Ministry of Health of the Russian Federation (Ministry of Health of Russia)

On approval of the Procedure for conducting tests in order to approve the type of measuring instruments, as well as the list of medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, in respect of which tests are carried out in order to approve the type of measuring instruments

Appendix No. 1

to the order of the Ministry of Health

Russian Federation

The procedure for conducting tests for the purpose of approval of the type of measuring instruments of medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, in respect of which tests are carried out for the purpose of approving the type of measuring instruments

1. For the purposes of state registration of medical devices, this Procedure establishes the rules for conducting tests for the purpose of type approval of measuring instruments of medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements (hereinafter referred to as tests for the purpose of type approval, medical devices), authorized by the federal executive authority in the field of state regulation of ensuring the uniformity of measurements.

2. Tests for the purpose of type approval are subject to medical devices included in the List of medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, in respect of which tests are carried out for the purpose of type approval of measuring instruments, approved by this order.

3. Applicants for testing for the purpose of type approval (hereinafter referred to as the applicant) are:

1) manufacturer of the medical device;

2) an authorized representative of the manufacturer of a medical device, which is a legal entity registered on the territory of the Russian Federation, authorized by the manufacturer of a medical device to represent its interests on issues of circulation of a medical device in the territory of the Russian Federation, including related procedures for conformity assessment, state registration, and whose name may be issued a registration certificate for a medical device.

4. Tests for the purpose of type approval are carried out by organizations accredited to carry out testing of measuring instruments in accordance with the legislation of the Russian Federation on ensuring the uniformity of measurements, the scope of which accreditation includes testing for the purpose of type approval of measuring instruments of medical products (hereinafter referred to as the tester).

The applicant receives information about the areas of accreditation of testers from the federal executive body that carries out accreditation in the field of ensuring the uniformity of measurements, or from the state register of accredited organizations carrying out activities to ensure the uniformity of measurements.

5. To conduct tests for the purpose of type approval, the applicant sends the tester an application to conduct tests for the purpose of type approval (hereinafter referred to as the application), as well as the documents specified in paragraph 7 of this Procedure.

6. The application shall indicate:

1) name of the medical product (indicating the accessories necessary to use the medical product for its intended purpose);

2) application number;

3) information about the manufacturer of the medical device:

4) information about the authorized representative of the manufacturer of the medical device:

full and (if available) abbreviated name, including corporate name, organizational and legal form of the legal entity, address of its location, as well as telephone numbers and (if available) email address of the legal entity;

5) addresses of places of production of the medical device;

6) the purpose of the medical device established by the manufacturer of the medical device;

7) type of medical device in accordance with the nomenclature classification of medical devices;

8) class of potential risk of using a medical device in accordance with the nomenclature classification of medical devices;

9) code of the All-Russian Product Classifier for a medical device.

7. Attached to the application:

1) a duly certified copy of a document confirming the authority of a representative of the manufacturer of a medical device;

2) regulatory documentation for a medical device;

3) technical documentation for the medical device;

4) operational documentation for the medical device, including instructions for use or operating instructions for the medical device;

5) a photographic image of the general appearance of the medical device along with accessories necessary for using the medical device for its intended purpose (at least 18x24 cm in size);

6) documents confirming the results of technical tests of a medical device;

7) the declared metrological and technical characteristics of the medical device, subject to verification during testing for the purpose of type approval, including accuracy indicators;

8) information about the availability of the software product used for the operation of the medical device and obtaining measurement results;

9) information on mandatory metrological and technical requirements for a medical product (if any).

The applicant has the right to submit other documents and information to the tester on his own initiative.

8. All documents for testing for type approval must be submitted in Russian. If the original documents are drawn up in a foreign language, they are presented with a duly certified translation into Russian.

9. The tester reviews the application and the documents attached to it, makes a decision on the possibility of conducting tests for the purpose of type approval and, within fourteen days after receiving the application:

1) if the decision is positive, send the applicant a draft agreement (contract) for testing for the purpose of type approval;

2) in case of a negative decision (refusal to conduct tests for the purpose of type approval), sends a letter to the applicant with a reasoned justification for the decision.

10. The basis for the tester’s decision to refuse to conduct tests for the purpose of type approval is the non-compliance of the submitted documents with the provisions of paragraphs 7 and 8 of this Procedure, as well as with the provisions of the Procedure for testing standard samples or measuring instruments for the purpose of type approval, approved by order of the Ministry of Industry and Trade Russian Federation dated November 30, 2009 N 1081 (registered by the Ministry of Justice of the Russian Federation on December 25, 2009 registration N 15866) (hereinafter referred to as Order of the Ministry of Industry and Trade of Russia dated November 30, 2009 N 1081).

11. After signing the agreement (contract), the tester develops, coordinates with the applicant and approves a test program for the purpose of type approval.

12. The test program for the purpose of type approval is developed in accordance with paragraph 24 of the Procedure for testing standard samples or measuring instruments for the purpose of type approval, approved by Order of the Ministry of Industry and Trade of Russia dated November 30, 2009 N 1081.

13. The test program for type approval must include:

1) determination of metrological characteristics of a medical product, including accuracy indicators expressed in units of quantities approved for use on the territory of the Russian Federation;

2) checking compliance with mandatory metrological and technical requirements for a medical device (if any), including requirements for its components, software and operating conditions;

3) identification of software and assessment of its impact on the metrological characteristics of the medical device (if software is available);

4) development or selection of verification methods and its testing;

5) determining the need for periodic verification;

6) determining the interval between periodic verifications;

7) analysis of the design of the medical device being tested for the presence of restrictions on access to certain parts of it (including software) in order to prevent unauthorized settings and interventions that could lead to distortion of the measurement results performed by the medical device.

14. After approval of the test program for the purpose of type approval, the applicant submits samples of the medical device for testing for the purpose of type approval.

15. The tester conducts tests for the purpose of type approval in accordance with the test program for the purpose of type approval.

16. The results of specific tests provided for in the test program for the purpose of type approval are documented in reports of the relevant tests.

17. The test reports indicate:

1) name of the test report;

2) information about the samples of the medical device submitted for testing (name of the medical device, serial numbers of the submitted samples);

3) a list of items of the test program for the purpose of type approval, for which tests were carried out;

4) test results.

18. Based on the test results, the tester draws up a test report for the purpose of type approval.

19. The test report for type approval shall indicate:

1) name of the medical product;

2) the date of signing the test report for the purpose of type approval, its registration number (if available);

3) information about testing:

a) name of the applicant;

b) the name of the tester indicating the number of the tester’s accreditation certificate;

c) name of the manufacturer of the medical device;

d) timing of testing for type approval;

e) the basis for conducting tests for the purpose of type approval, indicating the date and number of the application for testing for the purpose of type approval;

f) place of testing for type approval;

4) information about medical product samples submitted for testing for type approval:

a) name of the type of the tested sample of the medical product;

b) serial numbers of the submitted samples;

5) general information about the test results for the purpose of type approval:

a) the name of the test program for type approval purposes, in accordance with which the tests were carried out;

6) evaluation of test results (positive or negative);

7) detailed information on test results:

a) established values ​​of metrological and other technical characteristics;

b) the fact of testing the verification method with information about it;

8) draft description of the type of measuring instrument;

9) information on the results of checking compliance with mandatory metrological and technical requirements for measuring instruments (if included in the test program).

The protocols of all tests performed, the draft description of the type of measuring instrument and the verification methodology constitute an annex to the test report for the purpose of type approval and are its integral part.

20. The test report for the purpose of type approval is drawn up on the tester’s letterhead in two copies and signed by the head and representatives of the tester’s organization (indicating the date), certified by the tester’s official seal.

21. One copy of the test report for the purpose of type approval with an appendix is ​​sent to the applicant within a period not exceeding three working days from the date of registration, for submission to the federal executive body of the Russian Federation that carries out state registration of medical devices.

22. Approval of the type of measuring instrument and the issuance of a certificate of approval of the type of measuring instrument is carried out on the basis of Order of the Ministry of Industry and Trade of Russia dated November 30, 2009 No. 1081.

Appendix No. 2

List of medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, in respect of which tests are carried out in order to approve the type of measuring instruments

	Names of medical products	Medical characteristics and quantities determined using measurements	Names (units) of measured quantities
	Medical thermometers	Human body temperature	Temperature (°C)
	Medical scales	Weight (mass) of a person	Weight (kg)
	Medical height meters	Human height	Linear size (cm)
	Medical dynamometers	The force developed by a muscle group	Strength (daN)
	Medical ergometers	Power-metered physical activity	Mechanical power (W)
	Medical tonometers	Systolic and diastolic blood pressure values	Gas pressure in the air cuff with recording of the intensity of pressure micropulsations (mm Hg)
	Medical products for studying external respiration parameters (spirographs, pneumotachographs, etc.)	Volumes and flow rates of inhaled (exhaled) air	Gas volume (ml) Gas flow rate (l/sec)
	Medical products for studying the composition of inhaled and exhaled air (oximeters, capnometers, breathalyzers)	Concentrations: oxygen (oximetry), carbon dioxide (capnometry), ethanol vapor (alcometry)	Percentage or quantitative content of oxygen, carbon dioxide, ethanol vapor in inhaled and (or) exhaled air
	Trial glasses kits	Deviations in the characteristics of the visual apparatus (myopia, farsightedness, strabismus, astigmatism, etc.)	Optical power (dopter) and other optical-physical quantities
	Medical audiometers	Characteristics of the hearing analyzer	Intensity of test tonal sound signals (dB) of various frequencies, with air and bone sound conduction
	Universal clinical dosimeters for radiation therapy	Dose characteristics of photon and electron radiation during radiation therapy	Absorbed dose (Gy), dose rate (Gy/s), radiation energy (MeV)
	Clinical X-ray dosimeters	Dose characteristics of radiation during X-ray diagnostic studies	Absorbed dose (Gy), dose rate (Gy/s), product of absorbed dose and radiation beam area (cGy×cm)
	Photon radiation dosimeters for radiation monitoring at personnel workplaces	Dose characteristics of photon radiation at personnel workplaces	Absorbed dose (μSv), dose rate (μSv/hour) of photon radiation
	Clinical radiometers	Activity of radioactive drugs used for biomedical research, diagnosis and treatment of diseases	Radioactivity of gamma-emitting radionuclides (Bq, Ci)
	Photometers, spectrophotometers, medical photocolorimeters	Concentration of substances and enzyme activity in liquid biological samples	Optical density of solutions of test substances (OD units)

What is the main goal technical support for medical activities is to unconditionally ensure the quality of medical processes and their results, ensuring their unconditional safety, i.e. provision of safe and high-quality medical services , I hope no one doubts this... Hence the corresponding quality requirements for medical equipment and, in particular, for its technical and operational characteristics. Another thing is that the types of medical equipment, from the point of view control their operating technical parameters, are not classified for their use in these medical processes...
Everyone seems to understand that it is necessary to control, but from what side should we approach their metrological control, and are metrologists needed for this? ... Therefore, for clarity, medical equipment should be classified as follows:

Technical means- medical equipment - directly measuring the physiological parameters of the human body and the products of its vital activity, naturally, should refer to measuring instruments for medical purposes - SIMN ... And this is one group of medical equipment controlled by metrologists that needs periodic ( ) metrological verification.

Technical means that influence the human body for medicinal purposes by certain physical factors produced by them must be classified as means of medical and technical influence - SMTV . This is another group of medical equipment, which, for organizational and technical reasons, must be monitored by metrologists. And because It is almost impossible to measure the dose that the human body perceives of the SMTB produced by influencing physical factors, then for these products, metrologists must monitor the real values ​​​​of the influencing medicinal physical factors produced by them, and for this purpose periodic ( and, if necessary, extraordinary) calibration of these means.

Technical means that do not directly contact the patient and do not affect his body, do not change the physiological parameters of the body’s vital activity, but provide the necessary conditions for the implementation of therapeutic and diagnostic processes, and on the technical parameters of the technical condition of which only ensuring the quality of these processes depends, should be classified as means of technical assurance of the quality of medical processes - STOCMP . This group of medical equipment ( thermostats, sterilizers, etc.) must also be controlled by metrologists and subject to periodic ( and, if necessary, extraordinary) metrological verification...

Well, what about built-in in medical technology measuring instruments - SI , and the need for their metrological verification, I think there are no questions...

And while there is no such organizational classification, there will always be a lack of understanding of the need for metrological support for the use of this or that medical equipment and the willfulness of the need for its metrological control... Therefore, the only thing left to do is to approve classification group and clearly classify medical equipment...

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LETTER from the Ministry of Health of the Russian Federation dated 07/26/2001 25108058-01-32 ABOUT THE LIST OF MEDICAL DEVICES RELATED TO MEDICAL MEASUREMENT DEVICES... Relevant in 2018

LIST OF MEDICAL DEVICES RELATED TO MEDICAL MEASUREMENT DEVICES (MSD) AND SUBJECT TO STATE METROLOGICAL CONTROL AND SUPERVISION

I. FUNCTIONAL DIAGNOSTICS DEVICES
1. Electrocardiographs	Biopotentials of organs	Electrical
2. Telemetric electrocardiographs (with signal transmission via telephone line or radio channel)
3. Cardiac monitors
4. Wearable ECG recorders
5. Electroencephalographs
6. Electromyographs, neuromyographs
7. Gastrographs	Electrical impedances of the skin organs of the body
8. Rheographs
9. Rheoplethysmographs
10. Rheoencephalographs	Light transmission	Optical
11. Photoplethysmographs
12. Phonocardiographs	Acoustic component of vibration of organs and blood vessels	Acoustic
13. Devices for measuring and analyzing heart rate (HR)	Time intervals and frequency of organ functioning	Time and frequency
14. Devices for measuring blood pressure using the direct method		Pressure
15. Blood pressure meters using the indirect method
16. Devices for measuring intracranial and cerebrospinal fluid pressure
17. Devices for measuring intraocular pressure	Pressure of blood and biofluids in organs and vessels	Pressure
18. Spirographs, volumeters		Volumes and flow rates of gases and liquids
19. Oxyspirographs
20. Oxycarbospirographs
21. Pneumotachographs
22. Medical scales	Body weight Muscle strength	Measurement of mass, force
23. Medical dynamometers
24. Bicycle ergometers and ergometers	Job
25. Anthropometric meters	Linear dimensions of body parts	Linear - angular
26. Keratometers	Radius of curvature of the cornea	Linear - angular
27. Visual field perimeters
28. Ophthalmorefractometers	Optical power, vertex refraction	Optical - physical
29. Ophthalmometers
30. Trial glasses kits
31. Audiometers	Hearing analyzer parameters	Vibro - acoustic
32. Exhaled air gas analyzers	Composition and concentration of gases in exhaled air	Physico-chemical
33. Meters of partial pressure of gases in blood and biofluids	Content of gases in blood and biological fluids	Physico-chemical
34. Oxygen meters	Blood hemoglobin oxygen saturation level	Physico-chemical
35. Pulse oximeters
36. Medical mercury thermometers 37. Medical electric thermometers 38. Medical radiometers	Temperature of the body, skin and internal anatomical structures	Physico-chemical

II. BIOLOGICAL SAMPLE ANALYZERS
39. Colorimetric and photometric medical laboratory measuring instruments:	Optical Density	Optical - physical
Blood and biofluid enzyme activity analyzers Biochemical analyzers Hematological analyzers	Concentration of glucose, lipids, hemoglobin and other substances in blood and biofluids
40. Medical polarimeters
41. Medical nephelometers
42. Luminometers and chemiluminometers	Optical density Concentration of glucose, lipids, hemoglobin, and other substances in blood and biofluids	Optical - physical
43. Analyzers of the composition and properties of biosamples, volumetric, capillary, mechanical, medical:
Thromboelastomers Coagulometers Hydrometers Viscometers	Density, viscosity, elasticity of bioassays	Physico-chemical
49. Conductometric medical laboratory measuring devices	Concentration, number of blood cells	Physico-chemical

Notes 1. The list is mandatory for use throughout the Russian Federation.

2. Medical products that include built-in measuring instruments (IMUs) are not measuring instruments. The operational documentation for such medical devices must indicate the means and methods of testing and verification of VSI, as well as the procedure for their implementation.

3. The frequency of verification and the type of verification of the SIMN is determined during testing for the purposes of type approval and is indicated in the description for the State Register of Measuring Instruments of the Russian Federation, the passport and in the methodological documents for verification.

4. This List can be clarified and supplemented by agreement between the State Standard of Russia and the Ministry of Health of Russia.

From the Ministry of Health
Russian Federation -
Deputy Head
Department of State
quality control,
efficiency, safety
medicines
and medical equipment
A.A.TOPOKOV

From the State Committee
Russian Federation
on standardization
and metrology -
Head of Department
metrology
V.M.LAKHOV

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