The nomenclature classifier of the Medisatati has been developed. We study a new nomenclature of medical products. Nomenclature classification of medical products by classes, depending on the potential risk of their application.

Date of entry into force on 06.06.2012

In accordance with Part 2 of Article 38 of the Federal Law of November 21, 2011 N 323-FZ "On the basis of the health of citizens in Russian Federation"(Meeting of the legislation of the Russian Federation, 2011, N 48, Art. 6724) and decree of the President of the Russian Federation of May 21, 2012 N 636" On the structure of federal executive authorities "(" Russian Gazeta ", 2012, N 114) Order:

Approve:

nomenclature classification of medical products by type according to Appendix N 1;
nomenclature classification of medical products by classes, depending on the potential risk of their use according to Appendix N 2.

Minister
V.I.Skvortsov

Appendix N 1.

Russian Federation
dated June 6, 2012 N 4N

Nomenclature classification of medical devices by type

The nomenclature classification of medical devices (hereinafter - classification) by type contains a numerical designation (number) of the type of medical product, the name of the type of medical product, as well as nine-digit digital codes (AAA BB VV GG) used to determine the types of medical devices.

When classifying in the first position, the numerical designation (six-digit number) of the type of medical product (N) is located, in the second position - the name of the type of medical product (view), in the third position - three-digit digital codes (AAA 00 00 00) according to the classification sign "Purpose of medical Products "(Table 1), on the fourth position - two-digit digital codes (000 BB 00 00) according to the classification sign" The requirements of the sterilization of medical devices "(Table 2), on the fifth position - two-digit digital codes (000 00 BB 00) by classification "Technologies of the use of medical devices" (Table 3), on the sixth position - two-digit digital codes (000 00 00 gg) according to the classification feature of the "Medical Development Area" area (Table 4).

The encoding algorithm used to classify medical devices by type is shown in the scheme:

N View AAA BB VV GG
│ │ │ │ │ │
│ │ │ │ │ └──\u003e Areas of application of medical devices
│ │ │ │ │
│ │ │ │ └────\u003e Medical Appliances Technologies
│ │ │ │
│ │ │ └──────\u003e Requirements for the sterilization of medical devices
│ │ │
│ │ └─────────\u003e Purpose of medical devices
│ │
│──────────────\u003e Name of the type of medical product
│
└────────────────\u003e Room of Medicine View

Table 1. Appointment of medical products according to classification sign (AAA)

	Appointment of medical devices	Code Designation
	prevention of diseases
	diagnosis of diseases, states and clinical Situation
	cardiography
	encephalography
	radioscopy, radiography
	angiography
	cT scan
	magnetic-resonant tomography
	positron emission computed tomography
	ultrasound diagnostics
	in-Vitro Diagnostics
	histological and cytological diagnostics
	genetic diagnostics
	endoscopy
	blood gases, external parameters breathing, composition of inhaled and exhaled air and Gas exchange
	measurements of medical characteristics and values
	self-test
	monitoring the state of the human body
	pathologist studies
	forensic-medical examination
	treatment and medical rehabilitation of diseases

	physiotherapy
	radiotherapy
	anesthesia and resuscitation
	surgery
	abdominal surgery
	thoracic surgery
	neurosurgery
	cardiovascular Surgery
	organs and tissue transplantation
	kombstiology
	maxillofacial Surgery
	dental surgery
	plastic surgery
	restoration, replacement, change of anatomical structures or physiological functions of the body
	compensation of physical disadvantage or disability
	prevention, abortion, control Conception
	mixed-hospital equipment, including medical Products not intended for use directly in diagnostic, therapeutic purposes or for medical research, as well as do not provide Direct influence on clinical status assessment Patient, research results or treatment Process

Table 2. Requirements for sterilization of medical devices according to classification sign (BB)

	Name	Code Designation
	non-sterile disposable medical Use
	sterile Medications Disposable Use
	sterilized medical products multiple applications whose sterility is ensured as in the first application, and with each subsequent Application using appropriate methods Sterilization
	non-sterile medical products multiple Applications
	equipment for sterilization of medical devices

Table 3. Technologies for the application of medical devices by classification (explosive) (AAA)

	Name	Code Designation
	inactive medical products, functioning which do not require an energy source, except Energy generated by human body or power gravity (gravity)
	active medical products for operation which need to use the energy source, different from the generated human body or force gravity (gravity)
	inactive implantic medical products
	active implantable medical products
	biomedical products, including such materials, as products of cellular technologies and fabric Engineering, Bioimplants, Selfcomcommodific Biopolymers, fabric adhesives and suture materials
	surgical instruments intended for surgical intervention (cutting, drilling, sawing, scratching, bobbies, bonding, Spreading, Rocking, Piercing)
	prosthetic Orthopedic Products
	technical means of rehabilitation of persons with disabilities

Table 4. Areas of medical use of medical devices according to classification sign (GG)

	Areas of medical application	Code Designation
	obstetrics and gynecology
	allergology and immunology
	angiology
	balneology and water bouquet
	gastroenterology
	hematology
	genetics
	hyurgy
	dermatovenerology
	desmurgy
	diabettology
	infectious diseases
	cardiology
	coloproctology
	therapeutic physical education I. sports medicine
	narcology
	neurology
	neonatology
	nephrology
	oncology
	otorinolaryngology
	ophthalmology (including optics)
	pediatrics
	psychiatry
	pulmonology
	rheumatology
	stomatology
	sudology
	traumatology and orthopedics
	transfusiology
	urology
	widespread

Appendix N 2.
to the order of the Ministry of Health
Russian Federation
dated June 6, 2012 N 4N

Nomenclature classification
Medical products for classes
Depending on the potential risk of their application

1. At the nomenclature classification of medical products by classes, depending on the potential risk of application (hereinafter - the classification of medical devices), medical products are divided into four classes. Classes have designations 1, 2a, 2b and 3.

I. Classification of medical devices (except medical
products for diagnostics in vitro)

2. When classifying medical devices, each medical device can only be assigned to one class:

class 1 - Low Risk Medical Products;
class 2a - Medical products with middle degree risk;
class 2B - medical products with an increased risk;
class 3 - Medical products with a high risk.

3. When classifying medical devices, they take into account their functional purpose and conditions of application, as well as the following criteria:

the duration of the use of medical devices;
invasiveness of medical devices;
the presence of contact of medical devices with a human body or interrelation with it;
the method of introducing medical devices to the human body (through anatomical cavity or surgical path);
application of medical devices for vital organs and systems (heart, central system blood circulation, central nervous system);
application of energy sources.

4.1. Non-invasive medical products refer to class 1 if none of the provisions presented below are not applied, with the exception of the provisions set out in paragraph 4.4.1.

4.2. Non-invasive medical products intended for conducting or storing blood, liquids or body tissues, liquids or gases for the purpose of subsequent infusion, transfusion or injection into the body belong to the class 2a.

4.3. Non-invasive medical products intended to change the biological or chemical composition of blood, other body fluids or liquids intended for infusion into the body belong to class 2B. However, in cases where the therapeutic effects consists in filtration, centrifugation, gas exchange or heat exchange to change the biological or chemical composition of blood, other liquids of the body or liquids intended for infusion into the body, medical products refer to class 2a.

4.4. Non-invasive medical products that come into contact with damaged skin:

4.4.1. refer to class 1 if they are used as mechanical barriers or for compression;

4.4.2. refer to class 2B if they are used for wounds that can be heated only by secondary healing;

4.4.3. Class 2a, if they are used in all other cases (including medical products that are intended mainly to affect the microenvironment of the Russian Academy of Sciences).

4.5. Invasive medical products (with the exception of surgical invasive), the use of which is associated with anatomical cavities in the human body and which are not intended to join the active medical product:

4.5.1. class 1, if these are short-term uses (continuous use for no more than 60 minutes);

4.5.2. Class 2a, if these are temporary use (continuous use for no more than 30 days), but in cases where these medical products are temporarily used in the oral cavity to the pharynx, in a rumor passage to the eardrum or in the nasal cavity, they relate to class 1;

4.5.3. refer to class 2b if these medical products long use (continuous use for more than 30 days), however, in cases where these medical products are long used in the oral cavity to the pharynx, in a rumor passage to the eardrum or in the nasal cavity and cannot be resubbable by the mucous membrane, they relate to class 2a ;

4.5.4. All invasive medical products (with the exception of surgical invasive), the use of which is associated with anatomical cavities in the body and which are intended for attaching to an active medical product of class 2a or higher class, refer to class 2a.

4.6. Surgical invasive short-term medical products refer to class 2a, however if they are:

4.6.1. Designed for diagnosis, observation, control or correction of heart pathologies, the central circulatory system or the central nervous system In direct contact with the organs or parts of these systems, then refer to class 3;

4.6.2. are reusable surgical instruments, then refer to class 1;

4.6.3. Designed to transmit energy in the form of ionizing radiation, then refer to class 2B;

4.6.4. Designed to cause a biological effect, dissolve completely or largely, then refer to class 2B;

4.6.5. Designed for the introduction of drugs through a dosing system that uses potentially dangerous method Introduction, then refer to class 2b.

4.7. Surgical invasive medical products of temporary use refer to class 2a, however if they are:

4.7.1. Designed for diagnosis, observation, control or correction of the pathologies of the heart or the central circulatory system in direct contact with the organs or parts of these systems, then refer to class 3;

4.7.2. directly contact with the central nervous system, then refer to class 3;

4.7.3. Designed to transmit energy in the form of ionizing radiation, then refer to class 2B;

4.7.4. Designed to cause a biological effect, to dissolve completely or in a significant part, then refer to class 3;

4.7.5. Chemical changes in the body are undergoing or administered drugs, then refer to class 2B (with the exception of medical products implanted in teeth).

4.8. Implantized medical products, as well as surgical invasive medical products of long-term use refer to class 2B, but if they are:

4.8.1. Designed for implantation in the teeth, then refer to class 2a;

4.8.2. directly in contact with the heart, the central system of blood circulation or the central nervous system, then refer to class 3;

4.8.3. Designed to cause a biological effect or dissolve completely or largely, then refer to class 3;

4.8.4. Chemical changes are undergoing in the body or administered medicinal drugs into the patient's body, then class 3 (with the exception of medical products implantable in teeth).

4.9. Active therapeutic medical products:

4.9.1. Active medical products that are intended to transmit energy or energy exchange are class 2a. However, if the transfer of energy to the human body or the exchange of energy with it is a potential danger due to the characteristic features of medical devices, taking into account the effects on the body part, to which energy is applied (including active medical devices intended for creating ionizing radiation, radiation therapy), they refer to class 2b;

4.9.2. Active medical products intended to manage active therapeutic medical products of class 2B are class 2B.

4.10. Active diagnostic medical products refer to class 2a if they are intended for:

4.10.1. The transmission of energy absorbed by the human body, however, if the function of the medical product is the illumination of the patient's body in the visible range of the spectrum, they refer to class 1;

4.10.2. distributions of radiopharmaceutical drugs introduced into the patient's body;

4.10.3. ensuring direct diagnostics or control of vital functions of the body, however, if they are intended to control vital physiological parameters, the changes of which could lead to direct hazard for the patient (for example, changing the function of the heart, breathing or activity of the central nervous system), then they relate to class 2b;

4.10.4. Management of active diagnostic medical products of class 2B belong to class 2B.

4.11. Active medical products intended to be administered to the patient's medication drugs, physiological fluids or other substances and (or) eliminating them from the body belong to the class 2a. However, if the method of administration (derived) is a potential danger, taking into account the type of appropriate substances, parts of the body and methods of application, then they relate to class 2b.

4.12. Other active medical products refer to class 1.

4.13. Medical products, which include a substance, which is a drug or other biologically active agent and affecting human body In addition to the impact of the medical product, class 3.

4.14. Medical products designed to control conception or to protect against sexually transmitted diseases are classified to class 2B, however, if they are implanted or invasive medical products of long-term use, they are class 3.

4.15. Medical products intended for disinfection of medical devices belong to class 2a, however, if they are intended for cleaning, washing, disinfection contact lenses, they belong to class 2b.

4.16. Inactive medical products used to obtain diagnostic X-rays belong to Class 2A.

4.17. Medical products that were manufactured using dead animal tissues or derivatives belong to Class 3, however, if they are intended to come into contact only with intact skin, they relate to class 1.

4.18. Blood containers, blood and blood substitute drugs belong to class 2B.

6. If you can use different positions when classifying to a medical device, it is applied, as a result of which the medical product class is established, which corresponds to the greatest degree of potential risk.

II. Medical Classification for Diagnostics
in vitro.

8. When classifying medical devices for diagnostics in vitro (hereinafter - medical products), each medical device can only be assigned to one class:

class 1 - Medical products with low individual risk and low risk for public health;
class 2a - Medical products with moderate individual risk and / or low risk for public health;
class 2B - Medical products with high individual risk and / or moderate risk for public health;
class 3 - Medical products with high individual risk and / or high risk for public health.

9. When classifying medical devices to classes, depending on the potential risk of application, it is necessary to take into account the following provisions:

9.1. Medical products designed to identify infectious agents in the blood, blood components, blood derivatives, cells, tissues or organs in order to assess the possibility of their transfusion or transplantation, medical products intended to identify infectious agents that may cause human life threatening diseases, With high distribution risk and which provide decisive information for the setting of the correct diagnosis, refer to class 3.

9.2. Medical products, which are used to determine blood groups or types of tissues in order to guarantee the immunological compatibility of blood, blood components, cells, tissues, or organs that are intended for transfusion or transplantation belong to class 2B, with the exception of the AVO system, the rhesus of the system (C, C, D, E, E), Kell Systems, Kidd Systems and Duffy Systems belong to Class 3.

9.3. Medical products refer to class 2B if they are intended for the following purposes:

9.3.1. To identify infectious agents of sexually transmitted diseases;
to identify in the cerebrospinal fluid or blood of infectious agents with moderate risk of distribution and which provide decisive information to form a proper diagnosis;

9.3.2. To identify the presence of infectious agents when there is a significant risk that an erroneous result may be the cause of death or the loss of the patient's surveyed or fetus;

9.3.3. When screening pregnant women in order to determine their immune status in relation to infections;

9.3.4. In determining the status of infectious disease or immune status, in the presence of risk that the erroneous result will lead to a therapeutic solution that causes the inevitable danger to the patient's life;

9.3.5. when screening for choosing patients for election therapy or for diagnosis (for example, diagnosis of cancer);

9.3.6. with genetic testing when the test result leads to serious human life interference;

9.3.7. To control the levels of drugs, substances or biological components, when there is a risk that incorrect result will lead to a therapeutic solution that causes a vital situation for the patient;

9.3.8. In the treatment of patients suffering from life-threatening infectious disease;

9.3.9. In screening of congenital fruit diseases.

9.4. Medical products intended for sampling and self-control studies belong to class 2b, excluding those medical products, the result of the analysis of which is not a critical medical status or preliminarily, requires comparison with the corresponding laboratory tests, refer to class 2a.

9.5. Medical products that do not have a measuring function, which in their objective properties can be used as overall, but have special characteristics, in accordance with which the manufacturer is intended for use in the diagnostic procedures in in vitro (without specifying specific types of laboratory tests / analytes) belong to the class one.

9.6. Medical products not covered by the provisions of paragraphs 9.1 - 9.5 belong to the class 2a, including:

9.6.1. Medical products with measuring function (analyzers) with a non-fixed list of laboratory studies, which depends on the applied reagent sets (test systems). The interdependence of the analyzer and the reagents used, as a rule, does not allow to evaluate the analyzer separately, but this does not affect its classification to class 2a;

9.6.2. Medical products, when using which the therapeutic decision must be taken after further research;

9.6.3. Medical products used to monitor and treat oncological diseases.

10. If the medical device is intended for use in combination with other medical products, then classes are installed for each medical product.

11. Calibration and control materials with quantitatively and qualitatively specified values \u200b\u200binclude the same class as medical products, for controlling which they are intended.

12. For special software, which is an independent product and used with a medical product, set the same class as for the medical product itself.

Act Editorial 06.06.2012

Name Document	Order of the Ministry of Health of the Russian Federation of 06.06.2012 N 4N "On approval of the nomenclature classification of medical devices"
Document type	order
Accepted by	ministry of Health of the Russian Federation
Document Number	4N
Date of adoption	04.11.2012
Date of editorial	06.06.2012
Registration number in the Ministry of Justice	24852
Date of registration in the Ministry of Justice	09.07.2012
Status	act
Publication	"Russian Gazeta", N 245, 24.10.2012
Navigator	Notes

Order of the Ministry of Health of the Russian Federation of 06.06.2012 N 4N "On approval of the nomenclature classification of medical devices"

Appendix 1. Nomenclature classification of medical devices by type

The encoding algorithm used to classify medical devices by type is shown in the scheme:

View

AAA

Medical Products

Medical Application Technologies

Medical sterilization requirements

Name of the type of medical product

Medical type number

Table 1. Appointment of medical products according to classification sign (AAA)

N p / n	Appointment of medical devices	Code designation
1	prevention of diseases	100
2	diagnosis of diseases, states and clinical situations	200
3	cardiography	201
4	encephalography	202
5	radioscopy, radiography	203
6	angiography	204
7	cT scan	205
8	magnetic-resonant tomography	206
9	positron emission computed tomography	207
10	ultrasound diagnostics	208
11	in-Vitro Diagnostics	209
12	Histological and cytological diagnostics	210
13	genetic diagnostics	211
14	endoscopy	212
15	studies of blood gases, external respiratory parameters, composition of inhaled and exhaled air and gas exchange	213
16	measurements of medical characteristics and values	214
17	self-test	215
18	monitoring the state of the human body	216
19	pathologist studies	217
20	forensic-medical examination	218
21	treatment and medical rehabilitation of diseases	300
22	therapy	301
23	physiotherapy	302
24	radiotherapy	303
25	anesthesia and resuscitation	400
26	surgery	500
27	abdominal surgery	501
28	thoracic surgery	502
29	neurosurgery	503
30	cardiovascular Surgery	504
31	organs and tissue transplantation	505
32	kombstiology	506
33	maxillofacial Surgery	507
34	dental surgery	508
35	plastic surgery	509
36	restoration, replacement, change of anatomical structure or physiological functions of the body	600
37	Compensation of physical disadvantage or disability	700
38	prevent, interrupt pregnancy, conception	800
39	inspection equipment, which includes medical products, not intended to be applied directly to diagnostic, therapeutic purposes or for medical research, as well as do not directly affect the clinical assessment of the patient's condition, research results or course of therapeutic process.	900

Table 2. Requirements for sterilization of medical devices according to classification sign (BB)

N p / n	Name	Code designation
1	non-sterile disposable medical	01
2	sterile Medications Disposable Use	02
3	sterilized medical products of multiple use, the sterility of which is ensured by both the first use and every one subsequent use using appropriate sterilization methods.	03
4	non-sterile multi-use medical products	04
5	Equipment for sterilization of medical devices	05

Table 3. Technologies for the application of medical devices according to the classification feature (explosive)

N p / n	Name	Code designation
1	inactive medical products, the functioning of which does not require an energy source, with the exception of the energy generated by the human body or gravity (gravity)	01
2	active medical products for the functioning of which it is necessary to use a source of energy other than the generated human body or gravity (gravity)	02
3	inactive implantic medical products	03
4	active implantable medical products	04
5	biomedical products, including materials such as products of cellular technologies and tissue engineering, bioimplants, self-aromatic biopolymers, tissue adhesives and suture materials	05
6	surgical tools intended for surgical intervention (cutting, drilling, sawing, scratching, bobbins, bonding, spreading, rocking, piercing)	06
7	prosthetic Orthopedic Products	07
8	technical means of rehabilitation of persons with disabilities	08

Table 4. Areas of medical use of medical devices according to classification sign (GG)

N p / n	Areas of medical application	Code designation
1	obstetrics and gynecology	01
2	allergology and immunology	02
3	angiology	03
4	balneology and water bouquet	04
5	gastroenterology	05
6	hematology	06
7	genetics	07
8	hyurgy	08
9	dermatovenerology	09
10	desmurgy	10
11	diabettology	11
12	infectious diseases	12
13	cardiology	13
14	coloproctology	14
15	medical Physical Culture and Sports Medicine	15
16	narcology	16
17	neurology	17
18	Neonatology	18
19	nephrology	19
20	oncology	20
21	otorinolaryngology	21
22	ophthalmology (including optics)	22
23	pediatrics	23
24	psychiatry	24
25	pulmonology	25
26	rheumatology	27
27	stomatology	28
28	sudology	29
29	traumatology and orthopedics	30
30	transfusiology	31
31	urology	31
32	widespread	32

Appendix N 2.
to the order of the Ministry of Health
Russian Federation
dated June 6, 2012 N 4N

Ministry of Health of the Russian Federation

Order of June 6, 2012 No. 4N
"On approval of the nomenclature classification of medical devices"

In accordance with Part 2 of Article 38 of the Federal Law of November 21, 2011 N 323-FZ "On the Based on the Health of Citizens in the Russian Federation" (Meeting of the legislation of the Russian Federation, 2011, N 48, Art. 6724) and Decree of the President of the Russian Federation May 21, 2012 N 636 "On the structure of federal executive authorities" ("Russian Gazeta", 2012, N 114) Order:

Approve:

nomenclature classification of medical products by type according to Appendix N 1;

nomenclature classification of medical products by classes, depending on the potential risk of their use according to Appendix N 2.

Minister V.I.Skvortsova

Appendix N 1.
Russian Federation
dated June 6, 2012 N 4N

Nomenclature classification of medical devices by type

The encoding algorithm used to classify medical devices by type is shown in the scheme:

Table 1. Purpose of medical devices

according to the classification feature (AAA)

	Appointment of medical devices	Code Designation
	prevention of diseases
	diagnosis of diseases, states and clinical situations
	cardiography
	encephalography
	radioscopy, radiography
	angiography
	cT scan
	magnetic-resonant tomography
	positron emission computed tomography
	ultrasound diagnostics
	in-Vitro Diagnostics
	histological and cytological diagnostics
	genetic diagnostics
	endoscopy
	studies of blood gases, external respiratory parameters, composition of inhaled and exhaled air and gas exchange
	measurements of medical characteristics and values
	self-test
	monitoring the state of the human body
	pathologist studies
	forensic-medical examination
	treatment and medical rehabilitation of diseases

	physiotherapy
	radiotherapy
	anesthesia and resuscitation
	surgery
	abdominal surgery
	thoracic surgery
	neurosurgery
	cardiovascular Surgery
	organs and tissue transplantation
	kombstiology
	maxillofacial Surgery
	dental surgery
	plastic surgery
	restoration, replacement, change of anatomical structure or physiological functions of the body
	compensation of physical disadvantage or disability
	prevention, abortion, control Conception
	inspection equipment, which includes medical products, not intended to be applied directly to diagnostic, therapeutic purposes or for medical research, as well as do not directly affect the clinical assessment of the patient's condition, research results or course of therapeutic process.

Table 2. Requirements for sterilization of medical devices

according to the classification feature (BB)

	Name	Code Designation
	non-sterile disposable medical
	sterile Medications Disposable Use
	sterilized medical products of multiple use, the sterility of which is ensured by both the first use and every one subsequent use using appropriate sterilization methods.
	non-sterile multi-use medical products
	equipment for sterilization of medical devices

Table 3. Medical Appliances Technologies

according to the classification feature (explosives)

	Name	Code Designation
	inactive medical products, the functioning of which does not require an energy source, with the exception of the energy generated by the human body or gravity (gravity)
	active medical products for the functioning of which it is necessary to use a source of energy other than the generated human body or gravity (gravity)
	inactive implantic medical products
	active implantable medical products
	biomedical products, including materials such as products of cellular technologies and tissue engineering, bioimplants, self-aromatic biopolymers, tissue adhesives and suture materials
	surgical tools intended for surgical intervention (cutting, drilling, sawing, scratching, bobbins, bonding, spreading, rocking, piercing)
	prosthetic Orthopedic Products
	technical means of rehabilitation of persons with disabilities

Table 4. Medical Medical Applications Areas

products according to classification feature (GG)

	Areas of medical application	Code Designation
	obstetrics and gynecology
	allergology and immunology
	angiology
	balneology and water bouquet
	gastroenterology
	hematology
	genetics
	hyurgy
	dermatovenerology
	desmurgy
	diabettology
	infectious diseases
	cardiology
	coloproctology
	medical Physical Culture and Sports Medicine
	narcology
	neurology
	neonatology
	nephrology
	oncology
	otorinolaryngology
	ophthalmology (including optics)
	pediatrics
	psychiatry
	pulmonology
	rheumatology
	stomatology
	sudology
	traumatology and orthopedics
	transfusiology
	urology
	widespread

Appendix N 2.
to the order of the Ministry of Health
Russian Federation
dated June 6, 2012 N 4N

Nomenclature classification of medical products by classes, depending on the potential risk of their application

1. At the nomenclature classification of medical products by classes, depending on the potential risk of application (hereinafter, the classification of medical products) Medical products are divided into four classes. Classes have designations 1, 2a, 2b and 3.

I. Classification of medical devices (except medical
Products for diagnostics in vitro)

2. When classifying medical devices, each medical device can only be assigned to one class:

class 1. - medical products with low risk;

class 2A. - medical products with a medium risk;

class 2B. - medical products with an increased degree of risk;

class 3. - Medical products with a high risk.

3. When classifying medical devices, their functional purpose and application conditions, as well as the following criteria are taken into account, as well as the following criteria:

the duration of the use of medical devices;

invasiveness of medical devices;

the presence of contact of medical devices with a human body or interrelation with it;

the method of introducing medical devices to the human body (through anatomical cavity or surgical path);

application of medical devices for vital organs and systems (heart, central circulatory system, central nervous system);

application of energy sources.

4. When classifying medical devices to classes, depending on the potential risk of application, it is necessary to take into account the following provisions:

4.1. Non-invasive medical products refer to class 1 if none of the provisions presented below are not applied, with the exception of the provisions set out in paragraph 4.4.1.

4.4. Non-invasive medical products that come into contact with damaged skin:

4.4.1. refer to class 1 if they are used as mechanical barriers or for compression;

4.4.2. refer to class 2B if they are used for wounds that can be heated only by means of secondary healing;

4.4.3. Class 2a, if they are used in all other cases (including medical products that are intended mainly to affect the microenvironment of the Russian Academy of Sciences).

4.5.1. class 1, if these are short-term uses (continuous use for no more than 60 minutes);

4.5.3. refer to class 2b if these medical products for long-term use (continuous use for more than 30 days), but in cases where these medical products are long used in the oral cavity to pharynx, in a rumor passage to the eardrum or in the nasal cavity and not may be resorbable by the mucous membrane, they relate to class 2a;

4.6. Surgical invasive short-term medical products refer to class 2a, however if they are:

4.6.1. Designed for diagnosis, observation, control or correction of heart pathologies, the central circulatory system or the central nervous system in direct contact with the organs or parts of these systems, then refer to the class 3;

4.6.2. are reusable surgical instruments, then refer to class 1;

4.6.3. Designed to transmit energy in the form of ionizing radiation, then refer to class 2B;

4.6.4. Designed to cause a biological effect, dissolve completely or largely, then refer to class 2B;

4.6.5. Designed for the introduction of drugs through the dosing system, using a potentially dangerous method of administration, then refer to class 2B.