Where do I need to apply for the GB/T19083 mask test report?

GB19083-2010 Technical requirements for medical protective oral placement:

This standard specifies the technical requirements, test methods, signs and instructions, packaging, transportation and storage of medical protective oral devices (hereinafter referred to as oral devices).

 

This standard is applicable to self-priming filter medical protective mouth placements that filter airborne particles and block droplets, blood, body fluids, secretions, etc. in a medical working environment.

 

For the testing requirements of the new GB32610/T standard, it is suggested to arrange the following testing items. As long as the following items are passed, the mall can successfully pass the audit;

1. Filtration efficiency testing, for both oily media and salty media, simulation testing is required, and only if they meet the requirements can be considered as passed, and there are three levels, level 1, level 2, and level 3.

 

2. The protective effect is divided into four levels: A, B, C, and D. The level is determined according to the positioning requirements of the product.

 

The protection effect level is set according to the air quality category in the national air quality standard. The protection effect level is divided into four levels from low to high: D, C, B, and A. The corresponding use environment is as follows: D level adaptation For moderate (PM2.5 concentration s150ug/m3) and below, C level is suitable for heavy (PM2.5 concentration ≤250ug/m3) and below, B level is suitable for severe pollution (PM2.5 concentration ≤350ug/m3) ), Class A is used when the PM2.5 concentration reaches 500ug/m3. According to the requirements of the standard, wearing the mouth properly can reduce the inhaled PM2.5 concentration to less than 75ug/m3, and make the air quality inhaled reach the level of good and above.

 

3. Oral inhalation resistance and expiration resistance detection.

YY0469-2004 "Technical Requirements for Oral Placement in Medical Surgery" standard, important technical indicators include filtration efficiency, bacterial filtration efficiency and respiratory resistance, and cytotoxicity, skin irritation, delayed hypersensitivity, etc.! Among them, particulate matter filtration detection is very important. It also reflects the basic requirements of oral placement, the filtration efficiency of particulate matter (reflected in the filter material of the oral placement) and the adhesion between the oral placement and the wearer's face (reflected in the reliability of the design structure and fixing method of the oral placement) ), to standardize the basic safety protection performance of the protection port. For the samples submitted for inspection, the company must ensure that the mouth and face have good adhesion, otherwise no matter how good the filter material is, it will not pass the test!

 

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