Physical performance inspection and analysis report of medical protective masks

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 mask that can prevent infections caused by airborne infectious agents with a diameter of ≤5μmg or close (≤1m) contact with droplet-borne diseases. The main physical properties of medical protective masks include: basic mask requirements, mask belt, filtration efficiency, airflow resistance, synthetic blood penetration, and adhesion. 1. Sample source and product standards for sampling 1.1 Quantity and distribution of samples received This national sampling received a total of 8 batches of inspection products. The sampling sources of samples and the distribution of production enterprises are shown in Table 1. 1.2 Product standard situation This inspection involves a total of 6 production enterprises, of which the product implementation standards of 2 enterprises in Henan are GB 19083-2010 [1], and the standards of 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 product technical requirements. Two of the company registered product standards added the item of 'loading filter efficiency2. 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 belt 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: Sodium chloride aerosol or similar solid aerosol in an environment with a relative humidity of 30%±10% and a temperature of 25°C±5°C should be used. Median diameter (CMD): 0.075μm±0.020μm; geometric standard deviation of particle distribution: ≤1.86; concentration: ≤200 mg/m3] for testing. The air flow is set to 15 L/min±2 L/min, and the cross-sectional area through which the air flows is 100 cm2. 2.1.3.2 Equipment: TSI-8130 material filterability tester; 2.1.4 Air flow resistance 2.1.4.1 Inspection method: the same 2.1.3.2.1.4.2 Equipment: TSI-8130 material filterability tester. 2.1.5 Synthetic blood penetration 2.1.5.1 Inspection method: (1) Pretreatment: Pretreat the mask sample in an environmental test box at a temperature of 21°C±5°C and a relative humidity of 85%±5% for 4 hours. The mask sample is taken out of the environmental box for testing within 1 min; (2) Talc powder needs to be sprinkled on the inner surface of the mask to increase the visibility of the droplets; (3) The sample is taken out of the pretreatment chamber, positioned and fixed on the sample The fixed device allows the synthetic blood to be sprayed onto the target area. Place the spray head at (300±10) mm away from the sample target area; (4) Spray the synthetic blood to the medical mask sample. Ensure that the synthetic blood is sprayed to the target area of u200bu200bthe mask. The test is carried out within 60 s after the sample is taken out of the pretreatment chamber; (5) Check the observation surface of the sample (10 ± 1) s after the synthetic blood is sprayed to the target area. Under proper lighting conditions, pay attention to whether there is synthetic blood on the observation surface of the mask or can show signs of synthetic blood. 2.1.5.2 Equipment: LYF-227 synthetic blood penetration tester for medical masks. 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 is started. (2) Select 10 subjects, half male and half, head shape conforming to GB/T2428-1998 [2] Chinese head shape series. The male shaves his beard. Wear a mask according to the instructions for use. Check before the test, including that the mask has no tendency to move, the mask strap should not be too loose or too tight, the nose clip fits the bridge of the nose, and the surrounding area should not leak. No further adjustments are allowed during the test process. The subjects were required to do the following 6 prescribed actions, each for 1 min: (a) Normal breathing-standing posture, normal breathing rate, no speech. (B) Take a deep breath-stand up, breathe slowly and deeply, and be careful not to exhale excessively. (C) Turn your head left and right-in a standing posture, slowly turn your head to one side to the extreme position and then turn to the other side. There should be inhalation at each extreme position. (D) Move your head up and down-slowly lower your head, then slowly raise your head, there should be an inhalation action at the limit position of the head. (E) Speak-speak loudly and slowly. Ask the subject to count down from 100 or read an article. (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 have a total fitness factor that meets the requirements. 2.1.6.2 Equipment: TSI-N95-COMPANION adhesion tester. 2.2 Inspection results The physical performance inspection results are shown in Table 2. 2.3 Judgment principles All inspection items are judged according to product registration standards or technical requirements. 3. Analysis of non-conformance items 3.1 Filtration efficiency 3.1.1 Features and functions Filtration efficiency refers to the percentage of particulate matter in the air filtered by a mask under specified conditions; medical protective masks can filter particulate matter in the air, blocking droplets, blood, and body fluids , Secretions, etc. 3.1.2 Importance Filter efficiency is the fundamental factor that determines the protective effect of masks. 3.1.3 Reason analysis The filtration efficiency of raw materials is not up to standard, and the quality is problematic. 3.1.4 Suggestions for improvement It is recommended that the manufacturer should strictly control the filtration efficiency of the raw materials of the product. 3.2 Adhesion 3.2.1 Features and functions Adhesion of a mask refers to the degree of adhesion between the periphery of the mask and the face of a specific user, and is a barrier item to prevent the entry of harmful substances. 3.2.2 Importance If the protective mask cannot be closely attached to the user's face, harmful substances in the air will enter the mask from the leak and cause harm to the human respiratory tract. 3.2.3 Cause analysis (1) The material of the nose clip is too soft, the position of the nose clip leaks, and the mask does not fit well with the human nose;

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