Raws li puncture cov cuab yeej kho mob uas tuaj rau hauv kev sib cuag ncaj qha nrog tib neeg cov ntshav thiab cov ntaub so ntswg subcutaneous, cov koob txhaj tshuaj ntshav tau ua tiav los ntawm thoob ntiaj teb kev ua tau zoo thiab cov ntawv pov thawj kev nyab xeeb hauv kev lag luam thoob ntiaj teb.ISO 9001: 2015zoo tswj system thiabISO 13485 Kev Tswj Xyuas Kev Lag Luamcov cuab yeej kho mob-cov kev tswj xyuas tshwj xeeb tau dhau los ua qhov nyuaj rau kev nkag mus rau cov lag luam thoob ntiaj teb. Ib lub tuam txhab cov ntawv pov thawj thiab kev ua raws cai ncaj qha txiav txim siab nws lub ntiaj teb channel layout thiab kev ua lag luam qhov chaw. Thaum muaj kev lag luam nce ntxiv hauv kev lag luam khoom siv kho mob thoob ntiaj teb, kev sib tw dhau ntawm kev ua raws li cov ntawv pov thawj rau cov koob tshuaj ntshav tseem ceeb qhia txog kev ua lag luam segmentation ntawm siab - kawg thiab nruab nrab - rau - qis - kawg ntu hauv ntiaj teb cov saw hlau, nrog rau cov kev ua si tseem ceeb ntawm European thiab Asmeskas cov tuam txhab Pacific 7} thiab Asia Pacific.

Raws li daim ntawv pov thawj mob siab rau rau kev lag luam khoom siv kho mob, ISO 13485 tsom rau kev tswj hwm zoo thoob plaws tag nrho cov khoom lag luam lifecycle. Nws tswj xyuas cov kev qhia tshwj xeeb uas suav nrog kev tshuaj xyuas cov khoom siv raw, kev ua tiav, kev tsim cov chav huv, kev ua kom tsis muaj menyuam, kuaj cov khoom tiav, thiab cov txheej txheem traceability. Nws ua haujlwm raws li qhov yuav tsum tau ua ua ntej rau kev nkag mus rau hauv kev lag luam loj suav nrog EU CE, Canada MDL, thiab Australia TGA. ISO 9001: 2015 hais txog kev tswj hwm kev ua tau zoo, lav qhov muaj peev xwm tsim khoom ruaj khov, thiab ua raws li qhov yuav tsum tau ua hauv kev lag luam nkag rau cov lag luam tawm thoob plaws Asia -Pacific, South America, thiab Africa.

Nyob rau hauv lub teeb ntawm cov khoom yam ntxwv ntawm bloodletting koob, ntawv pov thawj saib xyuas cov chaw ntawm peb lub ntsiab txuas: Ua ntej,kev ua raws li cov khoom siv. 304 / 316 stainless hlau thiab nitinol alloy yuav tsum tau nrog rau cov ntaub ntawv pov thawj thiab biocompatibility test reports.Second,tswj txheej txheem. Koob tip sharpness, koob lub cev txoj kab uas hla kam rau ua, thiab nto roughness yuav tsum ua raws li cov qauv tsim nyog rau puncture devices.Third,kev ua kom tsis muaj menyuam. Cov txheej txheem kev ua kom tsis muaj menyuam ib txwm muaj xws li boiling thiab qhib nplaim tshuaj tua kab mob tau raug phased tawm los ntawm lub ntiaj teb no kev ua lag luam. Ethylene Oxide (EO) thiab gamma ray sterilization nrog Sterility Assurance LevelSAL 10⁻⁶tau dhau los ua cov kev daws teeb meem tseem ceeb rau kev ua kom tsis muaj menyuam rau cov koob tshuaj ntshav niaj hnub no.

Lub ntiaj teb no bloodletting koob lag luam yog kom meej meej stratified los ntawm cov ntawv pov thawj: Lub zos nyob sab Europe thiab American hom txhua tus tuav dual ISO 13485 + ISO 9001 ntawv pov thawj, tsom rau pov tseg sterile bloodletting koob thiab siab - kawg nitinol lub cev txoj kev kho koob. Lawv ua tus tswj hwm lub siab -kawg kev lag luam hauv Tebchaws Europe, Amelikas, Nyiv thiab Kaus Lim Qab Teb, txaus siab rau cov khoom lag luam siab thiab muaj zog channel teeb meem. Ua lag luam hauv Suav teb tau txais daim ntawv pov thawj dual. Kev vam khom rau cov peev txheej tsim khoom, lawv lees txais OEM / ODM xaj rau European thiab Asmeskas cov khoom lag luam thaum tsim cov khoom lag luam tsim cov lag luam tawm tshiab hauv Middle East, Southeast Asia thiab Latin America.Me thiab nruab nrab-cov tuam txhab loj nyob rau sab hnub tuaj Asia, Is Nrias teb thiab lwm thaj chaw tsuas yog tuav cov ntawv pov thawj ISO 9001, feem ntau muab cov khoom lag luam uas tsis muaj kev lees paub rau cov khoom lag luam tsawg {0} cov chaw muag khoom me me, cov chaw muag khoom me me {0} featuring muaj kev nyab xeeb txaus ntshai thiab kev sib tw tus nqi hnyav.

Hais txog cov qauv kev lag luam, European Union thiab North America tau tsim cov txheej txheem kev lag luam los ntawm cov ntawv pov thawj nruj heev los txwv kev nkag mus ntawm cov khoom qis - kawg. Kev txhawb nqa los ntawm kev ua tiav cov ntawv pov thawj txhawb nqa thiab muaj peev xwm tsim tau zoo, Tuam Tshoj tau dhau los ua lub ntiaj teb tus xa khoom loj tshaj plaws ntawm cov koob txhaj tshuaj ntshav, muab ntau dua 80% ntawm lub ntiaj teb nruab nrab - mus rau - qis- kawg kev ua lag luam, thaum nws tus kheej hom kev faib tawm tseem qis dua 15%.

Nyob rau hauv lub neej yav tom ntej, raws li thoob ntiaj teb kev saib xyuas rau kev nyab xeeb ntawm ib txwm siv lub cev kho mob cov cuab yeej kho mob txuas ntxiv nce, ISO 13485 ntawv pov thawj yuav hloov mus rau hauv cov qauv kev lag luam, nrog rau cov tuam txhab tsis ua raws cai maj mam tshem tawm. Tuam Tshoj cov tuam txhab lag luam yuav tsum tau ua kom muaj peev xwm sau npe rau cov lag luam nyob sab Europe thiab Asmeskas, tsim kom muaj tag nrho -chain testing system suav nrog kev ua kom tsis muaj menyuam, biocompatibility thiab ntim khoom siv tau. Raws li kev muaj peev xwm ua tau raws li qhov muaj peev xwm ua tau zoo, lawv tuaj yeem tawg mus rau hauv siab -kawg thoob ntiaj teb kev lag luam raws thiab khiav tawm ntawm qhov tsis zoo ntawm qhov qis - nqi OEM kev sib tw.