National Mask Standard: What Is The Difference Between The Global Mask Entry Standard And The Mask Standard?

Data released by the national development and Reform Commission in early March showed that China's daily productivity and output of respirators continued to grow rapidly, and both of them exceeded 100 million. More and more enterprises have increased the daily production of respirators by expanding their capacity, increasing production and changing production.

With the development of new crown pneumonia in the world, the problem of masks shortage is becoming more and more serious. In addition to ensuring domestic supply, China's mask manufacturers also undertake more and more overseas orders, but the masks made by different countries have different standards. To this end, the global textile network Xiaobian specially organized some major countries in the world for masks certification and testing requirements, specifically summarized as follows:

China

The protective ability of medical masks in China is from high to low in medical masks, medical surgical masks and general medical masks. Different types of masks follow different standards, and the applicable scope of different masks varies. The main criteria of respirators in China are GB2626-2019 respirator, self-priming filter particulate respirator, GB/T32610-2016 daily protective mask technical specification, YY/T0969-2013 disposable medical mask, YY0469-2011 medical surgical mask and GB19083-2010 medical mask.

GB 2626-2019

The first edition of the standard was released in 1981 (GB2626-1981). There were three updates in 1992, 2006 and 2019 respectively. The 2019 edition was changed to "respirator, self-priming filter particle respirator" and two words without "supplies". The GB2626-2019 version was published in 2019-12-31 and implemented by 2020-07-01. The standard specifies the classification and labeling, technical requirements, testing methods and identification of respirator with self-priming filter. The standard is put forward by the State Administration of work safety and the National Standardization Committee for personal protective equipment (SAC/TC112) is in charge. Compared with the 2006 edition, following the basic principles of scientificity, standardization, coordination and timeliness, according to the trend of scientific progress and product development, we should adjust the respiratory resistance index without reducing the protective ability, improve the detection method, optimize the lower side view of the half mask, and improve the comfort of the product. The scope of application is shown in Figure 6.

The standard filter elements are classified into two categories according to their filtration performance (KN and KP). KN class is only suitable for filtering non oil particles, including KN90 (> 90%), KN95 (95%), KN100 (99.97% or 99.97%) three levels. Class KP is suitable for filtering components of oily and non oily particulates, including KP90 (> 90%), KP95 (95% or more) and KP100 (above 99.97%) three levels. The numbers after KN and KP refer to the level of filtering efficiency. The higher the number, the better the filtering effect. KN masks do not test blood penetration and surface moisture resistance. Therefore, such masks can block viruses for a short time, but they can not be used to contact patients who may have spatter or to contact patients for a long time.

GB/T 32610-2016

The technical standard of the daily protective mask is the standard of the civil respirator, which is put forward by the China Federation of textile industry. The national textile Standardization Technical Committee (SAC/TC209) is in charge. The scope of application is shown in Figure 6.

According to the filtration efficiency, it is divided into grade I, grade II and grade III, and the corresponding filtration efficiency: salt medium is greater than 99%, equal to 95% or more than 90%, and the oil medium is respectively equal to 99%, more than 95%, or more than 80%. The protective effects of respirators are A, B, C and D from high to low. The ambient air quality of respirators at various levels is serious, serious and below, heavy and below, moderate and below. Respirators at all levels should reduce the concentration of inhaled particulate matter (PM) to less than 75 g/m (air quality index categories above and above) in the corresponding air pollution environment. When the respirator protection level is grade A, the filtration efficiency should reach level II and above. When the mask protection level is B, C and D, the filtration efficiency should reach grade III and above.

YY/T 0969-2013

The standard is the industry standard for disposable medical masks, issued in 2013-10-21 and implemented by 2014-10-01. General medical masks conform to this standard and are suitable for general protection of medical staff. They are only used in general medical environment (see Figure 6). There are many common medical masks, such as medical care and disposable medical. There are no medical masks in the name of "protection" and "surgery". They are all general medical masks. The core indicators of this level respirator include bacterial filtration efficiency, ventilation resistance, no barrier to blood and no requirement for tightness, see chart 3.

YY 0469-2011

Medical surgical mask (YY0469-2011) is an industry standard for medical surgical masks, issued at 2011-12-31, and 2013-06-01 is implemented. The first edition (YY0469-2004) of the medical surgical mask standard has been replaced by the 2011 edition. Disposable masks worn by clinical medical staff in the course of invasive operation (see Figure 6) are medical masks commonly used in operation room and other body fluids and blood spatter risk environments. The outer package must be clearly labeled as surgical surgical masks. The core indicators of this type of respirator include bacterial filtration efficiency, particle filtration efficiency, synthetic blood penetration resistance and ventilation resistance (see Table 3). There is no strict requirement for face tightness, such as the standard of medical respirator, the filtration efficiency of bacteria is more than 95%, and the filtration efficiency of particles is Limited (> 30%).

GB 19083-2010

The technical requirements of GB19083-2010 medical masks were released in 2010-09-02, 2011-08-01 was implemented, the first version was GB19083-2003, and was formulated in the national situation against SARS. It was released and implemented in April 29, 2003. There is no medical masks before SARS. This standard is suitable for filtering particulate matter in the air under medical work environment, blocking droplets, blood, body fluids, secretions, etc., including all kinds of infectious viruses (see Fig. 6). The key indicators of this type of respirator include particle filtration efficiency, synthetic blood penetration resistance, ventilation resistance, surface moisture resistance, good adhesion, and total fitness factor (see Table 3). The medical respirator has good adhesion with the wearer's face. According to the non oil particle filtration efficiency, the medical respirator is divided into 1 levels (> 95%), 2 level (99% or 3) (99.97% or more). The respirator provides that the filtration efficiency of the respirator for non oily particles is more than 95%, which is in line with N95 or FFP2 or above.

The NIOSH standard of the United States has graded the filter material and filtration efficiency of the mask, which is highly recognized worldwide. According to the filter material of the middle layer of the mask, it can be divided into three kinds: N, R and P series. According to the filtering efficiency, each can be divided into three levels (see Table 4). N is used to protect non oil suspended particles. Usually non oil particles refer to coal dust, cement dust, acid mist, microorganism, etc. the droplets produced by talking or coughing are not oily. In the current haze pollution, most of the suspended particles are non oily. Oily particles refer to cooking fumes, oil fumes, asphalt fumes, and so on, such as cooking oil fumes are oily particles. R and P are used to protect non oily and oil-bearing particulates. Compared with R series, the P series takes longer time, and the specific time of use is marked according to different manufacturers. The N95 respirator is a kind of respirator with a filtration efficiency of more than 95% in the N series. It is ensured that the air can pass through the mask when the density of the face is tightened by the wearer's face tight density test. The N95 certification number is issued for the test. During the special period of SARS prevention, WHO temporarily recommended medical staff to use the NIOSH N95 mask. The N95 respirator is not equivalent to the medical respirator. The medical respirator requires the mask to reach the N95 requirement and has the surface moisture resistance and blood barrier ability.

The ASTMF2100 standard is a medical standard. This standard divides the respirator into three grades: low protection (Level1), medium protection (Level2) and high protection (Level3). The higher the level, the better the protective performance. Level1 and Level2 masks are usually called procedure mask; Level3 masks can be used in the operating room, also called surgical mask. When exposure to the virus is particularly great, higher level protection should be chosen.

ASTM certification requires masks to meet the relevant standards in four aspects: bacterial filtration efficiency, particle filtration efficiency, synthetic blood penetration resistance and pressure difference. See Table 3. Level1 can block 95% of bacterial particles, even if it reaches a low protection standard, it is enough to protect the general community users. Level2 and Level3 (medium to high protection standard) require masks to block at least 98% bacteria and particulates. The pressure difference is only less than 49.0Pa/cm, and the lower protection standards are looser, because it is difficult to maintain better air permeability while achieving better protection. The main difference between medium and high protection standards is that the high protection (Level3) standard has higher requirements for blocking liquid capability. The medical N95 respirator needs to meet the FDA Surgical Masks-Premarket Notification Submissions Guidance forIndustry and FDA Staff standard. At the same time, it also meets the requirements of the mask for the respirator, and tests the synthetic blood penetration and surface moisture resistance.

European Union for European masks (Conformite) Europeenne (CE) certification standards include BSEN140, BSEN14387, BSEN143, BSEN149 and BSEN136. Among them, BSEN149 is used mostly as a respirable respirator for respirable particles. According to the particle penetration rate tested, it can be divided into three grades: P1 (FFP1), P2 (P2), and (BSEN140). The low filtration effect is more than 80%, the low filtration effect is more than 94%, and the low filtration effect is more than 97%. The FFP2 respirator is much more efficient than the respirator, KN95 mask and N95 mask mentioned above.

Medical masks must follow the BSEN14683 Medical face masks-Requirement sand test methods, which can be divided into three grades: low standard Type I, then Type II and Type II R. See Table 3. The last version is BSEN14683: 2014, which has been replaced by the new version of BSEN14683: 2019. One of the major changes in the 2019 edition was pressure difference. The pressure difference of Type I, Type II and Type II R increased from 29.4, 29.4 and 49.0Pa/cm in 2014 to 40, 40 and 60Pa/cm respectively.

AS/NZS1716: 2012 is the standard for respiratory protection in Australia and New Zealand, which stipulates procedures and materials that must be used in the manufacture of particle respirators, as well as specified testing and performance results, to ensure the safety of their use.

The standard is divided into three categories, P1: low filtration effect is more than 80%, P2: low filtration effect is more than 94%, and P3: low filtration effect is more than 99%. The standard of medical masks in Australia is AS4381: 2015, which is divided into Level1, Level2 and Level3 according to the core indicators.

Japan's JIS T8151: 2018 standard is the standard of respiratory protection devices, and is also the verification standard of Japan's Ministry of health and labour (MHLW).

DS1: low filtration effect is more than 80%; DS2: low filtration effect is more than 99%; DS3: low filtration effect is more than 99.9%.

Korea's mask standard KF (Korean filter) series, KF series standard is issued by South Korea's food and Drug Administration (Ministry of Food and Drug Safety, MFDS) issued by the mainstream mask standard in Korea (Drug).

KF series are divided into KF80, KF94 and KF99.

KF80: is more than 80% (only salt medium); KF94: is more than 94% (oil and salt medium); KF99: is more than 99% (oil and salt medium).