Russia: Medical oxygen cylinders are not medical devices

The Russian Federal Healthcare Supervision Service (RosZdravNadzor) published a letter clarifying how safety of medical oxygen cylinders is regulated.

In particular, the letter explains that medical oxygen cylinders are not considered medical devices and are not subject to special registration that is required for medical devices. However, during the use of medical oxygen cylinders, it is required to comply with the following regulations:

Decision of the EurAsian Economic Commission No. 41 dated 2 July 2013 adopting Technical Regulation on the Safety of Equipment Operating Under Excessive Pressure;

State standard GOST 12.2.052-81 SSBT Equipment operating on gaseous oxygen. General safety requirements.

State standard GOST 5583-78 (ISO 2046-73) Gaseous oxygen for technical and medical purposes. Technical Specifications.

State standard GOST 6331-78 Liquid oxygen for medical and technical purposes.

All medical oxygen cylinders must be accompanied by a safety passport.  Cylinder marking must comply with clauses 29-32 of the Technical Regulation on the Safety of Equipment Operating Under Excessive Pressure. For example, cylinders must be painted in light blue colour and be marked with the text “Medical oxygen” written in black letters.

In addition, according to State standard GOST 5583-78 (ISO 2046-73), each batch of medical oxygen and each cylinder or a monoblock container with medical oxygen must be accompanied with a document confirming its quality and containing the following information:

- Name of the manufacturer and its trademark;

Product name and type;

Batch number and cylinder number;

Date of manufacture; and

Volume of oxygen (in cubic meters).

For medical oxygen a registration number of a pharmaceutical (from the state pharma registry of Russia) must also be specified in the accompanying documentation.

Law: Letter No. 01i-2746/17 of 3 November 2017