home Calculators Medical products used in surgical hospitals. On approval of the list of medical products. What it is

Medical products used in surgical hospitals. On approval of the list of medical products. What it is

Medical products occupy a special place in the domestic pharmaceutical market.

The regulatory framework of the Russian Federation establishes a special procedure for introducing them into the market, selling and storing them.

There are different classifications of medical products depending on what procedures they are intended to perform and what their potential danger to humans is.

In the article you can download all the current lists of medical products.

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From the article you will learn:

Definition of medical devices

Medical products are all kinds of auxiliary devices, equipment, care items, reagents, consumables and other items used in the process of providing medical care.

Medical products have a number of characteristic features:

they are used independently or in combination with other products;
some products can only be used together with other objects necessary for preventive measures, diagnosis, therapy and recovery from illness, as well as monitoring the condition of the patient’s body, research, replacement, rehabilitation, modification of physiological properties or human anatomy;
Medical devices are subject to important requirements for efficiency and safety. They should help achieve a positive effect after their use, but these products are not allowed to cause harm to the patient;

Medical products are divided into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification.

Order of the Ministry of Health of the Russian Federation dated June 6, 2012 N 4n approved the Nomenclature Classification of Medical Devices by Type and the Nomenclature Classification of Medical Devices by Class depending on the potential risk of their use.
The list of medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, in respect of which tests are carried out in order to approve the type of measuring instruments, was approved by Order of the Ministry of Health of Russia dated August 15, 2012 N 89n.
The list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements performed when carrying out activities in the field of healthcare, and mandatory metrological requirements for them, including indicators of measurement accuracy, was approved by Order of the Ministry of Health of Russia dated February 21, 2014 N 81n.

Medical Device Safety Monitoring: SOP for Internal Control

Let us give an approximate assortment of medical products for patient care, as well as those intended for treatment and prophylactic, sanitary and hygienic tasks:

individual pharmacy kits;
blood suction cups;
bandages;
eye baths;
ankles;
sponges;
heating pads;
tourniquets to stop bleeding;
injection needles;
catheters;
uterine rings;
medical, polyvinyl chloride, compress oilcloth;
teething rings for children;
different types of crutches;
backing circles;
forceps;
knee pads;
various prostheses;
surgical scissors;
finger pads;
eye blades;
breast pumps;
disposable diapers;
gloves;
pads and tampons;
eye droppers;
oxygen pillows;
individual rubber belts;
masks and respirators;
syringes;
baby pacifiers;
reagents;
reagents;
means for protection;
glasses for medicines;
test system;
medical thermometers;
jockstraps;
tubes;
support clothing (stockings and knee socks);
medical syringes.

Patient care facilities consist of:

Dressings consist of:

Medical products, checking according to Roszdravnadzor checklists

Roszdravnadzor began checking how the system for handling medical devices is organized in clinics, using checklists. How to prepare for such an inspection and what to pay attention to, read the recommendations of the Chief Nurse System.

The expert told how to follow eight steps to avoid getting fined by the department. Download the package of necessary documents - current SOPs and checklists for working with medical devices.

Medical instruments are diverse in their functionality and scope, however, the main groups can be distinguished:

tweezers;
probes and inhalation masks for anesthesia;
gynecological, surgical, microsurgical, laparoscopic and endoscopic instruments;
anesthesia kits;
endoscopic trocars;
spinal needle;
incubation tubes;
cosmopores;
furrier's needles;
cuvettes;
stilettos;
trocars;
tracheostomy sets;
Farabeuf hooks;
various pins;
spatulas;
bacteriological loops;
clamps;
tourniquets;
mirrors;
needle holders;
cuvettes for equipment;
sterilization bags and box;
bactericidal irradiator;
tripods;
tazomer;
frontal reflector;
manual ophthalmoscope;
fork;
pressure measuring instruments;
expander;
dynamometer;
tables for examining color sensation and visual acuity;
blood count readers.

Let us recall that the Code of the Russian Federation on Administrative Offenses provides for administrative punishment for the sale of medical devices that do not comply with the established rules.

Medical products, circulation

All types of goods classified as medical devices go through a number of successive stages from the moment of their creation, the totality of which constitutes the process of circulation of medical devices.

On the territory of Russia, the circulation of medical devices that are registered in accordance with the legislation of the country is not prohibited.

Those products of medical equipment and devices that are made according to the individual order of the patient and are intended only for personal use are not subject to state registration.

Ready collection for a nurse

How can the chief nurse control work with medical devices in order to pass inspection by Roszdravnadzor?

Roszdravnadzor began using sheets with control questions during scheduled inspections of medical organizations. The Federal Supervisory Service approved them by order No. 10449 dated December 20, 2017. The document came into force on February 6, 2018.

To organize internal control over work with medical devices, use the new checklists of Roszdravnadzor.

Ildar Bulatovich Minulin, chief specialist of the Federal State Budgetary Institution “Center for Monitoring and Clinical-Economic Expertise” of Roszdravnadzor, Ph.D. n. explained how to control the quality and safety of medical devices in a hospital:

Define Responsibility
Check maintenance documents and control deadlines
Carry out technical condition monitoring in a timely manner
Eliminate low-quality, unregistered and falsified medical products from circulation

The expert provided a complete algorithm for quality control and safety when working with medical devices in the form of a memo-presentation to the manager. The instructions are available in the journal "Chief Nurse".

Procedure for importing medical devices

Federal authorities determine the procedure by which medical devices must be imported into the country for their further official registration.

The Government of the Russian Federation establishes the grounds and rules for organizing doping control, during which a test system or special materials are used.

This measure is necessary precisely at the stage of import into the territory of the Russian Federation.

Registration

Before registration, it is determined how high quality and effective the product is, for which it must pass a series of serious tests, both technical and clinical.

Toxicology tests and other tests may also be performed. The set of preliminary measures for checking a medical device depends on its type and operational features.

The procedure for conducting such events is established by the authorized state body.

After successful testing, the organization that owns the rights to the medical device must receive an official document confirming this registration certificate. For its registration it is necessary to pay a state duty, the amount of which is specified in the Tax Code of the Russian Federation.

names of registered objects (for example, syringes, surgical scissors, needles, etc.);
registration date and number, validity period of the certificate;
purpose;
class of potential operational risk;
OKP code;
name and location of the organization;
manufacturer's address;
information about interchangeability.

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The assortment of pharmacies must necessarily include goods for sanitary and hygienic purposes and patient care items, since in case of serious illnesses, after surgical interventions, for non-ambulatory patients and in other cases, they are necessary to ensure human life. They belong to medical products, the range of which includes hygiene and dressing products, medical clothing, etc.

Medical products (IMD) are medical products made of glass, polymer, rubber, textile and other materials, sets of reagents and control materials for them, other consumables and products, mostly single-use, that do not require maintenance during use (order of the Ministry of Health RF No. 444 dated December 13, 2001 “On the validity period of registration certificates for medical products and medical equipment”).

This group of products accounts for about 20% of the total medical device market, which emphasizes its importance for the medical industry. Currently, only a fifth (20%) of products in this area are domestic.

Order of the Ministry of Health and Medical Industry No. 161 dated June 9, 1995 regulates the assortment list of medical products, patient care, prevention, sanitation and hygiene items that should be in pharmacies.

Assortment list of medical products, patient care items, prevention, sanitation and hygiene for pharmacies (Order No. 161 of the Ministry of Health and Medical Industry of the Russian Federation dated June 9, 1995)

First aid kits (sets) individual, first aid, universal, mother and child

Bandages

Blood suction cups

Compress paper

Eye baths

Ankles

Hemostatic tourniquets

Injection needles

Colostomy bags and collection bags

Catheters

Oilcloth lining, compress, polyvinyl chloride, medical

Children's dental rings

Uterine rings

Crutches for adults, children, teenagers and tips for them

Backing circles

Esmarch mugs (irrigator)

Ophthalmic scapulas

Breast pumps

Urinals

Knee pads

Fingertips

Medical scissors

Disposable diapers

Women's hygiene bags (pads), tampons

Medical gloves

Eye pipettes

Spittoons

Sippy cups

Oxygen pillows

Hygienic rubber belts

Ice bubbles

Respirators, medical masks

Baby pacifiers

Syringes

Means of contraception (caps, condoms, intrauterine devices)

Cups for taking medicines

Bedpans

Suspensions - Medical thermometers

Medical tubes

Stockings, half-stockings (knee socks) medical

Medical syringes

Certain products (catheters, scissors, thermometers, syringes, etc.) are discussed in other topics. This topic discusses groups of other products.

According to their functional purpose, sanitation, hygiene and patient care products can be systematized into groups presented on

Classification of sanitary and hygiene products, patient care items by functional purpose

Patient care items for taking medications, mainly liquids and water, include cups, sippy cups, eye pipettes, etc.

To perform some medical procedures, blood suction cups, Esmarch cups, hemostatic tourniquets, gloves, syringes, thermometers, etc. are used.

If the patient is in bed rest, sanitary and hygiene products for the toilet are needed: bedpans, urinals, colostomy bags, oilcloth.

Certain products are intended for the personal hygiene of patients, in particular, bandages, catheters, uterine rings, spittoons, jockstraps, etc.

At the same time, the assortment also includes sanitary and hygiene products that are needed by healthy people, children, women, including pregnant women, for example, first aid kits, children’s dental rings, breast pumps, finger pads, pacifiers, feminine bags, masks, medical respirators and etc.

In recent years, groups or series of products designed to solve certain problems of healthy or sick people have appeared on the Russian pharmaceutical market. For example, the company Artsana (Italy) offers a group of products - care products

for newborns and young children, as well as accessories for nursing women, including:

Physiological project KiKKO:

Physiological nipples have original design features, namely: an anti-hiccup valve in combination with unloading channels-grooves that regulate the flow of air into the bottle;

Physiological “drop” pacifiers have a teardrop shape;

Physiological bottles consist of a cup cap, a physiological nipple, a hygienic plug, a bottle, a valve that prevents colic in children, and a removable bottom;

The adjustable breast pump is designed for expressing breast milk in nursing women.

The Tena series of products - for the care of patients with urinary incontinence, includes adult diapers and absorbent sheets. The use of these products simplifies patient care and provides the patient with a feeling of comfort.

Types of goods:

“Lady” diaper pads for women have an anatomical shape, are suitable for use both night and day, invisible under clothing; Normal, extra, super types are available, in packages of 7-12 pcs.;

“Slip” pads are available in two sizes: M - medium, L - large, 10 pcs. packaged;

“Comfort” pads are supplied complete with fixing panties;

“Bed” sheet pads, size 60x60 or 60x90, 20-30 pcs. packaged.

These goods are of domestic production: the company "SCA Hygiene Products" (Russia).

A certain group of products consists of personal hygiene products for women during the menstrual cycle and for every day. These include pads, tampons, bags that perform one function - absorption (absorption) of body secretions and ensuring women's comfort.

Hygienic intravaginal products for use on “critical” days - Tampax tampons are made from specially bleached cotton fiber, viscose or a mixture thereof, and have a return cord. Available in three types: mini, normal and super-super plus; 8 pcs per pack

They are compact and allow a woman to lead an active lifestyle. Researchers from the Russian Association of Obstetricians and Gynecologists have proven that they do not cause changes in the vaginal microflora and are safe for women’s health. Tampons should be changed every 4-8 hours. At the same time, you need to know the precautions, because if an unexpected deterioration in your health occurs when using tampons (fever, vomiting, diarrhea, muscle pain, dizziness, etc.), you should immediately consult a doctor. The cause may be toxins produced by staphylococcus. These health changes are called toxic shock syndrome. There are no reported cases of TSS in Russia yet. The use of tampons during the postpartum period, especially during surgical interventions, is undesirable and is possible only after consultation with a doctor. Issued by branches of Procter and Gamble (USA).

Procter and Gamble (USA) also produces a series of hygiene products for women, in particular:

“Olways Ultra” - hygiene products for use on “critical” days, and are available in four types depending on the characteristics of these days for women: 1) light - pad length 240 mm; 2) normal - 284 mm; 3) super - 284 mm; 4) night - 302 mm.

These pads absorb moisture well, as they have a unique “Driven” top layer, consisting of extremely fine three-dimensional funnel-shaped pores. It allows moisture to enter the gasket and prevents it from coming to the surface under pressure. The pads have elongated elastic “wings” for reliable fixation to the laundry. The materials from which the pads are made do not support the growth and reproduction of bacteria, do not irritate the skin and do not cause allergies. Pads are changed 4-6 times a day. Shelf life: 2 years. Produced by company branches in Germany, Hungary, and Turkey.

A series of "Oldaze" pads is available for daily use. They have a softer surface, control the appearance of unpleasant odors, create comfortable conditions for the female body, and prevent skin irritation and the feeling of diaper rash.

The pads available are "Oldaze Black" in black, "Oldaze Black Tanga" - black, "Oldaze Tanga" - regular color, with a shape modified for underwear, "Oldaze Ladge" - large, normal - medium, resin - small, in packs of 16-22 pieces, shelf life 2 years. Made in Germany.

Series O.BI. (o.b.) - tampons are made of viscose, cotton, have a non-woven surface and a return cord. Available in different sizes to suit different discharge volumes. Requires changes every 3-6 hours. Tampons O.BI. Comfort have a special silky surface. In packs of 8 and 16 pcs. Produced by Johnson & Johnson (Austria).

A series of sanitary napkins (pads) for daily use “Care Free” are made of cotton, the surface is soft, impregnated with a special solution containing various substances that maintain the natural acid-base balance of the intimate area, chamomile extract prevents the possibility of inflammation and irritation. Thin, flexible, shape follows the lines of the body, securely fixed on underwear. In packages from 16 to 30 pcs., may be black,

Various types are available: “Care Free”, “Care Free Black”, “Care Free Flexiform” (breathable), “Care Free Fresh” (with the aroma of freshness), “Care Free Ultra” (for use on menstrual days), etc. Produced by Johnson & Johnson (Italy).

IN The assortment of pharmacies must necessarily include goods for sanitary and hygienic purposes and items for patient care, since in case of severe illnesses, after surgical interventions, for non-ambulatory patients and in other cases they are necessary to ensure human life. They belong to medical products, the range of which includes hygiene and dressing products, medical clothing and more.

Medical products (MPD)- these are medical products made of glass, polymer, rubber, textile and other materials, sets of reagents and control materials for them, other consumables and products, mainly single-use, which do not require maintenance during use (Order of the Ministry of Health of the Russian Federation No. 444 of December 13. 2001 “On the validity period of registration certificates for medical products and medical equipment”).

Assortment list of medical products,

items for patient care, prevention, sanitation

and hygiene for pharmacies

(Order No. 161 of the Ministry of Health and Medical Industry of the Russian Federation dated June 9, 1995)

- First aid kits (sets) individual, first aid, universal, mother and child - Bandages - Blood suction cups - Compress paper - Eye baths - Ankles - Heating pads - Sponges - Hemostatic tourniquets - Injection needles - Colostomy bags and collection bags - Catheters - Oilcloth lining, comp-Ressnaya, polyvinyl chloride, medical Children's dental rings Uterine rings - Crutches for adults, children, teenagers and tips for them - Backing circles - Esmarch circles (irrigator) - Eye blades - Breast pumps - Urinals - Knee pads - Fingertips

- Medical scissors - Disposable diapers - Women's hygienic bags (pads), tampons - Medical gloves - Eye pipettes - Spittoons - Sippy cups - Oxygen pillows - Hygienic rubber belts - Ice packs - Respirators, medical masks - Children's pacifiers - Syringes - Preventive measures ( caps, condoms, intrauterine devices) - Cups for taking medications - Bed beds - Suspensories - Medical thermometers - Canes - Medical tubes - Medical stockings, half-stockings (knee socks) - Medical syringes

Certain products (catheters, scissors, thermometers, syringes, etc.) are discussed in other topics. This topic discusses groups of other products.

According to their functional purpose, sanitary, hygiene and patient care products can be systematized into groups presented in Fig. 10.

Rice. 10. Classification of sanitary and hygiene products, patient care items by functional purpose.

To patient care items for taking medications, mainly liquid, water, intended for cups, sippy cups, eye pipettes, etc.

To perform certain medical procedures blood suction cups, Esmarch cups, hemostatic tourniquets, gloves, syringes, thermometers, etc. are used.

If the patient is in bed rest, sanitary and hygiene products are required. for toilet: bedpans, urinals, colostomy bags, oilcloth.

Individual products are intended for personal hygiene of patients, in particular, bandages, catheters, uterine rings, spittoons, jockstraps, etc.

At the same time, the range also includes sanitary and hygiene products that are needed healthy people, children, women, incl. and for pregnant women, for example, first aid kits, children’s dental rings, breast pumps, finger caps, pacifiers, feminine bags, masks, medical respirators, etc.

In recent years, groups or series of products designed to solve certain problems of healthy or sick people have appeared on the Russian pharmaceutical market. For example: the company Artsana (Italy) offers a group of products - products for the care of newborns and young children, as well as accessories for nursing women, including:

Physiological project KiKKO:

- physiological nipples have original design features, namely: an anti-hiccup valve in combination with unloading channels-grooves that regulate the flow of air into the bottle;

- physiological pacifiers “drop” have a teardrop shape;

- physiological bottles consist of a cup cap, a physiological nipple, a hygienic plug, a bottle, a valve that prevents colic in children, and a removable bottom;

- adjustable breast pump Designed for expressing breast milk in nursing women.

Product series Tena- for the care of patients with urinary incontinence, includes adult diapers, absorbent sheets. The use of these products simplifies patient care and provides the patient with a feeling of comfort.

Types of domestically produced goods: SCA Hygin Products (Russia):

“Lady” diaper pads for women have an anatomical shape, are suitable for use both night and day, invisible under clothing; Normal, extra, super types are available, in packages of 7-12 pcs.

“Slip” pads are available in 2 sizes: M - medium, L - large, 10 pcs. packaged;

“Comfort” pads are supplied complete with fixing panties;

“Bed” sheet pads, size 60x60 or 60x90, 20-30 pcs. packaged.

Hygienic intravaginal products for use on “critical” days - tampons Tampax made from specially bleached cotton fiber, viscose or a mixture thereof, and have a return cord. Available in 3 types: mini, normal and super-super plus; 8 pcs per pack

They are compact and allow a woman to lead an active lifestyle. Researchers from the Russian Association of Obstetricians and Gynecologists have proven that they do not cause changes in the vaginal microflora and are safe for women’s health. Tampons should be changed every 4-8. hour. At the same time, you need to know the precautions, because... If, when using tampons, an unexpected deterioration in your health occurs (fever, vomiting, diarrhea, muscle pain, dizziness, etc.), you should immediately consult a doctor, because the cause may be toxins produced by staphylococcus. These health changes are called toxic shock syndrome. There are no reported cases of TSS in Russia yet. The use of tampons during the postpartum period, especially during surgical interventions, is undesirable and is possible only after consultation with a doctor. Produced by branches of Procter & Gamble (USA).

Procter and Gamble (USA) also produces a series of hygiene products for women, in particular:

Olweiz ultra- hygiene products for use on “critical” days, and they are available in 4 types depending on the characteristics of these days for women: 1) light - pad length 240 mm; 2) normal - 284 mm; 3) super - 284 mm; 4) night - 302 mm.

These pads absorb moisture well because they have a unique “Dry-Viv” top layer, consisting of tiny three-dimensional funnel-shaped pores. It allows moisture to enter the gasket and prevents it from coming to the surface under pressure. The pads have elongated elastic “wings” for reliable fixation to the laundry. The materials used to make the pads do not support the growth and reproduction of bacteria, do not irritate the skin and do not cause allergies. Pads are changed 4-6 times a day. Shelf life: 2 years. Produced by company branches in Germany, Hungary, and Turkey.

A series of pads is available for daily use Oldaze. They have a softer surface, control the appearance of unpleasant odors, create comfortable conditions for the female body, and prevent skin irritation and the feeling of diaper rash.

Gaskets are available Oldeyes black black color, Oldeyes black tanga- black color, Oldeyes tanga- regular color, with a shape modified to match underwear, Oldies ludge- big, normal- average, resins- small size, 16-22 pieces in packs, shelf life 2 years. Made in Germany.

Series OBI.(o.b.) - tampons are made of viscose, cotton, have a non-woven surface and a return cord. Available in different sizes to suit different discharge volumes. Requires changes every 3-6 hours. Tampons OBI. Comfort have a special silky surface. In packs of 8 and 16 pcs. Produced by Johnson and Johnson (Austria).

A series of sanitary napkins (pads) for daily use Care free made of cotton, the surface is soft, impregnated with a special solution containing various substances that maintain the natural acid-base balance of the intimate area, chamomile extract prevents the possibility of inflammation and irritation. Thin, flexible, shape follows the lines of the body, securely fixed on underwear. In packages from 16 to 30 pcs., may be black,

Various types are available: Care free, Care free black, Care free flexiform(breathable), Care free fresh(with the aroma of freshness), Care free ultra(for use on critical days), etc. Produced by Johnson and Johnson (Italy).

Rubber compound composition:

1.1.pure bases contain more than 90% rubber, the rest is sulfur.

1.2.unfilled bases - contain about 90% rubber, sulfur, accelerators, activators, antioxidants, etc.

2.vulcanizing agents. Vulcanization is the addition of substances with the help of which rubber macromolecules are cross-linked with the help of sulfur at the site of double bonds. This process can only occur under certain conditions:

1) using three types of sulfur: ground sulfur, precipitated sulfur and “sulfur color”

2) using metal oxides and some synthetic resins

3) using nuclear irradiation of the raw rubber mixture

4) radiation-chemical vulcanization.

3.vulcanization accelerators:

3.1.inorganic - metal oxides, concentrated acids.

3.2.organic – thiurans, thiazoles.

4.softeners – thiophenols, thionapthols, pentons, renacites.

5.fillers:

5.1.active – white soot, silicon oxide, black soot.

5.2. inactive fillers - thinners - chalk, talc, barite, gypsum.

6.antioxidants (antioxidants).

Rubber aging occurs as a result of destruction. Externally it manifests itself as fragility, brittleness, cracks, hardness. These processes manifest themselves under the influence of oxygen, heat, and irradiation. Substances that protect against thermal and oxide aging are divided into:

1) physical action: wax, paraffin, ozokerite, ceresin. These substances, when sweated, form a protective film on the surface, that is, they protect the product from aging.

2) chemical action: phenols, amines, aromatic hydrocarbons. These substances are very active and primarily react with oxygen in the air.

7.special substances:

7.1.anti-fatigue – p-phenyldiamine

7.2.antiozonants – antilux, santaflux and flexozon

7.3.Phenols protect from light aging.

Types of rubber:

1.Styrene butadiene rubber - the most common type in the 19th century. Currently the cheapest. It is not resistant to temperature influences, so it quickly fails.

2.Polychloropropylene rubber is resistant to light, ozone, and oils. Used for non-woven textiles.

3.Polyisoprene rubber – used to replace products made by dipping.

4. Silicone rubbers are very expensive, but have high strength over a wide temperature range. Used in plastic surgery, for the manufacture of catheters, etc.

5.Thermoplastic elastomers combine the properties of thermoplastics and rubber. They are used to make parts that have long-term contact with the body.

Related information.

Registration N 24852

In accordance with Part 2 of Article 38 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collection of Legislation of the Russian Federation, 2011, N 48, Art. 6724) and the Decree of the President of the Russian Federation dated May 21, 2012 N 636 “On the structure of federal executive bodies” (Rossiyskaya Gazeta, 2012, N 114) I order:

Approve:

nomenclature classification of medical products by type according to Appendix No. 1;

nomenclature classification of medical devices into classes depending on the potential risk of their use in accordance with Appendix No. 2.

Minister V. Skvortsova

Appendix No. 1

Appendix No. 2

Nomenclature classification of medical devices into classes depending on the potential risk of their use

1. When nomenclature classification of medical devices into classes depending on the potential risk of use (hereinafter referred to as the classification of medical devices), medical devices are divided into four classes. The classes are designated 1, 2a, 2b and 3.

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

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

class 1 - low-risk medical devices;

class 2a - medical devices with an average degree of risk;

class 2b - medical devices with an increased degree of risk;

class 3 - medical devices with a high degree of risk.

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

duration of use of medical products;

invasiveness of medical devices;

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

method of introducing medical devices into the human body (through anatomical cavities or surgically);

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

use of energy sources.

4. When assigning medical devices to classes depending on the potential risk of use, the following provisions must be taken into account:

4.1. Non-invasive medical devices are classified as Class 1 if none of the provisions below apply, except for the provisions set out in paragraph 4.4.1.

4.2. Non-invasive medical devices intended to carry or store blood, body fluids or tissues, fluids or gases for subsequent infusion, transfusion or administration into the body are classified as Class 2a.

4.3. Non-invasive medical devices intended to alter the biological or chemical composition of blood, other body fluids, or fluids intended for infusion into the body are classified in Class 2b. However, where the therapeutic effect involves filtration, centrifugation, gas exchange or heat exchange to change the biological or chemical composition of blood, other body fluids or fluids intended for infusion into the body, medical devices are classified as Class 2a.

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

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

4.4.2. belong to class 2b if they are used for wounds that can only be healed by secondary healing;

4.4.3. belong to class 2a if they are used for all other purposes (including medical devices that are intended primarily to affect the microenvironment of wounds).

4.5. Invasive medical devices (except for surgical invasive ones), the use of which is associated with anatomical cavities in the human body and which are not intended for connection to an active medical device:

4.5.1. belong to class 1 if these medical devices are of short-term use (continuous use for no more than 60 minutes);

4.5.2. belong to class 2a if these medical products are for 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 the ear canal to the eardrum or in the nasal cavity, they belong to class 1;

4.5.3. belong to class 2b if these medical products are of long-term use (continuous use for more than 30 days), but in cases where these medical products are used for a long time in the oral cavity to the pharynx, in the ear canal to the eardrum or in the nasal cavity and not can be resorbed by the mucous membrane, they belong to class 2a;

4.5.4. All invasive medical devices (except surgical invasive ones), the use of which is associated with anatomical cavities in the body and which are intended to be attached to an active medical device of class 2a or a higher class, belong to class 2a.

4.6. Surgical invasive medical devices for short-term use are classified in class 2a, but if they:

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

4.6.2. are reusable surgical instruments, they belong to class 1;

4.6.3. are intended to transmit energy in the form of ionizing radiation, then they belong to class 2b;

4.6.4. are intended to cause a biological effect, to be absorbed completely or to a significant extent, then they belong to class 2b;

4.6.5. are intended for the administration of medicinal products through a dosing system using a potentially dangerous method of administration, then they belong to class 2b.

4.7. Surgical invasive medical devices for temporary use are classified in class 2a, but if they:

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

4.7.2. directly contact the central nervous system, they belong to class 3;

4.7.3. are intended to transmit energy in the form of ionizing radiation, then they belong to class 2b;

4.7.4. are intended to cause a biological effect, to be absorbed completely or in large part, then they belong to class 3;

4.7.5. undergo chemical changes in the body or administer medications, then they belong to class 2b (with the exception of medical devices implanted into teeth).

4.8. Implantable medical devices, as well as surgical invasive medical devices for long-term use, are classified in class 2b, however, if they:

4.8.1. intended for implantation into teeth, they belong to class 2a;

4.8.2. are in direct contact with the heart, central circulatory system or central nervous system, then belong to class 3;

4.8.3. are intended to cause a biological effect or to be absorbed completely or to a significant extent, then they belong to class 3;

4.8.4. undergo chemical changes in the body or introduce drugs into the patient’s body, then they belong to class 3 (with the exception of medical devices implanted into teeth).

4.9. Active therapeutic medical devices:

4.9.1. active medical devices that are intended to transmit energy or exchange energy are classified in class 2a. However, if the transfer of energy to or exchange of energy with the human body poses a potential danger due to the characteristics of medical devices, taking into account the effect on parts of the body to which the energy is applied (including active medical devices intended to create ionizing radiation, radiation therapy), then they belong to class 2b;

4.9.2. active medical devices intended to control class 2b active therapeutic medical devices are classified as class 2b.

4.10. Active diagnostic medical devices belong to class 2a if they are intended for:

4.10.1. transmission of energy absorbed by the human body, however, if the function of the medical product is to illuminate the patient’s body in the visible range of the spectrum, then they belong to class 1;

4.10.2. distribution of radiopharmaceutical drugs introduced into the patient’s body;

4.10.3. provide direct diagnosis or monitoring of vital body functions, but if they are intended to monitor vital physiological parameters, changes in which could lead to immediate danger to the patient (for example, changes in cardiac function, respiration or central nervous system activity), then they are classified as class 2b;

4.10.4. management of active diagnostic medical devices of class 2b, belong to class 2b.

4.11. Active medical devices intended for introducing drugs, physiological fluids or other substances into the patient’s body and (or) removing them from the body belong to class 2a. However, if the method of administration (excretion) represents a potential hazard, taking into account the type of substances involved, the part of the body and the method of application, then they belong to class 2b.

4.12. Other active medical devices are classified as Class 1.

4.13. Medical products, the components of which include a substance that is a drug or other biologically active agent and affects the human body in addition to the effect of the medical device, belong to class 3.

4.14. Medical devices intended to control conception or protect against sexually transmitted diseases are classified in class 2b, but if they are implantable or invasive medical devices for long-term use, they are classified in class 3.

4.15. Medical products intended for the disinfection of medical devices belong to class 2a, but if they are intended for cleaning, rinsing, disinfecting contact lenses, then they belong to class 2b.

4.16. Inactive medical devices used to obtain diagnostic x-rays are classified as Class 2a.

4.17. Medical devices that have been manufactured using necrotic animal tissue or derivatives are classified as Class 3, but if they are intended to come into contact only with intact skin, they are classified as Class 1.

4.18. Containers for blood, blood products and blood substitutes belong to class 2b.

5. If a medical device is intended for use in combination with other medical devices, then classes are established for each medical device.

6. If different provisions can be applied to a medical product during classification, then the provisions are applied, as a result of which the class of the medical product corresponding to the greatest degree of potential risk is established.

7. For special software that is an independent product and used with a medical device, the same class is established as for the medical device itself.

II. Classification of medical devices for in vitro diagnostics

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

class 1 - medical devices with low individual risk and low risk to public health;

class 2a - medical devices with moderate individual risk and/or low risk to public health;

class 2b - medical devices with a high individual risk and/or moderate risk to public health;

class 3 - medical devices with a high individual risk and/or a high risk to public health.

9. When assigning medical devices to classes depending on the potential risk of use, the following provisions must be taken into account:

9.1. Medical products intended for the detection of infectious agents in blood, blood components, blood derivatives, cells, tissues or organs for the purpose of assessing the possibility of their transfusion or transplantation, medical devices intended for the identification of infectious agents that can cause diseases that threaten human life , with a high risk of spread and which provide crucial information for making a correct diagnosis are classified as class 3.

9.2. Medical products that 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, belong to class 2b, with the exception of the ABO system, Rh system (C , c, d, e, e), Kell systems, Kidd systems and Duffy systems, belong to class 3.

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

9.3.1. to identify infectious agents of sexually transmitted diseases;

to detect infectious agents in the cerebrospinal fluid or blood with a moderate risk of spread and which provide decisive information for making a correct diagnosis;

9.3.2. to detect the presence of infectious agents when there is a significant risk that an erroneous result may cause death or incapacitation of the patient or fetus being examined;

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

9.3.4. when determining the status of an infectious disease or immune status when there is a risk that an erroneous result will lead to a therapeutic decision that poses an imminent danger to the patient's life;

9.3.5. when screening to select patients for selective therapy or for diagnostics (for example, diagnosing cancer);

9.3.6. in genetic testing, when the test result leads to serious interference in a person’s life;

9.3.7. to monitor levels of drugs, substances or biological components when there is a risk that an incorrect result will lead to a therapeutic decision causing a life-threatening situation for the patient;

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

9.3.9. in screening for congenital fetal diseases.

9.4. Medical products intended for testing samples and self-monitoring belong to class 2b, excluding those medical devices whose analysis results do not have a critical medical status or are preliminary and require comparison with relevant laboratory tests, belong to class 2a.

9.5. Medical products that do not have a measuring function, which, due to their objective properties, can be used as general laboratory ones, but have special characteristics, according to which they are intended by the manufacturer for use in in vitro diagnostic procedures (without specifying specific types of laboratory tests/analytes) belong to class 1 .

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

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

9.6.2. medical devices for the use of which a therapeutic decision must be made after further research;

9.6.3. medical devices used for monitoring and treatment of cancer.

10. If a medical device is intended for use in combination with other medical devices, then classes are established for each medical device.

11. Calibration and control materials with quantitatively and qualitatively specified values belong to the same class as the medical devices for which they are intended to control.

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