Kev Sau Npe Cov Khoom Siv Kho Mob, Cov Qauv & Hauv -Kev Tswj Xyuas Tsev Kho Mob Ntawm PTC Koob
Jul 06, 2026
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NMPA Classification (Tuam Tshoj)
PTC/Chiba puncture koob rau kev siv tshuaj (biopsy, biliary nkag, kua) → Chav Kawm IIIkhoom siv kho mob
Classification code:02-07-01(Percutaneous puncture instrument) ib qhov tseebCov Khoom Siv Kho Mob Classification Catalog
Yuav tsum tau rau npe:
- Cov Khoom Siv Khoom Siv (saib GB 15811 / ISO 7864, YY / T 0282, YY / T 0616 rau kev thov kev kuaj ntshav)
- Hom kev xeem (CNAS-lab tau lees paub)
- Kev soj ntsuam lom neeg (ISO 10993 / GB / T 16886)
- EO sterilization validation (ISO 11135 / GB 18279)
- Kev soj ntsuam kev soj ntsuam (cov ntaub ntawv + ntau qhov sib npaug lossis kev sim tshuaj kho mob)
- Cov ntaub ntawv tswj kev pheej hmoo (ISO 14971 / YY / T 0316)
IFU & labeling
Cov qauv siv tau
- GB 15811/ISO 7864: Sterile hypodermic koob - qhov ntev, lub zog, to, taub
- YY/T 0282:Hypodermic koob (ib nrab saws)
- YY/T 0616 series:Biopsy koob
- ISO 9626:Stainless hlau koob tubing
- ISO 11607 / GB / T 19633:Ntim rau terminally sterilized li
- ISO 13485:Kev tswj xyuas kom zoo (tus neeg tsim khoom yuav tsum tuav daim ntawv pov thawj + dhau NMPA QS audit)
Labeling & IFU yuav tsum suav nrog
Lub npe: "PTC Sterile PTC Puncture Koob / Chiba Koob"
Gauge, ntev, bevel kaum sab xis, khoom siv
Kev npaj siv: "Image-coj percutaneous nplua- koob aspiration, biliary/cystic puncture, pib nkag rau micro-puncture system"
Contraindications & ceeb toom: coagulopathy, kab mob raws txoj kev, ib zaug - siv xwb, tsis re-sterilization
LOT No., hnub tas sij hawm, txoj kev ua kom tsis muaj menyuam, daim ntawv pov thawj No., cov ntaub ntawv tsim khoom
Tsev Kho Mob Kev Muag Khoom & Kev Nkag Mus
- Kev Ntsuam Xyuas Kev Tsim Nyog:NMPA Class III daim ntawv pov thawj (scope npog biopsy / percutaneous puncture), Mfg Daim ntawv tso cai, ISO 13485, batch COA, daim ntawv pov thawj kom tsis muaj menyuam
- Kev sib tw Tech Parameters:Bevel lub kaum sab xis (25℃± 3℃rau 22G-23G), max penetration force (piv txwv li, Tsawg dua lossis sib npaug rau 0.6 N), sab hauv Ra, muaj lub suab nrov / qhov tob, Luer xauv kev ncaj ncees, EO residue txwv
- SPD / UDI:Scan & taug qab los ntawm UDI (Device Identifier + Production Identifier); kev ceeb toom tas sij hawm & rov qab npaj tau
- Kev Tshaj Tawm Tsis Txaus Siab:Koob tawg, tawg tsis zoo, xav tias muaj feem cuam tshuam cov tshuaj tiv thaiv → NMPA ADR soj ntsuam system
- Kev cob qhia neeg siv: Chaw tsim tshuaj paus / tus neeg sawv cev rau demo micro-txoj kev sib pauv, nqus cov txheej txheem, siv lub suab nrov; koom rau hauv department SOP
Ntshuam kev txiav txim siab
Imported Chiba koob xav tauNMPA ntshuam npe ("国械注进" No.) - CE/FDA ib leeg tsis txaus rau Tuam Tshoj ua lag luam
Cov ntaub ntawv kev lis kev cai: thawj COA, CFS (Certificate of Free Sale), ua ntej -pom zoo suav daim ntawv kos duab
Kev ua raws cai muaj zog ua kom ntseeg tau tias tsuas yog qhov tseeb, kev ua tau zoo- siv tau Chiba koob mus txog chav txheej txheem - tiv thaiv ob tus neeg mob kev nyab xeeb thiab kev lav phib xaub.
