As the COVID-19 virus spreads rapidly, masks become extremely important for individual protection. In order to help stakeholders understand the standards of surgical masks in China and their differences from those in Europe and the US, the Center for the Management of Medical Device Standards of the National Medical Products Administration of China conducted technical comparison between these standards. SESEC translated the document to English for you reference.
In China, medical masks are registered as Class II medical devices and domestic products are registered and approved by the medical products administrations at provincial levels. Particle Filtration Efficiency (PFE) and Bacteria Filtration Efficiency (BFE) are the most important technical parameters. Through a comparative study, the key technical parameters of China’s medical mask standards are basically the same as those of foreign standards.
As for features and conditions of application, medical masks in China fall into three categories as follows:
- Medical Protective Mask: Used to filter particulate matter in the air and block droplets, blood, body fluids, secretions and the like in medical working environments. China implements GB19083-2010 Technical Requirements of Medical Protective Masks, in which PFE is divided into three grades: the first level ≧ 95%, the second ≧ 99%, and the third ≧ 99.97%. China’s PFE is consistent with that of standards in the US (NIOSH 42 CFR 84) and the EU (EN 149: 2001). The requirements in synthetic blood penetration, surface moisture resistance, non-one-way air valve and tightness are basically the same.
- Medical Surgical Mask: Used by clinical doctors and nurses in invasive operations. The Chinese standard for medical surgical masks is YY0469-2011 Surgical Mask. It stipulates that PFE must be ≧ 30%, and BFE ≧ 95%, which is equivalent to the type II R in the EU’s standard EN14683-2014.
- Disposable Surgical Mask: Used to block pollutants ejected from the oral or nasal cavity in general medical environments. China’s standard YY / T0969-2013 Disposable Surgical Masks stipulates that BFE must be ≧ 95%, and there is no requirement for PFE. It is equivalent to the EU’s standard EN14683-201 type I / II, and the technical specifications are basically the same.