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From this we can see that all medical masks belong to Class II medical devices. If we want to produce masks, we must carry out corresponding design and development,Medical Disposable Coverall, produce samples under GMP conditions, compile product technical requirements according to the Measures for the Registration and Management of Medical Devices, send them to registration inspection, prepare registration data and register products. Because they are exempted from clinical use, they are listed in the catalogue. Therefore, it is not necessary to conduct clinical trials, but it is necessary to conduct clinical evaluation and submit a comparative description of the declared products and similar products already on the market. The comparison description shall include the working principle, product material, structure and composition, main technical performance indicators, disinfection/sterilization methods,Against Bacteria Breathable KN95 Face Mask, intended use, household use, etc. Production process of disposable medical mask: the transportation distance should be short and straight, and the circuitous and round-trip transportation should be avoided as far as possible. The following figure shows the mask production process and room layout of the 100, Full Body Disposable Coverall ,KN95 Face Mask with Five Layers,000-level purification workshop (D-level purification workshop) of a medical device company in Zhejiang. (Above) Logistics schematic diagram of mask production workshop of a medical device company in with a fluctuation of ± 2 ℃. The humidity of the clean room is controlled at 30-50% in winter and 50-70% in summer. When there is no special requirement for temperature and humidity,Medical Full Body Coverall, it is better to wear clean work clothes without feeling comfortable. Its functional layout, equipment and facilities and management requirements can be referred to the Guide to the Key Points of Medical Device Clean Room (Area) Inspection. Relevant standards applicable to medical masks Medical mask products should apply the following standards according to their own characteristics, but not limited to quoting the following standards: Return to Sohu to see more Responsible Editor:. zjyuan-group.com
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