In 2020, the rampant spread of the novel coronavirus has made masks an indispensable item in our lives. However, the classification, functions and requirements of masks are rich and varied. When buying masks, have you ever paid attention to the implementation standards printed on the packaging? Qualified masks must meet the requirements of national standards, and different standards have different requirements for mask performance. In order for everyone to correctly choose the masks they need, Tailin Biotechnology has briefly interpreted the mask standards in my country and some other countries to help everyone better understand the standards.

　　1. my country's current mask standards

　　According to my country's mask standards, masks can be divided into three types: labor protection masks, medical masks and protective masks.

　　1. Labor protection mask standards

　　The standard for labor protection masks in my country is GB 2626-2006 "Self-priming filter-type anti-particle respirator for respiratory protective equipment", which was promulgated by the former General Administration of Quality Supervision, Inspection and Quarantine and the National Standardization Administration. It is a full-text mandatory standard and was implemented on December 1, 2006. It is mainly aimed at industrial dust masks and is suitable for self-priming filter-type respiratory protective equipment that protects against various types of particles. It stipulates the technical requirements, test methods and identification of self-priming filter-type anti-particle respirators for respiratory protective equipment. The standard divides masks into three levels according to the filtration efficiency of masks: 90 (KN90, KP90), 95 (KN95, KP95), and 100 (KN100, KP100). The numbers indicate the size of the filtration efficiency. The KN series is tested with sodium chloride particles, and the KP series is tested with oil particles. See Table 1 and Table 2 for specific requirements and classifications.

　　Table 1 Classification of masks in GB2626-2006

 

　　Table 2 GB2626-2006 Mask filtration efficiency levels and requirements

　　Note: The test flow rate of this standard is 85L/min. The index requirements for respiratory resistance are: inhalation resistance does not exceed 350Pa, and exhalation resistance does not exceed 250Pa.

　　The revised version GB 2626-2019 "Respiratory Protection Self-priming Filter-Type Particulate Respirator" was officially released on December 31, 2019, and is scheduled to be officially implemented on July 1, 2020. The new standard adds requirements such as respirator materials and leakage detection methods for detachable parts of the product.

　　2. Standards for medical masks

　　There are three currently effective standards for medical masks in my country: YY/T 0969-2013 "Disposable Medical Masks", YY 0469-2011 "Medical Surgical Masks", and GB 19083-2010 "Technical Requirements for Medical Protective Masks". The differences in the scope of application and regulations of these three standards are as follows: YY/T 0969-2013 "Disposable Medical Masks" is a conventional mask used by ordinary medical staff. This standard is a recommended standard for the pharmaceutical industry and was implemented on October 1, 2014. The core performance requirement is that the bacterial filtration efficiency (BFE) must be ≥95%, and the microbial indicators of the mask are specified (see Table 3). YY 0469-2011 "Medical Surgical Masks" was issued by the State Food and Drug Administration and is a mandatory standard for the pharmaceutical industry. It was implemented on December 31, 2011. This standard specifies the technical requirements, test methods, marking and instructions for use, as well as packaging, transportation and storage of medical surgical masks. This standard stipulates that the bacterial filtration efficiency requirements of masks are consistent with YY/T 0969, and adds the particle filtration efficiency (PFE) requirement of ≥30% and the synthetic blood penetration performance requirement, so as to provide better protection when blood contacts the mask during surgery. The main performance requirements of this standard are shown in Table 4. GB 19083-2010 "Technical Requirements for Medical Protective Masks" was promulgated by the former General Administration of Quality Supervision, Inspection and Quarantine and the National Standardization Administration and implemented on August 1, 2011. This standard stipulates the technical requirements, test methods, marking and instructions for use, packaging, transportation and storage of medical protective masks. It is suitable for self-priming filtering medical protective masks that filter particulate matter in the air and block droplets, blood, body fluids, secretions, etc. in medical working environments. This standard emphasizes the protective performance of masks, slightly relaxes the microbial indicators of non-sterile masks (see Table 3), and divides the mask filtration efficiency levels into 1-3 levels, with a filtration efficiency of ≥95% for level 1, ≥99% for level 2, and ≥99.97% for level 3 (see Table 5 for details).

　　Table 3 Comparison of microbial indicators of masks (all three sterile masks are required to be sterile)

 

　　Table 4 Main performance requirements of YY0469-2011 masks

 

　　表5 GB19083-2010 口罩的过滤效率级别及要求

　　注：该标准的测试流量为(85±2)L/min，口罩的吸气阻力不超过343.2Pa(35 mmH20)。有合成血液穿透要求：将2mL 合成血液以10.7KPa(80 mmHg)压力喷向口罩，口罩内侧不应出现渗透。

　　3、防护口罩标准

　　GB/T 32610-2016《日常防护型口罩技术规范》由原国家质检总局、国家标准化管理委员会发布，是我国首个民用防护口罩国家标准，于2016年11月1日实施。该标准涉及口罩原料要求、结构要求、标签标识要求、外观要求等，主要指标包括功能性指标颗粒物过滤效率、呼气吸气阻力指标、密合性指标等。该标准要求口罩应能安全牢固地护住口鼻，不应存在可触及的锐利角和锐利边缘，对甲醛、染料、微生物等可能会对人身体造成伤害的因素做了详细规定，以保障公众佩戴防护口罩时的安全性。

　　表6 GB/T 32610-2016 口罩的过滤效率级别及要求

 

　　表7 GB/T 32610-2016 口罩的防护效果要求

 

　　表8 GB/T 32610-2016 口罩适用的环境空气质量

　　注：该标准的测试流量为85L/min。当口罩的防护级别达到A级，其过滤效率级别应该为Ⅰ级或Ⅱ级，当口罩的防护级别在B、C、D级时其过滤效率级别应该为Ⅱ级或Ⅲ级。

　　除国标外，还有一些团体标准，目前团体标准和内容简介如下：TAJ1001-2015《PM2.5 防护口罩》由中国纺织商业协会提出制定的团体标准，2016年3月1日实施，该标准是针对雾霾防护而编制的。T/CTCA 7-2019 《普通防护口罩》由中国纺织品商业协会提出制定的团体标准，2020年1月30日实施，适用于日常生活中滤除花粉、柳絮、细菌颗粒物和阻隔鼻腔或口腔呼出或喷出污染物所佩戴的防护型口罩。T/CNTAC 55-2020、T/CNITA 09104-2020《民用卫生口罩》由中国纺织工业联合会和中国产业用纺织品行业协会共同提出的团体标准，2020年3月11日发布、实施，适用于日常环境中普通人群用于阻隔飞沫、花粉、微生物等颗粒物传播的民用卫生口罩。

　　二、国外现行的口罩标准

　　国外口罩标准将口罩分为劳动防护类、医用防护类两种。各国均有不同的口罩标准，列举几个国外标准作介绍。

　　1、美国劳保口罩标准：NIOSH Standards (Title 42 CFR Part 84)

　　表9 NIOSH 标准口罩的级别及要求

 

　　注：该标准的测试流量为85L/min。呼吸阻力的指标要求为：吸气阻力不超过 350pa，呼气阻力不超过250pa。

　　2、欧盟劳保口罩标准 EN 149:2001+A1-2009

　　表10 EN149标准 口罩的级别级要求

　　注：该标准的测试流量为 95L/min。

　　3、美国医疗卫生口罩标准 ASTM F2100-19

　　表11 ASTM F2100标准 口罩的级别及要求

　　4、 欧盟医疗卫生口罩标准 EN14683:2019

　　注a：TYPEⅠ医用口罩只能用于病人和其他人以降低传染病传播的风险，特别是在流行病或大流行情况下。TYPEⅠ口罩不适用于医疗保健人员在手术室或其他有类似要求的医疗环境中使用。

　　三、小结

　　目前我国的劳保口罩和防护口罩以氯化钠颗粒物或油类颗粒物进行过滤效率检测;医用口罩以微生物和颗粒物进行过滤效率检测，部分还有血液穿透要求。国外标准将口罩分为劳动防护类、医用防护类两种，其中欧盟对防护类口罩的最低截流标准低于国内要求，其余标准规定的指标和国内差异不大。

　　四、参考文献

　　1. GB 2626-2006《呼吸防护用品 自吸过滤式防颗粒物呼吸器》

　　2. GB 2626-2019 《呼吸防护 自吸过滤式防颗粒物呼吸器》

　　3. YY 0469-2011《医用外科口罩》

　　4. GB 19083-2010《医用防护口罩技术要求》

　　5. T/CNTAC 55-2020、T/CNITA 09104-2020《民用卫生口罩》

　　6. GB/T 32610-2016《日常防护型口罩技术规范》

　　7. TAJ1001-2015《PM2.5 防护口罩》

　　8. T/CTCA 7-2019《普通防护口罩》

　　9. NIOSH Standards (Title 42 CFR Part 84)

　　10. EN 149:2001+A1-2009

　　11. ASTM F2100-19

　　12. EN14683:2019