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Comparative analysis of domestic and foreign standards for mask testing
Protective masks are one of the effective protective products to prevent respiratory infectious diseases, and they play an important role in epidemic control and protection. Satisfying the various quality standards of protective masks is essential to protecting the health and safety of the people. For protective masks, materials that maintain people's livelihood, once there is a quality problem, it may attract the attention of the whole people and cause irreparable damage to the brand image. Therefore, the detection of protective masks is an indispensable key link. European Mask Test Evaluation: In Europe, surgical masks must carry the CE mark and comply with EN 14683: Medical Masks: Test Methods and Requirements. The standard defines surgical masks as: medical equipment covering the mouth, nose and chin to ensure that the spread of infection sources between hospital staff and patients can be restricted. In terms of performance, masks are tested as final products and must meet different requirements. Masks are classified into 4 categories based on the results of the following tests: Bacterial Filtration Efficiency (BFE), Breathability, Splash Resistance (Synthetic Blood), Microbial Cleanliness, Biocompatibility. Since surgical masks are considered Class I medical devices, manufacturers must The European Medical Device Regulation No. 2017/745 makes the necessary risk assessment and testing. In addition, Europe has also formulated the following standards for personal protective masks: Testing and evaluation of masks in the United States: FDA (U.S. Food and Drug Administration) is the government agency that regulates medical devices in the US market. Masks are considered to be Class 2 medical equipment. The FDA has drafted standards, and manufacturers must comply with these standards in order to obtain a license to sell products on the market. This standard applies to surgical masks, surgery, dentistry and laser treatments. The FDA strongly recommends that manufacturers clearly indicate the purpose of the product on the packaging. Masks are subject to the same test as described in the European standard EN14683. The difference is that the FDA also stipulates the measurement of the filtration efficiency of inert particles (latex) and the fire test. The American standard ASTM F2100-19 'Medical Mask Material Performance Standard Specification' describes the tests and requirements that the materials used in the production of masks must meet. Several tests are not performed on the final product, but on different materials, but they must be tested in accordance with the final use of the mask. The performance of the materials that make up the mask is evaluated through six tests: • Bacterial adaptation efficiency • Pressure difference • Air permeability • Splash resistance • Particle filtration efficiency • Fire test China's testing and evaluation of masks: Medical mask products should be applied to the following according to their own characteristics Standards, but not limited to the following standards: Related product standards: 1. Medical protective masks: should comply with GB19083-2010 'Technical Requirements for Medical Protective Masks'; 2. Medical surgical masks: should comply with YY 0469-2011 'Medical Surgical Masks' ; 3. Disposable medical masks: should meet the requirements of YY/T 0969-2013 'Disposable medical masks'.
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