Dab tsi yog cov khoom kuaj rau lub qhov ncauj qhov ntswg

(1) Kev tiv thaiv kev ua haujlwm
Bacterial Filtration Efficiency (BFE)
Cov qauv siv tau: YY / T 0969-2013, YY 0469-2011, ASTM F2101
Technical parameters: Qhov kev kuaj mob yog Staphylococcus aureus ATCC 6538, qhov nruab nrab particle loj ntawm aerosol yog (3.0 ± 0.3) μm, thiab cov qauv ntws yog 28.3 L / min.
Kev ntsuas qhov tsim nyog: Ntau dua lossis sib npaug li 95% (kev kho mob pov tseg) Ntau dua lossis sib npaug li 98% (kev phais, Hom IIR).
Particle Filtration Efficiency (PFE)
Cov qauv siv tau: GB 19083-2023, GB 2626-2019, EN 149:2001+A1: 2009
Technical parameters: NaCl aerosol 0.075 μm, DOP lossis paraffin roj 0.185 μm, ntws tus nqi 85 L / min.
Cov ntsuas tau tsim nyog: Ntau dua lossis sib npaug li 95% (KN95, FFP2); Ntau dua lossis sib npaug li 99% (GB 19083 Qib 3).
Synthetic ntshav nkag
Cov qauv siv tau: YY 0469-2011, ASTM F1862, ISO 22609
Technical parameters: Txhaj siab 16.0 kPa (120 mmHg), txhaj ntim 2 mL, txhaj tshuaj nrug 305 hli.
Tsim nyog Performance index: Tsis muaj kev nkag mus rau sab hauv ntawm lub npog ntsej muag.

(2) Lub cev thiab txhua yam khoom
Lub zog tawg ntawm daim npog ntsej muag thiab cov ntsiab lus txuas
Cov qauv siv tau: GB 19083-2023 5.6, EN 14683: 2019+AC: 2019
Technical parameters: Static stretching ceev 100 mm / min, clamping dav 25 mm, loading 10 N thiab tuav rau 5 vib nas this.
Cov ntsuas tsim nyog: Tsis muaj kev tawg lossis swb.
Flammability
Cov qauv siv tau: YY 0469-2011 5.8, 16 CFR 1610
Technical parameters: nplaim qhov siab (40 ± 4) mm, combustion sij hawm 5 vib nas this, tag nrho ntawm 10 qauv.
Cov ntsuas tau tsim nyog: Lub sijhawm tom qab hlawv Tsawg dua lossis sib npaug li 5 vib nas this, lub sijhawm smoldering Tsawg dua lossis sib npaug li 5 vib nas this, tsis muaj hlawv - dhau.
Siab sib txawv
Cov qauv siv tau: YY/T 0969-2013 5.7, EN 14683: 2019
Technical tsis: Gas flow rate 8 L/min, test area 4.9 cm².
Kev ntsuas qhov tsim nyog: Tsawg dua lossis sib npaug rau 49 Pa (kev kho mob pov tseg) Tsawg dua lossis sib npaug rau 60 Pa (Hom IIR).

(3) Biocompatibility
Raws li GB / T 16886 series, lub ntsej muag kho mob yuav tsum ua kom tiav:
Cytotoxicity test (MTT txoj kev, txheeb ze tus nqi loj dua lossis sib npaug li 70%)
Cov tawv nqaij khaus (txoj kev luav, PII Tsawg dua lossis sib npaug rau 2.0)
Ncua sijhawm - hom tshuaj tiv thaiv kab mob siab (guinea pig maximization test, qib Tsawg dua lossis sib npaug rau 1)

(4) Kev nyab xeeb tshuaj
Ethylene oxide residue
Cov qauv siv tau: GB / T 16886.7, ISO 10993-7
Test method: Headspace - gas chromatography, txwv kev txwv 0.1 ug/g.
Qhov ntsuas tau tsim nyog: Tsawg dua lossis sib npaug li 10 ug / g (luv- lub sijhawm tiv tauj ntaus ntawv).
Formaldehyde, azo dyes
Cov qauv siv tau: GB / T 32610-2016, GB 18401-2010
Tsim nyog Performance index: Formaldehyde Tsawg dua lossis sib npaug li 20 mg / kg; Decomposable carcinogenic aromatic amine dyes raug txwv.

Ua tsis taus pa
Cov qauv siv tau: GB 2626-2019 6.5, EN 149: 2001+A1: 2009
Technical tsis: Inspiratory flow rate 95 L/min, expiratory flow rate 85 L/min.
Cov ntsuas tsim nyog: KN95 inhalation Tsawg dua lossis sib npaug rau 350 Pa, exhalation Tsawg dua lossis sib npaug rau 250 Pa.
Chaw Tuag
Cov qauv siv tau: GB 2626-2019 6.9
Technical parameters: CO₂ concentration yuav tsum tsis pub tshaj 1% ntawm cov pa nqus tau pa.
Tsim nyog index: Cov kab noj hniav tuag tsawg dua los yog sib npaug li 15 mL.
Fit Test
Cov qauv siv tau: GB 19083-2023 5.14, OSHA 29CFR1910.134
Test method: Quantitative Fitness factor (QNFF) Ntau dua lossis sib npaug li 100, thiab 8 qhov kev xeem ua tau ua los ntawm TSI PortaCount.

Tsis siv neeg lim khoom Tester (TSI 8130A, DRK-506)
Muaj nuj nqi: Synchronous tso zis ntawm PFE thiab siab sib txawv; Dual -channel hloov rau ntsev thiab roj zog; Qhov tseeb txaus yog ± 1%, thiab nws tau nruab nrog NIST daim ntawv pov thawj calibration.
BFE Test System (Andersen Cascade Impactor)
Muaj nuj nqi: Rau -theem biological sampling, particle loj segmentation 0.65-7.0 μm; Thaum siv ua ke nrog lub txee biosafety, nws ua raws li GLP cov cai.
Synthetic Blood Testing Machine (DRK-M601
Muaj nuj nqi: Cov tshuaj tsuag yog kho tau los ntawm 0 mus rau 40 kPa, lub nozzle puab txoj kab uas hla yog 0.84 hli, thiab nws yog txawm peem rau nrog ib tug sab hauv HEPA lim los tiv thaiv tus ntoo khaub lig- paug.
Tensile xeem tshuab (Instron 3345)
Muaj nuj nqi: Tag nrho ntawm 1 N txog 5 kN, kev daws teeb meem hloov chaw 0.5 μm, ntsib ISO 7500-1 0.5 qib raug.
Gas chromatography-mass spectrometry (GC-MS 5977B)
Muaj nuj nqi: EO txwv kom muaj nuj nqis 0.02 ug/g, txhawb ntau- kev soj ntsuam kev hnov ​​​​mob (MRM), thiab tau lees paub los ntawm CNAS 17025.

Qhov ntsuas BFE yog 92%, uas yog qis dua tus nqi txwv ntawm 95%
Lub hauv paus ua rau: Qhov hluav taws xob hluav taws xob ntawm cov ntaub meltblown tsis txaus (tsuas yog 25 kV), thiab qhov muaj peev xwm attenuation yog ntau dua 30%.
Kev txhim kho: Ua kom cov hluav taws xob hluav taws xob nce mus rau 45 kV thiab ntxiv qhov ntsuas kub tsis tu ncua ntawm 60℃rau 24 teev, nrog rau qhov muaj peev xwm tuav tau ntau dua lossis sib npaug li 80%.
Lub siab sib txawv ntawm 78 Pa yog siab dua 49 Pa
Lub hauv paus ua rau: Lub meltblown grammage tau nce mus rau 35 g / m², thiab qhov nruab nrab fiber ntau yog 2.1 μm.
Kev txhim kho: Txo cov gram hnyav rau 25 g / m², ib txhij nce qhov kub ntawm lub qhov cub cua kub, kho cov fibers mus rau 1.5 μm, txo qhov siab sib txawv rau 42 Pa, thiab tswj BFE ntawm 98%.
Qhov seem EO yog 18 ug / g
Cov hauv paus ntsiab lus: Lub sij hawm tsom xam tsuas yog 7 hnub, thiab cov ntim khoom siv PE hnab tsis muaj cua permeability.
Kev txhim kho: Qhov ntsuas kub ntawm lub tsev qiv ntawv tsom xam yog 45 degree, tau txais kev tso pa tawm, thiab daim ntawv lim ntshav - cov hnab yas tau siv los hloov. Tom qab 14 hnub ntawm kev tshuaj xyuas, EO tau txo qis rau 4 ug / g.

US FDA 510 (k
ASTM F2100 Theem 3 daim ntawv qhia yuav tsum: BFE Ntau dua lossis sib npaug rau 98%, PFE Ntau dua lossis sib npaug rau 98%, siab sib txawv<5.0 mmH₂O, synthetic blood 160 mmHg.
Biocompatibility yuav tsum tau ua raws li ISO 10993-5 thiab -10.
EU CE MDR (EU) 2017/745
Cov khoom tsis muaj menyuam yuav tsum tau muab daim ntawv pov thawj CE los ntawm lub cev ceeb toom (NB), ua raws EN 14683:2019+AC: 2019.
Microbial txwv: Tsawg dua lossis sib npaug li 30 CFU / g, aseptic lav qib SAL 10⁻⁶.
Japanese PMDA
Lub npog ntsej muag yuav tsum ua raws li JIS T 8159: 2021, nrog cov ntsiab lus ntsev ntawm PFE Ntau dua lossis sib npaug li 95% thiab ua pa tsis ua pa tsawg dua lossis sib npaug li 80 Pa.
Yog xav paub ntxiv txog kev tshuaj xyuas "cov khoom siv hluav taws xob", xa mus rau Q&A PFSB/ELD/OMDE Ceeb Toom 0707-1.

Ayida manufacturing: Polylactic acid (PLA) meltblown thiab PBAT / PLA degradable spunbond tau suav nrog hauv Ministry of Industry thiab Information Technology cov ntawv teev cov khoom lag luam ntsuab rau xyoo 2025, thiab cov kev ntsuas degradation zoo sib xws yuav tsum ua raws li GB / T 19277.1-2011.
Kev paub txog kev txawj ntse: Kev paub txog qhov tsis xws hauv online (qhov, qhov hluav taws xob) raws li lub tshuab tsis pom kev thiab AI kev kwv yees ua qauv, ua tiav lub voj kaw ntawm "ntaus - tawm tswv yim - txheej txheem tus kheej- hloov kho".
Kev hloov kho tus qauv: GB 19083-2023 yuav tsum tshem tawm cov qauv tsim nrog li qub thiab ntxiv "quantitative fit" Hoobkas random soj ntsuam. Nws xav tias "Virus Filtration Efficiency (VFE)" yuav raug qhia ua ib yam khoom xaiv hauv xyoo 2026, nrog rau qhov loj me ntawm (1.5-3.0) μm, siv phage Phi-X174.