Guidance for transparent medical mask technical specifications: Overview
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About this guide
This guidance document outlines the design and performance requirements for single-use transparent medical masks. This document only applies to transparent medical masks that comply with:
- the technical specifications of EN 14683 or ASTM F2100 or
- other test requirements mentioned
It does not apply to transparent face coverings used for communications, as these face coverings are not considered a medical device under the Medical Devices Regulations. Transparent face coverings only help to provide source control (that is, to help protect others from the spread of SARS-CoV-2 by an infected wearer) and do not meet medical mask standards.
About transparent medical masks
Transparent medical masks help reduce the spread of SARS-CoV-2 virus by an infected person. Like other medical masks, the materials are expected to provide some level of protection to the wearer based on their ability to filter out small aerosolized particles.
However, unlike respirators, the testing of medical masks:
- is limited to the materials only
- does not account for air gaps
Furthermore, medical masks do not fit snugly around the nose and mouth as do respirators. For this reason, their ability to filter very small particles (including virus particles in the air) is more limited than that of a well-fitted respirator.
Standard medical masks are opaque. The SARS-CoV-2 pandemic (COVID-19) has clearly shown that these masks put a significant number of people, including health care workers and teachers, at a disadvantage.
Many individuals and groups would benefit from the use of a transparent medical mask. These include:
- health care workers who have hearing impairments
- patients who have hearing impairments
- speech and language therapists and their patients
- teachers who teach students with special learning needs;
- students who have special learning needs
- health care workers working with patients with:
- learning disabilities
- mental health conditions
- conditions that affect cognition, such as dementia
Transparent medical masks make it easier for the wearer to communicate. Visual cues are important to people with hearing impairments and special learning needs. A transparent medical mask allows the mouth of the wearer to be seen.
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