Kangaroo Doctor Yu Medical Approval 20182140714 implements the YY0469-2011 standard.
Medical and surgical supplies must comply with YY0469 standards.
The product technical requirements formulated by the company itself are also formulated based on compliance with this standard. Medical surgical masks belong to Class II medical devices, and Class II devices need to undergo registration review before they can be put on the market. The registration review process includes the review of product technical requirements.
Generally speaking, this product also needs to undergo registered type inspection. The so-called type inspection simply means that all items are tested once, and it is done by a qualified testing laboratory, and a pre-evaluation will also be issued. Report. In this report, the testing situation will be summarized. If the mandatory standards are not met, the product cannot be registered at all.
"YY0469-2011 Medical Surgical Mask" is a book published by China Standards Press on August 6, 2011. The author is the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and the National Standardization Administration of China committee.
The protection effect level is set according to the air quality category in the national air quality standards. The protection effect level is divided into four levels from low to high: D level, C level, B level, A level, corresponding to The usage environment is as follows: Class D is suitable for moderate pollution (PM2.5 concentration ≤150ug/m3) and below, Class C is suitable for severe pollution (PM2.5 concentration <250ug/m3) and below.
Level B is suitable for severe pollution (PM2.5 concentration ≤350ug/m3), and level A is used when the PM2.5 concentration reaches 500ug/m3. Properly wearing a mask in accordance with the standard requirements can reduce the concentration of inhaled PM2.5 to below 75ug/m3, making the air quality inhaled into the body reach a good level or above.
Reference for the above content? Baidu Encyclopedia YY0469-2011 Medical Surgical Mask