Certification of face masks in Russia
Face masks sold in the Russian Federation can be assigned to one of the following categories:
-Medical devices (medical products);
-Personal protective equipment; and
-Other face masks.
Medical face masks
Manufacturers of medical face masks can use the standard called GOST R 58396-2019 “Medical face masks. Requirements and test methods”. This standard can be used for masks intended to restrict the transmission of infectious agents from medical personnel to patients (e.g. during surgical operations). This standard is the first one that has set out requirements for medical masks in Russia. It has been drafted taking into consideration the requirements of EN 14683:2014.
GOST R 58396-2019 sets out requirements for the construction, design and functional characteristics as well of test methods of face masks. Masks conforming to this standard are intended to be used to restrict the transmission of infections from medical personnel to patients and can also be used to restrict the emission of infectious agents from an infected person during sneezing or coughing.
This standard has been developed within the framework of the Technical Committee on Standardisation No. 011 “Medical devices, apparatus and equipment” (TK 011).
Russia is also developing a “preliminary national standard” (PNST) that is called "Facial gauze masks". As at 18 April 2020, this document is undergoing a public discussion. Its adoption is planned for June 2020. A “preliminary national standard” is an experimental standardisation document and is normally in force for a period of up to 3 years. A decision on whether to extend its application is taken based on the practical results of its implementation. Normally, at the end of its initial period of validity a decision is taken on whether to extend its application, to repeal it or to improve / enhance its provisions.
For the development of this PNST, typical technical conditions (TU) developed by JSC "IPPC TLP", TU 21.20.24-001-00302178-2020 "Medical gauze mask" and TU 32.50.50-002-00302178-2020 "Medical mask from non-woven materials were used.
Personal protective equipment (PPE) masks
Face masks classified as personal protective equipment (PPE) that protect respiratory organs are governed by the EAEU Technical Regulation (TR) on the Safety of Personal Protective Equipment (TR TS 019/2011). The requirements applicable specifically to PPE face masks are set out in the standards that have been included into the list of standards the use of which gives presumption of compliance with the TR on PPE (TR TS 019/2011). These standards are:
- GOST 12.4.293-2015 (EN 136: 1998) “Respiratory protective devices. Face masks. General technical requirements”; and
- GOST 12.4.294-2015 (in line with EN 149:2001+А1:2009) “Respiratory protective devices. Filtering half masks to protect against aerosols”.
Other face masks
Face masks other than PPE or medical devices are classified as sanitary-hygienic products that are not regulated by any specific unified requirements. Manufacturers of “other” face masks can develop and approve their own Technical Conditions (TUs) (internal requirements) or to request other manufacturers of face masks to allow the use of TUs that have already been adopted and approved. There is a TU Registry in Russia is maintained by an organisation called STANDARTINFORM that is subordinate to the main Russian standardisation authority – Rosstandart.
On 13 April 2020, TU 13.92.29-005-00302178-2020 called “Hygienic Face Masks” have been registered in the Russian TU Registry and can be used by all mask manufacturers.