https://www.lookmedchina.com/news-txhua yam-koj-yuav tsum-paub-txog-trocar-needles.html

Kev nyab xeeb thiab kev ua tau zoo ntawm cov cuab yeej kho mob yog lub hauv paus ntawm kev siv tshuaj kho mob. Raws li cov khoom siv ua haujlwm lossis tsis muaj zog, cov khoom siv pov tseg ob npaug - xaus cannulakoob arov ua raws li cov kev cai nruj me ntsis thaum ob qho tib si ua ntej- kev pom zoo hauv khw thiab tom qab- kev saib xyuas kev lag luam. Tsab ntawv xov xwm no yuav tshawb txog txoj kev ua raws cai los ntawm kev hais txog cov xwm txheej xws li kev tswj hwm hauv tsev thiab txawv teb chaws, cov ntsiab lus tseem ceeb ntawm kev soj ntsuam kev pheej hmoo, thiab kev saib xyuas qhov xwm txheej tsis zoo.

I. Yuav tsum tau rau npe nrog Tuam Tshoj National Medical Products Administration

Hauv Suav teb, cov koob tshuaj uas siv tau ob npaug - xaus catheter feem ntau yog cais raws li Chav Kawm II lossis Chav Kawm III cov khoom siv kho mob (nyob ntawm seb lawv puas tau nkag mus rau hauv nruab nrab cov hlab ntsha lossis seb lawv puas muaj tshuaj pleev xim). Cov txheej txheem sau npe muaj xws li:

• Classification txhais:Yog tias cov khoom tsuas yog muaj cov khoom siv dag zog thiab tsis muaj zog, nws raug cais raws li Chav Kawm II; yog tias nws muaj cov haujlwm xws li electrocoagulation, kaw cov yeeb yaj kiab, lossis cov tshuaj txhawb nqa - tso tawm, nws tau hloov kho mus rau Chav Kawm III.
• Hom Kev Tshuaj Xyuas:Nws yuav tsum tau ua kom tiav nyob rau hauv lub teb chaws lees paub qhov chaw xeem, npog cov khoom xws li qhov loj me, puncture force, sealing kev ua tau zoo, compatibility kev ua tau zoo, thiab biocompatibility (GB/T 16886 series).
• Kev sim tshuaj kho mob:Cov khoom lag luam II feem ntau raug zam los ntawm kev sim tshuaj, tab sis cov ntaub ntawv sib piv ntawm tib yam khoom yuav tsum tau muab; Cov khoom siv hauv chav kawm III yuav tsum tau mus rau qhov kev cia siab randomized tswj kev sim, nrog rau qhov kawg ntawm qhov tseem ceeb yog puncture kev vam meej thiab qhov teeb meem tshwm sim.

Quality Management System:Lub tuam txhab tsim khoom yuav tsum tau txais daim ntawv pov thawj ISO 13485 thiab tau dhau los ntawm -kev tshuaj xyuas qhov chaw los ntawm NMPA.

II. FDA 510 (k) thiab CE MDR

• US FDA:Feem ntau cov khoom siv pov tseg ob npaug -tipped cannula koob tuaj yeem ua lag luam los ntawm 510(k) txheej txheem, thiab nws yog qhov tsim nyog los ua pov thawj qhov sib npaug ntawm cov khoom lag luam raug cai (Predicate Device). Cov kev sib piv tseem ceeb muaj xws li: rab koob tip geometric qhov ntev, puncture force curve, thiab seal valve lifespan. Nyob rau hauv xyoo tas los no, FDA tau ntxiv dag zog rau kev tshuaj xyuas kev nyab xeeb ntawm cov ntaub ntawv txheej, yuav tsum tau muab cov ntaub ntawv pov tseg thiab cov khoom degradation.
• EU CE:Raws li MDR 2017/745, lub cev ceeb toom (NB) yuav tsum raug xaiv los tshuaj xyuas. Tshwj xeeb tseem ceeb yog muab tso rau ntawm kev soj ntsuam soj ntsuam (MEDDEV 2.7/1 Rev.4) thiab tshaj tawm -kev lag luam soj ntsuam ua raws-up (PMCF). Cov kev pheej hmoo tshiab coj los ntawm ob - lub taub hau qauv (xws li kev tsis ua haujlwm ntawm kev hloov cov tshuab, cov khoom tawg tawg) yuav tsum tau txheeb xyuas kom meej hauv daim ntawv tshaj tawm txog kev pheej hmoo.

III. Cov ntsiab lus tseem ceeb ntawm Kev Tswj Xyuas Kev Nyab Xeeb

Raws li ISO 14971, kev soj ntsuam kev pheej hmoo rau cov khoom pov tseg ob npaug - tas catheter koob yuav tsum tsom rau cov hauv qab no:

R1 Stuck ob - lub taub hau hloov mechanism Tsis tuaj yeem ua tiav kev ua haujlwm, yuam rab koob tshem tawm Tsim cov txheej txheem rov ua dua, ntxiv phau ntawv xauv lub luag haujlwm; 100%. simulate 500 lub sij hawm ntawm cov cuab yeej sib pauv rau kev ntsuas kev laus kom nrawm R3 Koob lub taub hau pob txha uas tseem nyob hauv lub cev Cov ntaub so ntswg puas tsuaj, yuav tsum tau phais theem ob Txais siab - lub zog stainless hlau; tsim cov ntsiab lus tsis muaj zog ntawm lub hauv paus ntawm rab koob taub hau kom ntseeg tau tias kev puas tsuaj tshwm sim sab nraum lub cev R4 Txheej detachment particles Local o lossis embolism Txheej adhesion test (grid method); txwv qhov siab tshaj particle loj kom tsawg dua lossis sib npaug li 10 μm

IV. Tshaj tawm - teev Kev Saib Xyuas thiab Cov Txheej Txheem Tsis Zoo

Cov ntawv ceeb toom tsis zoo ntawm qhov muab pov tseg ob zaug -tipped cannula koob feem ntau suav nrog: kev ua tsis tiav, cov pa tawm thaum lub sij hawm pneumoperitoneum, tom qab phais mob ntawm qhov chaw sib tsoo, thiab cov twj paj nruag tawg, thiab lwm yam. Raws li FDA MAUDE database, tag nrho ntawm 287 cov ntaub ntawv ntsig txog tau txais nyob rau hauv 2023, ob npaug ntawm cov teeb meem (xws li cov teeb meem ntawm 2023, suav nrog 5% ntawm cov teeb meem uas muaj feem xyuam nrog cov teeb meem ntawm 2023. malfunction nyob rau hauv switching). Cov chaw tsim khoom yuav tsum tsim kom muaj lub tshuab teb sai sai, ua cov hauv paus ua rau kev tshuaj xyuas rau cov teeb meem zoo sib xws, thiab, yog tias tsim nyog, pib rov qab.

V. Txoj Cai Tswjfwm Yav Tom Ntej

• UDI Unique Identifier:Kev lag luam loj thoob ntiaj teb tau siv UDI raws li qhov yuav tsum tau ntsuas los pab txhawb kev taug qab thiab rov qab los. Vim yog cov txheej txheem nyuaj ntawm ob - tas cov koob txhaj tshuaj cannula, nws raug nquahu kom ua tib lub sijhawm kos cov khoom batch thiab cov batch ntawm cov khoom tseem ceeb ntawm lub ntim.
• Tiag - pov thawj ntiaj teb:Cov cai tswjfwm tau hais ntxiv txog qhov tseeb-cov ntaub ntawv hauv ntiaj teb (RWD) thiab txhawb cov tuam txhab kom sau cov kev ua haujlwm tom qab ua raws- cov ntaub ntawv los txhawb kev nthuav dav lossis hloov tshiab ntawm phau ntawv qhia khoom.
• Sustainable txoj cai txhim kho:EU tab tom tham txog kev tsim qauv ecological rau cov khoom siv kho mob pov tseg. Nyob rau hauv lub neej yav tom ntej, nws yuav txwv tsis pub siv cov uas tsis yog - cov yas rov ua dua tshiab, yuam cov tuam txhab tsim cov kev daws teeb meem zoo ib puag ncig.

Cov ntsiab lus

Txoj kev taug kev mus rau kev ua raws li cov khoom siv pov tseg ob zaug - xaus cannula koob yog fraught nrog cov teeb meem, tab sis nws kuj yog ib qho tseem ceeb hauv kev tsim cov khoom lag luam credibility. Cov tuam txhab lag luam yuav tsum suav nrog cov tswv yim tswj kev pheej hmoo los ntawm qhov pib ntawm tus txheej txheem tsim thiab ua kom lawv cov kev siv thoob plaws hauv lub neej ntawm kev tshawb fawb thiab kev tsim kho, tsim khoom, thiab tom qab- kev lag luam tawm. Tsuas yog nyob rau hauv txoj kev no lawv tuaj yeem yeej kev ntseeg siab ntawm cov kws kho mob thiab cov neeg mob thiab nyob twj ywm invincible hauv kev sib tw ua lag luam hnyav.