MINISTRY OF HEALTH
RUSSIAN FEDERATION

LETTER

On the list of medical devices related to measuring instruments medical purpose and subject to state metrological supervision and control

No longer valid due to publication
letters of the Ministry of Health and Social Development of Russia dated April 6, 2012 N 25-4/10/2-3381
____________________________________________________________________

I ask you to take into account in your work and bring to the attention of the heads of subordinate healthcare institutions, other interested institutions, organizations and enterprises the attached "List of medical devices related to medical measuring instruments and subject to state metrological supervision and control", approved by the Ministry of Health of Russia and the State Standard of Russia.

Deputy Minister
A.V. Katlinsky

List of medical devices related to medical measuring instruments (IMN) and subject to state metrological supervision and control

APPROVE
Deputy Minister
health care
Russian Federation
V.Katlinsky
June 6, 2001

Vice-chairman
State Committee
Russian Federation

V.N. Krutikov
June 6, 2001

SCROLL
medical devices related to medical measuring instruments (IMN) and subject to state metrological supervision and control

Notes:

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

2. Medical devices, which include built-in measuring instruments (ITM), are not measuring instruments. The operational documentation for such medical devices should indicate the means and methods for testing and verifying the IVS, as well as the procedure for their implementation.

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

4. This list may be updated and supplemented by agreement between the State Standard of Russia and the Ministry of Health of Russia.

Deputy Head of Department
state quality control,
efficiency, safety
medicines and medical equipment
Ministry of Health of Russia
A.A. Toporkov

Head of Metrology Department
State Committee
Russian Federation
for standardization and metrology
V.M.Lakhov

Electronic text of the document
prepared by CJSC "Kodeks" and checked against:

New Pharmacy,
N 1, 2002

MEASURING INSTRUMENTS for medical purposes- technical means that have normalized metrological characteristics and are used to determine the values ​​of physical quantities empirically. To S. and. include measures that reproduce physical quantities of a given size, measuring instruments and transducers, as well as measuring installations and systems consisting of them.

All S. applied in health care institutions and. are divided into means of general economic (general technical) purpose, used in all sectors of the national economy, and special ones. To general technical S. and. include, for example, universal S. and. for measuring mass (balances and weights), electrical and radio engineering quantities (pointer and digital ammeters and voltmeters, oscilloscopes, generators), temperature (lab. thermometers), pressure in vessels (technical pressure gauges and pressure vacuum meters), optical quantities (photoelectrocolorimeters, refractometers, spectrophotometers, dioptrimeters), etc. The use of these S. and. in healthcare facilities is allowed provided that they comply with the norms and rules established by the M3 of the USSR. Most measurements in medicine can only be carried out with the help of S. and., specially created according to the technical assignment M3 of the USSR, having a medical purpose and, as a rule, not designed for use in other sectors of the economy, science and technology; with some design changes, they can only be used for measurements on animals in biology and veterinary medicine, as well as in laboratories conducting research in agriculture or in the field of protection environment.

Depending on design features and a way of use of the measuring information distinguish the following main types S. and. honey. destination. 1. Measure honey. destination - reproduces a physical quantity of the same size (an unambiguous measure), for example, a standard sample of a chemical. hemoglobincyanide substances, which is a measure of spectral optical density, an "artificial ear" device, which is a measure of acoustic conductivity, etc., or a number of physical quantities of the same name of various sizes (multi-valued measure, set of measures), for example, sets of trial spectacle lenses - measures optical-geometric quantities, stadiometers - measures of linear dimensions, etc. 2. Measuring device honey. purpose - generates a signal of measuring information in a form accessible for direct perception by the observer (electrocardiograph, hand dynamometer, sphygmomanometer, etc.). 3. Measuring transducer honey. purpose - its measurement information signal is convenient for further conversion, processing, storage, but cannot be directly perceived by the observer, for example, signals from an intragastric pH probe, temperature or pressure sensor, requiring the use of secondary measuring instruments. 4. Measuring installations and measuring systems honey. appointments - a set of functionally united S. and. honey. appointment, general technical S. and. and auxiliary devices; in installations, signals of measuring information are perceived directly by the observer (polygraphs, monitor installations), and in systems these signals are generated in a form convenient for subsequent processing (information-computing medical systems and complexes). 5. Medical dispensers - a combination of constant or variable measures with auxiliary devices for issuing measured amounts of substances (pharmaceutical dispenser, injector with dose measurement, medical micropipette).

According to the scope of S. and. honey. appointments are divided into the following groups: to determine fiziol. indicators and functional diagnostics; for lab. biol analyses. samples; for san.-gig. control of the environment and working conditions; to control doses of therapeutic and surgical energy effects.

Depending on belonging to a certain field of physics or chemistry, all physical quantities in metrology are usually referred to one of the types of measurements: mechanical, linear-angular, electrical, radio engineering, optical-physical, acoustic, thermal-physical, physical-chemical and biochemical, measurements parameters of ionizing radiation.

Within each group S. and. honey. appointments are classified according to the nature of the measured physical quantity (table).

Constant complication of S. and. honey. appointments, application in traditional honey. measuring devices of new principles for the transformation of primary measuring information makes such a classification ambiguous in cases where the studied medical and biological quantity and the directly measured physical quantity refer to different types. Most often it concerns indirect measurements. So, in plethysmography, the parameters of blood filling of organs, vessels or parts of the body are studied, i.e., mechanical measurements, however, the measuring transducers used in this case have indisputable signs of belonging to optical (photoplethysmography) or electrical (rheopletismography) devices; in studies of blood hemodynamics, the use of ultrasonic Doppler, electromagnetic and radioisotope transducers leads to a similar situation, and in the lab. devices - spectrophotometric converters.

According to S.'s design and. honey. assignments can be stand-alone or built-in. Autonomous S. and. usually measure parameters of an organism, make laboratory and a dignity. measurements. S. i. honey. appointments for controlling doses of exposure are most often devices built into physiotherapy equipment. Also, S. and are usually built-in. in equipment for replacing functions, organs and systems; biopotential and rhythm meters in electrical stimulators, blood flow velocity meters in heart-lung machines, etc.

According to the scope and their place in the verification scheme S. and. honey. appointments are divided into workers, used for measurements not related to the transfer of unit sizes, and exemplary - for checking working C. and. The following are used as exemplary: working S. and., specially adjusted in order to obtain higher metrological characteristics, specially designed exemplary S. and., to-rye are usually not used for direct working use; standard samples of the composition or properties of biol. samples In all cases, these funds must be certified and approved as exemplary.

Metrological properties of S. and. are described by a set of normalized metrological characteristics, to-rye are selected from among those established in the State System for Ensuring the Uniformity of Measurements. The main purpose of this choice - to provide an opportunity of an estimation by means of this S. and. the actual measurement error in real operating conditions and application modes with a given confidence level. Based on this principle, the complex of standardized metrological characteristics of S. and. in general case form from static and dynamic (if necessary) characteristics of the transducer or output value, statistical estimates of the systematic and random components of the error, parameters or influence functions external factors on the errors of S. and., additional metrological characteristics and non-informative parameters of the output signal, depending on the specific types of S. and.

In the USSR, by order of M3 of the USSR and the USSR State Committee for Standards of July 5, 1979, measuring instruments honey. appointments are subject to metrological supervision in generally accepted forms. State tests of S. and. honey. appointments before putting them into production (state acceptance tests) are carried out jointly by the head organization of the metrological health service (see) and the leading metrological in-volume of the State Standard. According to the results of state acceptance and subsequent honey. tests by the decision of Gosstandart S. and. honey. appointments are entered in the State Register of Measuring Instruments, and by the decision of the M3 of the USSR they are allowed to be used in honey. practice, to industrial production or import. In the state control tests carried out in the production process by the territorial bodies of the State Standard, the bodies of the metrological health service take part. Verka S. and. honey. appointment upon release from production is carried out in the form of state primary verification, and upon release from repair, during storage and operation - in the form of periodic departmental verification by the bodies of the metrological health service. The frequency of verification during storage and operation is determined by the metrological reliability and intensity of use of C. and. honey. destination. On average, one verification is established per year. It is carried out in strict accordance with normative documents on methods and means of verification, agreed with the metrological institute of the State Standard and the service Ch. metrologist M3 USSR.

Table. LIST OF MEASURED VALUES AND PARAMETERS WITH EXAMPLES OF MEDICAL MEASUREMENTS

A. N. Grishin, R. I. Utyamyshev.

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

Application No. 1

to the order of the Ministry of Health

Russian Federation

The procedure for conducting tests in order to approve the type of measuring instruments 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 in order to approve the type of measuring instruments

1. This Procedure, for the purpose of state registration of medical devices, establishes the rules for conducting tests in order to approve the type of measuring instruments for medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements (hereinafter, respectively - 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 in order to approve the type of measuring instruments approved by this order.

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

1) manufacturer of a medical device;

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

4. Tests for the purpose of type approval are carried out by organizations accredited to test measuring instruments in accordance with the legislation of the Russian Federation on ensuring the uniformity of measurements, the scope of accreditation of which provides for testing in order to approve the type of measuring instruments for medical devices (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 engaged in activities to ensure the uniformity of measurements.

5. To conduct tests for the purpose of type approval, the applicant sends to the tester an application for testing 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 device (with an indication of the accessories necessary for the intended use of the medical device);

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 company name, legal form legal entity, address of its location, as well as telephone numbers and (if any) e-mail address of the legal entity;

5) addresses of places of manufacture of the medical product;

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

7) type of medical product in accordance with nomenclature classification medical products;

8th grade potential risk use of a medical device in accordance with the nomenclature classification of medical devices;

9) code of the All-Russian classifier of products for a medical device.

7. Attached to the application:

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

2) regulatory documentation for a medical device;

3) technical documentation for a medical device;

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

5) photographic image general view medical device together with accessories necessary for the intended use of the medical device (at least 18x24 cm in size);

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

7) claimed metrological and specifications medical device subject to verification during type approval tests, including accuracy indicators;

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

9) information on the mandatory metrological and technical requirements for the medical device (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 the purpose of type approval must be submitted in Russian. If the original documents are in foreign language, they are submitted with duly certified translation into Russian.

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

1) in case of a positive decision, sends to 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 decision by the tester 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 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 of the Russian Federation of November 30, 2009 N 1081 (registered by the Ministry of Justice of the Russian Federation on December 25, 2009 registration N 15866) (hereinafter - the order of the Ministry of Industry and Trade of Russia of November 30, 2009 N 1081).

11. The tester, after signing the agreement (contract), develops, agrees with the applicant and approves the 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 the purpose of type approval should include:

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

2) verification of compliance with mandatory metrological and technical requirements to the medical device (if any), including the requirements for its components, software and operating conditions;

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

4) development or selection of a verification methodology and its testing;

5) determining the need for periodic verification;

6) determination of the interval between periodic verifications;

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

14. After the approval of the test program for the purpose of type approval, the applicant submits samples of the medical product 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 by the test program for the purpose of type approval are documented in relevant test reports.

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 samples submitted);

3) a list of items of the test program for the purpose of type approval, on 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 the purpose of type approval shall indicate:

1) name of the medical device;

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

3) information about the test:

a) the 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 testing for the purpose of type approval, indicating the date and number of the application for testing for the purpose of type approval;

e) location of type approval tests;

4) information about the samples of the medical device submitted for testing in order to approve the type:

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

b) serial numbers of submitted samples;

5) general information on the results of tests for the purpose of type approval:

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

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

7) detailed information on the test results:

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

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

8) draft description of the type of measuring instrument;

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

The protocols of all tests carried out, the draft description of the type of measuring instrument and the verification procedure form an annex to the test report for the purpose of type approval and are an integral part of it.

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 (with the date), certified by the official seal of the tester.

21. One copy of the test certificate for the purpose of type approval with an attachment 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, which carries out state registration of medical devices.

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

Application No. 2

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 in order to approve the type of measuring instruments

That which is the main goal technical support medical activities is the unconditional assurance of the quality of medical processes and their results, ensuring their unconditional safety, i.e. providing safe and quality medical services , I hope no one doubts this ... This implies 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, in terms of control their working technical parameters, are not classified by their use in these medical processes...
Everyone, it seems, understands that it is necessary to control, but from what side to 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, of course, 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 affecting medicinal purposes on the human body by certain physical factors produced by them, should refer to means of medical and technical impact - SMTV . This is another group of medical equipment, which, for organizational and technical reasons, must be controlled by metrologists. And since Since the dose perception by the human body of the produced SMTV affecting physical factors is almost impossible to measure, then metrologists should control the real values ​​of the acting therapeutic effects produced by them. physical factors, and for this, 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 implementation of medical and diagnostic processes, and on the technical parameters of the technical condition of which only the quality assurance of these processes depends, should be classified as means of technical quality assurance of medical processes - STOKMP . This group of medical equipment ( thermostats, sterilizers, etc.) should also be controlled by metrologists and subject to periodic ( and, if necessary, extraordinary) metrological verification ...

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

And as long as there is no such organizational classification, there will always be a misunderstanding of the need for metrological support for the use of one or another medical equipment and the willfulness of the need for its metrological control ... Therefore, the matter is small - to approve classification group and clearly classify medical equipment ...

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

LIST OF MEDICAL DEVICES RELATED TO MEASURING INSTRUMENTS FOR MEDICAL PURPOSE (SYM) AND SUBJECT TO STATE METROLOGICAL CONTROL AND SUPERVISION

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

2. Medical devices, which include built-in measuring instruments (ITM), are not measuring instruments. The operational documentation for such medical devices should indicate the means and methods for testing and verifying the IVS, as well as the procedure for their implementation.

3. The frequency of verification and the type of verification of 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, passport and methodological documents for verification.

4. This List may be updated 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 technology
A.A. TOPORKOV

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