Since 2020, masks have transformed from emergency supplies to regular public health protection consumables. The iterative upgrades of mandatory standards such as GB 19083-2023 "Medical Protective Masks", YY 0469-2011 "Medical Surgical Masks", and GB 2626-2019 "Respiratory Protection - Self-inhalation Filtering Particulate Respirators" have put forward more stringent and quantifiable technical requirements for manufacturing enterprises. Testing, as the sole means of compliance evaluation, is not only related to market access but also directly affects the safety of terminal usage. Based on the current valid standards, this article systematically sorts out the testing items, technical principles, equipment configuration and quality risk points of all types of masks, for reference by production, supervision and third-party institutions.
Inspection Items and Standard Basis
(1) Protective performance
Bacterial Filtration Efficiency (BFE)
Applicable standards: YY/T 0969-2013, YY 0469-2011, ASTM F2101
Technical parameters: The test strain was Staphylococcus aureus ATCC 6538, the median particle size of the aerosol was (3.0±0.3) μm, and the sampling flow rate was 28.3 L/min.
Qualified index: ≥95% (disposable medical) ≥98% (surgical, Type IIR).
Particle Filtration Efficiency (PFE)
Applicable standards: GB 19083-2023, GB 2626-2019, EN 149:2001+A1:2009
Technical parameters: NaCl aerosol 0.075 μm, DOP or paraffin oil 0.185 μm, flow rate 85 L/min.
Qualified indicators: ≥95% (KN95, FFP2); ≥99% (GB 19083 Level 3).
Synthetic Blood Penetration
Applicable standards: YY 0469-2011, ASTM F1862, ISO 22609
Technical parameters: Injection pressure 16.0 kPa (120 mmHg), injection volume 2 mL, injection distance 305 mm.
Qualified index: No penetration on the inner side of the mask.
(2) Physical and mechanical properties
The breaking strength of mask straps and connection points
Applicable standards: GB 19083-2023 5.6, EN 14683:2019+AC:2019
Technical parameters: Static stretching speed 100 mm/min, clamping width 25 mm, loading 10 N and holding for 5 seconds.
Qualified indicators: No breakage or slippage.
Flammability
Applicable standards: YY 0469-2011 5.8, 16 CFR 1610
Technical parameters: Flame height (40±4) mm, combustion time 5 seconds, a total of 10 samples.
Qualified indicators: Afterburning time ≤5 seconds, smoldering time ≤5 seconds, no burn-through.
Differential Pressure
Applicable standards: YY/T 0969-2013 5.7, EN 14683:2019
Technical parameters: Gas flow rate 8 L/min, test area 4.9 cm².
Qualified index: ≤49 Pa (disposable medical) ≤60 Pa (Type IIR).
(3) Biocompatibility
According to the GB/T 16886 series, medical masks need to complete:
Cytotoxicity test (MTT method, relative proliferation rate ≥70%)
Skin irritation (rabbit method, PII≤2.0)
Delayed-type hypersensitivity reaction (guinea pig maximization test, grade ≤1)
(4) Chemical safety
Ethylene oxide Residue
Applicable standards: GB/T 16886.7, ISO 10993-7
Test method: Headspace - gas chromatography, quantification limit 0.1 μg/g.
Qualified index: ≤10 μg/g (short-term contact device).
Formaldehyde, azo dyes
Applicable standards: GB/T 32610-2016, GB 18401-2010
Qualified index: Formaldehyde ≤20 mg/kg; Decomposable carcinogenic aromatic amine dyes are prohibited.
Comfort and fit performance
Breathing Resistance
Applicable standards: GB 2626-2019 6.5, EN 149:2001+A1:2009
Technical parameters: Inspiratory flow rate 95 L/min, expiratory flow rate 85 L/min.
Qualified indicators: KN95 inhalation ≤350 Pa, exhalation ≤250 Pa.
Dead Space
Applicable standard: GB 2626-2019 6.9
Technical parameters: The CO₂ concentration shall not exceed 1% of the inhaled gas.
Qualified index: Dead cavity volume ≤15 mL.
Fit Test
Applicable standards: GB 19083-2023 5.14, OSHA 29CFR1910.134
Test method: Quantitative fitness factor (QNFF) ≥100, and 8 action tests were conducted using TSI PortaCount.
Key Testing Equipment and Metrological Traceability
Automatic filter material Tester (TSI 8130A, DRK-506)
Function: Synchronous output of PFE and pressure difference; Dual-channel switching for salt and oil properties; The flow accuracy is ±1%, and it is equipped with an NIST traceable calibration certificate.
BFE Test System (Andersen Cascade Impactor)
Function: Six-stage biological sampling, particle size segmentation 0.65-7.0 μm; When used in conjunction with a biosafety cabinet, it complies with GLP requirements.
Synthetic Blood Testing Machine (DRK-M601
Function: The spray pressure is adjustable from 0 to 40 kPa, the nozzle inner diameter is 0.84 mm, and it is equipped with an internal HEPA filter to prevent cross-contamination.
Tensile testing machine (Instron 3345)
Function: Full range from 1 N to 5 kN, displacement resolution 0.5 μm, meeting ISO 7500-1 0.5 grade accuracy.
Gas chromatography-mass spectrometry (GC-MS 5977B)
Function: EO quantification limit 0.02 μg/g, supports multi-reaction monitoring (MRM), and certified by CNAS 17025.
Quality Control and Analysis of Nonconforming Cases
The measured BFE is 92%, which is lower than the limit value of 95%
Root cause: The electret voltage of the meltblown fabric is insufficient (only 25 kV), and the surface potential attenuation is greater than 30%.
Improvement: Increase the electrified voltage to 45 kV and add a constant temperature analysis at 60 ℃ for 24 hours, with a potential retention rate of ≥80%.
The pressure difference of 78 Pa is higher than 49 Pa
Root cause: The meltblown grammage has risen to 35 g/m², and the average fiber diameter is 2.1 μm.
Improvement: Reduce the gram weight to 25 g/m², simultaneously increase the temperature of the hot air oven, refine the fibers to 1.5 μm, lower the pressure difference to 42 Pa, and maintain the BFE at 98%.
The residual EO is 18 μg/g
Root cause: The analysis time was only 7 days, and the packaging used PE bags had poor air permeability.
Improvement: The temperature of the analysis library was 45 ℃, forced ventilation was adopted, and dialysis paper-plastic bags were used instead. After 14 days of analysis, the EO was reduced to 4 μg/g.
Additional Requirements for Export Compliance
U.S. FDA 510(k
ASTM F2100 Level 3 report is required: BFE≥98%, PFE≥98%, pressure difference <5.0 mmH₂O, synthetic blood 160 mmHg.
Biocompatibility shall be carried out in accordance with ISO 10993-5 and -10.
EU CE MDR (EU) 2017/745
Sterile products must be issued a CE certificate by a notified body (NB), in compliance with EN 14683:2019+AC:2019.
Microbial limit: ≤30 CFU/g, aseptic guarantee level SAL 10⁻⁶.
Japanese PMDA
The mask should comply with JIS T 8159:2021, with a salt content of PFE≥95% and breathing resistance ≤80 Pa.
For additional screening for "radioactive substances", refer to Q&A PFSB/ELD/OMDE Notification 0707-1.
Future Trends and Prospects
Ayida manufacturing: Polylactic acid (PLA) meltblown and PBAT/PLA degradable spunbond have been included in the Ministry of Industry and Information Technology's green product directory for 2025, and the corresponding degradation rate test shall be in accordance with GB/T 19277.1-2011.
Intelligent detection: Online defect recognition (holes, sparks) based on machine vision and AI prediction models, achieving a closed loop of "detection - feedback - process self-adjustment".
Standard upgrade: GB 19083-2023 mandatorily abolishes the design with valves and adds "quantitative fit" factory random inspection. It is expected that "Virus Filtration Efficiency (VFE)" will be introduced as an optional item in 2026, with a particle size range of (1.5-3.0) μm, using the phage Phi-X174.
Conclusion
Mask testing has evolved from "emergency compliance" to "full life cycle quality management". Only by establishing a four-level inspection system covering raw material entry, process monitoring, finished product release and market random inspection can enterprises develop steadily in the increasingly strict domestic and international regulatory environment. Regulatory authorities and third-party laboratories also need to continuously upgrade the accuracy of equipment and data traceability capabilities to jointly ensure the safety of public wearing.