EN 14683 2019 specifies the construction, design, performance, and testing requirements for medical masks that are intended to prevent infective agents from being transmitted from patients to staff during medical settings. An appropriate microbial barrier for medical masks can be used to reduce the transmission of infective agents from the mouth and nose of an asymptomatic carrier, or a patient suffering from clinical symptoms.
There are 7 types of surgical masks for EU Market:
- Type I: Bacterial filtering effectiveness > 95%.
- Type IR: Bacterial filtering effectiveness > 95%, splash-resistant
- Type II: Bacterial filtering effectiveness > 98%.
- Type IIR: Bacterial filtering effectiveness > 98%, splash-resistant
- FFP1:Bacterial filtering effectiveness ≥ 80%
- FFP2: Bacterial filtering effectiveness ≥ 94%
- FFP3: Bacterial filtering effectiveness ≥ 99%
There are 5 types of surgical masks for EU Market:
- Level 1: Bacterial filtering effectiveness ≥ 95%,
- Level 2: Bacterial filtering effectiveness ≥ 98%,
- Level 3: Bacterial filtering effectiveness ≥ 98%,
- N95:Bacterial filtering effectiveness ≥ 95%
- N99: Bacterial filtering effectiveness ≥ 99%
To understand the following terminology, please check this ASTM standard article for a detailed explanation.
- BFE (Bacterial Filtration Efficiency)
- Fluid Resistance
- Delta P (Pressure Differential)
- Spread the Flame
- ISO Certification
The standard specification of both ASTM F200-19 and EN 14683:2019 Barrier Levels are placed into comparison by Nelson Labs Medical Face Mask Tests and Requirements.
Wintop Surgical Masks are EN 14683:2019 Type II and have the BFE of more than 98%, which is similar to masks that are of ASTM F200-19 Level 2 (Barrier Testing BFE).
Quoted from Health Science Authority, ” In contrast to a thin, single-layered or double-layered paper mask, a surgical mask usually consists of three layers of flat or pleated fabric. ” It is also stated that an ideal surgical mask should
- Has the manufacturer’s name printed on its packaging.
- Has a bacterial filtration efficiency of 95% or higher.
- Carries an expiry date on its packaging.
- Does not contain materials that you are allergic to.
- Provides a good fit.
Sources:
https://www.nelsonlabs.com/testing/surgical-face-masks-and-general-use-masks-astm-f2100/
