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Comparative analysis of domestic and foreign standards for mask testing1
Protective masks are one of the effective protective equipment to prevent respiratory infectious diseases, and play a pivotal role in epidemic control and protection. Meeting various quality standards for protective masks is crucial to ensuring the health and safety of the public. For protective masks, a material that maintains 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 Assessment: In Europe, surgical masks must be CE marked and comply with EN 14683: Medical masks: Test methods and requirements. The standard defines a surgical mask as a medical device that covers the mouth, nose, and chin to ensure that it limits the spread of infectious agents between hospital staff and patients. In terms of performance, masks are tested as final products and must meet different requirements. Masks are classified into 4 classes 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 2017/745 makes the necessary risk assessment and testing. In addition, Europe has also established standards for personal protective masks as follows: U.S. Test Evaluation of Masks: FDA (U.S. Food and Drug Administration) is the government agency that regulates medical devices on the U.S. market. Masks are considered Class 2 medical devices. The FDA has drafted standards that manufacturers must adhere to in order to obtain a license to market a product. The standard applies to surgical masks, surgery, dental and laser treatments. FDA strongly recommends that manufacturers clearly indicate the purpose of the product on the packaging. Masks are subject to the same tests as described in European Standard EN14683, except that the FDA also specifies the measurement of inert particle (latex) filtration efficiency and a fire test. The American standard ASTM F2100-19 'Standard Specification for the Performance of Materials for Medical Masks' describes the tests and requirements that the materials used in the production of masks must meet. There are several tests that are not performed on the final product, but on different materials, but must be tested according to the end use of the mask. The performance of the materials that make up the mask is assessed through six tests:•Bacterial adaptation efficiency•pressure difference•Breathability•splash resistance•Particle Filtration Efficiency•Fire test China's test evaluation of masks: Medical mask products should apply the following standards according to their own characteristics, but not limited to citing the following standards: Relevant product standards Among them: 1. Medical protective masks: should comply with GB19083-2010 'Technical Requirements for Medical Protective Masks' ; 2. Medical surgical masks: should meet the requirements of 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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