Los ntawm ISO 13485 mus rau FDA 510 (k): Muaj pes tsawg Hurdles Puas Yuav Tsum Tau Ncauj?

Txawm hais tias Veress koob yog qhov yooj yim, raws li cov cuab yeej siv kho mob, nws txoj kev lag luam thiab kev kho mob yog nruj me ntsis tswj hwm los ntawm cov koom haum tswj hwm hauv ntau lub teb chaws thoob ntiaj teb. Cov kev qhia tshwj xeeb uas koj tau hais (ntev, txoj kab uas hla, cov duab) tsuas yog lub taub dej khov. Dab tsi tiag tiag txiav txim siab seb cov khoom puas tuaj yeem nkag mus rau hauv chav ua haujlwm yog seb nws puas ua raws li cov txheej txheem zoo thiab cov qauv kev nyab xeeb.

International Standard Framework

ISO 13485: 2016:Qhov yuav tsum tau muaj rau Kev Tswj Xyuas Zoo hauv Cov Khoom Siv Kho Mob. Cov chaw tsim khoom ntawm Veress koob yuav tsum tsim kom muaj kev ua tiav zoo uas npog tag nrho cov txheej txheem los ntawm kev tsim thiab kev tsim kho, kev yuav khoom, kev tsim khoom, kev tshuaj xyuas, kev cia khoom, thiab tom qab- kev muag khoom. Cov ntsiab lus tseem ceeb suav nrog: kev tswj hwm kev pheej hmoo (ISO 14971), kev tswj hwm kev hloov pauv, kev tshuaj xyuas cov neeg muag khoom, kev tswj hwm cov khoom tsis raug cai, kev kho thiab kev tiv thaiv (CAPA), thiab lwm yam.

ISO 10993 Series:Kev ntsuam xyuas Biocompatibility. Raws li Veress koob yog cov khoom siv uas tuaj rau hauv luv luv -lub sij hawm sib cuag nrog cov ntaub so ntswg (<24 hours), they need to undergo tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, and pyrogenicity. Material changes (such as switching to a different brand of stainless steel) or process changes (such as altering the electro-polishing parameters) may trigger a re-evaluation.

ISO 11607:Sterile Barrier Systems. Lub ntim ntawm cov tshuaj pov tseg Veress yuav tsum tau ua pov thawj ntawm kev sib khi lub zog, microbial barrier kev ua tau zoo, thiab kev laus ruaj khov. Cov khoom ntim khoom siv feem ntau yog Tyvek / PE zaj duab xis sib xyaw, uas yuav tsum tau kuaj cov ntsiab lus seem (EO residual Tsawg dua lossis sib npaug li 10 ug / g) tom qab ethylene oxide sterilization.

Kev nkag mus rau kev lag luam los ntawm US FDA

Hauv Tebchaws Meskas, Veress koob feem ntau raug cais raws li Class II cov cuab yeej kho mob (cov khoom lag luam: GCJ) thiab raug raws li 510(k) ua ntej- txheej txheem ceeb toom kev lag luam. Tus neeg thov yuav tsum ua kom pom tias cov khoom tshiab yog qhov sib npaug ntawm cov khoom sib npaug uas twb tau raug cai ua lag luam (Predicate Device) hais txog kev siv, cov yam ntxwv, cov ntaub ntawv, kev ua tau zoo, thiab lwm yam. Cov ntaub ntawv xa tuaj suav nrog:

Cov lus piav qhia thiab cov duab kos (nrog rau tag nrho cov khoom me me kam rau ua)

Cov ntaub ntawv muaj pes tsawg leeg thiab cov ntaub ntawv pov thawj

Daim ntawv qhia txog kev ua kom tsis muaj menyuam

Biocompatibility test report

Cov ntaub ntawv ntsuas kev ua tau zoo (kev nkag mus rau lub zog, lub caij nplooj ntoos hlav quab yuam, airtightness, qaug zog lub neej, thiab lwm yam)

Labels thiab cov neeg siv phau ntawv

Kev soj ntsuam kuaj mob (yog muaj)

Lub sijhawm tshuaj xyuas FDA feem ntau yog 90 txog 180 hnub. Yog tias cov khoom muaj cov ntaub ntawv tshiab, tsim qauv tshiab, lossis cov lus qhia tshiab, nws yuav tsum tau muab cov ntaub ntawv kho mob ntxiv lossis hloov kho mus rau PMA (Pre- Kev Pom Zoo Kev Lag Luam).

EU CE Certification

Raws li EU MDR 2017/745, Veress koob ntog nyob rau hauv Class IIa lossis IIb cov khoom siv (nyob ntawm seb nws puas rov siv tau thiab qib kev pheej hmoo). Cov chaw tsim khoom yuav tsum tau kuaj xyuas los ntawm lub cev ceeb toom thiab tau txais CE cim. Cov ntsiab lus tseem ceeb suav nrog:

Kev npaj cov ntaub ntawv kev kawm (nrog rau kev tsim, kev tsim khoom, kev ua haujlwm, kev soj ntsuam kev soj ntsuam, thiab kev tswj hwm kev pheej hmoo)

Kev soj ntsuam kev soj ntsuam (CER), raws li cov ntaub ntawv tshawb fawb thiab/lossis cov ntaub ntawv kuaj mob

Tshaj tawm - phiaj xwm saib xyuas kev lag luam (PMS) thiab daim ntawv tshaj tawm kev nyab xeeb tsis tu ncua (PSUR)

Kev ua haujlwm ntawm Cov Ntaus Ntaus Cim Cim (UDI) thiab sau npe database

Tuam Tshoj NMPA Kev Sau Npe

Hauv Suav teb, Veress koob, raws li cov cuab yeej siv kho mob ua haujlwm lossis tsis ua haujlwm, yuav tsum tau sau npe raws li "Txoj Cai ntawm Kev Sau Npe ntawm Cov Khoom Siv Kho Mob." Lawv raug cais raws li Class II lossis Class III (yog tias lawv muaj cov tshuaj pleev xim lossis cov haujlwm tshwj xeeb). Cov txheej txheem sau npe suav nrog:

Cov khoom tsim kev cai tsim qauv (saib rau YY / T qauv, xws li YY 0876-2013 "Laparoscopic Needle Insertion Devices")

Hom tshuaj ntsuam xyuas (ua tiav los ntawm lub xeev lossis lub teb chaws kuaj cov cuab yeej kho mob)

Kev zam kev sim tshuaj lossis kev coj ua (rau Veress koob nrog cov thev naus laus zis, kev zam feem ntau ua tau)

Kev ntsuam xyuas kev tswj xyuas kev ua tau zoo (ua raws li "Kev Ua Haujlwm Zoo rau Kev Kho Mob")

Kev tshuaj xyuas kev sau npe thiab kev pom zoo

Cov Ntsiab Lus Qhia Txog Kev Ua Haujlwm thiab Kev Ntsuas Kev Ntsuas

Tsis hais lub teb chaws twg, lub Hoobkas tshuaj xyuas ntawm Veress koob yuav tsum npog cov khoom hauv qab no:

Cov Khoom Siv Ntsuas Cov Qauv Ntsuas Cov Txheej Txheem Kev Pom Zoo thiab qhov chaw zoo Tsis muaj burrs, khawb, xeb me ntsis, lossis kev ntxhov siab Kev tshuaj xyuas Kev pom (10x magnifying iav) Dimensions (sab nraud txoj kab uas hla, puab txoj kab uas hla, ntev) kam rau ua ± 0.1 hli Micrometer, daim duab ntsuas ntsuas Inclined dav hlau lub kaum sab xis Nominal zog qhov project (2) Nominal℃force ± 2 (raws li tus nqi tsim) Lub caij nplooj ntoos hlav nro ntsuas tshuab Cua nruj Tshav Tshab Tsawg dua lossis sib npaug li 0.5 mL hauv qab 20 kPa siab rau 30 vib nas this Air nruj tester Puncture quab yuam tsawg dua los yog sib npaug rau 10 N (simulating tib neeg daim tawv nqaij + silicone ncoo) Universal khoom kuaj tshuab Corrosion resistance ntsev tsuag tshuaj ntsuam xyuas 24 teev tsis muaj liab 1 1 GB / s thiab tom qab ua kom tsis muaj menyuam Comparative test

Reusability vs. Ib -Siv sij hawm: Qhov txawv ntawm Kev Tswj Xyuas Zoo

Reusable hom:Kev txheeb xyuas ntxiv ntawm qhov rov ua dua ntawm cov txheej txheem ntxuav thiab kom tsis muaj menyuam yuav tsum tau ua. Feem ntau, cov khoom yuav tsum muaj peev xwm tiv taus tsawg kawg yog 50 lossis 100 lub voj voog rov ua dua thiab raug kuaj ua haujlwm tom qab txhua lub voj voog. Cov neeg tsim khoom yuav tsum muab cov lus qhia ntxaws ntxaws (nrog rau kev ntxuav phau ntawv, ntxuav ultrasonic, siab - siab tsis muaj qhov ntsuas, thiab lwm yam).

Hom pov tseg:Kev tsom xam yog nyob rau qib aseptic assurance (SAL Tsawg dua lossis sib npaug ntawm 10⁻⁶) thiab txee lub neej ruaj khov. Kev ntsuas kev laus nrawm (feem ntau ntawm 55℃rau 6 lub hlis, sib npaug rau 2-3 xyoos) thiab kev simulation kev thauj mus los yuav tsum tau ua.

Cov ntsiab lus

Los ntawm lub rooj tsavxwm kos duab mus rau lub rooj ua haujlwm, ib rab koob Veress yuav tsum dhau los ntawm peb qhov teeb meem: kev cai, kev ua tau zoo, thiab kev ua haujlwm. Rau cov neeg yuav khoom, xaiv cov khoom lag luam uas tau txais cov ntawv pov thawj (xws li CE, FDA, thiab NMPA) tsis yog tsuas yog kev ua raws cai nkaus xwb tab sis kuj yog kev cog lus rau kev nyab xeeb ntawm cov neeg mob.