The Ministry of Health of the Republic of Uzbekistan The Pharmaceutical Industry Development Agency
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What Are the Requirements for a Medical Mask?

In modern conditions, a medical mask has become an important and integral part of the daily life of every citizen. Due to the pandemic, the production of medical masks has increased several times, and they are in great demand among the population. For masks to be effective, manufacturers must strictly adhere to all technical requirements for medical protective equipment when manufacturing them. Below are the basic requirements for nonwoven medical masks in accordance with the approved standards.

Requirements for medical masks in the Republic of Uzbekistan are regulated by the state standard O’zDSt 3452:2020. This is the standard EN14683:2014 ‘Masks medical. Requirements and test methods’ and it came into force on July 1, 2020.

In accordance with this standard, the main parameters and characteristics of medical masks are established; in particular, medical masks must consist of the following components:

  • Filter (front) part (body);
  • Elastic bands;
  • Plastic wire designed for flexibility in the upper part of the mask.

By agreement with consumers, a medical mask can be made in different colors, as well as different shapes and textures, with additional functions, in particular, with a protective layer covering the face (to protect the face from various drops), as well as with a sweat protection function or with a lock on the nose. The filtering part (body) consists of a filtering layer and must be located between the two outer layers.

When using the mask, it should not flake or tear. The presence of tears and surface contamination on the filter is not allowed. The mass of the mask without packaging should not exceed 10 grams.

Requirements for materials

The following materials are used in the manufacture of masks:

  • non-woven fabric made of hypoallergenic polypropylene (Spanbond);
  • filtering layer of non-woven fabric (Melt-blown);
  • reinforced plastic wire;
  • elastic band.

It is allowed to use other similar materials in the manufacture of masks in accordance with applicable regulatory documents, as well as the use of imported products that meet quality and safety requirements for finished products.

Packaging

Each mask can be packed in a plastic bag (in accordance with GOST 12302) in the amount of 5 to 100 pieces. The open side of the package, filled with a mask, is glued. Bending of masks is not allowed.

Labeling

The packaged mask must have an inscription and a colorless typewritten font and labeling applied to the package. The labelling consists of the following information:

  • manufacturer’s name, legal and production addresses, manufacturer’s phone numbers;
  • product name and instructions for use;
  • sizes, cm;
  • serial number;
  • number of masks in a package, pcs;
  • date of manufacture (year, month);
  • warranty period (year, month);
  • storage conditions;
  • barcode (if available).

Transportation and storage

Packed medical masks can be transported by any type of transport in accordance with the transportation rules provided for this type of transport. During transportation, the container with masks must be protected from external and mechanical influences. Medical masks must be stored in containers prepared by the manufacturer, in a room with a temperature not exceeding 40°C and in packages where the humidity does not exceed 70%. During transportation, the container with the mask must be protected from moisture. It is forbidden to transport medical masks in combination with oils, organic solvents, chemicals, poisons and other substances.

The shelf life of masks is 5 years from the date of manufacture.

Press Office, the Pharmaceutical Industry Development Agency

 

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