The present specification details the testing procedures and standards for materials employed in the fabrication of medical face masks utilized in healthcare services including surgical procedures and patient care.

The specification focuses on medical masks with ties (commonly known as surgical masks) and those with ear loops (referred to as procedure masks or isolation masks).

It establishes a classification for the performance of medical face mask materials, which is derived from tests for bacterial filtration efficiency, differential pressure, sub-micron particle filtration efficiency, resistance to penetration by synthetic blood, and flammability.

This specification does not encompass all aspects of medical face mask design and performance. It does not conduct a specific evaluation of the effectiveness of medical face mask designs in terms of their overall barrier and breathability characteristics.

The specification does not specify any design criteria for medical face masks. However, it distinguishes surgical masks from procedure or isolation masks by noting that surgical masks have ties for adjusting the fit, while procedure or isolation masks use ear loops for attachment to the wearer’s face.

Additionally, this specification does not cover the requirements for regulated respiratory protection devices, such as respirators, which may be required in certain healthcare settings and for exposure to inhalation hazards.