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Three main standards for medical protective masks in China
There are three main standards for medical masks in China: the national standard GB19083-2010 "Technical Requirements for Medical Protective Masks", which is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee, and the industry proposed and under the jurisdiction of the State Food and Drug Administration. Standard YY0469-2011 "Medical Surgical Masks", and the industry-standard YY/T0969-2013 "Disposable Medical Masks" were proposed and managed by the State Food and Drug Administration.
1 China National Standard GB19083-2010 "Technical Requirements for Medical Protective Masks"
(1) Standard source
GB19083-2010 "Technical Requirements for Medical Protective Masks" is a mandatory national standard, proposed by the State Food and Drug Administration, and under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee.
(2) Technical content
This standard is mainly applicable to medical protective masks, which not only filter particles in the air but also block droplets, blood, body fluids, secretions, etc. In terms of terms and definitions, this standard does not provide a specific definition of particulate matter (including particle size).
From the perspective of filtration efficiency of masks, the filtration efficiency levels of medical protective masks for non-oily particles can be divided into 1, 2, and 3 levels, and the filtration efficiency of masks is 95%, 99%, and 99.97%, respectively.
From the perspective of standard technical requirements, in addition to filtration efficiency, GB19083-2010 also includes basic requirements for masks, nose clips, mask straps, airflow resistance, synthetic blood penetration, surface moisture resistance, microbial indicators, ethylene oxide residues, and resistance There are requirements on flammability, skin irritation, and tightness. Compared with the versatility of GB2626-2006 "Respiratory Protective Equipment Self-priming Filtering Anti-Particulate Respirator", these all reflect the characteristics of medical protective masks.
2 China Industry Standard YY0469-2011 "Medical Surgical Masks"
(1) Standard source
This standard is a mandatory standard for the pharmaceutical industry, enforced within the scope of the pharmaceutical industry, and is proposed and managed by the State Food and Drug Administration.
(2) Technical content
Mainly medical surgical masks and disposable masks are worn by clinical medical staff during invasive operations.
Compared with other mask standards, its filtration efficiency is relatively special, emphasizing that the filtration efficiency of bacteria is not less than 95%, and the filtration efficiency of non-oily particles is only required to be not less than 30%.
In addition to filtration efficiency, YY0469-2011 "Medical Surgical Masks" has the following characteristics: appearance, structure and size, nose clip, mask belt, synthetic blood penetration, pressure difference, flame retardant performance, microbial indicators, ethylene oxide residue, skin There are technical requirements for irritation, cytotoxicity, and delayed-type hypersensitivity, reflecting the characteristics of medical surgical masks.
3 Chinese industry standard YY/T0969-2013 "Disposable Medical Masks"
(1) Standard source
This standard is a recommended standard for the pharmaceutical industry, proposed and managed by the State Food and Drug Administration.
(2) Technical content
The disposable medical masks specified in this standard are only suitable for ordinary medical environments, not for medical protective masks and medical surgical masks. YY/T0969-2013 "Disposable Medical Masks" emphasizes that the bacterial filtration efficiency (BFE) should not be less than 95%, but does not specify the filtration efficiency of non-oily particulate matter.
In addition, YY/T0969-2013 "Disposable Medical Masks" also stipulates appearance, size structure, nose clip, mask belt, ventilation resistance, microbial indicators, ethylene oxide residue, cytotoxicity, skin irritation, Delayed-type hypersensitivity reactions, etc.
Holymed Medical Group's non-woven medical products Division, established in the year of 1980, is one of the first manufacturers which produce non-woven medical products in China. Such as disposable medical surgical mask, you can click to view more details.
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What’s the difference between Bacterial Filtration Efficiency and Particle Filtration Efficiency? Follow along to learn more about BFE and PFE.
By now, you’re probably all too familiar with what it is like to wear a facemask. After the outbreak of COVID-19, these personal protective equipment items are far more common than ever before.
N95和KN95的口罩有什么区别?
N95口罩和KN95口罩有区别吗？
这个简单易懂的图表解释了N95和KN95口罩之间的区别。N95口罩是美国口罩标准；KN95是中国口罩标准。虽然两种口罩之间有很多不同之处，但这两种口罩在大多数人关心的功能上是一样的。
口罩制造商3M说，“有理由认为”中国的KN95“相当于”美国的N95。欧洲(FFP2)、澳大利亚(P2)、韩国(KMOEL)和日本(DS)的口罩标准也非常相似。
N95和KN95的共同之处
两种口罩都能捕捉95%的颗粒。在这个指标上，N95和KN95口罩是相同的。
因为一些测试标准说N95和KN95口罩能够过滤95%的0.3微米和以上的颗粒，很多人会说它们只能过滤95%的0.3微米以上颗粒。他们以为口罩不能过滤小于0.3微米的微粒。举个例子，这是《南华早报》 的一张图。他们甚至说“N95口罩可以防止佩戴者吸入直径大于0.3微米的颗粒物”。
但是，其实口罩比许多人以为的还能捕捉更小的颗粒。根据经验数据可以看到，实际上口罩在过滤更小的颗粒方面是非常有效的。
N95和KN95口罩的区别
这两种标准都要求口罩在捕捉盐颗粒(NaCl)时进行过滤效果检测，都以每分钟85升的速度进行测试。但是，N95和KN95之间有一些区别，在这里强调一下。
这些差异都不大，对于一般使用口罩的人来说没有太大的区别。但是，这里有一些比较关键的差异：
1.如果制造商要拿到KN95的标准，需要对真人进行口罩密封测试，而且漏率（从口罩侧面漏过去的颗粒百分比）需要≤8%。N95标准的口罩不要求密封测试。（记住：这是国家对商品的要求。很多工业公司和医院会自己要求员工做密封测试。）
2.N95口罩对吸气时的压降要求比较高。这代表着它们需要更透气一点。
3.N95口罩对呼气时的压降也有稍微严格的要求，这应该有助于提高口罩的透气性。
总结：N95和KN95口罩的区别
总结：虽然只有KN95口罩需要通过密封测试，但N95口罩和KN95口罩都是被认可能够过滤95%的颗粒。另外，N95口罩对透气性有比较强的要求。
How To Use Electrospinning Nanofiber Technology To Make Super-Efficient Air Filtration Membrane?
Although the electrospun nanofiber-based filters show improved filtration efficiency and enhanced service life compared with microfiber filters, some drawbacks still remain for these filters, including inadequate filtration performance and low-quality factor, due to the thick fibers (>100 nm) and relatively large pore size. In 2012, Wang et al. first presented the fabrication of PA-66 nanofiber/net membranes, which are composed of conventional nanofibers and 2D spiderweb-like nanonets through an advanced hydrodynamic technique called electrospinning/netting. These novel nanonet structures, including coverage rate and pore size, can be facilely controlled by tuning the solution properties (the content of additives) and process parameters. Taking advantage of the integrated properties of small diameter, small pore size, and high porosity, the nanofiber/net membranes possessed a high purification efficiency of 99.9% and relatively low air resistance and can be employed as filtration media in various filtration fields. In 2017, Zhang et al. fabricated novel poly(m-phenylene isophthalamide) (PMIA) nanofiber/net membranes, which were composed of conventional nanofibers and a 2D Steiner tree network (w20 nm), for high-efficiency air filtration by using the electrospinning/netting process for the first time. The bimodal structure of the as-prepared PMIA membranes can be regulated by polymer concentration optimization, dodecyl trimethylammonium bromide additive inspiration, and ambient conditions, especially relative humidity. By virtue of structural features such as extremely small diameter, small pore size, and high porosity, PMIA nanofiber/net membranes showed superlightweight (0.365 g/m2) with ultrathin thickness (w0.5 mm) and robust mechanical property (72.8 MPa), which made them promising candidates for high-performance air filtration against 300-500 nm aerosol particles, with high a removal efficiency of 99.999%, as shown in Fig. 12.9.
