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 refer to products medical purposes, which includes hygiene and dressing products, medical clothing, etc.

Medical products (MPD) are medical products made of glass, polymer, rubber, textile and other materials, reagent kits and control materials for them, others consumables and products, mostly single-use, that 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”).

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.

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Assortment list of medical products, patient care, prevention, sanitation and hygiene items 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

Colostomy bags and collection bags

Oilcloth lining, compress, polyvinyl chloride, medical

Children's dental rings

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Crutches for adults, children, teenagers and tips for them

Esmarch mugs (irrigator)

Women's hygiene bags (pads), tampons

Hygienic rubber belts

Ice bubbles

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Respirators, medical masks

Means of contraception (caps, condoms, intrauterine devices)

Cups for taking medicines

Suspensions - Medical thermometers

Stockings, half-stockings (knee socks) medical

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

By functional purpose sanitary, 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.

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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, sanitation 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 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

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for newborns and children early age, 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.

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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.

“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. in packaging;

“Comfort” pads are supplied complete with fixing panties;

“Bed” sheet pads, size 60×60 or 60×90, 20-30 pcs. in packaging.

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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 Russian Association 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, since if an unexpected deterioration in health occurs when using tampons (fever, vomiting, diarrhea, muscle pain, dizziness, etc.), then 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. Using tampons in postpartum period, especially during surgical interventions, is undesirable and is possible only after consultation with a doctor. Produced by branches of Procter and Gamble (USA).

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

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“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) normalmm; 3) super - 284 mm; 4) night mm.

These pads absorb moisture well, as they have a unique “Driven” top layer, consisting of very 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 and provide control over the appearance of unpleasant odor, create comfortable conditions for female body, prevent skin irritation and diaper rash.

The pads available are "Oldaze Black" in black, "Oldaze Black Tanga" - black, "Oldaze Tanga" - regular color, with a shape modified to fit underwear, "Oldaze Ladge" - large, normal - medium, resin - small size, in packs of 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. Issued different sizes, intended for use with different volumes of discharge. 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).

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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, maintaining 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 periods), etc. Produced by Johnson & Johnson (Italy).

Medical products

The Russian pharmaceutical market offers a huge number of different products. A special place in this list is occupied by medical devices (MPD). The legislation establishes a special procedure for their registration, storage and sale.

Sales rules individual species goods approved by Decree of the Government of the Russian Federation No. 55 “On approval of the rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer’s requirement to provide them free of charge for the period of repair or replacement of similar goods, and a list non-food products of proper quality, which cannot be returned or exchanged for a similar product of a different size, shape, dimension, style, color or configuration” (hereinafter referred to as the Rules), provides a list of goods belonging to the group of medical devices.

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Based on Art. 72 of the Rules for medical equipment include:

Medical equipment products, including instruments, equipment, devices and medical devices;

Medical products made of rubber, textiles, glass, polymer and other materials and spare parts for them, intended for the prevention, diagnosis, treatment of diseases at home, rehabilitation and patient care;

Frames for corrective glasses and lenses for vision correction;

Prosthetic and orthopedic products and spare parts for them;

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Reagent kits and diagnostic tools;

Home (car) pharmacy kits (kits);

Other medical materials and supplies.

The legislation of the Russian Federation, namely Order No. 735 “On approval of the administrative regulations of the Federal Service for Surveillance in Healthcare and social development for the performance of the state function of registering medical devices” (hereinafter referred to as Order No. 735), a special procedure for registering medical devices sold in the Russian Federation is established.

Registration of medical devices is a state control and supervisory function performed by the Federal Service for Surveillance in Healthcare and Social Development with the aim of allowing medical devices to be produced, imported, sold and used in the Russian Federation. In accordance with clause 1.3 of Order No. 735, all medical products intended for use are subject to registration. medical use on the territory of the Russian Federation and including instruments, devices, tools, devices, kits, systems with software, equipment, devices, dressings and sutures, dental materials, reagent kits, control materials and reference materials, calibrators, consumables for analyzers, products from polymer, rubber and other materials, software, which are used in medical purposes separately or in combination with each other. Registration of a medical device is carried out in the name of a legal entity or individual entrepreneur indicated in the registration application. When implementing state registration Russian and foreign medical devices are subject to the same requirements. Registration is carried out by the Federal Service for Surveillance in Healthcare and Social Development based on the results of relevant tests and assessments confirming the quality, effectiveness and safety of products. Information about the number and date of registration of the medical device must be available to the consumer (printed on the packaging, label, instructions for use, operating manual), and also contained on promotional products intended for the end consumer.

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Also, the Rules for the sale of certain types of goods establish a special procedure and rules for the sale of medical devices. The most important requirements are the following.

1. The seller of these products is obliged to comply with the mandatory requirements, taking into account the profile and specialization of his activity, established in state trade standards, as well as sanitary, veterinary, and fire safety rules.

2. The seller must have necessary premises, equipment and inventory that ensure, in accordance with the requirements of standards, the preservation of the quality and safety of goods during their storage and sale at the point of sale, appropriate trading conditions, as well as the ability for buyers to correctly select goods.

3. The seller is obliged to have a Book of Reviews and Suggestions, which is provided to the buyer upon his request.

4. Is obliged to bring to the attention of the buyer the company name (name) of his organization, its location (legal address) and operating hours, placing the specified information on the organization’s sign.

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5. The seller is obliged to promptly bring to the attention of the buyer the necessary and reliable information about goods and their manufacturers, providing the opportunity to correctly select goods.

Information in mandatory must contain:

The company name (name) and location (legal address) of the manufacturer of the goods, the location of the organization (organizations) authorized by the manufacturer (seller) to accept claims from buyers and carry out repairs and maintenance goods;

Designation of standards, mandatory requirements which the product must comply with;

Information about the main consumer properties of the product;

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Rules and conditions for the effective and safe use of the product;

Warranty period, if it is established for a specific product;

Service life or expiration date, if established for a specific product, as well as information about necessary actions the buyer upon expiration of the specified periods and the possible consequences of failure to perform such actions, if the goods, after the expiration of the specified periods, pose a danger to the life, health and property of the buyer or become unsuitable for their intended use;

Price and terms of purchase of goods.

6. When selling goods, the buyer is given the opportunity to familiarize himself with the necessary goods independently or with the help of the seller. The buyer has the right to inspect the offered product, demand that its properties be tested in his presence or a demonstration of its operation, unless this is excluded due to the nature of the product and does not contradict the rules adopted in retail trade.

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7. Before being supplied to the sales floor, medical products must undergo pre-sale preparation, which includes unpacking, sorting and inspection of the goods; checking the quality of the product (by external signs) and availability necessary information about the product and its manufacturer (supplier). Pre-sale preparation medical equipment products also includes, if necessary, removal of factory lubricant, checking for completeness, assembly and adjustment.

It is also important to remember that medical devices of good quality that do not suit the buyer in size, shape, dimensions, style, color or configuration cannot be exchanged or returned.

Code of the Russian Federation on administrative offenses provided administrative punishment for violation of established rules for the sale of certain types of goods. Thus, violation of these rules for officials entails the imposition of an administrative fine in the amount of 1 to 3 thousand rubles; for legal entities – from 10 to 30 thousand rubles.

Lyudmila Tulinova, legal consultant of JSC Management Company"Pharmacy Chain 36.6"

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On approval of the List of medical products (as amended as of June 29, 2017)

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List of medical products

List of medical products,

necessary for the provision of inpatient medical care,

as well as ambulance and emergency medical care

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Absorbent, adsorbent, sorbent, enterosorbent, hemosorbent, biomaterial

Cataract removal device, phacoemulsifier

Sputum collection jar

Bed and surgical linen, fabric, clothing, shoes for patients and staff

Baby food bottle

Urethral bougie and conductor to it

Paper for compresses

Tool hanger

Fork for lowering and tying ligatures

Gel lubricant for condoms

Rubber heating pad, thermochemical heating pad, etc.

Ophthalmic needle (microneedle)

Arterial and venous needle

Atraumatic surgical needle

Blood collection needle

Vitreous suction needle

Blood transfusion needle

Needle for cardiac puncture

Needle for pneumothorax

Hypodermic needle

Needle for performing Mantoux reaction

Vaccination needle

Needle for puncture of the posterior vaginal vault

Needle for puncture and drainage of the maxillary (maxillary) cavity

Needle for puncture of the subclavian vein

Needle for puncture intravascular introduction of conductors and catheters

Needle for puncture biopsy

Needle for fontanel puncture

Needle for stitching palatal arches

Needle for endoscopy and laparoscopy

Epidural needle

Needle and set for spinal tap

Single use injection needle

Bone marrow needle with stop

Needle with clamp for intravenous infusions

Spinal needle (instruments)

Dental needle for anesthesia

Blunt needle for lacrimal canaliculus

Needle plug for skin cancer treatment

Needle holder for atraumatic needles

Compression products (clothing)

Medical absorbent products for patient care

Plaster and polymer products for immobilization

Products for normalization blood pressure

Products for reconstructive surgery

Products and accessories for traumatology and orthopedics

Hydroxyapatite products for maxillofacial surgery

Treatment and prophylactic products for personal hygiene

Disposable products for ostomy patients

Individual dressing products

Prosthetic and orthopedic products for fixation and restriction of movement of various parts of the human body

Polymer connecting products

Implant (graft) from bone and soft tissue of a donor (deceased person)

Ophthalmic implant (transplant)

Dental implant (transplant) with tools for installation

Surgical implant (graft)

Sterilization progress indicator

Indicator of drip blood transfusion mode

Instruments for the phacoemulsification machine

Surgical instruments for minimally invasive interventions

Growth hormone injection

Oral irrigator

Channel filler (root needle)

Cannulas for cardiac surgery

Intravenous and umbilical cannula

Suprapubic cannula for urine drainage

Cannula for puncturing the ventricles of the brain

Cannula for washing the maxillary sinus

Ear cannula for washing the attic

Capillary for clinical research

Catheter (probe) for suction and drainage

Rectal catheter (probe)

Catheter (stent) for cardiology and angiography

Ureteral catheter (stent)

Radiopaque catheter (stent) (visceral, spinal, cerebral)

Radiopaque ureteral catheter (stent), urological

Silicone catheter (stent), ventricular catheter

Peripheral intravenous catheter, single-use intravascular

Catheter for infusion into small veins (butterfly needle)

Catheter for blood transfusion in newborns

Maleko self-retaining large-headed latex catheter for single use

Nelaton catheter for bladder drainage

Nasal (nasopharyngeal) catheter (otolaryngological)

Pezzer catheter, self-retaining, large-headed, latex

Rubber, latex, polymer catheter

Tracheobronchial catheter for mucus suction (set)

Female urethral catheter

Male urethral catheter

Foley catheter for bladder drainage

Endobronchial and endotracheal polymer catheter

Catheter, tube, line for anesthesiology

Blood Vessel Terminal

Terminal holder for blood vessels

Rubber dielectric mat

Silicone ring for laparoscopic sterilization

Set of radiocirculographic attachments

Set of forming accessories

Conductometer (total mineralization meter)

Conicotome (device with a needle)

IV connector

Cooling container (hypothermic package)

Working container and equipment for working containers

Thermal insulation container for infusion solutions

Interhull shipping container

Intrauterine contraceptive (spiral)

Sterilization box (biks) for storing sterile instruments and material

Dyes and dye sets

Liquid nitrogen cryoapplicator

Removal hook foreign bodies from the ear

Hook for isolating nerve trunks

Hook for rhinoplasty (for retracting the wings of the nose)

Heart hook

Zygomatic arch hook

Hook for removing foreign bodies and polyps

Hook for removing foreign bodies from the nose

Plate hook according to Farabeuf

Serrated surgical hook

First rib cutter

Nippers for traumatology

Obstetric, gynecological and removal curette ovum and placental tissue

Laryngeal and nasal curette

Surgical blades (microblades)

Blades for scalpels

Measuring tape (ruler)

Intraocular lenses (eye lenses) and instruments for implantation

Ophthalmic lenses and prisms

Contact lenses and accessories

Spectacle lenses and blanks for them

Eye tray (for lens mass)

Spoon for micro-operations on the larynx

Spoon for spinal surgery

Spoon for paranasal sinuses

Spoon for removing gallstones

Medical spoon for taking scrapings from the rectal mucosa

Medical spoon for curettage of fistulas

Buyalsky's spatula for pushing out entrails

Tissue separator

Foreign body removal spatula

Main lines for hemodialyzers, hemofilters and hemoconcentrators, main line system

Line for drug administration

Blood pressure cuff

Cuff for tightening the transverse arch of the foot

Cuff and medallion for newborn

Anesthesia mask, breathing

Arterial embolization material

Material for bone tissue regeneration

Organic material for vitreous replacement

Suture material (catgut)

Suture material (surgical threads)

Suture material made of metal wire

Linen suture material

Monofilament polypropylene suture material

Material suture silk

Consumables for taking and storing blood samples

Consumable materials for the artificial kidney and hemodialysis apparatus

Membrane for hemodialysis

Mechanical device for the treatment of joint-muscular pathology

Bag (container) for collecting urine

Microshower for washing the maxillary and maxillary sinuses

Microbeads (for anti-burn beds)

Radiopaque polymer microembolus

Air-conditioned aseptic module

Urine collector for precise measurement

Venous valve kit

Venosection kit

Paracentesis bayonet-shaped knife (needle)

Knife for operations in the mouth and nose

Knife for cutting plaster casts

Hooked knife, banana-shaped

Ophthalmic surgical knife, capsulotome

Resection knife (spear-shaped)

Cartilage costal knife

Eye scissors, intraocular

Scissors for laparoscopy

Metal scissors

Nail scissors

Scissors for otorhinolaryngology

Scissors for dressings

Scissors for cutting the umbilical cord, horizontally curved

Bandage Cutting Scissors with Button

Scissors for fetal dissection, vertically curved

Scissors for resection and coagulation

Sinusotomy scissors

Hair scissors

Scissors for urology

Enucleation scissors

Scissors for proctoscope for rectal biopsy

Scissors with one sharp end, straight

Vertical curved surgical scissors

Surgical scissors for cutting soft tissues in deep cavities

Olive for clearing the nose and auditory tubes

Tool adapter

Air hose adapter

Loop for traction of cervical and thoracic vertebrae

Eye tweezers, ophthalmic

Tweezers for applying and removing metal staples

Fenestrated tweezers for holding a brain tumor

Curved fenestrated tweezers for collecting lip mucosa

Plate tweezers for electrocoagulation

Straight surgical ocular tweezers

Tweezers-spoon for dispensing tablets

Eye pipette (ophthalmic)

Glass pipette for hemoglobinometer

Capillary pipette (Pasteur)

Plate for pushing out the entrails

Plate for connecting bone fragments

Spinal fixation plate

Plate for eyelid surgery

Plate, glass for mixing cement

Film for surgical operations

Film for surgical treatment hernias

X-ray medical film

Strip, indicator plate for express urine analysis

Blade, saw blade

Sacrolumbar belt (bandage)

Preparations, reagents for allergy testing

Test tube and microtube

Catheter plug

Sampler for determining bacterial air pollution

Guide for catheter insertion

Wire Saw Guide

Conductor for tubes (mandrin)

Wire for polyp loops

Wire for splinting

Prosthesis (endo-exoprosthesis) of the mammary gland

Prosthesis (endoprosthesis) upper limbs with installation tools

Prosthesis (endoprosthesis) of the eyeball

Prosthesis (endoprosthesis) for skull defects

Bile duct prosthesis (endoprosthesis)

Prosthesis (endoprosthesis) of blood vessels (xenoprostheses, endoprostheses)

Prosthesis (endoprosthesis) of limb joints and instruments for implantation

Spinal prosthesis (endoprosthesis)

Prosthesis (endoprosthesis) of trachea and larynx

Prosthesis (endoprosthesis, bioprosthesis, xenobioprosthesis) of the heart valve and ventricle

Synovial Fluid Prosthesis

Rubber ice bubble

Reagents and consumables for bacteriological research

Reagents, reagents for biochemical research

Reagents, reagents for the diagnosis of infectious diseases

Reagents, reagents for immunological research

Reagents, reagents for hemostasis studies

Reagents, reagents for radioimmunological studies

Reagents, reagents for serological studies

Reagents, reagents, materials for hematological research

Reagents, reagents, solutions, preparations for clinical laboratory research

Reagents for X-ray film processing

Rotator for removing rotational moments acting on the stump when walking

Handle for wire saws

Collection of gynecological aspirate

Drill for craniotomy

Eye scalpel, ophthalmological

General surgical (microsurgical) pointed scalpel

Skeletal Traction Brace

Umbilical Cord Brace

Staples for attaching bones, ligaments, etc.

Staples for stitching wounds

Intrauterine contraceptive devices

Tools for verification and testing of erythrocyte aggregation analyzers

Surgical products: dressings, napkins, films

Personal protective equipment for medical staff when working with infectious material

Means of transportation

Dressings (gauze, bandages, bags, bandages)

Bandage-type dressings

Fixing and compression dressings, elastic, rubber, Martens bandages, bandages

Care products for turbines, micromotors, handpieces

Portable sanitary and hygienic product

Radiocontrast agent for the gastrointestinal tract

Glass for disinfecting instruments

Cup for biopsy material

Wojacek chisel (flat and grooved)

Cover glass and slide glass

Rod for osteosynthesis

Serum for KDL

Packaging containers

Test strips for urine analysis

Test system for detecting thyroid diseases

Test system for detecting malignant diseases

Test system, kit, strips

Test system, strips for detecting infectious diseases

Test system, strips for determining pregnancy

Test system, strips, plates for biochemical studies

Test system, strips for determining blood glucose

Crucibles for foundry equipment

Bone Cavity Graft

Tube for washing purulent cavities

Medical rubber tube, PVC

Neurosurgical silicone tube for external and internal drainage

Optical tube for endoscopes

Rectal tube, vaginal

Tracheal tube, endotracheal tube, tracheostomy tube, tracheotomy tube, tube set and accessories

Diamond-shaped dressing pad

Tourniquet, pneumatic tourniquet (pneumatic bleeding control system)

Intravenous infusion device

Enteral nutrition device

Fixator and set of fixators for osteosynthesis

Fixation to the wire for skeletal traction

Metal T-bar clamp

Filter for blood products, hemofilter

Filter, light filter for photometers

Surgical cutter for craniotomy

Fundus camera, retinal camera

Case for sterile storage of the syringe

Treatment clock with sound signal

Body bag

Stockings (tights) for therapeutic and prophylactic and anti-varicose veins

Cotton balls or gauze

Plaster spatula

Spatula for chest surgery

Tongue spatula

Syringe for intralarynx infusions

Syringe for intrauterine infusions

Syringe for disinfection and sterilization of root canals

Syringe for rinsing cavities with accessories

Syringe for rectal infusion

Single use insulin syringe

Medical syringe and reusable injection devices

Single use medical injection syringe

Pin for osteosynthesis

Brush (ruff) for endoscopes

Vaginal forceps for children

Tool pick-up pliers

Forceps for grasping and holding long bones

Lung grasping forceps

Forceps for removing bone fragments (sequestral)

Forceps for removing kidney stones, gallstones and bladder stones

Pliers for making wire bars

Umbilical Cord Stapling Forceps

Forceps for operations on the nasal septum and paranasal sinuses nose

Pliers for bending the edges of plaster casts

Tongs for opening container bags

Ear, nose and throat packing forceps

Papilloma removal forceps

Forceps for removing the fertilized egg

Forceps for installing artificial stapes

Forceps for a non-separable otolaryngological instrument

Cystoscope forceps

Forceps for endoscopes

Beak-shaped forceps for crowns

Uterine two-pronged forceps

Uterine three-pronged forceps

Single-tooth forceps for retracting the uterus (bullet)

Polyp fenestrated forceps

Polyp ear forceps

Shield for transporting patients with spinal injuries

Evacuator (catheter) for removing stones

Other medical products necessary to provide high-tech medical care in medical organizations in accordance with the established task.

Other medical products necessary for the provision of high-tech medical care in medical organizations in accordance with the established task

Metal structures necessary for performing traumatological, orthopedic, neurosurgical, microsurgical and maxillofacial surgical interventions in medical organizations in accordance with the established task.

Medical products list

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Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological supervision (control). Requirements for medical products and medical equipment

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1. OBJECTIVES AND SCOPE OF APPLICATION

This document is adopted in order to protect the life and health of citizens, property of individuals or legal entities, state or municipal property; security environment and preventing actions that mislead acquirers.

Sanitary and hygienic assessment of medical devices and medical equipment (hereinafter referred to as medical devices and medical equipment) is carried out in order to confirm the safety of products.

The list of products classified as objects of this document includes medical products and medical equipment, including:

Software and hardware systems for automation, processing medical information, including:

MEDICAL PRODUCTS:

Dressings, sutures and auxiliary materials (bandages, films, bandages, plasters, sanitary napkins; medical hygroscopic surgical, hygienic, ophthalmic, sterile and non-sterile cotton wool; plaster bandages; anti-burn dressings, hemostatic absorbable, etc., cotton-gauze products, including napkins, bandages, dressing bags; adhesive plasters, other means intended for contact with damaged areas. skin and mucous membranes; surgical threads; adhesives, sorbents, hemostatic powders, ultrasound gels) (HS codes 3005.00 0.10 0.10 0.00 0.00 0);

Products in contact with blood, blood products, substances for intravascular administration (exfusion, infusion and transfusion devices, single-use injection syringes, intravascular catheters, medical tubes, plugs for sealing blood vessels, etc.; containers for blood, drugs from blood, blood substitutes and infusion solutions; fibers, membranes, sorbents for devices and devices for replacing the functions of organs and systems of the body: artificial circulation devices, artificial kidneys, for hemosorption; sets of lines and functional elements for devices) (HS codes 00 0.00 0.00.00 1.00 1.00);

Medical instruments, devices, apparatus (catheters, probes, drainages, bougies various types, polymer consumables and components for devices for aspiration, drainage and enteral nutrition; parts of endoscopes, sensors, electrodes and other devices in contact with the skin or mucous membranes, gynecological instruments made of polymer materials - mirrors, etc.; inhalers, mouthpieces for spirometers, etc.; housings, sound-conducting tubes, earmolds for hearing aids; microspheres for anti-burn beds of the “Clinitron” type) (HS codes VED00 0,);

Hospital linen, overalls for medical personnel, materials for medical products (disposable medical products made of non-woven materials: surgical linen, linen and products for patient care (sheets, towels, etc.), clothing for medical personnel; non-woven materials for the manufacture of disposable medical products with and without impregnations and additives; medical underwear, compression products, elastic bandages, stockings, socks, knee socks, panties, bandages, etc.; rubber mixtures, raw materials for the manufacture of rubber and latex materials and products; lining oilcloths; X-ray protective materials and products - aprons, bibs, gloves, shoe covers) (HS codes 00 0.00 0, 4014, 4015);

Sanitary and hygienic products, items for patient care (feminine sanitary pads, diapers, diapers, diapers for children and adults; surgical, examination, anatomical gloves; feminine hygiene tampons; condoms; syringes, Esmarch mugs, enema tips; urine and colostomy bags, bedpans, heating pads, ice packs, cryopacks) (HS codes 00 0.00 0.00 0, 4014, 4015, 4818.10 0.30 0.00 0.00 0.00 0);

Products for ophthalmology (intraocular lenses, contact lenses, other products; eye prostheses; spectacle lenses for vision correction, spectacle frames; gels for ophthalmic surgery) (HS codes 9003.00 0,);

Products for internal and external prosthetics (heart valves, cardio- and neuromuscular stimulators, internal organ prostheses, implantable sensors, devices for continuous dosed administration medicinal substances, bone cements, intrauterine contraceptives and rings; implantable gels; exoprostheses of the mammary gland, prosthetic and orthopedic products and semi-finished products for them) (HS codes 00 0, 9021.00 0.00 0);

Components and parts of medical devices and apparatus (cases and parts of medical devices and apparatus, chambers for hyperbaric oxygenation, etc., controlled compression devices, oxygen tents; materials in contact with the skin of the child of chambers of neonatal incubators, incubators for newborns; parts of oxygen and anesthesia-respiratory equipment, including masks, breathing circuits, etc., oxygen pillows, other materials and products intended for direct and indirect contact with the human body) (HS codes 00 0.00 0, 9019.00 00.00 1 .00 0.00 0).

MEDICAL EQUIPMENT PRODUCTS

Vacuum-pressure devices for infusion and irrigation: aspiration and drainage systems, suction, pumps, insufflators, irrigators (HS codes 4001, 9018)

Diagnostic devices for ENT offices, for otoscopy, ophthalmology (HS codes 9018)

Devices for the rehabilitation of hearing and speech, speech translation devices and electronic hearing aids (HS codes 9021.00 0)

Devices and devices for replacing the functions of organs and systems of the body, hemoconcentrators (HS code 9018.00)

Hemodialysis equipment (artificial kidneys, devices artificial kidney and dialyzers) (HS code 00 0)

Apparatuses and devices artificial ventilation lungs, anesthesia-respiratory devices, inhalers and turbo-inhalers, including ultrasonic ones, aerosol therapy devices, compensation and treatment of oxygen deficiency (HS code 00 0, 9019)

Laser devices for dermatology, cosmetology, dentistry, surgery, ophthalmology, physiotherapy, etc. (HS code 00 0)

Aeroionizers, air conditioning equipment, medical equipment for air purification and enrichment (HS code 00 0)

Treadmills for carrying out stress tests, stress systems for electrocardiography (HS code 9018)

Ultrasonic and electrosurgical destructors-aspirators, electrosurgical instruments, generators for sealing vessels (HS code 9018)

External automatic defibrillators (HS code 9018)

Automatic injector-syringes for angiography, computer and magnetic resonance imaging, pen-injectors (HS code 00 0)

Tools for stitching, cutting, etc. surgical with drive (HS code 9018)

Sets of sensors for ultrasonic scanners (HS code 00 0)

Consumable materials for the care of medical equipment (abrasive materials, solutions, oils) (HS code 00 0.10 0)

Medical furniture (tables, bedside tables, functional beds, gurneys, chairs, cabinets), mattresses and waterbeds (HS code 9402, 9403, 9404)

Resuscitation monitors, cardiac monitors, including modular, portable, etc. (HS code 00 0)

Bactericidal ultraviolet irradiators (HS code 00 0)

Dental prosthetic equipment (HS code 9018)

Diagnostic and treatment equipment for interventional electrophysiology, external counterpulsation systems (HS code 9018)

Dental equipment: workplace for a dentist, patient, assistant, dental units (HS code 00 0)

Devices for measuring blood pressure and pulse rate, oximeters, capnometers, etc. with and without sensors (HS code 00 0)

Radiotherapy and X-ray therapy devices and apparatus (in terms of measurements and assessment of noise characteristics, electromagnetic fields, etc.) (HS code 9022)

Software and hardware complexes for automated systems, automation and processing of medical information (HS code 9018, 9030)

Systems for heating and resuscitation for newborns (incubators, installations and phototherapeutic lamps) (HS code 9018)

Patient heating systems (electric blankets) (HS code 00 0)

Monitoring systems, telemetric medical systems (HS code 00 0)

Therapeutic systems for adjustable compression (HS code 9018)

Dental radiovisiographs, visiographic devices (HS code 9022)

Technical means for the rehabilitation of disabled people (HS code 9021)

Magnetic resonance imaging scanners, lithotripters, shock wave therapy devices (HS code 00 0.00 05)

Ultrasound devices, diagnostic, surgical and therapeutic, ultrasonic scalpels (HS code 9018.00 0)

Washing, disinfection, sterilization installations (based on ultraviolet, ultrasound, microwave), steam, dry heat, incl. for automatic disinfection of flexible endoscopes, for the disposal of medical waste (HS code 0)

Electrodiagnostic equipment: rheographic computer complexes, cardiac monitors and electrocardiographs, electroencephalographs, neuro-, myo-diagnostic complexes (HS code 9018.00 0.00 0.00 0, 9030)

Endoscopic and video endoscopic devices, instruments and systems; multimedia systems, video endoscopic, magnifying (HS code 9018.00 0.00 0)

Equipment for physiotherapy, therapeutic cosmetology (HS code 9018)

Devices for massage and skin cleansing (HS code, 00 00)

Relaxation and recovery systems (HS code 9018)

Stimulators for electro- and magnetic therapy, autobioresonance applicators (HS code 9018.50 0)

Physiotherapeutic devices (based on the effects of ultrasound, laser, infrared radiation, thermal radiation), devices for electrotherapy low-frequency, high-frequency, quantum, etc., based on constant, pulse currents and magnetic fields, etc. (HS code 00 0, 9018.00 0)

Medical radiation treatment and diagnostic installations, computed tomographs, mammographs, densitometers, computed radiography systems, scintigraphic equipment (HS code 9018.00 0, 9022)

The provisions of this document apply to materials intended for direct and indirect contact with human skin and mucous membranes used in the manufacture of medical equipment.

The provisions of this document do not apply to:

medical devices for in vitro diagnostics;

medicines, including those made from human blood and plasma;

human: blood or blood components, plasma, medicinal products derived from blood or plasma, as well as products that, when introduced into circulation, include the mentioned substances;

human cells or tissues intended for transplantation, as well as onto products that are made either using or from the tissues or cells of the human body;

tissues or cells of animal origin intended for transplantation, except for products that are made either using or from dead tissues of animal origin;

glass and metal products (syringes, containers, packaging, medical instruments, furniture);

scales, height meters for adults.

The list of medical products and medical equipment with HS codes for which a sanitary and epidemiological report is required is presented in Appendix 1.

2. BASIC CONCEPTS

The following terms are used in this document:

medical devices (MPD) - products intended for use in medical practice- devices, dressings and sutures, dental materials, products made of polymer, rubber and other materials that are used for medical purposes individually or in combination and which are intended for:

prevention, diagnosis, treatment of diseases, rehabilitation, medical procedures, medical research, replacement or modification of parts of tissues, organs and the human body, restoration or compensation of impaired or lost physiological functions, control of conception;

impact on the human body in such a way that their functional purpose is not realized through chemical, pharmacological, immunological or metabolic interaction with the human body.

medical equipment products (IMT) – instruments, devices, instruments, devices, complexes, systems with program control, equipment intended for use on humans for the purpose of: research, diagnosis, observation, treatment, prevention, alleviation of illness, compensation for injury or disability, and maintaining physiological functions;

medical products: medical products and medical equipment - any instruments, devices, instruments, devices, materials or other products, used individually or in combination with each other, including software necessary for their intended use, which are intended by the manufacturer for use person for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease,

Diagnose, monitor, treat, alleviate or compensate for injury or disability,

Research, replacement or modification of anatomy or maintenance of physiological functions,

provided that their principal effect is not based on the pharmacological, immunological or metabolic effect of use, but which may contribute to the introduction into the body, or delivery to the surface of the human body, of agents causing the above effects;

Accessories: items that, although not independently medical devices, are specifically intended by the manufacturer to be used in conjunction with them so that medical devices can be used in accordance with their intended purpose;

customized product: a product manufactured in accordance with terms of reference, in which a duly qualified physician or other person with appropriate qualifications and authority in writing, on his or her own responsibility, makes specific requirements for design or manufacture. Such a product must be intended exclusively for a specific patient. A commercially available product that is manufactured, or modified, in accordance with the specific requirements of a duly qualified physician or other person with appropriate qualifications and authority is not a personal-use product;

manufacturer: legal entity or individual, as an individual entrepreneur, is responsible, when put into circulation in his own name, for the design, manufacture, packaging and/or labeling of this product, system assembly or modification of the product, regardless of whether this activity is carried out by the person himself or a third party on his behalf. Manufacturers are not persons who assemble or modify products for a specific patient, provided that such products have already been put into circulation;

intended purpose: use of the product in accordance with the manufacturer’s information indicated on the labeling, instructions and/or advertising material;

instructions for use (operation manual), operational documentation - documents containing information about methods of operation (use) of products and safety measures;

medical personnel - persons who, by the nature of their activities, permanently or temporarily work with medical products and medical equipment and may be exposed to physical, chemical and biological factors generated by these products;

migration of harmful chemicals into model environments - the release of chemicals from materials or products into model environments (air, distilled water, etc.) during sanitary and chemical tests under certain experimental conditions;

formulation (of product material) - the percentage content in the material of the raw materials used in its manufacture (polymer, synthetic, artificial, rubber, rubber-fabric);

composition (of product material) - a list of raw materials in the material used in its manufacture (polymer, synthetic, artificial, rubber, rubber-fabric);

accompanying documentation – documentation accompanying the product (technical passport, description, operating manual or instructions for use, label, test reports, certificates, sanitary and epidemiological reports, etc.), containing its technical characteristics, safety requirements for use, etc. .

user qualification requirements - a list of knowledge, abilities, skills and experience that the user must have in order to safely use the products;

ultraviolet bactericidal installation - a group of bactericidal irradiators that provide a given level of bactericidal efficiency indoors:

open irradiators - irradiators in which the direct bactericidal flow from the lamps and reflector (or without it) covers a wide area in space up to the solid angle 4;

closed irradiators and (recirculators) - irradiators in which the bactericidal flow from lamps located in a small enclosed space of the irradiator housing does not have an exit to the outside;

combined irradiators - irradiators equipped with two bactericidal lamps, separated by a screen in such a way that the flow from one lamp is directed outward to the lower zone of the room, and from the other to the upper zone, while the lamps can be turned on together or separately;

electrification (of materials) – the ability of a material to accumulate an electrostatic charge.

3. General requirements for medical products and medical equipment

During operation, medical devices should not create levels of harmful factors (physical, chemical and biological) in the workplace of medical personnel and other users that exceed the maximum permissible levels in accordance with the requirements of sanitary legislation.

Products must ensure the safety of the patient or the safety and health of users or, where appropriate, other persons, and any risk associated with their use must be acceptable in relation to the benefit to the patient and the level of health and safety provided.

The specifications and performance of the product must not cause such harmful effects as to jeopardize the safety of patients and medical personnel or other persons during the useful life of the product as specified by the manufacturer when used in accordance with the manufacturer's instructions.

For each type of medical device, raw materials and materials for their manufacture, the manufacturer draws up and approves in the prescribed manner regulatory and technical documentation, including recipe or composition.

The regulatory documentation and other materials submitted for sanitary and hygienic assessment for medical devices indicate:

Product purpose and scope;

Description of the product indicating (if necessary) the type and duration of contact with the body;

Composition or formulation of the materials used;

Hygienically important technical parameters and characteristics (for medical equipment products),

The operational documentation for medical equipment products indicates all possible types hazards (i.e. physical and other factors generated by this equipment), their hygienically significant technical parameters and characteristics, as well as requirements and means of ensuring safety during operation and maintenance of products.

For medical equipment products that are sources of physical factors, in the accompanying documentation (in the technical data sheet or in technical conditions or in the technical passport) the following information is provided:

For all products that are sources of noise or vibration (containing moving parts, pumps, compressors, fans, electric motors, etc.) - information on sound levels (if necessary, on the levels and frequencies of local or general vibration) recorded during all nominal operating modes of the equipment;

For diagnostic, therapeutic, auxiliary (disinfecting) equipment that is a source of ultrasound - information about the acoustic parameters of ultrasound sources - the acoustic output of all sensors, therapeutic heads or other sources: operating frequencies, ultrasound output power (peak values ​​of vibration velocity, ultrasound intensity), area working surfaces of sensors (therapeutic heads);

For equipment that is a source of electromagnetic fields - a list of all sources included in the product, characteristics of each source, including: frequency of generated electromagnetic fields, generated power, if possible - maximum values ​​of electric and (or) magnetic field strength, energy flux density, induction permanent magnetic field(for MRI – in addition, the rate of change of the magnetic field, gradient, specific absorption); for sources operating in pulsed modes - frequency, shape, duration and repetition period of pulses, as well as the expected maximum operating time of each source; if necessary, safe distances (safe or controlled access zones);

Phototherapeutic, bactericidal equipment that is a source of ultraviolet radiation is indicated: types, power, number of ultraviolet lamps, spectral characteristics of UV radiation in the wavelength range from 100 to 400 nm or radiation intensity in ranges A (over), B (over), C (rel.m), information on the concentrations of ozone released into the air during equipment operation, as well as the recommended distance and duration of operation; for bactericidal irradiators it must be indicated whether they are allowed for operation in the presence or absence of people;

For equipment that is a source of radiation in the visible, infrared wavelength range, the following is indicated: wavelength, intensity or power of radiation at the maximum of the operating pulse; if necessary - brightness, illumination, pulsation coefficient; for LED sources - axial luminous intensity, solid angle of radiation, other passport characteristics of the LED;

Equipment that is a source of laser radiation is indicated (for all sources included in the installation): laser type, wavelength, output power, operating modes (continuous, intermittent, periodic, pulsed), beam diameter and divergence, diameter of nozzles and optical fibers, spot diameter on the irradiated surface, for pulsed modes - energy density in the beam, pulse parameters, pulsation frequency, exposure duration, radiation characteristics of pilot lasers - wavelength and radiation power, laser hazard class of all sources;

For adjustable compression systems and compression products - levels of pressure applied;

Air-ionizing treatment and prophylactic equipment is indicated with: voltage on the ionizing electrodes, concentrations of positive and negative air ions generated during various operating modes, indicating the recommended distance and duration of operation for each operating mode, as well as information on the concentrations of ozone released into the air during operation of the equipment ;

For all electrical products of medical equipment, the characteristics of power sources are presented (direct or alternating current, voltage, frequency of mains current, power consumption, phase pattern);

For all medical equipment products or their components intended for contact with the hands of medical personnel, the composition of the surface material, as well as the temperature of the surfaces under various operating modes of the equipment, must be indicated.

The design of products should, if possible, eliminate the impact of increased levels of physical factors on operating personnel and the user through the organization and use of interlocks, fences, screens, filters, protective covers and shelters, light signaling devices, timers, remote controls, etc. p.) . Noisy and vibrating equipment must be equipped with noise and vibration isolating elements. Electrical products must have protective grounding. When operating UV equipment, acrylic protection should be used where necessary and possible. Laser products of classes III and IV that generate radiation in the invisible part of the spectrum should be equipped with built-in class I and II lasers with visible radiation to visualize the main laser beam (pilot, aiming laser).

Medical products are classified by the degree of laser hazard by the manufacturer according to the output characteristics of the radiation using a calculation method in accordance with the requirements of current sanitary standards and regulations. The manufacturer is responsible for determining the hazard class of lasers. Control over the correctness of establishing the laser class is carried out by authorized bodies of state sanitary control (supervision).

Technical conditions for domestic laser products must be agreed upon with the authorized bodies of state sanitary control (supervision).

Prototypes of laser products must have a conclusion issued by authorized bodies of state sanitary control (supervision) on compliance with these Unified Sanitary Requirements, followed by permission for serial production.

Laser products for medical purposes must be equipped with a means to measure the level of laser radiation exposed to the patient and service personnel.

Laser products of class III-IV, before the start of their operation, must be accepted by a commission appointed by the administration of the institution, with the obligatory inclusion of representatives of authorized bodies of state sanitary control (supervision). The Commission establishes compliance with these Uniform Sanitary Requirements and decides on the commissioning of laser products. The decision of the commission is formalized in an act.

To put a class III and IV laser product into operation for the commission, the manufacturer submits the following documentation:

Passport for a laser product;

Operating and safety instructions;

Approved layout plan for laser products;

Sanitary passport (according to the established form)

Safety in the workplace when operating laser products must be ensured by the design of the product. Within the work area, levels of exposure to laser radiation and other adverse production factors should not exceed the values ​​​​established sanitary standards and rules and other regulatory documents.

Laser radiation propagation areas must be marked with laser hazard signs. If the laser beam extends beyond the controlled area, there must be a limiter at the end of its useful path.

Safety when working with open laser products is ensured by using personal protective equipment.

Production facilities in which laser products are operated must meet the requirements of current building codes and regulations and ensure the safety of servicing the products.

Lasers and laser products of any class must be marked in accordance with the requirements for this type of product, including on the explanatory sign they must contain (with the exception of class I products): information about the manufacturer, the maximum output energy (power) of laser radiation and the length radiation waves, laser hazard class.

The passport (form) for a laser product must indicate: radiation wavelength; output power (energy); temporal characteristics of laser radiation, laser hazard class; associated dangerous and harmful factors.”

And the products must be designed, manufactured and packaged in such a way that their technical characteristics and operational properties during the period of use of the products for their intended purpose do not experience harmful effects during transportation and storage of the product.

Medical products and medical equipment must be provided with a label (marking) informing the user about the manufacturer, the area of ​​application of the product, the terms and conditions of use and storage, as well as warning about safety measures when using the product.

The manufacturer of a BMI that generates levels of physical factors exceeding permissible levels must include personal protective equipment (anti-noise pads, safety glasses, mittens) in an amount of at least 2 pieces.

4. TYPES OF TESTS FOR MEDICAL DEVICES AND MEDICAL EQUIPMENT

Sanitary and chemical tests of product materials:

Odorimetric studies (assessment of the odor intensity of materials);

Qualitative and quantitative studies of the levels of migration of harmful substances from product materials into model environments (air, distilled water);

Assessment of integral indicators of the state of water inlets:

Organoleptic studies of water extracts (assessment of odor intensity, color, turbidity);

Measurement of the activity indicator of hydrogen ions (pH) in aqueous extracts from product materials and its changes compared to the control;

Assessment of reducing impurities

Estimation of UV absorption in the wavelength range

Assessment of the irritant effect of product materials and/or aqueous extracts from them on the skin;

Assessment of the irritant effect of materials and/or aqueous extracts from product materials on the mucous membranes of the eyes;

Assessment of acute toxicity indicators when administered into the peritoneum, stomach, subcutaneously, etc.);

Assessment of the sensitizing effect of product materials and/or aqueous extracts from them;

Assessment of the general toxic and skin-irritant effects of aqueous extracts from product materials on a culture of motile cells in vitro (toxicity index);

Assessment of hemolytic activity;

Microbiological tests (see Appendix 2, clause 1.1.2)

Physical testing methods for medical devices

Assessment of the electrification of product materials

Assessment of radiation indicators (for products using natural mineral materials and raw materials)

Physical testing methods for medical equipment products

Measuring the levels of generated physical factors (noise, general and local vibration, airborne and contact ultrasound, radiation: ultraviolet, optical range, infrared, laser, x-ray, electric, magnetic and electromagnetic fields and radiation, aeroionic composition, temperature of BMI surfaces available for contact user.

Tests with the participation of volunteers (for feminine sanitary pads, diapers, diapers, diapers for children and adults for medical purposes).

REQUIREMENTS FOR CONSUMER LABELING OF MEDICAL DEVICES AND MEDICAL EQUIPMENT AND USER INFORMATION

Information about medical devices and medical equipment must be provided by the manufacturer in the product labeling and documentation. The information, in addition to the address of the product manufacturer, must contain a list of indicators related to protective and operational properties, legal aspects placement of products on the market, as well as any other information that provides the intended user with the opportunity to adequately select and use the product and may be related to his health and safety.

The marking is applied directly to the product.

The marking must be clearly visible, legible, indelible, and placed on the product itself or in the instructions for use. If possible, the marking should be applied to the sales packaging. For products put into circulation in sterile form, markings must also be applied to sterile packaging. Marking is not applied if the product is too small, or its specific properties do not allow this.

It is prohibited to apply symbols or inscriptions that may mislead third parties regarding the meaning or graphic representation of the marking with a mark of circulation on the market. Any other marking may be applied to the product, its packaging or product instructions, provided that this does not adversely affect the visibility and legibility of the marking.

Marking applied directly to the product must contain: the name of the manufacturer and/or its trademark; protective properties; size (if available); regulatory document, the requirements of which the product meets; Appeal sign; dates of manufacture and expiration date; other information in accordance with the manufacturer's technical documentation.

The marking applied to the product packaging must contain: the name of the country of origin; name, legal address, trademark of the manufacturer; product name; regulatory document whose requirements the product meets; size (if available); methods of caring for the product; year of manufacture, expiration date or expiration date; Appeal sign; other information in accordance with the manufacturer's documentation.

Information must be applied in relief (embossing, engraving, casting, stamping). It is allowed to apply information in the form of pictograms, as well as with hard-to-remove paint directly on the product. Information must be easy to read and durable during storage, transportation, sale and use of products for their intended purpose.

Labeling must be in Russian. Additional use of other languages ​​is allowed in the case specified in the agreement between the manufacturer (seller) and the consumer, and the translation from a foreign language into Russian must be apostilled.

Packages with products must be marked with pictograms (signs and/or text) prescribing the conditions for storage and/or transportation of products established by the manufacturer in accordance with regulatory (operational) documentation.

The labeling indicates all the necessary information to ensure the safe operation of the product: its main technical characteristics, warning labels, danger signs (magnetic, laser or others for medical devices; information about the materials from which medical devices are made, etc.), requirements for the need use of personal protective equipment, safe distances or permissible duration of operation, etc. for BMI.

The operation of medical equipment products is carried out in accordance with the regulatory documentation for specific products and other sanitary legislation documents containing requirements for the relevant BMI characteristics.

Requirements for ensuring the safety of IMTs during their operation, specified on special signs, as well as warning signs and inscriptions are placed in prominent places on the products in which they are placed.

The manufacturer must provide information so that appropriate precautions can be taken and all hazards are properly controlled using a full range of protective measures.

The user of a BMI characterized by a high potential health hazard (UV devices, laser products, etc.) must be warned about the existing risk. The dangers of the products are indicated accordingly. The use of medical equipment products intended for the population at home must be carried out as prescribed by a doctor, in accordance with medical recommendations.

UV devices are marked with a warning inscription: “ATTENTION! UV radiation can cause damage to the eyes and skin. Please read the instructions carefully. Wear the supplied safety glasses." For UV devices intended for use in beauty salons and similar places, warning notices may be provided on a poster permanently affixed in the vicinity of the UV device.

UV devices whose brightness exceeds cd/m 2 are marked with a warning inscription: “Powerful light. Don't look at the emitter."

UV irradiation installations intended for operation in the absence of people are marked with an appropriate warning notice.

Laser products different classes are marked with warning signs - “Do not look into the beam”, “Laser radiation”, “Avoid exposure of eyes and skin to direct and scattered radiation”, “Laser aperture”, etc. indicating the class of the laser product. Laser products that generate radiation in the invisible part of the spectrum are marked with an appropriate warning label - “Invisible laser radiation”, etc.

The “Safety Requirements” sections of the operational documentation include the basic requirements for ensuring the safe operation of products, as well as for their production in accordance with the main documents of sanitary legislation with links to these documents, including: the production equipment used and the levels of harmful factors in the workplace , means of collective and individual protection, labor regimes, carrying out PMO of workers and production control (if necessary). This section must indicate that the product must be safe during production and use and must have a formalized sanitary and epidemiological certificate.

List of medical products and medical equipment with HS codes that are subject to sanitary and hygienic assessment for compliance with these Unified Sanitary Requirements

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To the owner of a medical center

In accordance with the requirements of Rospotrebnadzor (SES) 2018

1. Medical products are any instruments, devices, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body. Medical products can be recognized as interchangeable if they are comparable in functionality, quality and technical characteristics and are capable of replacing each other.

2. Medical products are divided into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.

3. The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical products, their state registration, production, manufacturing, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, state control, storage, transportation, sales, installation, adjustment, use, operation, including maintenance provided for by the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer), as well as repair, disposal or destruction. Manufacturer (manufacturer) medical device develops technical and (or) operational documentation in accordance with which production, manufacturing, storage, transportation, installation, adjustment, use, operation, including maintenance, as well as repair, disposal or destruction of a medical device are carried out. Requirements for the content of technical and operational documentation of the manufacturer (manufacturer) of a medical device are established by the authorized federal executive body.

4. On the territory of the Russian Federation, the circulation of medical devices registered in the manner established by the Government of the Russian Federation or the federal executive body authorized by it is permitted.

5. Medical products that are manufactured according to individual orders of patients, which are subject to special requirements for the prescription of medical workers and which are intended exclusively for personal use by a specific patient, as well as medical products intended for use in the territory of an international medical cluster or in territories of innovative scientific- technology centers are not subject to state registration. The specified medical products are not subject to the provisions of Part 3 of this article, which provide for the development by the manufacturer (manufacturer) of the medical device of technical and (or) operational documentation.

(see text in the previous edition)

6. The procedure for importing medical devices into the territory of the Russian Federation for the purposes of state registration is established by the authorized federal executive body.

7. Import into the territory of the Russian Federation and export from the territory of the Russian Federation of medical devices as part of doping control is carried out in the manner established by the Government of the Russian Federation.

8. For the purpose of state registration of medical devices, in the manner established by the authorized federal executive body, conformity assessment is carried out in the form of technical tests, toxicological studies, clinical trials and examination of the quality, effectiveness and safety of medical products, as well as testing for the purpose of approval of the type of measuring instruments (in relation to medical products related to measuring instruments in the field government regulation ensuring the uniformity of measurements, the list of which is approved by the authorized federal executive body).

9. For state registration of medical devices and examination of the quality of effectiveness and safety of medical devices, a state fee is charged in accordance with the legislation of the Russian Federation on taxes and fees.

10. In the manner established by the Government of the Russian Federation, the federal executive body authorized by it maintains the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, and places it on its official website on the Internet.

(see text in the previous edition)

11. B state register medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, the following information is entered:

(see text in the previous edition)

1) name of the medical product;

2) date of state registration of the medical device and its registration number, validity period of the registration certificate;

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

4) type of medical device;

5) class of potential risk of using a medical device;

7) name and location of the organization - the applicant of the medical product;

8) name and location of the organization - manufacturer (manufacturer) of the medical device or surname, first name and (if any) patronymic, place of residence of the individual entrepreneur - manufacturer (manufacturer) of the medical device;

(see text in the previous edition)

9) address of the place of production or manufacture of the medical device;

10) information about interchangeable medical products.

12. Falsified medical product - a medical product accompanied by false information about its characteristics and (or) manufacturer (manufacturer).

13. Poor-quality medical product - a medical product that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer) or, in the absence of such documentation, the requirements of other regulatory documentation.

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QUESTION: How to determine whether a product is a medical device?

QUESTION: How to determine whether a product is a medical device?
ANSWER: In accordance with the clarification of the Ministry of Health of the Russian Federation in letter dated January 11, 1999 N 2510/122-99-23 “The State Register of Medical Products includes domestic and foreign medical products, including medical equipment, spectacle optics products, medical products prescriptions, etc., approved by the Russian Ministry of Health for use in medical practice and registered. This register is not a document regulating the classification of certain products into separate classes.” For example, the inclusion of medical equipment products in the State Register of Medical Devices (as of January 1, 1999) indicates only the fact that these products are approved for medical use on the territory of the Russian Federation. When deciding whether to classify products into one class or another, you should use the product classification codes established by the All-Russian Product Classifier OK 005-93, approved by Resolution of the State Standard of the Russian Federation dated December 30, 1993 N 301 (as amended on July 12, 2001), then there are OKP codes given by the manufacturer in the product certificates of conformity. In accordance with this Classifier, medical devices are assigned to a class with OKP code 93, and medical equipment- to a class with OKP code 94. Note that the Classifier indicates generalized names of product classes. In a particular case, the OKP code should be determined in accordance with the manufacturer's documentation. If the manufacturer has not determined or has not indicated in the accompanying documents or technical documentation the code of the product it produces, then it can be assigned to the appropriate class independently in accordance with the Classifier codes.
Director of a law firm
"Yunico-94"
M.I.MILUSHIN
10.2001

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, sanitation 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 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. in packaging;

“Comfort” pads are supplied complete with fixing panties;

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

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. Produced 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 very 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 periods), etc. Produced by Johnson & Johnson (Italy).

1. Medical products are any instruments, devices, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, changing the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body. Medical products can be recognized as interchangeable if they are comparable in functionality, quality and technical characteristics and are capable of replacing each other.

2. Medical products are divided into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification of medical devices. The nomenclature classification of medical devices is approved by the authorized federal executive body.

3. The circulation of medical devices includes technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical products, their state registration, production, manufacturing, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, state control, storage, transportation, sales, installation, adjustment, use, operation, including maintenance provided for in the regulatory, technical and (or) operational documentation of the manufacturer, as well as repair, disposal or destruction.

4. On the territory of the Russian Federation, the circulation of medical devices registered in the manner established by the Government of the Russian Federation and the federal executive body authorized by it is permitted.

5. Medical products that are manufactured according to individual orders of patients, which are subject to special requirements for the prescription of medical workers and which are intended exclusively for personal use by a specific patient, are not subject to state registration.

6. The procedure for importing medical devices into the territory of the Russian Federation for the purposes of state registration is established by the authorized federal executive body.

7. Import into the territory of the Russian Federation and export from the territory of the Russian Federation of medical devices as part of doping control is carried out in the manner established by the Government of the Russian Federation.

8. For the purpose of state registration of medical devices, in the manner established by the authorized federal executive body, conformity assessment is carried out in the form of technical tests, toxicological studies, clinical trials and examination of the quality, effectiveness and safety of medical products, as well as tests for the purpose of approving the type of measuring instruments (in relation to medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the authorized federal executive body).

9. For state registration of medical devices and examination of the quality of effectiveness and safety of medical devices, a state fee is charged in accordance with the legislation of the Russian Federation on taxes and fees.

10. In the manner established by the Government of the Russian Federation, the federal executive body authorized by it maintains the state register of medical devices and organizations engaged in the production and manufacture of medical devices, and places it on its official website on the Internet.

11. The following information is entered into the state register of medical devices and organizations engaged in the production and manufacture of medical devices:

1) name of the medical product;

2) the date of state registration of the medical product and its registration number, the validity period of the registration certificate;

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

4) type of medical device;

5) class of potential risk of using a medical device;

6) code of the All-Russian Product Classifier for a medical device;

7) name and location of the organization - the applicant of the medical product;

8) name and location of the organization - manufacturer of the medical device or organization - manufacturer of the medical device;

9) address of the place of production or manufacture of the medical device;

10) information about interchangeable medical products.