European standard medical mask standard

Release time:

2019-10-07

Interpretation of EN 14683 European Medical Mask Standard

In addition to the FFP series, the European mask standard also has a medical mask standard.

Standard name: BS EN 14683:2014, Medical face masks-Requirements and test methods. The standard also specifies the requirements and test methods. Let's look at the requirements first.

1. appearance composition.

This part mainly stipulates that the materials used for masks should be reasonably harmless, without defects in use and.Packagingon shouldhow to label and so on,There are no substantial technical indicators.

Main technical indicators of 2.

As shown in the figure, European standard medical masks are divided into three types, namely Type I, Type II and TypeIIR, of which Class I is BFE95, but it is only for patients or other people to use in ordinary environments, and is not suitable for medical personnel to use in operating rooms or other similar environments. However, II and IIR are both required to reach BFE98,IIR has a higher level of anti-splash liquid requirement (16kPa), and the respiratory resistance requirement is also lower. The microbial indicators of the three requirements are the same. There are also biocompatibility standards, see EN ISO 10993-5 and EN ISO 10993-10.

This standard has three accessories at the same time. Annex A is an instruction for users, Annex B is a test method for BFE, and Annex C is a test method for respiratory resistance. Here is a brief look at Annex C.

As shown in the figure above, input a constant (8L/m) gas flow rate from 1 (as shown in the figure below),

4 is a 2.5cm diameter fixture to place the mask product, 3 and 5 are two pressure readings, 6 and 7 are valves and vacuum pumps. The pressure data read into 3 and 5 in turn are recorded as M1 and M2(pa) respectively, and the respiratory resistance (pressure difference) is equal to (M1-M2)/4.9, (4.9 is an area with a diameter of 2.5cm). Finally, the respiratory resistance in Pa/cm² can be calculated.

This resistance test method is consistent with the current resistance test of medical masks in the world, including China, the United States, Japan and so on. The principle is not complicated, and the main difference with the usual test filtration efficiency is the flow rate and the test area.

However, the problem has come. At present, TSI-8130 or similar testing instruments are the most common for civil use on the market. The flow rate can be set to 8L/m, but the area is 100cm.²What is the difference or how to compare it? We will discuss it with you in the next interpretation.

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ReferenceBS EN 14683:2014《Medical face masks-Requirements and test methods》