Standards for Face Masks

Posted by hw on November 26th, 2020

Before the production of the masks, we must first understand the corresponding national standards for masks. Qualified masks must meet the standard requirements, and different standards have different requirements for face mask making machine performance. 

Sincerely remind, before the production of masks, companies must understand mask standards for export mask use, export place/country, to avoid the creation of Unnecessary Losses. Don’t take any chances by producing to strict standards. 

 Chinese standards for masks 

According to China’s standards for masks, masks can be divided into three categories: labor masks, medical masks, and protective masks.

1 Standards for labor masks

The standard for labor protection masks in China is GB 2626-2006. Mainly for industrial dust masks, suitable for self-absorption filtered respiratory protection supplies for protection against particles of all kinds. It specifies the technical requirements, testing methods, and labeling of self-priming, filtered, anti-particulate respirators for respiratory protection articles.

According to the filtering efficiency of the mask, the mask is divided into three grades: 90 (KN90, KP90), 95 (KN95, KP95). 100 (KN100, KP100). The numbers indicate the size of the filtration efficiency, and the KN series is detected by sodium chloride particles, while the KP series is detected by oil particles. 

2 Standards for medical masks

There are three existing standards for medical masks in China: YY/T 0969-2013 “Disposable medical masks”, YY 0469-2011 “Medical surgical mask”, GB 19083-2010 “Medical protective mask technology Requirements”.

YY/T 0969-2013, disposable medical masks, is for the use of ordinary medical and nursing staff for routine masks. The standard is a recommended standard for the pharmaceutical industry, implemented on October 1, 2014, the core performance requirements for the bacterial filtration efficiency (BFE) requirement of ≥95% and an indicator for microorganisms in the mask is specified.

YY 0469-2011, medical surgical masks, the standard specifies the technical requirements, test methods, marking and instructions for use and packaging, transport, and storage. The standard specifies the BFE requirements of the mask and YY/T 0969, increased PFE (≥30%), and synthetic blood penetration performance requirements for better protection in the case of surgical blood contact with the mask.

GB 19083-2010, Medical protective masks, implemented on August 1, 2011. The standard specifies the technical requirements, test methods, marking and instructions for use and packaging, transport and storage for medical protective masks, which suitable for use in medical work environments to filter particles from the air and block droplets, blood, body fluids, and secretions.

Note: The test flow rate for this standard is (85±2)L/min and the inspiratory resistance of the mask does not exceed 343.2Pa (35mmH20). Synthetic blood penetration requirements: spray 2mL of synthetic blood into the mask at 10.7KPa (80mmHg), there should be no penetration on the inside of the mask.

3 Standards for protective masks

GB/T 32610-2016, the first standard for civilian protective machine of China, was implemented on Nov 1, 2016. The standard covers mask raw material requirements, structural requirements, labeling and marking requirements, appearance requirements, etc., and the main indicators include functional indicators Particle filtration efficiency, exhalation and inhalation resistance index, airtightness index, and so on.

GB 32610 standard requires masks should be able to safely and securely protect the nose and mouth, there should be no accessible sharp corners and sharp edges, formaldehyde, dyes, microorganisms, and other factors that may cause harm to the human body to make detailed provisions to ensure the safety of the public when wearing protective masks.

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