Medical protective mask physical performance inspection and analysis report

Medical protective masks refer to self-priming filter dust-proof medical protective masks that can filter particles in the air and block droplets, blood, body fluids, secretions, etc. This is a diameter that prevents airborne transmission≤5μmg infectious agent or close (≤1m) Masks infected with droplet-borne diseases. The main physical properties of medical protective masks are: basic requirements of masks, mask belts, filtration efficiency, airflow resistance, synthetic blood penetration, and tightness. 1. Sample sources and product standards for sampling 1.1 Quantity and distribution of samples received A total of 8 batches of samples were received in this national sampling. See Table 1 for the source of sample inspection and the distribution of production enterprises. 1.2 Product standard situation This inspection involves a total of 6 production enterprises, of which 2 enterprises in Henan have product implementation standards of GB 19083-2010[1], and 2 enterprises in Guizhou and Shanghai The product implementation standard is the YZB standard, and the products of the two enterprises in Guangdong and Sichuan implement the product technical requirements. 2 of the enterprise registered product standards have added“Load filter efficiency”Item, missing from 2 enterprise registered product standards“tightness”project. 2. Physical performance inspection 2.1 Inspection items 2.1.1 Basic requirements for masks 2.1.1.1 Inspection method: visual inspection. 2.1.1.2 Equipment: None. 2.1.2 Mask strap 2.1.2.1 Inspection method: measure by visual inspection and tensile test device. 2.1.2.2 Equipment: heavy hammer. 2.1.3 Filtration efficiency 2.1.3.1 Inspection method: should be used when the relative humidity is 30%±10% at 25°C±Sodium chloride aerosol or similar solid aerosol in the environment at 5°C [particle median diameter (CMD): 0.075μm±0.020μm; geometric standard deviation of particle distribution:≤1.86; Concentration:≤200 mg/m3] were tested. Air flow set at 15 L/min±2 L/min, the cross-sectional area of ​​airflow passing through is 100 cm2. 2.1.3.2 Equipment: TSI-8130 material filterability tester; 2.1.4 Airflow resistance 2.1.4.1 Inspection method: the same as 2.1.3. 2.1.4.2 Equipment: TSI -8130 Material Filterability Tester. 2.1.5 Synthetic blood penetration 2.1.5.1 Test method: (1) Pretreatment: put the mask sample at a temperature of 21°C±5°C, 85% relative humidity±Pretreated in a 5% environmental test chamber for 4 h. The mask sample was taken out of the environmental chamber for testing within 1 minute; (2) talc powder needs to be sprinkled on the inner surface of the mask to increase the visibility of droplets; (3) the sample was taken out of the pretreatment chamber, positioned and fixed on the sample The immobilization device allows the synthetic blood to be ejected onto the target volume. Place the jet head at a distance from the sample target area (300±10) mm position; (4) spray the synthetic blood to the medical mask sample. Ensure that the synthetic blood is sprayed on the target area of ​​the mask. The test is carried out within 60s after the sample is taken out from the pretreatment chamber; (5) after the synthetic blood is sprayed to the target area (10±1) s Check the observation surface of the sample. Under suitable lighting conditions, note the presence or indication of synthetic blood on the viewing side of the mask. 2.1.5.2 Equipment: LYF-227 Medical Mask Synthetic Blood Penetration Tester. 2.1.6 Tightness 2.1.6.1 Inspection method (1) The equipment self-checks the number of particles in the air. After passing the test, start the test. (2) Select 10 subjects, half male and half, with head shape conforming to GB/T2428-1998 [2] Chinese head shape series. Male shaves beard. Wear a mask according to the instructions for use. Before the test, it should be checked, including that the mask has no tendency to move, the mask belt should not be too loose or too tight, the nose clip should be attached to the bridge of the nose, and there should be no air leakage around it. No further adjustment is allowed during the testing process. The subjects were asked to perform the following 6 prescribed actions, each for 1 min: (a) Normal breathing——Stand in a standing position, breathe at a normal rate, and do not speak. (b) take a deep breath——Stand in a standing position and take slow, deep breaths, taking care not to exhale too much. (c) Turn left and right——Standing in a standing position, slowly turn your head to one side to the limit and then turn to the other side, inhaling at each limit. (d) Move the head up and down——Slowly lower your head, then slowly raise your head, and inhale at the extreme position of raising your head. (e) to speak——Speak loudly and slowly. Ask subjects to count down from 100 or read a passage. (f) normal breathing——Same as (a). Select 10 subjects, wear masks according to the instruction manual, perform 6 prescribed actions, and test according to the following methods. At least 8 subjects should meet the requirements for total fitness factor. 2.1.6.2 Equipment: TSI-N95-COMPANION tightness tester. 2.2 Test results The physical performance test results are shown in Table 2. 2.3 Judgment Principles All test items are judged according to product registration standards or technical requirements. 3. Analysis of non-conformities 3.1 Filtration efficiency 3.1.1 Features and functions Filtration efficiency refers to the percentage of particulate matter in the air that the mask filters out under specified conditions; medical protective masks can filter particulate matter in the air and block droplets, blood, and body fluids , secretions, etc. 3.1.2 Importance Filtration efficiency is the fundamental factor determining the protective effect of masks. 3.1.3 Reason analysis The filtration efficiency of the raw materials is not up to standard, and there is a problem with the quality. 3.1.4 Suggestions for improvement It is suggested that manufacturers should strictly control the filtration efficiency of raw materials of products.
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