How to check information about a measuring instrument

To undergo state registration, the registration dossier must include information on classifying a medical device as a measuring instrument. The list of measurements when carrying out activities in healthcare is presented in the Resolution of the Government of the Russian Federation of November 16, 2020 No. 1847 "On approval of the list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements".

How to check information about a measuring instrument?

Figure 1 – Scheme for checking information about a measuring instrument

1. Go to the FSIS Rosstandart website.
2. Select the sections “Metrology Subsystem “ARSHIN” and open the “Public Portal”
3. On the side panel, select “Approved types of measuring instruments” and a window with filters for searching appears on the screen:

1. Number in the state register;
2. Name of MI;
3. MI type designation;
4. Manufacturer.

Knowing one of the data, you can check the presence of the product in the state register of measuring instruments. Having found the required product, you can click the filter 5) Actions and view the verification method and type description.

How to check product verification information?

Verification of measuring instruments is the determination by the metrological body of the errors of measuring instruments (or verification of their compliance with permissible standards) and the establishment of their suitability for use. Verification is carried out for a batch of medical products in accordance with the established verification methodology, in an accredited testing laboratory. Based on the verification results, each serial number of the product from the verified batch is entered into the FGIS "ARSHIN".

Figure 2 – Scheme for checking the presence of verification of a product

1. Go to the FSIS Rosstandart website.
2. Select the sections "Metrology Subsystem "ARSHIN" and open the "Public Portal"
3. On the side panel, select " Information on the results of verification of measuring instruments" and a window with filters for searching appears on the screen. Knowing one of the data (serial number, number in the state register, name of the type of measuring instrument, etc.), you can easily find the desired product and see the date of its verification.

1. Russian Federation. Government. "On approval of the list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements": Resolution of the Government of the Russian Federation of November 16, 2020 No. 1847 (with amendments and additions);
2. Federal State Information System of Rosstandart.