National standard medical surgical mask standard

Release time:

2019-04-02

The medical surgical mask standard is the the People's Republic of China pharmaceutical industry standard: YY 0469-2011. This standard specifies the relevant characteristics of domestic medical surgical masks. Let's take a brief look at some of the main contents of this standard.

1. Appearance

Appearance includes size, composition, structure and so on. First of all, in terms of size, it is recommended that ordinary disposable rectangular masks should not be less than 17cm * 17cm after expansion. Then the mask must have a nose clip (that is, what we call the nose bridge strip), the mask band is firmly connected, and so on (for specific data, please refer to the standard details).

2. barrier filtration

The national standard medical mask standard requires that the bacterial filtration efficiency (BFE) must be greater than or equal to 95%, the non-oily particle filtration efficiency (PFE) must be greater than or equal to 30%, and the gas exchange pressure difference must be less than or equal to 49Pa/cm2, which can block the penetration of synthetic blood.

3. other requirements

This standard also clearly stipulates that the mask has a certain flame retardant properties, microbial indicators, ethylene oxide residue, no irritation to the skin and so on.

In addition to this provision, the standard also provides for the performance of the test methods.

The above is the main content of this standard, through the above simple summary, it can be understood that the national standard medical surgical mask is mainly BFE95 mask.

The author understands that at present, enterprises that apply for medical device production license can only produce masks that meet this standard, and the relevant departments will randomly inspect the enterprises in production at any time, and violators will be severely punished! Therefore, surgical masks must now reach BEF95 or more, mask manufacturers must purchase meltblown non-woven fabrics that can reach BFE95 or more as the filter layer of the mask.

At present, both domestically and internationally, medical masks need to reach BFE95 or more, and some countries and regions even need to reach BFE99 or more.

Dexing Company has invested heavily in the introduction of Japan's Carson's meltblown non-woven fabric production line and the TSI-8130A filter material detector, the latest and most authoritative testing equipment in the world, in order to ensure that each batch of BFE meltblown cloth can meet or even exceed the corresponding standards.

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