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The scope of application of medical masks

Mar 31, 2020

According to the standards and important technical indicators required by various medical masks, medical protective masks are suitable for the protection of airborne respiratory infections by medical staff and related staff, and the protection level is high: medical surgical mouths are suitable for medical staff or related personnel Basic protection, and protection against the spread of blood, body fluids and splashes during the invasive operation. The protective effect of ordinary medical masks on pathogenic microorganisms is inaccurate, and it can be used for one-time hygiene care or pathogenic microorganisms in ordinary environments The blocking or protection of particles other than pollen.

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Related requirements

Medical masks belong to the second category of medical devices. All provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the requirements of the “Notice on Strengthening the Supervision of Medical Masks” (Food and Drug Administration Office (2009) No. 95), strengthen the supervision of the adoption of standards for approved medical masks in their jurisdictions , Strictly require relevant enterprises to organize production and standardize the use instructions and packaging labels in accordance with national standards, industry standards or registered product standards, and guide medical institutions and the public to choose the appropriate masks according to the purpose of use.

Various kinds of medical masks containing sterilization, bacteriostasis and anti-virus are expected to be used as anti-bacterial and anti-virus medical masks according to the management of the third category of medical devices. Currently, the National Bureau has not approved such products. Relevant manufacturing enterprises should apply for registration to the National Bureau in accordance with relevant regulations, and only after obtaining approval for a medical device registration certificate can they produce and sell.


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