyibanda ku binyabuzima no kuboneza urubyaro.Mu buryo nk'ubwo, icyemezo cya plastiki gifite ibisabwa bitandukanye bitewe nurwego rwumutekano no guhuza no gukoresha ibiryo.
Ku bijyanye n’imikoreshereze, izi mpamyabumenyi zirashobora gufasha abaguzi guhitamo neza ibicuruzwa bakoresha mubipfunyika hamwe nibikoresho.Kurugero, PET na HDPE bikunze gukoreshwa mumacupa yamazi, mugihe polyakarubone ikoreshwa mumacupa yumwana hamwe nigikombe kugirango irambe n'imbaraga zayo.LFGB yemewe na silicone na plastike birakwiriye mubiribwa bitandukanye birimo imigati, imigati n'ibikoresho byo guhunika ibiryo.
Muri rusange, icyemezo cya silicone yo mu rwego rwibiryo na plastiki bigira uruhare runini mukurinda umutekano nubuziranenge bwibicuruzwa dukoresha mubisabwa byo guhuza ibiryo.Mugusobanukirwa itandukaniro riri hagati yibi byemezo, abaguzi barashobora guhitamo neza ibicuruzwa bakoresha kandi bakumva bafite ikizere ko bo nimiryango yabo bafite umutekano.
Igihe cyo kohereza: Jun-30-2023