Muaj ntau cov piv txwv ntawm kev ua kom tsis muaj menyuam txoj kev xaiv ib ntus. Hauv qab no yog ob peb qhov xwm txheej tshwm sim-raws li cov xwm txheej ua tau zoo, txhua qhov ua tau zoo rau qhov kub thiab av noo ib puag ncig ntawm Wuhan, txhim kho kev sim qhov tseeb thiab kev ua raws li tus nqi:
1. Cov khoom siv sterile urinary catheter pov tseg (nrog rau cov khoom siv yas thiab cov khoom ntim khoom)
Kev xaiv ua ntu zus: G → EO (Gamma → Ethylene Oxide)
Tus lej ntawm lub voj voog: 3
Tsim kom muaj nuj nqis: Tag nrho cov khoom siv yog sterilized los ntawm gamma irradiation ntawm lub Hoobkas; Rau kev siv tshuaj kho mob, ib nrab EO sterilization yuav tsum tau vim yog kev puas tsuaj, simulating qhov xwm txheej no.
Key control points: Packaging materials (Tyvek + PP) should not adhere or become brittle after EO; Plastic catheter components should have a light transmittance >90% thiab tsis muaj atomization.
Kev Hloov Kho Hauv Zos: Ntxiv 24-teev pretreatment ntawm 75% RH los simulate noo noo nqus thaum Wuhan warehouse cia;
Cov txiaj ntsig: Ua tiav FDA 510 (k) daim ntawv thov, ua kom muaj kev ruaj ntseg ntim khoom raws li ntau txoj hauv kev kom tsis muaj menyuam.
2. Reusable Endoscope Channel Valve (PC + Silicone Composite Structure)
Kev Xaiv Sequence: Hloov EO → S → EO cycles
Tus naj npawb ntawm Cycles: 10 lub voj voog (nrog 5 lub voj voog siv tshuaj kho mob)
Interval:
EO → S: 72 teev (ua kom tiav EO daws teeb meem);
S → EO: 48 teev (kom qhuav qhov sib npaug).
Cov ntsiab lus tseem ceeb: Silicone sealing nplhaib hardness hloov<10%; PC valve body free from stress cracking (visual inspection + microscopy); Channel inner wall free of biofilm residue (ATP detection).
Tus nqi: Realistically simulates lub endoscope tu thiab sterilization txheej txheem, kom tsis txhob muaj kev pheej hmoo ntawm hla- kis kab mob hauv chaw kho mob.
3. Hauv Vitro Diagnostic Equipment Reagent Kit Housing (Radiation-Resistant Modified PC)
Kev Xaiv Sequence: G → S → G (Gamma → Chav → Gamma)
Tsim Rationale: Pib gamma sterilization ua ntej xa khoom; Kev ua kom tsis muaj menyuam thaum muaj xwm txheej ceev yuav tsum tau ua ntej kawg - siv vim muaj paug; Re- ua kom tsis muaj menyuam tom qab simulated rov qab los rau kev saib xyuas ntawm gamma irradiation.
Number ntawm lub voj voog: 3
Cov Kev Sib Tw Tseem Ceeb: Hloov PC yog qhov ua rau yellowing nyob rau hauv ob chav irradiation + kub siab (ΔE> 3); Kev cuam tshuam lub zog txo ntawm lub tsev snap- haum qauv < 15%.
Kev ntsuas kev ua kom zoo: Ua HPLC tshawb pom ntawm bisphenol A nag lossis daus tom qab txhua lub voj voog, kom ntseeg tau <0.1 ppm; Ntsuas cov qauv kev ruaj ntseg siv cantilever beam notched impact test (ISO 179).
4. Implantable Drug Delivery Pump Reservoir (PEEK + Medical Silicone)
Kev Xaiv Sequence: S → EO → G (Steam → Ethylene Oxide → Gamma)
Number ntawm lub voj voog: 5
Tsim Kev Tsim Nyog: Ua ntej, chav ua kom tsis muaj menyuam simulates preoperative tua kab mob; ces, EO kev kho mob rau aseptic ntim; Thaum kawg, gamma irradiation raws li kev tiv thaiv zaum kawg, kev sim nyob rau hauv huab cua.
Cov Ntsiab Cai: Silicone capsule phab ntsa: tsis o, tsis muaj exudation (GC-MS); PEEK plhaub: tensile zog tuav> 85%; EO residue <10 ppm hauv txhua lub voj voog (headspace GC-MS).
