EAT. Astapenko, k.t., head of the Office of the Organization of State Control and Registration of Medical Development of Roszdravnadzor, V.S. Antonov., k.f.-m.n., assistant Director General, FGBU "TSMIKEE" Roszdravnadzor, MM Sukhanova, deputy Head of the Office of the Organization of State Control and Registration of Medical Development of Roszdravnadzor
The article is devoted to the practical application of the nomenclature classification of medical devices by type. The objectives and objectives of the nomenclature classification of medical devices are described. The structure of the type of medical product is given.
Currently, in the Russian Federation, work is underway to improve the regulatory legal acts in the field of treatment of medical devices, aimed at harmonizing Russian and international legislation, the prerequisites for which the entry of the Russian Federation in 2013 is among the participants of the International Medical Product Regulators forum (IMDRF).
From November 4, 2012, the order of the Ministry of Health of Russia from 06.06.2012 No. 4N "On Approval of the Nomenclature Classification of Medical Developments" came into force. Appendix No. 1 of this document determined the structure of the nomenclature classification of medical products by type (hereinafter referred to as the nomenclature classification), but in practice it did not find its use. In connection with the foregoing, as well as on the basis of the commission of the Chairman of the Government of the Russian Federation D.A. Medvedev develop and approve the classifier of medical devices, based on the international nomenclature of medical devices, the Ministry of Health of Russia, together with Roszdravnadzor, was carried out on the development of the Russian nomenclature classifier of medical devices.
Under the classification means a multi-stage division of the logical volume of the concept or any combination of units on the system of coinled concepts or classes of objects. The ultimate goal of the classification is to determine the place in the system of any unit, and thereby establishing between them the presence of some connections.
The main problem arising from the creation of a logical, consistent, universal system of identification of medical devices is to compare medical and technical criteria. Based on world practice, it can be concluded that the identification of medical devices is possible only when using a multidimensional structure of the criteria.
Currently, the global nomenclature of medical devices (GMDN) is becoming increasingly important in world practice (hereinafter - Global Nomenclature, GMDN), developed by the non-state organization GMDN Agency (United Kingdom) and used in 65 countries of the world. To date, the above nomenclature contains about 22,000 kinds of medical products. In the European Medical Database, Eudamed is made in the product of the product of the global nomenclature. In April 2012, an agreement was reached between the GMDN agency and the International Organization for the Standardization of Health Terminology (IHTSDO) on the use of a global nomenclature for medical devices as a basis for a standardized clinical terminology section (Snomed CT). In accordance with IMDRF documents, the GMDN nomenclature is integrated into an international project of unique identification of medical devices (UDI).
It should be noted that the nomenclature classification of medical devices by type is directed primarily:
To identify medical devices in state and interstate control of their quality, efficiency and safety;
- to identify medical devices when they are included in the standards and procedures for providing medical care;
- on the planning of equipping medical and preventive institutions, taking into account the types of medical activities, as well as on the application by ministries of health and other executive bodies for various purposes.
Based on the above, the development of the nomenclature classification of medical devices by type was conducted on the basis of the GMDN global nomenclature, taking into account its adaptation to Russian legislation in the treatment of medical devices, for which on May 26, 2014, an agreement was signed between Roszdravnadzor and the GMDN agency about the transfer of access rights and the procedure for using a global international nomenclature of medical devices.
The fundamental regulatory legal act regulating relations arising in the field of health protection in the Russian Federation is the Federal Law of 21.11.2011 No. 323-FZ "On the basics of the health of citizens in the Russian Federation" (hereinafter - the Law No. 323-FZ). Article 38 of this law gives the definition of medical devices, regulates the procedure for registering, circulation, classification (including by types and classes, depending on the potential risk of their application), import, maintaining a state register of medical devices and organizations (individual entrepreneurs), carrying out the production and manufacture of medical devices.
In connection with the development and implementation of the nomenclature classification of medical devices by type in the Russian Federation and in pursuance of the provisions of Art. 38 of Law No. 323-FZ amended the following regulatory legal acts:
Resolution of the Government of the Russian Federation dated December 27, 2012 No. 1416 "On approval of the rules of state registration of medical devices";
- Order of the Ministry of Health of the Russian Federation of 06.06.2012 No. 4N "On Approval of the Nomenclature Classification of Medical Products" (hereinafter referred to as Order No. 4N).
Thus, from July 29, 2014, in connection with the entry into force of the Decree of the Government of the Russian Federation dated July 17, 2014 No. 670 "On Amendments to the Rules of State Registration Registration Regulations", Roszdravnadzor is empowered to ensure the organization of work on the formation and maintenance of the Nomenclature Classification of Medical Products Views, and from January 06, 2015 by order of the Ministry of Health of the Russian Federation of 09/25/2014 No. 557n "On Amendments to Appendix No. 1 to the Order of the Ministry of Health of the Russian Federation of 06.06.2012 No. 4N" On Approval of the Nomenclature Classification of Medical Products "changes are made to Nomenclature classification of medical devices by types.
According to the order number 4, the nomenclature classification contains ( drawing):
Numerical designation of the type of medical product - six-digit identification unique record number;
- Name of the type of medical product;
- Description of the type of medical product.
The name of the species is not a standardized name of a particular medical product, but determines the view or a species group, which is a set of products with the same or similar purpose and device (design).
A description of the type of medical product is formed on the basis of 6 classification features of the formation of the type of medical product: scope, invasiveness, sterility, frequency of use, structural features and operational features, which allows you to unambiguously carry out the classification of the medical product to the type of nomenclature classification.
The nomenclature classification of medical devices by type is formed by groups and subgroups and is posted on the official website of Roszdravnadzor www.roszdravnadzor.ru in the "Electronic Services" section.
The name and description of the type of medical product over time, changes may be made, which is associated with an increase in the requirements for detailing a particular type, or the appearance of fundamentally new types of medical devices, which requires constant actualization of the nomenclature classification. In this regard, Roszdravnadzor is actualized data of the nomenclature classification of medical devices by type at least once a month with the placement of these changes on the official website of Roszdravnadzor. Considering the fact that the type of medical product is also reflected in the relevant record of the state register of medical devices and organizations (individual entrepreneurs), carrying out the production and manufacture of medical devices, the changes in Roszdravnadzor also involves notifying the relevant manufacturers of medical products, the codes of which were subject to change due to Actualization of the nomenclature classification.
Thus, the introduction of medical products to the Russian practice of medical devices, harmonized with international, was a significant step towards the modernization of legislation in the field of treatment of medical devices. If initially the main area of \u200b\u200bits application was considered to be identifying medical devices in monitoring adverse events, then the application of the nomenclature classification is relevant in various fields related to the health of the population of the Russian Federation.
The nomenclature classification of medical products by type is posted on the attached CD-disk.
Instructions for finding species in the nomenclature classification of medical devices by type
The nomenclature classification of medical devices by type (hereinafter referred to as the nomenclature classification) approved by the Order of the Ministry of Health of the Russian Federation of June 6, 2012 No. 4N "On Approval of the Nomenclature Classification of Medical Developments".
The nomenclature classification is placed in electronic form on the official website of the Federal Health Supervision Service in the Internet Information and Telecommunications Network.
The nomenclature classification contains:
Numeric designation of the type of medical product - a six-digit identification unique entry number, presented on the site in the first column of the table (Code column),
Name of the type of medical product (Column "Name"),
Description of the type of medical product (column "Description").
The name of the species is not a standardized name of a particular medical product, but determines the view or a species group, which is a set of products with the same or similar purpose and device (design).
The search for a species is performed primarily by name. To clarify the classification, a search for a description description is applied, which contains a description of the properties and classification features of the medical product.
The search for a nomenclature classification is possible to carry out in the following ways:
The search for the word or part of the word in the name of the species is made by placing the word or its part in the name search string.
The "Advanced Search" string allows you to navigate:
In the code code;
According to the word or part of the word in the description of the form;
According to the word or part of the word in the title of the section.
On the left side of the page there is a list of sections and subsections that allows you to select the species contained in this section (subsection). One species can relate to several sections (subsections). If you can not find a keyword view, it is recommended to carefully view the views included in the appropriate section. This allows you to choose additional keywords to search for species.
Simultaneous use of search for name and description, or simultaneous search on the name and selection of the appropriate section (subsection) allows you to narrow the search for the desired type.
An example of search.
Product name: Coronary Cobalt-chrome stents.
Step 1.
In the search bar to enter the word "stent". The table selected 174 types of species containing words, which include this combination of letters.
Step 2.
To narrow the search, you can simultaneously in the "extended search" in the line "Description" to introduce a part of the word "Coronary". Selected 14 records, in them - 6 different types (some species are repeated, as they relate to several subsections).
Step 3.
Viewing the species displayed allows you to choose the desired view:
218190 "Stent for coronary arteries uncovered metal."
Registration N 24852.
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. Skvortsova
Appendix N 1.
Appendix N 2.
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 devices 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 an average risk;
class 2B - medical products with an increased 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.
4.2. 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 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. 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 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;
4.5.4. 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 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.
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. Implated medical products, as well as surgical invasive medical products for long-term use, are classified as class 2B, however, 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 that is a drug or other biologically active agent and affecting the human body in addition to the impact of the medical product belong to the 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 to disinfect medical devices belong to class 2a, however, if they are intended for cleaning, washing, disinfection of contact lenses, they refer 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.
5. If the medical device is intended for use in combination with other medical products, then classes are installed for each medical product.
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 corresponding to the greatest degree of potential risk.
7. For special software, which is an independent product and used with a medical product, establish the same class as for the medical product itself.
II. Classification of medical devices for diagnostics in vitro
8. When classifying medical devices for diagnostics in vitro (hereinafter - medical items), each medical device can only be attributed 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 diseases threatening human life , with high distribution risk and which provide decisive information to form a proper diagnosis, refer to class 3.
9.2. Medical products, which are used to determine blood groups or tissue types, in order to guarantee the immunological compatibility of blood, blood components, cells, tissues or organs that are intended for transfusion or transplantation, refer to class 2B, with the exception of the AVO system, the rhesus of the system (with , 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 selecting 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 In Vitro diagnostic procedures (without specifying specific types of laboratory tests / analytes) refer to class 1 .
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 product 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 predetermined 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, establish the same class as for the medical product itself.
-
Respiratory Syzitial Virus Antigens IVD, Set, Immunochromatographic Analysis, Express Analysis
A set of reagents and other materials related to them intended for use with a high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample for a short period, compared with standard laboratory testing procedures using an immunochromatographic analysis method (IHA ). This test is usually used in laboratory analyzes or analyzes near the patient. -
Respiratory Syzitial Virus Antigene IVD, Set, Immunohemily Summer Analysis
A set of reagents and other related materials intended for use in high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample by immunohemonscent analysis. -
Respiratory Syzitial Virus Antigens IVD, Set, Direct Fluorescent Analysis
A set of reagents and other related materials intended for use with a high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample by direct fluorescent analysis. -
Respiratory Syzitial Virus Antigens IVD, Set, Immunohistochemical Reaction with Enzymatic Tag
A set of reagents and other materials related to them intended for use with a high-quality and / or quantitative determination of antigens of a respiratory syncytial virus (Respiratory Syncytial Virus) in a clinical sample by enzyme immunohistochemical staining. -
Respiratory Syncical Virus Antigens IVD, Antibodies
One or many immunoglobulins that can bind to specific antigenic determinants intended for use with high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample. -
Respiratory Syzitial Virus Antigens IVD, Reagent
A substance or reagent intended for use in conjunction with the source product for the IVD to perform a special function in the analysis, which is used with high-quality and / or quantitative antigens of the respiratory syncytial virus (Respirate Syncytial Virus) in the clinical sample. -
Respiratory Syzitial Virus Antigens IVD, Calibrator
The material used to establish reference values \u200b\u200bfor analysis intended for use with a high-quality and / or quantitative determination of antigens of a respiratory syncytial virus (Respiratory Syncytial Virus) in a clinical sample. -
Respiratory Syzitial Virus Antigens IVD, Set, Envunophersimal Analysis (ELISA)
A set of reagents and other materials related to them intended for use with high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample by enzyme immunoassay analysis (ELISA). -
Respiratory Syzitial Virus Antigens IVD, Control Material
The material used to confirm the quality of the analysis intended for use with a high-quality and / or quantitative determination of antigens of the respiratory syncytial virus (Respiratory Syncytial Virus) in the clinical sample. -
Respiratory Syncical Virus Antigens IVD, Set, Envunophersten Analysis (ELISA), Express Analysis
A set of reagents and other materials related to them, intended for use with a high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample for a short period, compared with standard laboratory testing procedures, using an enzyme immunoassay method (ELISA ). This test is usually used in laboratory analyzes or analyzes near the patient. -
Respiratory Syzitial Virus Antigens IVD, Set, Immunochromatographic Analysis
A set of reagents and other related materials intended for use with high-quality and / or quantitative determination of respiratory syncytial virus antigens (Respiratory Syncytial Virus) in a clinical sample Method of immunochromatographic analysis (IHA). -
C-terminal proorginin-Vasopressin / Coppentine IVD, set, immunohemiallyuminescent analysis
A set of reagents and other related materials intended for high-quality and / or quantitative definition of C-terminal Pro-Arginine Vasopressin (CT-ProAVP)), also known as Coppeptin, in a clinical sample by the method immunohemilyumine analysis. -
Retractor for eyeball fabric, reusable
Ophthalmological tool intended for use directly for temporary mechanical retraction / dilatation of eyeball tissues (for example, a rainbow shell, sclera) during an ophthalmic surgery. It can be a manual hook-made product or a self-speaking device. As a rule, it is made of high-quality stainless steel. This product is suitable for reusable. -
Retractor for eyeball fabric, disposable
A sterile ophthalmological tool intended for use directly for temporary mechanical retraction / dilatation of eyeball tissues (for example, a rainbow shell, sclera) during an ophthalmic surgery. It can be a manual hook-made product or a self-speaking device. As a rule, it is made of high-quality stainless steel. This is a disposable product. -
Cannula for chest drainage
A sterile semi-rigid or rigid tube introduced into the chest directly inside the pleural space is usually to facilitate the placement of the thoracic drainage. This is a disposable product. -
Introdouser for a suplocked catheter
Hard surgical instrument (tools) designed to create percutaneous supraid access through the bottom of the abdominal wall to the bladder to accommodate the drainage catheter. Includes acute trocar with blade and / or cannula / sleeve for visual access and is manufactured, as a rule, from high-quality stainless steel or durable plastic. This is a disposable product. -
Exudate absorption bandage, with hydrophilic gel, sterile
The sterile coating for wounds is usually made from hydrocolloid, hydraulic or alginate (salts and acids extracted from seaweed), designed to create a moisture-absorbing gel upon contact with the exudate of the wound; The product does not contain antibacterial substances. The product contributes to healing by absorbing the exudate from the RAS (for example, ulcers, burns, surgical wounds, gaps, scratches) with minimal softening of the wound, allowing the wound processing and creating a wet wedge for wound healing. The product can be produced in the form of a flat sheet / film, ribbons, harness, foam, liquid, paste or powder. After use, it is impossible to use the product again. -
The autoinager is pre-filled
Portable hand-made product, as a rule, in the form of a large handle, pre-filled with a drug and intended for use by the patient in order to carry out the subcutaneous injection of the dose of medication through a replaceable needle. The product, as a rule, has a dosage scale and is disposed of after the drug is ends inside the drug; Thus, the product is used for a short period of time (disposable). -
Autoinager used with interchangeable cartridge, mechanical
Portable manual mechanical product, as a rule, in the form of a large handle in which a drug cartridge is installed (not related to this type), intended for use by the patient in order to subcutaneize the dose of medication through a removable needle. The cartridge is installed in the product, and to select a dosage, as a rule, a special scale is used (for example, the dose is selected using a spring mechanism); When the drug ends, the cartridge is replaced with a new one. This product is suitable for reusable.
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 |
|
| 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 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 | BB | GG | |||||||||||||||||||||||||||||||
| > | 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
Cystitis during pregnancy: to cure and prevent repeated development can be pregnant during cystitis
Is it possible to make a pregnant cherry?
Cesarean without indications possible operation?
Cesarean section: from preparation for surgery before extracting from the maternity hospital What you need to make caesarean section
Menstrual-like bleeding in the middle of the cycle