For the purpose of preventing the spread of the new Coronavirus (SARS-CoV-2), it has been recommended health professionals to use masks that are regulated as medical devices (type II and IIR surgical masks) and as protective equipment individual [(self-filtering respiratory protection masks (FFP2 and FFP3)). Medical masks, commonly referred to as surgical masks, are medical devices which are intended to cover the mouth and nose of the health professional, functioning as a barrier designed to minimize the direct transmission of infectious agents between the professional and the patient. In this case the main purpose of the product is to protect the health and safety of the patient, regardless of simultaneously also protecting the professional. The standard EN 14683: 2019, harmonized within the scope of the Medical Devices Directive, is intended to masks for clinical use, classifying them into different types (I, II and IIR) according to their characteristics, namely: the efficiency of bacterial filtration, the differential pressure (mask permeability to air), splash resistance and microbial cleaning (bioburden). The following table, extracted from that standard, summarizes the performance characteristics of according to type of masks:
Masks that are intended to be worn by users with a view to protecting themselves against or more risks likely to threaten your health or safety are classified as equipments for individual safety. The standard EN 149: 2001 + A1: 2009 applicable to filtering respiratory protection devices (APR), namely the so-called “respirators” or “self-filtering semi-masks”, classifies these equipment in FFP1, FFP2 and FFP3, taking into account their filtration efficiency and leakage maximum inland (FFP3> FFP2> FFP1):
- Efficiency: low
- Total penetration (as tested): 22%
- Penetration into the filtering material (max): 20%
- Use case: plaster dust, concrete dust, some metallic particle
- Efficiency: medium
- Total penetration (as tested): 8%
- Penetration into the filtering material (max): 6%
- Use case: earthworks, stone, water-based spray paint, molds, fungi
- Efficiency: high
- Total penetration (as tested): 2%
- Penetration into the filtering material (max): 1%
- Use case: dangerous products, chemical and pharmaceutical products, virus and bacteria
Due to the rapid evolution of the COVID-19 pandemic, the use of masks is increasingly an issue debate, as a complementary measure to limit the transmission of SARS-CoV-2 in the community. Within the general framework of the exposure risk prevention guidelines, it is relevant to to promote a wider use of masks by the community, as well as to define which criteria and requirements that they must meet in terms of design, performance and usability. The definition of these criteria, namely in terms of filtration, breathability, dimensioning and resistance, were the subject of consensus by a group of experts with techniques in the medical-pharmaceutical, textile technology, infection and disinfection, standards and tests to be applied, inspection, etc. Simultaneously, there has been a mobilization of the national business fabric, to collaborate in the joint effort to combat the pandemic, reconverting the production lines for the manufacture of personal protective equipment and essential medical devices. These companies are available for placing on the market masks in single-use, or even reusable, fabric that failing to comply with the safety, health and performance requirements established in the
laws applicable to medical devices and personal protective equipment, may comply with the requirements to be defined for community use. The responsibility for the compliance of these masks with the requirements to be defined will rest with the manufacturer, choosing appropriate raw materials, designing, manufacturing and labeling the masks so that they comply with the defined requirements, as well as test them according to with the applicable normative references, in a laboratory recognized for this purpose.
Mask categorization by user type
Thus, a system for categorizing the masks used in the context of COVID-19 is adopted, considering its purpose:
Level 1: masks intended for use by healthcare professionals.
Level 2: masks intended for use by non-health professionals are exposed to contact with a large number of individuals.
Level 3: masks designed to promote group protection (use by individuals in the context of their professional activity, use by individuals in contact with others individuals with any type of mask and use in authorized outlets in confinement context, namely in interior spaces with multiple people).
The use of these masks does not imply any changes:
hand hygiene and respiratory etiquette;
the organization and procedures to be adopted, namely, by schools and employers that make it possible to improve the protection of employees.
Level 2 and level 3 masks classified as Textile Articles
Level 2 and level 3 masks, not classified as medical devices or equipment protection, and designated as textile articles, shall be tested by the methods in the previous table, taking into account that the results achieved with the model biological standard in the medical device standard, to assess filtration performance, correspond to the results given by the measurement of inert particles, as proposed in the standard for personal protective equipment. Resistance to wear during the time of use should also be considered, since that changes caused by wear can induce greater retention and growth bacterian. Regarding the reuse of these masks, performance studies should be carried out after simulating the actual use and the number of expected maximum reuse cycles. The information about the reuse process (washing, drying, conservation, maintenance) and the number of reuse must be provided by the manufacturer to the user. The user must also be informed of the performance characteristics and the product is not a medical device or a personal protective equipment, as well as the composition, should be made available through the labeling or marking of the textile product. Manufacturers shall notify ASAE of the manufacturing activity and the masks manufactured and maintain available to the authorities a brief technical file of the product including the characteristics of the raw material, the description of the manufacturing process, the information to be provided with the product and the laboratory tests and product compliance reports issued recognized, namely accredited laboratories for the indicated methods.