Order No. 257n by the Ministry of Health of the Russian Federation

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
of April 29, 2025 N 257n

ON APPROVAL OF THE LIST OF MEDICAL PRODUCTS RELATED TO MEASURING INSTRUMENTS IN THE SPHERE OF STATE REGULATION OF ENSURING UNIFORMITY OF MEASUREMENTS, AND THE PROCEDURE FOR CONDUCTING THEIR TESTS FOR THE PURPOSE OF APPROVING THE TYPE OF MEASURING INSTRUMENTS

In accordance with Part 8 of Article 38 of the Federal Law of November 21, 2011 N 323-FZ "On the Fundamentals of Health Protection of Citizens in the Russian Federation" and subparagraph 5.2.189 of paragraph 5 of the Regulation on the Ministry of Health of the Russian Federation, approved by Resolution of the Government of the Russian Federation of June 19, 2012 N 608 , I order:

1. To approve:

a list of medical products related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, in accordance with Appendix No. 1 to this order;

the procedure for testing medical devices related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, for the purpose of approving the type of measuring instruments in accordance with Appendix No. 2 to this order.

2. To recognize as invalid the order of the Ministry of Health of the Russian Federation of August 15, 2012 No. 89n "On approval of the Procedure for conducting tests for the purpose of approving the type of measuring instruments, as well as the list of medical products related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, in relation to which tests are conducted for the purpose of approving the type of measuring instruments" (registered by the Ministry of Justice of the Russian Federation on December 25, 2012, registration No. 26328).

3. This order shall enter into force on September 1, 2025 and shall remain in effect until September 1, 2031.

Minister
M.A. MURASHKO

Appendix No. 1
to the order of the Ministry of Health of the Russian Federation dated April 29, 2025 No. 257n

LIST
OF MEDICAL PRODUCTS RELATED TO MEASURING INSTRUMENTS IN THE SPHERE OF STATE REGULATION OF ENSURING THE UNITENESS OF MEASUREMENTS

N	Names of medical products	Measurements	Names (units) of measured quantities
1	Medical audiometer	Measuring the intensity of test tone sound signals of different frequencies using air and bone conduction	Sound intensity (Hz)
2	Medical scales	Measuring human weight	Weight (kg)
3	Medical dynamometer	Measuring the force developed by any group of human muscles	Force (daN)
4	Clinical universal dosimeter for radiation therapy	Measurement of absorbed dose in water, absorbed dose in biological tissue, air kerma in radiation therapy	Absorbed dose (Gy)
5	Clinical X-ray dosimeter	Measurement of absorbed dose in X-ray diagnostic studies: in biological tissue; air kerma; in the water	Absorbed dose (Gy)
		Dose (air kerma) length product for computed tomography	Gy cm
		dose (air kerma) area product	Gy m2
6	Photon radiation dosimeter for radiation monitoring at personnel workplaces	Measurement of ambient and directional dose equivalent rates at personnel workplaces and individual dose equivalent for personnel	Equivalent dose of ionizing radiation, effective dose of ionizing radiation (Sv)
7	Medical products for research of external respiration parameters	Measuring the volume of inhaled (exhaled) air	Gas volume (l)
		Measurement of volumetric air flow during breathing	Gas flow rate (l/sec)
8	Medical devices for studying the composition of inhaled and exhaled air (oxymeters, capnometers, breathalyzers)	Measurement of the percentage of oxygen and carbon dioxide in inhaled (or) exhaled air (artificial breathing gas mixture) under normobaric conditions: oxygen; carbon dioxide; measurement of mass concentration of ethanol vapor in exhaled air	Volume concentration of a substance (%) or mass concentration of a substance (mg/l)
9	Set of trial spectacle lenses	Measurement of optical and physical characteristics of sets of trial spectacle lenses	Optical power (Dptr)
10	Clinical radiometer	Measurement of radionuclide activity in preparations used for microbiological research, diagnosis and treatment of diseases	Radioactivity of radionuclides (Bq)
11	Medical stadiometer	Measuring human height	Length (mm)
12	Medical thermometer	Measuring human body temperature by contact method	Temperature (°C)
13	Medical tonometer	Blood pressure measurement (non-invasive)	Measurement of excess air pressure in the compression cuff (mmHg)
14	Photometer, spectrophotometer, photocolorimeter medical for clinical laboratory diagnostics	Measuring optical density values with subsequent recalculation of the measured value into the required parameter in accordance with the research methodology	Optical density of solutions of the substances under study (OD units)
15	Medical ergometer	Measuring dosed physical activity	Mechanical power (W)

Appendix No. 2
to the order of the Ministry of Health of the Russian Federation dated April 29, 2025 No. 257n

PROCEDURE
FOR TESTING MEDICAL DEVICES RELATED TO MEASURING INSTRUMENTS IN THE SPHERE OF STATE REGULATION OF ENSURING UNIT OF MEASUREMENTS, FOR THE PURPOSE OF APPROVING A TYPE OF MEASURING INSTRUMENTS

1. Testing for the purpose of approving the type of measuring instruments of medical devices related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements (hereinafter referred to as testing, medical devices, measuring instruments) shall be carried out on medical devices included in the List of medical devices related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, approved by this order.

2. Applicants for testing (hereinafter referred to as the applicant) are:

a) the manufacturer (producer) of the medical device;

b) an authorized representative of the manufacturer (producer) of a medical device - a legal entity or an individual registered as an individual entrepreneur, who are residents of the Russian Federation, authorized by the manufacturer (producer) of a medical device to represent its interests on matters of circulation of the medical device on the territory of the Russian Federation, including on matters of conformity assessment procedures and state registration of the medical device.

3. Tests are carried out by legal entities accredited in accordance with the legislation of the Russian Federation on accreditation in the national accreditation system in the field of ensuring the uniformity of measurements to perform tests of standard samples or measuring instruments <1> (hereinafter referred to as the tester), in accordance with their areas of accreditation.

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<1> Clause 9 of Article 2 of the Federal Law of June 26, 2008 No. 102-FZ "On Ensuring the Uniformity of Measurements" (hereinafter referred to as Federal Law No. 102-FZ).

4. To conduct the tests, the applicant or a person authorized by the applicant shall send to the tester (by registered mail with notification of delivery or in the form of an electronic document, by sending it to the tester's e-mail) an application for conducting the tests (hereinafter referred to as the application) with the documents specified in paragraph 6 of this procedure attached.

5. The application must include the following information:

a) name of the medical device;

b) in relation to the applicant:

legal entity - full and abbreviated (if any) name, organizational and legal form, taxpayer identification number (for a manufacturer who is a resident of the Russian Federation), registration address at the location, as well as telephone number and email address (if any);

an individual registered as an individual entrepreneur - last name, first name and patronymic (if any), details of the identity document, taxpayer identification number (for a manufacturer who is a resident of the Russian Federation), registered address of residence, as well as telephone number and email address (if any);

c) the type of medical device in accordance with the nomenclature classification of medical devices <2>;

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<2> Order of the Ministry of Health of the Russian Federation of June 6, 2012 No. 4n "On approval of the nomenclature classification of medical devices" (registered by the Ministry of Justice of the Russian Federation on July 9, 2012, registration No. 24852) with amendments introduced by orders of the Ministry of Health of the Russian Federation of September 25, 2014 No. 557n (registered by the Ministry of Justice of the Russian Federation on December 17, 2014, registration No. 35201), dated July 7, 2020 No. 686n (registered by the Ministry of Justice of the Russian Federation on August 10, 2020, registration No. 59225).

d) the class of potential risk of using a medical device in accordance with the nomenclature classification of medical devices <2>;

e) designation of the type of measuring instrument (the designation of the type of measuring instrument must be represented by a single alphanumeric designation for the approved type of measuring instrument);

f) information about the models (brands) of the medical device and accessories required for the use of the medical device for its intended purpose (if any);

g) the intended use of the medical device established by the manufacturer (producer);

h) information on the availability of software used to obtain measurement results;

i) the declared metrological and technical characteristics of the medical device, including accuracy indicators;

j) information on the technical documentation in accordance with which the verification of the medical device will be carried out;

k) information about the factory and (or) serial number (numbers) of the medical device specimen (specimens) being submitted for testing;

l) information on the availability of preliminary test reports for the medical device;

m) information on mandatory metrological and technical requirements for measuring instruments (if there are requirements in the technical documentation for the medical device). If there are such mandatory requirements, information is provided on documents confirming the compliance of the medical device with the mandatory requirements established for measuring instruments in accordance with Part 6 of Article 1 of Federal Law No. 102-FZ;

n) information for a medical device submitted for testing on the compliance of such medical device with Section VII "Medical Devices" of the Requirements for Industrial Products, presented for the purpose of classifying them as Russian industrial products, approved by Decree of the Government of the Russian Federation of July 17, 2015 No. 719 "On confirmation of production of industrial products" (if any).

6. The following documents are attached to the application:

a) technical documentation of the manufacturer (producer) for the medical device;

b) operating documentation of the manufacturer (producer) for the medical device (instructions for use or operating manual for the medical device);

c) color photographic images of the general appearance of the medical device, models (brands) of the medical device and accessories necessary for the use of the medical device for its intended purpose.

d) a copy of the power of attorney or other document confirming the authority of the person to submit the application on behalf of the applicant (in the case of the application being submitted by an authorized representative of the applicant).

7. If the documents for the medical device specified in paragraph 6 of this procedure are drawn up in a foreign language, they must be translated into Russian. The accuracy of the translation or the authenticity of the translator's signature must be notarized <3>.

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<3> Article 81 of the Fundamentals of the Legislation of the Russian Federation on Notaries of February 11, 1993 N 4462-1.

8. The tester shall review the application and documents specified in paragraph 6 of this procedure within 10 working days from the date of their receipt.

To conduct tests, the tester agrees with the applicant on the conditions for conducting them, including verification of the test results.

9. If it is impossible to conduct tests due to the absence of grounds for performing the work (lack of accreditation) and (or) the technical capability of the tester (malfunction or scheduled work on the tester's equipment), or the non-compliance of the submitted application and documents with the requirements of this procedure, the tester shall notify the applicant of this in writing (by sending a notification by registered mail with a return receipt requested or in the form of an electronic document to the applicant's e-mail address specified in the application) indicating the grounds for refusing to conduct the tests.

10. The tester develops, agrees with the applicant and approves a test program (hereinafter referred to as the test program) within the timeframes agreed upon between them.

The test program is developed in accordance with the provisions of national standards <4> establishing general requirements for measuring instruments, their development, testing and application (if there are relevant national standards), as well as mandatory metrological and technical requirements for measuring instruments established by the legislation of the Russian Federation on ensuring the uniformity of measurements and the legislation of the Russian Federation on technical regulation (if any).

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<4> Clause 2 of Article 2 of the Federal Law of June 29, 2015 N 162-FZ "On Standardization in the Russian Federation".

11. The test program shall specify the use in testing of primary reference measurement procedures (methods), reference measurement procedures (methods), certified measurement procedures (methods), standards of units of measurement that meet the requirements of the Regulation on standards of units of measurement used in the sphere of state regulation of ensuring the uniformity of measurements, approved by Decree of the Government of the Russian Federation of September 23, 2010 No. 734 , standard samples of the approved type, measuring instruments of the approved type and verified.

When conducting tests outside the Russian Federation using the standards of units of measurement and measuring instruments of the applicant, traceability <5> of the applied standards of units of measurement and measuring instruments to the national primary standards of units of measurement of foreign countries must be ensured.

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<5> Clause 18 of Article 2 of Federal Law N 102-FZ.

The test program is drawn up on paper or in the form of an electronic document.

The test program on paper is drawn up in the number of copies agreed upon between the tester and the applicant.

The agreement and approval of the test program is confirmed by the signatures of the heads or persons authorized by them of the applicant and the tester, respectively. The signature of the corresponding head or person authorized by him is certified by the seal (if any) of the organization.

The test program in the form of an electronic document is signed with the electronic signatures of the heads (persons authorized by them) of the applicant and the tester in accordance with the requirements of Federal Law No. 63-FZ of April 6, 2011 "On Electronic Signature" (hereinafter referred to as Federal Law No. 63-FZ).

12. The test program shall include the following information:

a) a description of the medical device as a test object, including its composition and completeness;

b) the number of medical device samples selected and submitted for testing;

c) the content and scope of testing of the medical device;

d) methods (techniques) for testing a medical device;

d) conditions for testing the medical device;

e) algorithms for processing the results obtained during testing of a medical device;

g) on the determination of the metrological and technical characteristics of a medical device, including accuracy indicators, expressed in units of quantities approved for use in the Russian Federation;

c) on verification of software identification (if software is available);

i) on the development or selection of a method for verifying a medical device (hereinafter referred to as a verification method) and its testing;

k) on determining the interval between verifications;

l) analysis of the design of the medical device being tested for the presence of access restrictions to certain parts of the medical device (including software) in order to prevent unauthorized adjustment and interference that may lead to distortion of the measurement results, for the presence of factory and (or) serial numbers ensuring the identification of each copy of the medical device, to establish the location, method and format of applying the factory and (or) serial number in order to ensure the ability to read and preserve the number during operation of the measuring instrument (in accordance with the requirements of Part 2 of Article 9 of Federal Law No. 102-FZ), for the possibility of applying the type approval mark and verification mark in places accessible for viewing.

13. If there are mandatory requirements for measuring instruments, as provided for in Part 1 of Article 9 of Federal Law No. 102-FZ, including requirements for their components, software and operating conditions of measuring instruments, verification of the medical device’s compliance with these requirements is provided for in the test program.

14. After approval of the test program, the applicant shall submit samples of the medical product for testing, as provided for in the test program, within the timeframes agreed upon between the tester and the applicant.

15. The tester conducts tests of medical devices in accordance with the test program within the timeframes agreed upon between the tester and the applicant.

The results of the work provided for in the test program are recorded in protocols.

16. The following information is indicated in the test reports:

a) information about the medical product samples submitted for testing (name of the medical product, factory numbers and (or) serial numbers of the submitted samples);

b) a list of test program items for which tests were carried out;

c) information on the timing of the tests;

d) information on standards of units of measurement, measuring instruments, standard samples, testing equipment and auxiliary means used in testing;

d) information on the compliance of the technical means used for testing with the requirements of the test program;

e) information about the location and conditions of the tests;

g) test results.

17. Test reports containing the results of testing verification methods are drawn up in accordance with the procedure for establishing, canceling verification methods and making changes to them, approved in accordance with Part 7 of Article 12 of Federal Law No. 102-FZ.

18. Based on the test results, within the timeframes agreed between the tester and the applicant:

a) a draft description of the type of measuring instrument is developed;

b) the verification procedure is sent to the Federal Agency for Technical Regulation and Metrology for the purpose of establishing it in accordance with the procedure for establishing, canceling verification procedures and amending them, approved in accordance with Part 7 of Article 12 of Federal Law No. 102-FZ (if the verification procedure has been developed specifically for this type of measuring instrument and has been tested with a positive conclusion on the feasibility of the verification procedure and the possibility of its application for verification of the approved type of measuring instrument);

c) a medical device testing report is drawn up;

d) evaluation of test results is organized at the state scientific metrological institute <6> (in the area of activity).

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<6> Part 5 of Article 21 of Federal Law No. 102-FZ.

19. The draft description of the type of measuring instruments is developed on paper or in the form of an electronic document.

On paper, all pages of the description of the measuring instrument type must have:

a) continuous numbering with the sheet number and the total number of sheets indicated on each sheet;

b) a place to indicate the position of the authorized person of the Federal Agency for Technical Regulation and Metrology signing the description of the type of measuring instrument;

c) space for signature and signature transcript;

d) a place for placing a seal and indicating the date of signing.

In the form of an electronic document, the draft description of the type of measuring instruments is signed with an enhanced qualified electronic signature of an authorized person of the Federal Agency for Technical Regulation and Metrology.

20. The following information is indicated in the draft description of the type of measuring instrument:

a) the name of the medical device and the designation of the type of measuring instrument;

b) the purpose of the medical device (contains a description of the measuring instrument of the approved type in terms of indicating what measurements and what quantities it is intended for);

c) a description of the medical device (including information on its design, operating principle, number of models (brands) of the medical device and accessories required for using the medical device for its intended purpose, their designation and design features, including an indication of the locations and methods of restricting access to the settings (adjustments), locations, methods and format of application of factory numbers and (or) serial numbers or alphanumeric designations that uniquely identify each copy of the medical device);

d) information about the software (including information about the description of the software, including its identification data, assessments of its impact on the metrological characteristics of the medical device and the level of protection of the software from unintentional and intentional changes - only if software is available);

d) metrological and technical characteristics (the metrological and technical characteristics, including the accuracy indicators of the medical device, are indicated);

e) a type approval mark (the location and method of applying the type approval mark to the medical device and/or accompanying documents are indicated), the requirements for which are approved in accordance with Part 7 of Article 12 of Federal Law No. 102-FZ;

g) completeness of the medical product (the completeness of the medical product in which the medical product is supplied to the consumer is indicated, including operating documents);

c) information on measurement techniques (methods) (the name of the section of technical and (or) operational documentation that contains the measurement technique (method), or the name of the measurement technique (method) is indicated);

i) regulatory documentation governing the requirements for safety, quality, as well as the expected effectiveness of the intended use and methods for monitoring the compliance of the medical device with these requirements <7>;

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<7> Paragraph ten of clause 4 of the Rules for state registration of medical devices, approved by Decree of the Government of the Russian Federation of November 30, 2024 N 1684 (hereinafter referred to as the Rules). According to clause 7 of the Decree of the Government of the Russian Federation of November 30, 2024 N 1684 "On approval of the Rules for state registration of medical devices" the Rules are valid until December 31, 2026.

k) information about the manufacturer (producer) of the medical device:

legal entity - full and abbreviated name (if any), organizational and legal form, taxpayer identification number (for a manufacturer who is a resident of the Russian Federation), registered address at the location, as well as telephone number and email address (if any);

an individual registered as an individual entrepreneur - last name, first name and patronymic (if any), details of the identity document, taxpayer identification number (for a manufacturer who is a resident of the Russian Federation), registered address of residence, as well as telephone number and email address (if any);

l) information about the tester (name of the legal entity that conducted the tests, address of registration at the location, unique number of the accreditation record in the register of accredited persons <8> (hereinafter referred to as the Register of Accredited Persons).

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<8> Clause 4 of Part 1 of Article 26 of the Federal Law of December 28, 2013 N 412-FZ "On Accreditation in the National Accreditation System".

21. The verification procedure for measuring instruments must comply with the requirements for verification procedures approved in accordance with Part 7 of Article 12 of Federal Law No. 102-FZ.

22. The medical device testing report shall be drawn up on paper or in the form of an electronic document.

The medical device testing report on paper is drawn up in three copies, each of which is endorsed by the authorized representative of the applicant and signed by the head (person authorized by him) of the tester who conducted the testing of the medical device, indicating the position held and signature decryption.

The signature of the manager or (his authorized person) is certified by the seal (if any) of the tester.

The medical device test report shall indicate the date of its signing by the tester and the applicant.

The medical device testing report in the form of an electronic document is signed with the electronic signatures of the heads (persons authorized by them) of the tester and the applicant in accordance with the requirements of Federal Law No. 63-FZ.

23. The following shall be indicated in the medical device testing report:

a) the title of the test report, indicating the name and designation of the type of measuring instrument submitted by the applicant;

b) in relation to the applicant - the full name of the legal entity or the last name, first name and patronymic (if any) of an individual registered as an individual entrepreneur;

c) information on the testing of the medical device (name of the tester, its unique accreditation record number in the Register of Accredited Persons, name of the medical device and designation of the type of measuring instruments submitted for testing, name of the manufacturer (producer) of the medical device, timing of the testing of the medical device, basis for testing with an indication of the date and application number, area of accreditation of the tester in accordance with which the testing was carried out, location of the testing of the medical device);

d) information on the samples of the medical device declared for testing and submitted for testing (name of the medical device and designation of the type of measuring instruments, factory numbers and (or) serial numbers) and a conclusion on the possibility of their further use;

d) information on the results of testing the medical device (name of the medical device and designation of the type of measuring instruments tested, name of the test program in accordance with which the tests of the medical device were conducted);

e) information on the results of testing the medical device in accordance with the testing program, including:

established values of metrological and technical characteristics of a medical device, confirmed by test results;

results of verification of compliance of the medical device with mandatory requirements (if included in the testing program);

software identification data (if any software);

results of the design analysis (the presence of design measures that ensure sufficient protection of the medical device from unauthorized adjustment and interference or the absence of the need for such protection, the presence or absence of factory and (or) serial numbers that ensure the identification of each copy of the medical device and indicate the location, method and form of application of the factory and (or) serial number, ensuring the ability to read and preserve the number during the operation of the medical device, the possibility or impossibility of applying the type approval mark and verification mark in places accessible for viewing);

the results of testing the verification methodology with their justification (validity of the choice of measurement methods during verification, feasibility of the procedures provided for by the verification methodology for confirming the compliance of the medical device with the metrological requirements, correctness and sufficiency of the verification means for assessing the metrological characteristics of the medical device with the required accuracy, ensuring traceability during verification, the possibility or impossibility of verifying individual measuring channels (for a medical device with several measuring channels) and (or) individual autonomous units from the composition of the medical device (for a medical device with several separate autonomous units), for a smaller number of measured values (for a medical device intended for measuring several values) or on a smaller number of measurement sub-ranges (for a medical device with several measurement sub-ranges), and the presence of relevant instructions on conducting verification in a reduced scope in the document on the verification methodology (if such verification is possible);

recommended interval between inspections with its justification;

the fact of development of a project to describe the type of measuring instrument;

g) information on the results of verification of mandatory metrological and technical requirements for a medical device (if included in the test program);

c) date of signing the medical device test report.

24. The medical device test report with appendices on paper in two copies or in the form of an electronic document shall be issued or sent (by registered mail with notification of delivery or in the form of an electronic document by sending it to the applicant's e-mail, the address of which is specified in the application) to the applicant within the timeframe agreed upon between the tester and the applicant. Test protocols shall be attached to the test report.

The medical device test report is accompanied by a draft description of the type of measuring instruments, verification methods, and a conclusion on the verification of test results.

The draft description of the type of measuring instruments is issued in two copies on paper, one of which must be endorsed on each sheet by the managers or authorized persons of the applicant and the tester, or in the form of an electronic document signed with enhanced qualified electronic signatures of the managers or authorized persons of the applicant and the tester.

The conclusion on the verification of test results must contain conclusions on the assessment of test results (positive or negative).

25. The results of tests of a medical device are considered positive if the following conditions are met simultaneously:

a) the metrological and technical characteristics of the medical device obtained as a result of testing correspond to those declared;

b) the obtained test results of the medical device comply with the requirements of the test program;

c) the test program, test report with test protocols, and draft description of the type of measuring instruments are drawn up in accordance with the requirements of this procedure.

26. If at least one of the conditions specified in paragraph 25 of this procedure is not met, the test results are considered negative.