What applies to medical products. Medical supplies list
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-walking patients and in other cases, they are necessary to ensure human life.
They belong to medical products, in the range of which are hygiene and dressings, medical clothing, etc.
Medical devices (IMD) are medical products made of glass, polymer, rubber, textile and other materials, reagent kits 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 Russian Federation No. 444 of December 13, 2001 “On the validity of registration certificates for medical devices and medical equipment”).
This group of products occupies about 20% of the total market of medical devices, which underlines its importance for the medical industry. At present, only a fifth (20%) of this type of production is domestic.
Order of the Ministry of Health and Medical Industry No. 161 dated June 9, 1995 regulates the assortment list of medical products, items for patient care, prevention, sanitation and hygiene, which should be in pharmacies.
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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 06/09/95)
First aid kits (sets) individual, first aid, universal, mother and child
Pouches and collection bags
Oilcloth underlay, compress, PVC, medical
Children's dental rings
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Crutches for adults, children, teenagers and tips for them
Esmarch's mugs (irrigator)
Packages (pads) for women, tampons
Belts hygienic rubber
Ice bubbles
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Respirators, medical masks
Means of protection (caps, condoms, intrauterine devices)
Medicine cups
Suspensions -Medical thermometers
Stockings, half-stockings (knee socks) medical
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Separate goods (catheters, scissors, thermometers, syringes, etc.) are discussed in other topics. This topic deals with groups of other products.
By functional purpose sanitation, hygiene and patient care products can be systematized into groups presented on
Classification of sanitary and hygiene products, patient care items according to their functional purpose
For patient care items for taking medicines, mostly liquid, water, cups, drinking bowls, eye pipettes, etc.
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To perform some medical procedures, blood suction cups, Esmarch mugs, hemostatic tourniquets, gloves, syringes, thermometers, etc. are used.
In the case of bed rest, the patient needs sanitary and hygiene products for the toilet: bedpans, urinals, colostomy bags, oilcloth.
Some products are intended for personal hygiene of patients, in particular, bandages, catheters, uterine rings, spittoons, suspensors, etc.
At the same time, the assortment also includes sanitary and hygiene products that are needed healthy people, children, women, including pregnant women, for example, first-aid kits, children's dental rings, breast pumps, fingertips, nipples, women's packages, masks, medical respirators, etc.
In recent years, groups or series of products have appeared on the Russian pharmaceutical market, designed to solve certain problems of healthy or sick people. 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 discharge channels-grooves that regulate the flow of air into the bottle;
Physiological "drop" pacifiers have a teardrop shape;
Physiological bottles consist of a cap-glass, a physiological nipple, a hygienic plug, a bottle, a valve that prevents the occurrence of colic and a removable bottom;
Adjustable breast pump is designed for expressing breast milk in lactating women.
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The Tena series of products - for the care of patients with urinary incontinence, includes adult diapers, absorbent sheets. The use of these tools simplifies patient care and provides the patient with a feeling of comfort.
Gaskets-dipers "Lady" for women, have anatomical shape, suitable for use both at night and during the day, invisible under clothing; normal, extra, super types are produced, in packs of 7-12 pcs.;
Slip pads are available in two sizes: M - medium, L - large, 10 pcs. packaged;
Gaskets "Comfort" are produced complete with fixing shorts;
Pads-sheets "Bad", size 60×60 or 60×90, 20-30 pcs. packaged.
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These goods are of domestic production: SCA Hygiene Products (Russia).
A certain group of products are personal hygiene products for women on the days of the menstrual cycle and for every day. These include pads, tampons, bags that perform one function - absorption (absorption) of body secretions and ensuring the comfort of women.
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. Three types are produced: mini, normal and super-super plus; in a package of 8 pcs.
They are compact and allow the woman to lead active image life. Researchers of 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 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 aureus. These health changes are called toxic shock syndrome. No cases of TSS have been registered in Russia yet. The use of tampons in postpartum period, especially when surgical interventions, undesirable and possible only after consulting a doctor. Issued by branches of Procter & Gamble (USA).
Procter & Gamble (USA) also produces a series of hygiene products for women, in particular:
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"Olwayz ultra" - hygiene products for use on "critical" days, and four types are produced depending on the characteristics of the course of these days in women: 1) light - the length of the gasket is 240 mm; 2) normalmm; 3) super - 284 mm; 4) night mm.
These pads absorb moisture well, as they have a unique "Drive" top layer, consisting of the smallest three-dimensional funnel-shaped pores. It lets moisture into the gasket and prevents it from escaping to the surface under pressure. The pads have elongated elastic "wings" for secure fixation to the linen. The materials from which 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 the company's branches in Germany, Hungary, Turkey.
For daily use, a series of pads "Oldayz" is produced. They have a softer surface, provide odor control, create a comfortable environment for the female body, and prevent skin irritation and diaper rash.
Black pads are produced, Oldeys Black Tanga is black, Oldeys Tanga is a regular color, with a shape changed for underwear, Oldeys Ludge is large, normal is medium, resin is small, in packs, 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. Various sizes are available to suit different discharge volumes. Requires a change every 3-6 hours. Tampons O.B.I. 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" is made of cotton, the surface is soft, impregnated with a special solution containing various substances supporting natural acid-base balance intimate area, chamomile extract prevents the possibility of inflammation and irritation. Thin, flexible, the shape follows the lines of the body, securely fixed on the underwear. In packs of 16 to 30 pieces, may be black,
Various types are produced: Care Free, Care Free Black, Care Free Flexiform (breathable), Care Free Fresh (with a fresh aroma), Care Free Ultra (for use in critical days), etc. Produced by the company "Johnson and Johnson" (Italy).
Medical products
A huge number of different products are presented on the Russian pharmaceutical market. Special place This list is occupied by medical devices (MD). The legislation establishes a special procedure for their registration, storage and sale.
Rules for the sale of certain types of 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 him free of charge for the period of repair or replacement of a similar product, and a list of non-food products of good quality , not subject to return or exchange for a similar product of a different size, shape, size, style, color or configuration ”(hereinafter referred to as the Rules), provide a list of goods belonging to the group of medical devices.
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Based on Art. 72 of the Rules for medical devices include:
Products of medical equipment, including tools, equipment, devices and medical devices;
Medical products made of rubber, textiles, glass, polymeric 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 (automobile) pharmacy kits (sets);
Other medical materials and means.
The legislation of the Russian Federation, namely Order No. 735 "On approval of the administrative regulations of the Federal Service for Supervision in the Sphere of Health and Social Development for the execution of the state function of registering medical devices" (hereinafter - Order No. 735), establishes a special procedure for registering medical devices sold in the Russian Federation.
Registration of medical devices is a state control and supervisory function performed by the Federal Service for Supervision in the Sphere of Health and Social Development in order to allow medical devices to be manufactured, imported, sold and used on the territory of the Russian Federation. In accordance with clause 1.3 of Order No. 735, all medical devices intended for medical use on the territory of the Russian Federation and including devices, devices, instruments, devices, kits, systems with software, equipment, devices, dressings and sutures, dental materials, reagent kits, control materials and standard samples, calibrators, consumables for analyzers, products made of polymer, rubber and other materials, software that are used for medical purposes individually or in combination with each other. Registration of medical devices is carried out in the name of a legal entity or an individual entrepreneur, indicated in the application for registration. When implementing state registration Russian and foreign medical devices are subject to the same requirements. Registration is carried out by the Federal Service for Supervision of Health 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 medical devices should be available to the consumer (applied on the packaging, label, instructions for use, operation manual), and also contained on advertising products intended for the end user.
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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 are the following requirements.
1. The seller of the said products is obliged to comply with the requirements, which are mandatory, taking into account the profile and specialization of his activity, established in the state standards of trade, as well as sanitary, veterinary, and fire regulations.
2. The seller must have the necessary premises, equipment and inventory to ensure, in accordance with the requirements of the 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 possibility of the correct choice of goods by buyers.
3. The seller is obliged to have a book of reviews and suggestions, which is provided to the buyer at 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 the mode of operation, placing the specified information on the signboard of the organization.
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5. The seller is obliged to promptly bring to the attention of the buyer in a clear and accessible form the necessary and reliable information about the goods and their manufacturers, which ensures the possibility of the correct choice of goods.
The information must contain:
Company name (name) and location (legal address) of the manufacturer of the goods, location of the organization (organizations) authorized by the manufacturer (seller) to accept claims from buyers and carry out repairs and maintenance of the goods;
Designation of standards, mandatory requirements which the product must comply with;
Information about the main consumer properties of the goods;
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Rules and conditions for the effective and safe use of the goods;
Warranty period, if it is established for a specific product;
The service life or expiration date, if they are established for a specific product, as well as information about the necessary actions of the buyer after the expiration of the specified periods and possible consequences if such actions are not taken, 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 or with the help of the seller with the necessary goods. The buyer has the right to inspect the offered goods, demand that a property check be carried out in his presence or a demonstration of its operation, unless this is excluded due to the nature of the goods and does not contradict the rules adopted in retail trade.
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7. Medical products must undergo pre-sale preparation before being submitted to the trading floor, which includes unpacking, sorting and inspection of the goods; quality control of goods outward signs) and the availability of the necessary information about the product and its manufacturer (supplier). Pre-sale preparation of medical equipment products also includes, if necessary, removal of factory grease, completeness check, 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 are not subject to exchange and return.
The Code of Administrative Offenses of the Russian Federation provides for administrative punishment for violation of the established rules for the sale of certain types of goods. Thus, violation of these rules for officials shall entail 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 adviser of CJSC " Management Company Pharmacy Chain 36.6
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On approval of the List of medical devices (as amended on 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 emergency and emergency medical care
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Absorbent, adsorbent, sorbent, enterosorbent, hemosorbent, biomaterial
Apparatus for cataract removal, phacoemulsifier
Sputum collection jar
Bed linen and surgical linen, fabric, clothing, shoes for the patient and staff
Baby food bottle
Buzh urethral and conductor to it
Paper for compresses
Tool hanger
Fork for lowering and tying a ligature
Lubricant gel for condoms
Heating pad rubber, thermochemical, etc.
Needle (microneedle) ophthalmic
Arterial and venous needle
Atraumatic surgical needle
Blood collection needle
Vitreous Suction Needle
Needle for blood transfusion
Cardiac Puncture Needle
Needle for pneumothorax
Hypodermic Needle
Needle for staging the Mantoux reaction
Vaccination needle
Needle for puncture of the posterior fornix of the vagina
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 a puncture biopsy
Fontanelle Puncture Needle
Needle for stitching palatine arches
Needle for endoscopy and laparoscopy
Epidural Needle
Needle and lumbar puncture kit
Single use injection needle
Bone marrow needle with emphasis
Needle with a clamp for intravenous injections
Spinal needle (instruments)
Anesthesia dental needle
Needle blunt for the lacrimal canaliculus
Fork Needle for Skin Cancer Treatment
Needle holder for atraumatic needles
Products (clothing) compression
Medical absorbent products for patient care
Plaster and polymer products for immobilization
Products for the normalization of blood pressure
Products for reconstructive surgery
Products and accessories for traumatology and orthopedics
Products from hydroxyapatite for maxillofacial surgery
Medical and prophylactic products for personal hygiene
Disposable products for ostomy patients
Individual dressing products
Prosthetic and orthopedic products for fixation and restriction of movement various parts human body
Polymer connecting products
Implant (graft) from bone and soft tissues of a donor (deceased person)
Implant (graft) ophthalmic
Dental implant (graft) with instruments for installation
Implant (transplant) surgical
Sterilization progress indicator
Drip transfusion mode indicator
Tools for the apparatus for phacoemulsification
Surgical instruments for minimally invasive interventions
Growth hormone injector
Oral irrigator
Canal filler (root needle)
Cannulas for cardiac surgery
Cannula intravenous and umbilical
Urine cannula, suprapubic
Cannula for puncturing the ventricles of the brain
Cannula for washing the maxillary (maxillary) sinus
Ear cannula for washing the attic
Capillary for clinical research
Catheter (probe) for suction and drainage
Catheter (probe) rectal
Catheter (stent) for cardiology and angiography
Catheter (stent) ureteral
Catheter (stent) radiopaque (visceral, spinal, cerebral)
Catheter (stent) radiopaque ureteral, urological
Silicone catheter (stent), ventricular catheter
Catheter, intravenous, peripheral, single-use intravascular
Small vein infusion catheter (butterfly needle)
Catheter for blood transfusion in newborns
Maleko catheter self-retaining large-headed latex single use
Nelaton catheter for bladder drainage
Nasal catheter (nasopharyngeal) (otorhinolaryngological)
Pezzera catheter self-retaining large-headed latex
Catheter rubber, latex, polymer
Tracheobronchial catheter for mucus suction (set)
Female urethral catheter
Male urethral catheter
Foley catheter for bladder drainage
Polymer endobronchial and endotracheal catheter
Catheter, tube, line for anesthesiology
Terminal for blood vessels
Clamp holder for blood vessels
Dielectric rubber mat
Silicone ring for laparoscopic sterilization
Set of radiocircular attachments
Forming kit
Conductometer (total mineralization meter)
Conicotome (needle device)
IV connector
Cooling container (hypothermic package)
Work container and equipment for work containers
Thermal insulating container for infusion solutions
Transport container
Intrauterine contraceptive (spiral)
Sterilization box (bix) for storing sterile instruments and material
Dyes and dye sets
Cryoapplicator on liquid nitrogen
Hook for extracting foreign bodies from the ear
Hook for isolating nerve trunks
Hook for rhinoplasty (for pulling back the wings of the nose)
Heart hook
Hook for zygomatic arch
Hook for removing foreign bodies and polyps
Hook for removing foreign bodies from the nose
Hook plate according to Farabef
Hook surgical serrated
Nippers for the first rib
Nippers for traumatology
Curette for obstetrics, gynecology and for the removal of the fetal egg and placental tissue
Curette laryngeal and nasal
Blades (micro blades) surgical
Blades for scalpels
Tape (ruler) measuring
Intraocular lenses (eye lenses) and implantation instruments
Ophthalmic lenses and prisms
Contact lenses and accessories
Spectacle lenses and blanks for them
Eye spoon (for lens mass)
Spoon for microoperations on the larynx
Spinal Spoon
Spoon for paranasal sinuses
Removal spoon gallstones
Medical spoon for taking scrapings from the rectal mucosa
Medical spoon for scraping fistulas
Buyalsky's spatula for pushing the insides
Spatula for tissue separation
Spatula for removing foreign bodies
Lines for hemodialyzers, hemofilters and hemoconcentrators, line system
Highway for drug administration
Blood pressure cuff
Cuff for tightening transverse vault feet
Newborn cuff and medallion
Anesthesia mask, respiratory
Material for arterial embolization
Material for bone tissue regeneration
Organic material for vitreous replacement
Suture material (catgut)
Suture material (surgical threads)
Suture material from metal wire
Linen suture material
Polypropylene monofilament suture material
Material suture silk
Consumables for taking and storing blood samples
Consumables for the apparatus "artificial kidney" and hemodialysis
Membrane for hemodialysis
Mechanoapparatus for the treatment of joint-muscular pathology
Bag (container) for collecting urine
Microshower for washing the maxillary and maxillary sinuses
Microballoons (for anti-burn beds)
Polymer microembolism radiopaque
Air-conditioned aseptic module
Urine bag for precise measurement
Set for venous valves
Set for venosection
Knife (needle) paracentesis bayonet
Knife for operations in the mouth and nose
Knife for cutting plaster casts
Knife hook-shaped, banana-shaped
Ophthalmic surgical knife, capsulotomy
Resection knife (spear-shaped)
Cartilaginous rib knife
Eye scissors, intraocular
Scissors for laparoscopy
Metal shears
Nail scissors
Otorhinolaryngology scissors
Dressing scissors
Umbilical cord cutting scissors horizontally curved
Scissors for cutting dressings with a button
Fetal dissection scissors vertically curved
Scissors for resection and coagulation
Sinusotomy scissors
hair scissors
Urology scissors
Enucleation scissors
Scissors for rectoscope for biopsy of the rectum
Scissors with one sharp end, straight
Scissors surgical vertically curved
Surgical scissors for dissection of soft tissues in deep cavities
Oliva for blowing the nose and auditory tubes
Tool adapter
Air hose adapter
Loop for stretching the cervical and thoracic vertebrae
Eye tweezers, ophthalmic
Tweezers for applying and removing metal brackets
Fenestrated forceps for holding a brain tumor
Curved fenestrated tweezers for taking the mucosa of the lip
Plate tweezers for electrocoagulation
Surgical eye tweezers straight
Spoon tweezers for dispensing tablets
Eye pipette (ophthalmic)
Glass pipette for hemoglobinometer
Capillary pipette (Pasteur)
Plate for pushing the insides
Plate for connection of bone fragments
Plate for fixation of the spine
Plate for eyelid surgery
Plate, glass for mixing cement
Film for surgical operations
Film for surgical treatment of hernias
X-ray medical film
Strip, indicator plate for express analysis of urine
Blade, saw blade
Belt (bandage) sacro-lumbar
Preparations, reagents for allergological testing
Test tube and micro test tube
Stopper for catheters
Sampler for determination of bacterial air pollution
Guidewire for catheter insertion
Guide for wire saws
Tube conductor (mandrin)
Wire for polyp loops
Wire for splinting
Prosthesis (endo-exoprosthesis) of the breast (mammary) gland
Prosthesis (endoprosthesis) of the upper limbs with tools for installation
Prosthesis (endoprosthesis) of the eyeball
Prosthesis (endoprosthesis) of skull defects
Prosthesis (endoprosthesis) of the bile ducts
Prosthesis (endoprosthesis) of blood vessels (xenoprostheses, endoprostheses)
Prosthesis (endoprosthesis) of limb joints and instruments for implantation
Prosthesis (endoprosthesis) of the spine
Prosthesis (endoprosthesis) of the trachea and larynx
Prosthesis (endoprosthesis, bioprosthesis, xenobioprosthesis) of the valve and ventricle of the heart
Synovial fluid prosthesis
Bubble rubber for ice
Reagents and consumables for bacteriological research
Reagents, reagents for biochemical research
Reagents, reagents for the diagnosis of infectious diseases
Reagents, reagents for immunological studies
Reagents, reagents for the study of hemostasis
Reagents, reagents for radioimmunoassays
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 aspirate gynecological
Drill for craniotomy
Ocular scalpel, ophthalmic
Scalpel pointed general surgical (microsurgical)
Skeletal Traction Brace
Umbilical cord brace
Staples for fixing bones, ligaments, etc.
Staples for suturing wounds
Intrauterine contraceptives
Means for verification and testing of erythrocyte aggregation analyzers
Tools for surgery: dressings, napkins, films
Personal protective equipment for medical staff when working with infectious material
Means of transportation
Dressings (gauze, bandages, bags, dressings)
Dressings of plaster type
Fixing and compression dressings, elastic bandages, rubber bandages, Martens bandages
Care products for turbines, micromotors, handpieces
Portable sanitary hygienic
X-ray contrast agent for the gastrointestinal tract
Glass for disinfection of instruments
Cup for biopsy material
Voyachek's chisel (flat and grooved)
Cover glass and slide glass
Rod for osteosynthesis
Serum for CDL
Container for packing
Urine test strips
Test system for the detection of thyroid diseases
Test system for the detection of malignant diseases
Test system, kit, strips
Test system, strips for the detection of infectious diseases
Test system, strips for determining pregnancy
Test system, strips, plates for biochemical research
Test system, strips for determination of glucose in blood
Crucibles for foundry equipment
Bone Cavity Graft
Tube for washing purulent cavities
Tube medical rubber, PVC
Neurosurgical silicone tube for external and internal drainage
Optical tube for endoscopes
Rectal tube, vaginal
Tracheal, endotracheal, tracheostomy, tracheotomy tube, tube set and accessories
Tupfer rhomboid dressing
Tourniquet, pneumatic tourniquet (pneumatic bleeding control system)
Device for intravenous infusion
Enteral feeding device
Retainer and set of fixators for osteosynthesis
Fixator to the spoke for skeletal traction
Metal T-retainer
Filter for blood products, hemofilter
Filter, light filter for photometers
Surgical cutter for craniotomy
Fundus chamber, retinal chamber
Case for sterile storage of the syringe
Hours procedural with a sound signal
Corpse bag
Stockings (tights) for therapeutic and prophylactic and anti-varicose veins
Cotton or gauze balls
Spatula for plaster
Spatula for chest surgery
Tongue spatula
Syringe for intralaryngeal infusions
Syringe for intrauterine infusions
Syringe for disinfection and sterilization of root canals
Cavity rinsing syringe with accessories
Syringe for rectal injections
Single use insulin syringe
Medical syringe and reusable injection devices
Single use medical injection syringe
Pin for osteosynthesis
Brush (ruff) for endoscopes
Children's vaginal forceps
Tongs for taking instruments
Forceps for grasping and holding tubular bones
lung grasping forceps
Forceps for extracting bone fragments (sequestral)
Forceps for extracting kidney and gallstones, stones from the bladder
Wire busbar pliers
Forceps for stapling the umbilical cord
Forceps for operations on the nasal septum and paranasal sinuses
Pliers for bending the edges of plaster casts
Tongs for opening bags-containers
Ear, nose and throat forceps
Papilloma forceps
Forceps for removing the ovum
Forceps for installing an artificial stirrup
Forceps for a non-separable otolaryngological instrument
Forceps for cystoscope
forceps for endoscopes
Beak-shaped forceps for crowns
Two-pronged uterine forceps
Three-pronged uterine forceps
Single-pronged forceps for retraction of the uterus (bullet)
Polyp fenestrated forceps
Polyp ear forceps
Shield for transporting patients with spinal injury
Evacuator (catheter) for removal of stones
Other medical products necessary for the provision of 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 supplies list
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Uniform sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological supervision (control). Requirements for medical devices and medical equipment
Your personal manager in Moscow (Moscow, Kasatkina st., 11)
Your personal manager in St. Petersburg (St. Petersburg, Sinopskaya nab., 22)
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1. PURPOSE AND SCOPE
This document is adopted in order to protect the life and health of citizens, property of individuals or legal entities, state or municipal property; protection environment and preventing actions that mislead purchasers.
Sanitary and hygienic assessment of medical devices and medical equipment (hereinafter - MD and BMI) is carried out in order to confirm the safety of products.
The list of products referred to the objects of this document includes medical devices and medical equipment, including:
Software and hardware complexes for automation, processing of medical information, including:
MEDICAL PRODUCTS:
Dressings, suture 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 products intended for contact with damaged skin and mucous membranes; surgical sutures; adhesives, sorbents, hemostatic powders, gels for ultrasound) (TN VED 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, stoppers 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: heart-lung machines, artificial kidneys, for hemosorption; sets of lines and functional elements for devices) (TN VED codes00 0.00 0.00.00 1.00 1.00);
Medical instruments, devices, devices (catheters, probes, drains, bougie 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 polymeric materials - mirrors, etc.; inhalers, mouthpieces for spirometers, etc.; housings, sound-conducting tubes, ear-moulds for hearing aids; microspheres for anti-burn beds of the "Klinitron" type) (codes TN VED00 0,);
Hospital linen, overalls for medical personnel, materials for medical devices (disposable medical products made of non-woven materials: surgical underwear, underwear and products for patient care (sheets, towels, etc.), clothing for medical personnel; non-woven materials for manufacture of disposable medical products with and without impregnations and additives, medical underwear, compression products, elastic bandages, stockings, socks, stockings, shorts, bandages, etc.; rubber compounds, raw materials for the manufacture of rubber and latex materials and products; oilcloths, X-ray protective materials and products - aprons, bibs, gloves, boot covers) (HS Codes 00 0.00 0, 4014, 4015);
Sanitary and hygienic products, items for patient care and (female sanitary napkins, diapers, diapers, diapers for children and adults; surgical, examination, anatomical gloves; female hygienic tampons; condoms; syringes, Esmarch mugs, enema tips; urine and colostomy bags, bedpans, heating pads, ice packs, cryopackages) (TN VED codes00 0.00 0.00 0, 4014, 4015, 4818.10 0.30 0.00 0.00 0.00 0);
Products for ophthalmology (intraocular, 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, prostheses of internal organs, implantable sensors, devices for continuous dosed administration of drugs, bone cements, intrauterine contraceptives and rings; implantable gels; breast exoprostheses, products prosthetic and orthopedic and semi-finished products for them) (HS codes 00 0, 9021.00 0.00 0);
Components and parts of medical devices and apparatuses (housings and details of medical devices and apparatuses, chambers for hyperbaric oxygenation, etc., adjustable compression devices, oxygen tents; materials that come into contact with the skin of a child in chambers of neonatal incubators, incubators for newborns; parts of oxygen and anesthesia and respiratory equipment, including masks, breathing circuits, etc., oxygen bags, 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).
PRODUCTS OF MEDICAL EQUIPMENT
Vacuum pressure devices for infusion and irrigation: suction and drainage systems, suctions, pumps, insufflators, irrigators (TN VED codes 4001, 9018)
Diagnostic devices for ENT rooms, for otoscopy, ophthalmology (TN VED codes 9018)
Hearing and speech rehabilitation devices, speech translation devices and electronic hearing aids (HS codes 9021.00 0)
Apparatus and devices for replacing the functions of organs and systems of the body, hemoconcentrators (TN VED code 9018.00)
Hemodialysis equipment (artificial kidneys, artificial kidney devices and dialyzers) (HS code 00 0)
Apparatus and devices for artificial lung ventilation, anesthetic-respiratory devices, inhalers and turbo-inhalers, including ultrasonic devices, aerosol therapy devices, compensation and treatment of oxygen deficiency (TN VED code 00 0, 9019)
Laser devices for dermatology, cosmetology, dentistry, surgery, ophthalmology, physiotherapy, etc. (HS code 00 0)
Air ionizers, air conditioning equipment, medical air purification and enrichment equipment (TN VED00 0 code)
Treadmills for stress testing, stress systems for electrocardiography (TN VED code 9018)
Ultrasonic and electrosurgical destructors-aspirators, electrosurgical instruments, generators for sealing vessels (TN VED code 9018)
External automatic defibrillators (TN VED code 9018)
Automatic syringe injectors for angiography, computed tomography and magnetic resonance imaging, injector handles (code TN VED00 0)
Stitching, cutting tools, etc. surgical with a drive (HS code 9018)
Sets of sensors for ultrasonic scanners (code TN VED00 0)
Consumables for the care of medical equipment (abrasive materials, solutions, oils) (HS code 00 0.10 0)
Medical furniture (tables, bedside tables, functional beds, wheelchairs, armchairs, cabinets), mattresses and waterbeds (HS code 9402, 9403, 9404)
Resuscitation monitors, cardiac monitors, including modular, portable, etc. (code TN VED00 0)
UV bactericidal irradiators (code TN VED00 0)
Dental equipment (TN VED code 9018)
Diagnostic and treatment equipment for interventional electrophysiology, external counterpulsation systems (TN VED code 9018)
Dental equipment: workplace dentist, patient, assistant, dental units (TN VED code 00 0)
Devices for measuring blood pressure and pulse rate, oximeters, capnometers, etc. with sensors and without sensors (code TN VED00 0)
Radiotherapy, X-ray therapy instruments and apparatus (in terms of measuring and evaluating noise characteristics, electromagnetic fields, etc.) (HS code 9022)
Software and hardware complexes for automated systems, automation and processing of medical information (TN VED code 9018, 9030)
Systems for heating and resuscitation for newborns (incubators, installations and phototherapy lamps) (HS code 9018)
Patient warming 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 (TN VED code 9022)
Technical means of rehabilitation of the disabled (HS Code 9021)
Magnetic resonance tomographs, lithotripters, devices shock wave therapy(TN VED code 00 0.00 05)
Ultrasonic devices, diagnostic, surgical and therapeutic, ultrasonic scalpels (TN VED code 9018.00 0)
Installations for washing, disinfection, sterilization (based on ultraviolet, ultrasound, microwave), steam, dry heat, incl. for automatic disinfection of flexible endoscopes, for disposal of medical waste (HS code 0)
Electrodiagnostic equipment: rheographic computer complexes, cardiac monitors and electrocardiographs, electroencephalographs, neuro-, myo-diagnostic complexes (TN VED code 9018.00 0.00 0.00 0, 9030)
Endoscopic and video endoscopic devices, instruments and systems; multimedia, video endoscopic, magnifying systems (TN VED code 9018.00 0.00 0)
Equipment for physiotherapy, medical cosmetology (TN VED code 9018)
Apparatus for massage and skin cleansing (TN VED code, 00 00)
Relaxation and recovery systems (HS code 9018)
Stimulators for electro- and magnetotherapy, autobioresonance applicators (TN VED code 9018.50 0)
Physiotherapy devices (based on exposure to ultrasound, laser, infrared radiation, thermal radiation), low-frequency, high-frequency, quantum electrotherapy devices, etc., based on direct, pulsed currents and magnetic fields, etc. (TN VED code 00 0, 9018.00 0)
Installations radiation medical medical and diagnostic, computed tomography, mammographs, densitometers, computer radiography systems, scintigraphic equipment (TN VED 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 products 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 which, when put into circulation, include the mentioned substances;
human cells or tissues intended for transplantation, as well as products that are made either using, or from themselves, 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, stadiometers for adults.
The list of medical devices and medical equipment with TN VED codes that require a sanitary and epidemiological conclusion is presented in Appendix 1.
2. BASIC CONCEPTS
The following terms are used in this document:
medical devices (IMN) - 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 with each other 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 damaged or lost physiological functions, control over 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.
products of medical equipment (IMT) - devices, devices, instruments, devices, complexes, systems with program management, equipment intended to be applied to a person for the purpose of: research, diagnosis, observation, treatment, prevention, alleviation of disease, compensation for injury or disability and maintenance of physiological functions;
medical devices: medical devices and medical equipment - any instruments, devices, devices, devices, materials or other products used individually or in combination with each other, including the software necessary for their intended use, which are intended by the manufacturer for use in person for the purpose of:
Diagnosis, prevention, monitoring, treatment or alleviation of a disease,
Diagnosis, observation, treatment, alleviation or compensation of an injury or disability,
Research, replacement or modification of the anatomy or maintenance of physiological functions,
provided that their principal effect is not based on the pharmacological, immunological or metabolic effect of the application, but which may contribute to the introduction into the body or delivery to the surface of the human body of agents that cause the above effects;
accessories: items that, although they are not medical devices on their own, are specifically designed by the manufacturer to be used in conjunction with them so that the medical devices can be used in accordance with the intended purpose;
personal device: a product manufactured in accordance with the terms of reference, in which a duly qualified physician or other person with the appropriate qualifications and authority in writing, under his own responsibility, imposes special requirements for design or manufacture. Such a device must be intended exclusively for a particular patient. A mass-produced product that is manufactured, or modified, to the specific requirements of a properly qualified physician or other person with the appropriate qualifications and authority is not a product for individual use;
manufacturer: a legal entity or natural person, as a sole trader, who is responsible, when put into circulation on his own behalf, for the design, manufacture, packaging and/or labeling of this product, assembly of the system 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 devices for a particular patient, provided that such devices have already been put into circulation;
intended purpose: use of the product in accordance with the manufacturer's information indicated on the label, in the instructions and / or in the promotional material;
instructions for use (operating manual), operational documentation - documents containing information on the methods of operation (application) of products and safety measures;
medical personnel - persons who, by the nature of their activities, permanently or temporarily work with medical devices 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-chemical tests under certain experimental conditions;
recipe (product material) - percentage in the material of raw materials used in its manufacture (polymer, synthetic, artificial, rubber, rubber-fabric);
composition (material of the product) - 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 data sheet, description, operating manual or instructions for use, label, test reports, certificates, sanitary and epidemiological conclusions, etc.), containing its technical characteristics, safety requirements for use, etc. .
user qualification requirements - a list of knowledge, skills, abilities and experience that the user must have in order to safely use products;
ultraviolet bactericidal installation - a group of bactericidal irradiators that provide a given level of bactericidal efficiency indoors:
open irradiators - irradiators in which a direct bactericidal flow from lamps and a reflector (or without it) covers a wide zone in space up to a 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 outlet to the outside;
combined irradiators - irradiators equipped with two bactericidal lamps separated by a screen so that the flow from one lamp is directed outward to the lower zone of the room, and from the other - to the upper one, while the lamps can be switched on together and separately;
electrizability (of materials) - the ability of a material to accumulate an electrostatic charge.
3. General requirements for medical devices and medical equipment
During operation, medical devices should not create levels of harmful factors (physical, chemical and biological) at the workplaces of medical personnel and other users that exceed the maximum allowable, in accordance with the requirements of sanitary legislation.
Devices must ensure the safety of the patient or the safety and health of users or, as appropriate, of others, 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.
The technical characteristics and performance of the device must not have such an adverse effect as to jeopardize the safety of patients and medical personnel or other persons during the service life of the device 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 the formulation or composition.
The regulatory documentation and other materials submitted for sanitary and hygienic assessment of medical products indicate:
Purpose of products and scope;
Description of the product, indicating (if necessary) the type and duration of contact with the body;
The composition or formulation of the materials used;
Hygienically significant technical parameters and characteristics (for medical equipment products),
The operational documentation for medical equipment products indicates all possible types of 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 the operation and maintenance of products.
For medical equipment products that are sources of physical factors, the following information is provided in the accompanying documentation (in the technical data sheet or in the technical specifications or in the technical passport):
For all products that are sources of noise or vibration (comprising moving parts, pumps, compressors, fans, electric motors, etc.) - information about sound levels (if necessary - about the levels and frequencies of local or general vibration) recorded during all nominal operating modes of the equipment;
For diagnostic, medical, auxiliary (disinfecting) equipment that is a source of ultrasound - information about the acoustic parameters of ultrasound sources - acoustic output of all sensors, therapeutic heads or other sources: operating frequencies, output power of ultrasound (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 that make up the product, the characteristics of each source, including: the frequency of the generated electromagnetic fields, the generated power, if possible - the maximum values of the electric and (or) magnetic fields, 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 estimated maximum duration of operation of each source; if necessary - safe distances (zones of safe or controlled access);
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 the ranges A (over), B (over), C (relative), information on the concentrations of ozone released into the air during operation of the equipment, as well as the recommended distance and duration of operation; for bactericidal irradiators, it should 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 radiation power at the maximum working pulse; if necessary - brightness, illumination, ripple factor; for LED sources - axial luminous intensity, solid angle of radiation, other passport characteristics of the LED;
The 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, pulse 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 - pressure levels;
For aeroionizing treatment and prophylactic equipment, the following is indicated: the voltage on the ionizing electrodes, the concentration of positive and negative air ions generated during various modes of operation, indicating the recommended distance and duration of operation for each mode of operation, 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, mains current frequency, power consumption, phases);
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 surface temperature under various operating modes of the equipment, must be indicated.
The design of products should, as far as possible, exclude the impact of increased levels of physical factors on maintenance 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 a protective earth. When operating UV equipment, where necessary and possible, acrylic protection should be used. Laser products of classes III, IV, generating radiation in the invisible part of the spectrum, should be equipped with built-in lasers of class I, II with visible radiation for visualization of the main laser beam (pilot, aiming laser).
According to the degree of laser hazard, medical products are classified by the manufacturer according to the output characteristics of the radiation by the calculation method in accordance with the requirements of the current sanitary norms and rules. 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).
Specifications for domestic laser products are agreed on a mandatory basis with the authorized bodies of state sanitary control (supervision).
Pilot samples of laser products must have a conclusion issued by the authorized bodies of state sanitary control (supervision) on compliance with these Uniform sanitary requirements, followed by permission for serial production.
Laser products for medical use must be equipped with means to measure the level of laser radiation affecting the patient and attendants.
Class III-IV laser products, prior to their operation, must be accepted by the commission appointed by the administration of the institution, with the mandatory inclusion of representatives of the authorized bodies of state sanitary control (supervision) in its composition. The Commission establishes the implementation of these Uniform sanitary requirements solves the issue of putting laser products into operation. The decision of the commission is formalized by an act.
To put a class III and IV laser product into operation, the manufacturer submits the following documentation to the commission:
Passport for a laser product;
Operation and safety instructions;
Approved plan for the placement of laser products;
Sanitary passport (according to the established form)
Safety in the workplace during the operation of laser products must be ensured by the design of the product. Within the working area, the levels of exposure to laser radiation and other adverse production factors must not exceed the values specified sanitary standards and rules and other regulations.
Zones of propagation of laser radiation must be marked with laser danger signs. If the laser beam goes outside the controlled zone, there must be a limiter at the end of its useful trajectory.
Safety when working with open laser products is ensured by the use of personal protective equipment.
Production facilities in which laser products are used must comply with the requirements of current building codes and regulations and ensure the safe maintenance of products.
Lasers and laser products of any class must be marked in accordance with the requirements for this type of product, including the explanatory sign 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: the wavelength of the radiation; output power (energy); temporal characteristics of laser radiation, laser hazard class; related 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 any harmful effects during transportation and storage of the product.
Products for medical purposes and medical equipment must be provided with a label (marking) informing the user about the manufacturer, the scope of the product, the terms and conditions of use and storage, as well as warning about safety measures during the operation of the product.
The manufacturer of a BMI that generates levels of physical factors that exceed the permissible levels must include personal protective equipment (anti-noise inserts, goggles, gloves) in the package at least 2 pcs.
4. TYPES OF TESTING MEDICAL DEVICES AND MEDICAL EQUIPMENT
Sanitary-chemical tests of product materials:
Odorimetric studies (assessment of the intensity of the smell of materials);
Qualitative-quantitative studies of migration levels harmful substances from product materials to model media (air, distilled water);
Assessment of integral indicators of the state of water retracts:
Organoleptic studies of water extracts (estimation of odor intensity, color, turbidity);
Measurement of the indicator of activity of hydrogen ions (pH) in water extracts from the materials of products and its changes compared to the control;
Assessment of reducing impurities
Evaluation of UV absorption in the wavelength range
Evaluation of the irritating effect of product materials and / or water extracts from them on the skin;
Evaluation of the irritating effect of materials and / or water extracts from the materials of products on the mucous membranes of the eyes;
Evaluation of indicators of acute toxicity when injected into the peritoneum, into the stomach, subcutaneously, etc.);
Evaluation of the sensitizing effect of product materials and / or water extracts from them;
Evaluation of the general toxic and skin-irritating effects of aqueous extracts from product materials on a culture of motile cells in vitro (toxicity index);
Assessment of hemolytic activity;
Microbiological tests (see Annex 2, clause 1.1.2)
Physical testing methods for medical devices
Evaluation of the electrified materials of products
Assessment of radiation indicators (for products using natural mineral materials and raw materials)
Physical methods for testing medical equipment products
Measurement of the levels of generated physical factors (noise, general and local vibration, air and contact ultrasound, radiation: ultraviolet, optical range, infrared, laser, X-ray, electric, magnetic and electromagnetic fields and radiation, air ion composition, surface temperature BMI available for contact user.
Volunteer trials (for women's sanitary napkins, diapers, diapers, diapers for children and adults for medical purposes).
REQUIREMENTS FOR CONSUMER LABELING OF MEDICAL PRODUCTS AND MEDICAL EQUIPMENT AND USER INFORMATION
Information about medical devices and medical equipment should be stated by the manufacturer in the labeling of products and in the documentation for it. Information, in addition to the address of the manufacturer of the products, must contain a listing of indicators related to the protective and performance properties, legal aspects of placing products on the market, as well as any other information that provides the intended user with an opportunity for adequate selection and use of the product and may be related to his health and security.
Marking is applied directly to the product.
The marking must be clearly visible, legible, indelible, and be applied 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, marking should also be applied to sterile packaging. Marking is not applied if the product is too small, or its specific properties do not allow it.
Markings or inscriptions that may mislead third parties as to the meaning or graphic representation of the marking with the mark of circulation on the market are prohibited. Any other marking may be affixed to the product, its packaging or the instructions for the product, 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 his trademark; protective properties; size (if any); regulatory document, the requirements of which the product complies with; Sign of conversion; date of manufacture and expiration date; other information in accordance with the technical documentation of the manufacturer.
The marking applied to the packaging of the product must contain: the name of the country of manufacture; name, legal address, trademark of the manufacturer; product name; normative document, the requirements of which correspond to the product; size (if any); ways to care for the product; year of manufacture, expiration date or expiration date; Sign of conversion; other information in accordance with the manufacturer's documentation.
Information should be applied in relief (embossing, engraving, casting, stamping). It is allowed to apply information in the form of pictograms, as well as hard-to-remove paint directly on the product. The information must be easy to read and stable during storage, transportation, sale and use of products for their intended purpose.
The marking must be written in Russian. Additional use of other languages is allowed in the case specified in the contract between the manufacturer (seller) and the consumer, while the translation from a foreign language into Russian must be apostilled.
Packages with products must be marked with pictograms (signs and / or text) that prescribe the conditions for storage and / or transportation of products established by the manufacturer in accordance with the regulatory (operational) documentation.
The labeling contains all the necessary information to ensure the safe operation of products: its main technical characteristics, warning labels, danger signs (magnetic, laser or other for BMI; information about the materials from which medical devices are made, etc.), requirements for the need use of personal protective equipment, safety 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 documents of sanitary legislation containing requirements for the relevant characteristics of BMI.
Requirements for ensuring the safety of IMT during their operation, indicated on special plates, as well as warning signs and inscriptions, are placed in prominent places of the products in which they are placed.
The manufacturer must provide information so that proper precautions can be taken and all hazards can be properly controlled using the full range of protective measures.
The user of a BMI characterized by a high potential health hazard (UV devices, laser products, etc.) should be warned about the risk. The danger of the products is indicated accordingly. The use of medical equipment products intended for the population in everyday life should be carried out as prescribed by a doctor, in accordance with medical recommendations.
UV devices are marked with a warning label: “ATTENTION! UV radiation can cause damage to eyes and skin. Read the instructions carefully. Wear the supplied safety goggles." For UV devices intended for use in beauty salons and similar places, warning labels 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 label: “Powerful light. Do not look at the emitter.
UV irradiators intended for operation in the absence of people are marked with an appropriate warning label.
Laser products of different classes are marked with warning labels - “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 the 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: to the production equipment used and the levels of harmful factors in the workplace , means of collective and individual protection, work regimes, conducting PMO of workers and production control (if necessary). This section should indicate that the products must be safe in production and use and must have a formalized sanitary and epidemiological conclusion.
List of medical devices and medical equipment with TN VED codes that are subject to sanitary and hygienic assessment for compliance with these Uniform Sanitary Requirements
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Professionals in any field of healthcare, whether it be science or the medical industry, have to decide every day a large number of urgent tasks that arise in the course of scientific and technological progress. One of the topical issues are the topics of concepts and classification of medical devices. According to the State Statistics Committee of Russia (Russian Statistical Yearbook: Stat. Sb. / Goskomstat of Russia. M., 2001. - P. 390), in our country in 2000, 2,726 enterprises operated in the medical industry, according to Vilensky A.V. and Fedoseeva V. N. (Vilensky A. V., Fedoseev V. N. Russian medical and technical market: state, problems, prospects // Economic Bulletin of Pharmacy. 2002. N 10) - over 1,500, and according to the Medprom website .ru (as of September 1, 2004), which is the largest Russian-language portal on medical devices, is about 1,600. The data of the last two sources are closer to the truth, since they indicate functioning and licensed enterprises, and not just registered ones. It should be noted that the number of domestically produced medical devices circulating on the Russian market has increased almost 3 times over the past 13 years (in 1991 there were 4.5 thousand, in 2004 - 12.5 thousand), that is, the annual increase in items amounted to over 615. This state of affairs makes it difficult for the domestic consumer (practitioner) to make a choice among the products offered to him.
A person in the modern world is under the pressure of an avalanche-like flow of information, which often causes him a feeling of confusion. Powerful information impact encourages us to make quick decisions, the correctness of which depends on our knowledge, experience and individual thought process.
What will help us choose the right direction and allow us to understand this situation?
In modern scientific knowledge, the concept of a systematic approach has become widespread, which focuses the modern researcher "on a holistic coverage of the studied processes and phenomena in their relationship and interaction with other phenomena, and thereby warns him against one-sidedness, incompleteness and limited results" (Ruzavin G.I. Concepts modern natural science. M .: Culture and sport, UNITI, 1997. - S. 8). Therefore, the development of any science is not reduced to a simple accumulation or cumulation of knowledge, but is associated with the interaction and development of two complementary processes - the differentiation and integration of knowledge. "Differentiation of scientific knowledge is a necessary stage in the development of science and it is aimed at a more thorough and in-depth study of individual phenomena and processes in a certain area of reality" (Ruzavin G.I., ibid., p. 22). As scientific knowledge emerged throughout the 20th century, many branches of major scientific disciplines emerged. Although the accuracy and depth of human knowledge about natural phenomena increased, at the same time the links between individual scientific disciplines and mutual understanding between scientists weakened. "In our time, it comes to the point that specialists from different branches of the same science often do not understand either the theories and methods of research of other branches, or its final results. Thus, the disciplinary approach threatens to turn a single science into a collection of isolated, isolated, narrow areas of research..." (Ruzavin G.I., p. 23).
Overcoming this limitation is possible only with the use of means and methods of an integrative, or interdisciplinary, approach. An interdisciplinary approach is associated not only with the application of concepts, theories and methods of one science to another, but, most importantly, in a systematic approach, since although the methods and methods of research in different sciences differ from each other, nevertheless general approach to knowledge, the method of inquiry remains essentially the same.
Concept system
Before us was placed not simple task- creation of a working classification of medical devices that would be acceptable both for manufacturers of these products and their consumers. Moreover, the convenience of using such a classification in practice is of particular importance.
The term "classification" denotes a system for distributing objects (concepts, real objects) according to some distinctive features (properties or relations between things), as a result of which each of them will be defined in a precisely specified class, section or group. In everyday life, each of us is faced with the questions of determining the place of an object. Therefore, "classification is one of the usual and frequently used operations, a means of giving our thinking rigor and clarity" (Ivin A. A. Logic. M .: Gardariki, 2003. - P. 104).
In this work, we will not consider the process of thinking itself (psychology deals with this, and psychiatry deals with various types of its violations), but we use logic as a working tool - a science that studies the process of thinking from the side of its results, the main products of thinking: concepts, judgments and conclusions . Although we should not forget that "the process of thinking and its results are inextricably linked and do not exist without each other, therefore psychology and logic are also connected and complement each other" (Sidorov P. I., Parnyakov A. V. Clinical psychology. - 2- e ed., supplementary - M.: GEOTAR-MED, 2002. - S. 144).
Before proceeding to our study, we will give definitions of the following concepts, which we will have to operate with.
concept- a form of thinking that reflects the most general and essential features, properties of an object or phenomenon of the objective world, expressed in a word. In the concept, as it were, all the ideas of a person about a given object or phenomenon were united. "The value of a concept for the process of thinking is very great, since the concepts themselves are the form that thinking operates on, forming more complex forms of thinking - judgments and conclusions. The ability to think is always the ability to operate with concepts, operate with knowledge" (Sidorov P.I. , Parnyakov A.V., ibid.).
The content of the concept is called the totality of the most essential features of an object, which is conceived in a given concept, and the totality of objects, which is conceived in a concept, is called the scope of the concept. Back in the 17th century, the law of the relationship between the volume and content of a concept was formulated (the logic of Port-Royal*): an increase in the content of a concept leads to a decrease in its volume and vice versa. So, increasing the content of the concept "microscope" by adding a new attribute "for cytodiagnostics", we pass to a new concept of a smaller volume - "microscope for cytodiagnostics". Diagnostic mistakes of a doctor can be associated with a violation of the logic of thinking in concepts, for example, about a specific disease - an overly broad or too narrow understanding of the content and scope of the concept about it, replacing the definition of the disease with its description with a list of individual symptoms. Similarly, a similar thing can happen to a specialist associated with medical devices when, trying to determine the place of any device, he will incorrectly explain the concept itself and use it.
* Port-Royal logic - a logical doctrine based on the principles of the philosophy of R. Descartes and B. Pascal, is set out in the book by A. Arno and P. Nicolas "Logic, or the Art of Thinking" (1662), in which logic is defined as a science that formulates methods of establishing the truth in the sciences of nature and mathematics.
Judgment- a form of thinking that reflects the relationship between concepts, expressed as an affirmation or negation. Judgments can be general (for example: "All gurneys are means for transporting patients"), private (for example: "Some suctions are mechanical"), singular (for example: "This apparatus is anesthesia and breathing"), true and false.
inference- this is a form of thinking, through which a new judgment (conclusion) is derived from one or more judgments (from existing knowledge - premises).
Classification is a special case of division - a logical operation on concepts (or objects). The sign by which the division is made is called division base. Thus, in each division there are divisible concept(objects), division base(sign) and division members.
When creating any classification, a certain conceptual apparatus, or a system of concepts, is used. Any classification is created by the researcher for certain goals set by him. It is important that the researcher has a clear idea of the content (meaning) of the concepts (terms) with which he works, uses them unambiguously, does not allow different interpretations of the same concept, which is often observed both in domestic and foreign specialized literature.
In our work, we will use definitions that, in our opinion, most fully reflect the properties of the objects under study, as well as the relationships between them, in other words, in the language of logic, predicates.
To date, confusion has persisted in the relationship between the concepts of "medical devices" and "medical equipment". This was discussed by the participants of the First All-Russian Forum "Medical Products of Russia 2002", which took place on May 15-16, 2002 in Moscow, and one of the speakers, the chief specialist of the Standardization Department of the State Standard of Russia, G. M. Menyailik, focused on this (" Modern tendencies standardization and certification of medical devices" - the report was published in "Medical devices. Russian market 2003". Catalog. Issue 1. Under the editorship of A.V. Vilensky - M.: Professional Center, 2002. - S. 102-111).
A typical definition of the term "medical equipment", reflecting an outdated semantic meaning, is given in the Introduction to the International Nomenclature System and the coding system for medical equipment in Russian and English based on the Universal Nomenclature System for Medical Equipment (UMDNS) of the American Information Agency (ECRI), translated into Russian in 1991: "Medical equipment is a wide class of devices, apparatus and systems used for the prevention, diagnosis and treatment of human diseases and in normal conditions functioning, not involved in metabolic processes. " And further. "There are more than 4,500 different types of products related to medical technology. This class of products includes the simplest disposable products (such as) spatulas or gauze pads, implant products such as artificial hip joints or pacemakers, and the most complex products such as biochemistry analyzers or CT scanners. This also includes diagnostic kits used by doctors and the patients themselves "(UMDNS, M .: VNIIIMT NPO "Ekran" of the Ministry of Health of the USSR, 1991. - S. - iii). The most familiar to humans are the properties of objects, so most often this or that classification of objects occurred according to this principle. But there are various relations between things, which are also expressed with the help of concepts. Apparently, the commentators of this classification did not take into account this circumstance. Therefore, in the specified source, the type of relations of the volumes of concepts, otherwise the relationship of subordination (subordination of volume), "medical equipment" and "medical products" can cause bewilderment at best, since here the volume of the concept "medical equipment" completely absorbs the volume of the concept "medical equipment". products".
The question of concepts is fundamental not only from the point of view of theoretical developments. Any incorrect definition of the term in the future can have a significant impact on practice. This is confirmed by data obtained from the Internet: the result of the Yandex search engine when entering a task for the phrase "Medical products" found 140,905 pages and 904 sites, for the phrase "Medical equipment" - 283,793 pages and 1,319 sites, for "Medical equipment" - 322,429 pages and at least 1,927 sites. The incorrect definition of concepts led to an absurd situation, since, following the logic, one would have to expect the phrase "Medical devices" as a result of the search largest number sites and pages.
In order to be accurate in our research, let's turn to the "Great Explanatory Dictionary of the Russian Language", published by the Institute for Linguistic Research at the Russian Academy of Sciences (St. Petersburg, Norint, 2000). In the "Explanatory Dictionary" the following definition of the concept of "product" is given: "Product is an object manufactured, developed by someone, a thing made." So, everything falls into place - the scope of the concept of "medical equipment" is part of the scope of the concept of "medical products", that is, the first is subordinate to the second. This circumstance was reflected in the Draft Federal Law "On Medical Devices" in 2002. It should be noted that this Law has not been adopted so far, which continues to cause confusion in terminology.
For the purposes of the proposed Classification, the following basic concepts are used.
medical devices- tools, fixtures, devices, devices, devices, complexes, equipment, reagents, control materials and samples used for medical purposes separately or in combination with each other.
Purpose of medical products:
for the prevention, diagnosis, treatment of diseases and other conditions, rehabilitation, convenience of medical procedures, medical research, replacement or modification of parts of the human body or physiological process;
· to influence the human body in such a way that their functional purpose is not realized through chemical, pharmacological, immunological interaction with the human body and does not affect its metabolism.
Medical equipment- machines, mechanisms, mechanical devices, automatic and semi-automatic devices used in medicine.
medical instrument- a tool, mostly manual, for the production of any medical work.
fixture- a device (usually the simplest), with the help of which any action, process, etc. is performed.
Medical instruments- a set of medical instruments and devices designed to ensure the performance of the main types of work in a particular area of medicine.
medical devices- technical means of measuring, analyzing, processing and providing information intended for diagnosis, prevention and treatment.
medical devices- technical devices that provide impact on the object by any type of energy in order to change the object or determine its characteristics.
Medical equipment- a set of devices, fixtures, instruments, mechanisms, etc., necessary for the performance of any work in medicine.
In modern literature, the following concepts are also distinguished.
Medical measuring instruments- medical products designed to measure quantities characterizing the state of the human body, and used in accordance with medical methods, which form the basis of their functional purpose (see the "Draft Federal Law "On Medical Products" in the catalog "Medical Products. Russian Market 2003". Issue 1. Edited by Vilensky A.V. - M .: Professional Center, 2002. - P. 191-211) Apparently, this concept was introduced in order to distinguish this group of devices from the mass of new generation medical equipment.
Medical devices belonging to the group "invitro" - medical products intended for diagnostics, which are reagents, reagent products, calibrators, control materials.
Medical devices belonging to the group of implant types- medical devices intended for prevention, diagnosis, treatment, rehabilitation and used in conditions of direct contact and / or interaction of medical devices with the patient's body.
The basis of classification is the functional purpose of the product
After determining the content of the concepts or the distinctive properties of medical products, we will try to highlight the sign by which we will classify the objects we study, that is, we will designate the basis of division.
Property - something that is inherent in any object, which constitutes its concrete existence. There is significant properties, without which the object cannot exist (it is them that we must designate and classify according to them), and non-essential properties, without which the existence of the object is possible. In our work, the essential (main distinguishing) property of any medical product is its purpose, that is, its function (lat. functio- execution). In a logical, especially in a mathematical sense, a function means the relation of the dependence of two changing quantities (variables) or a group of quantities, characterized by the fact that a change in one quantity results in a change in the other, that is, each value of one group always obeys each (or many) values of another in a certain way. groups.
The principle of classifying medical devices according to their functional affiliation was strongly recommended by Russian scientists (Vilensky A.V., Fedoseev V.N. Russian medical and technical market: state, problems, prospects // Economic Bulletin of Pharmacy. 2002. N 10), which was supported by the majority of domestic leading experts and was later reflected in the Draft Federal Law "On Medical Devices".
So, for the basis of division, we took functional affiliation medical device, which will help us to clearly define its specific role in the diagnostic or therapeutic process and take its appropriate place in the classification.
The basis of division adopted by us - functional affiliation - will not be replaced by other signs in the course of classifying medical devices. This requirement must be observed when creating all classifications without exception, as it is considered one of the main four elementary rules that must be observed when dividing concepts (objects). In addition to the above, we took into account the All-Russian classifier of products and the reporting forms of health care facilities, approved by the Ministry of Finance of the Russian Federation ("Report on the execution of estimates of income and expenses on budgetary funds").
Classification of medical devices
medical devices
Section 1. INSTRUMENTS AND APPARATUS FOR DIAGNOSIS, PREVENTION AND TREATMENT
Group 1. Tools, devices and devices for diagnostics
Subgroup A. Diagnostic tools
for gynecology;
for otorhinolaryngology;
for ophthalmology;
for dentistry;
for urology;
for surgery;
· to determine and monitor the main vital functions.
Subgroup B. Instruments and apparatus for laboratory diagnostics
for general clinical trials;
for biochemical research;
To determine the acid-base state and blood gases;
for studies of the electrolyte composition of blood and urine;
for immunological studies;
for serological studies;
for morphological studies;
for cytological studies
Subgroup B. Devices and devices for functional diagnostics, including for electrophysiological research methods
Subgroup G. Instruments and apparatus for radioisotope diagnostics
Subgroup D. Instruments and apparatus for X-ray diagnostics
Subgroup E. Instruments and apparatus for magnetic resonance research methods
Subgroup G. Instruments and apparatus for ultrasound research methods, including Doppler
Group 2. Tools, devices and devices for prevention and treatment
Subgroup A. Medical instruments
for obstetrics and neonatology;
for gynecology;
for otorhinolaryngology;
for ophthalmology;
for dentistry;
for traumatology and orthopedics
for urology;
for surgery;
for physiotherapy.
Subgroup B. Instruments and apparatus
for obstetrics and neonatology;
for gynecology;
for otorhinolaryngology;
for ophthalmology;
for dentistry;
for traumatology and orthopedics
for urology;
for surgery;
for physiotherapy.
Subgroup B. Surgical devices
Subgroup G. Anesthesia-respiratory and resuscitation equipment
Subgroup D. Devices and devices for blood service
Subgroup E. Devices for phototherapy and ultraviolet blood
Subgroup G. Devices for dialysis and hemosorption
Subgroup H. Laser devices
Subgroup I. Hyperbaric chambers
Group 3. Devices and devices of combined functions
Subgroup A. Mechanical and electromechanical suction
Subgroup B. Endoscopic technique
Subgroup B. Others
Section 2. MEDICAL EQUIPMENT
Group 1. Incubators for newborns
Subgroup A. Open
Subgroup B. Closed
Group 2. Beds, including functional ones
Group 3. Armchairs
Group 4. Operating tables
Group 5. Lamps
Subgroup A. Portable
lighting;
bactericidal;
Negatoscopes
Subgroup B. Stationary
lighting;
bactericidal;
negatoscopes.
Group 6. Equipment for water treatment
Group 7. Equipment for specialized departments and offices
Group 8. Pharmaceutical equipment
Group 9. Equipment for laboratories
Group 10. Shelter service equipment
Group 11. Equipment for sterilization departments
Group 12. Equipment for disinfection departments, including disinfection chambers
Group 13. Gas supply equipment
Group 14. General hospital equipment
Group 15 Equipment for the disposal of medical waste
Section 3. MEANS OF CORRECTION AND SUBSTITUTION OF THE FUNCTIONS OF ORGANS AND SYSTEMS
Group 1. Glasses, contact lenses
Group 2. Hearing aids
Group 3. Prosthetic and orthopedic products and means of rehabilitation
Group 4. Implants, artificial organs
Section 4. AUXILIARY MEDICAL FACILITIES AND EQUIPMENT
Group 1. Dressings and hygiene products
Group 2. Consumables, including dental
Group 3. Syringes and needles
Group 4. Chemical reagents and nutrient media
Group 5. Means for hemosorption and hemodialysis
Group 6. Medical scales
Group 7. Means for transporting patients, including emergency vehicles
Group 8. Auxiliary equipment
Subgroup A. Portable equipment;
Subgroup B. Stationary equipment.
Group 9. Spare parts
Group 10. Packaging materials and labels
Section 5. GLASS AND POLYMER MEDICAL PRODUCTS
Group 1. Items for special purposes
air ducts;
· catheters for aspiration of liquids;
catheters for vascular catheterization;
masks for anesthesia;
· corrugated hoses;
endotracheal tubes
surgical gloves, etc.
Group 2. Items for patient care
Group 3. Systems for the transfusion of biological fluids
Group 4. Pharmaceutical and laboratory glassware, ampoules, vials
Medical furniture
Ra section 1. HOSPITAL FURNITURE
Section 2. FURNITURE FOR LABORATORIES AND PHARMACIES
soft inventory
Section 1. MEDICAL CLOTHING
Section 2. CLOTHING AND SPECIAL ACCESSORIES
Section 3. CLOTHING FOR THE SICK AND HYGIENE EQUIPMENT
Means for disinfection, disinsection, deratization
This classification is proposed for creating catalogs of medical devices and is not perfect. It can be expanded by introducing the differentiation of medical devices according to their use in various fields of medicine, where the principle of functional purpose will also be preserved.
The most common division error is, of course, changing the base at one of the division steps. A typical example of such frequent mistakes made by the developers of classifications can serve as one of the domestic catalogs, where medical products are classified as follows:
Medical equipment:
equipment, tools, furniture for neonatology and pediatrics;
Surgical devices and devices, components and consumables for them;
Resuscitation and anesthesia equipment and patient monitoring systems, components and consumables for them<...>;
Therapeutic equipment (subgroups of equipment are distinguished here: physiotherapy, massage, hydrotherapy, etc.)<...>;
Equipment and tools for ambulance and emergency care;
dentistry, etc.
Medical instruments:
sets of tools;
individual instruments, implants;
catheters, drains, probes
Surgical supplies...
Equipment for auxiliary units etc.
Trying to analyze the principle of creating such a classification ( this phenomenon characteristic of many Russian catalogues), you understand that here there was a distortion of the generalization process - the essential properties of objects and the existing connections between them were not taken into account at all during the generalization operation. (When creating scientific classifications, this is unacceptable, so Professor F.V. Bassin used a figurative expression - "semantic tumor" to refer to such violations.) In the case under consideration, the classification, apparently, pursues the goals of its creators - the placement of modules with the same equipment with the possibility of their duplication and placement in different sections of the catalog. Allegedly, for the convenience of consumers.
As we said, any classification is created for certain purposes, and the choice of the basis for the classification is dictated precisely by this purpose. "Since there can be so many diverse and heterogeneous purposes, the same group of objects may be classified according to the most different grounds. The goals of divisions, and hence their foundations, are determined by certain practical or theoretical considerations, to which the division rules have nothing to do. The essence of these rules boils down to the requirement that the base, once it has been chosen, does not change in the future within the limits of the ongoing division "(Ivin A.A., ibid. - P. 111).
We hope that the classification of medical devices proposed by us will make it possible to more accurately classify medical devices and help to correctly orient not only domestic manufacturers of medical devices, but also the consumers of these products - medical workers.
07/30/2005 17:33 Kurilyak O.A.
The classification of Subgroup B Instruments and apparatus for laboratory research is obviously far from rational. The principle laid down in the classifier - according to the types of laboratory research does not work. The photometer can be used both for biochemical studies and for measuring hemoglobin concentration, as well as for performing immunoturbidimetric measurements. Today there is a wide range of combined type devices, for example,
devices for measuring electrolyte composition, blood counts, hematocrit, glucose and lactate.
The task of classifying laboratory equipment is not very simple and still has no rational solution.
I am happy to continue discussing this topic.
QUESTION: How can I tell if a product is a medical device?
QUESTION: How can I tell if a product is a medical device?
ANSWER: In accordance with the clarification of the Ministry of Health of the Russian Federation in letter N 2510 / 122-99-23 dated 01.11.99 "The State Register of Medical Devices includes domestic and foreign medical devices, including medical equipment, spectacle optics products, medical products appointments, etc., permitted by the Ministry of Health of Russia for use in medical practice and registered. This register is not a document regulating the assignment of certain products to separate classes. " For example, the inclusion of medical devices in the State Register of Medical Devices (as of 01.01.99) indicates only the fact that these products are approved for medical use in the territory of the Russian Federation. When deciding on the assignment of products to a particular class, one should use the product classification codes established by the All-Russian Classifier of Products OK 005-93, approved by the Decree of the State Standard of the Russian Federation of December 30, 1993 N 301 (as amended on July 12, 2001), then there are OKP codes given by the manufacturer in the product conformity certificates. In accordance with this Classifier, medical devices are assigned to the class with the OKP code 93, and medical equipment - to the class with the OKP code 94. Note that the Classifier indicates the 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 indicated in the accompanying documents or technical documentation the code of the products manufactured by him, then assigning it to the appropriate class can be done independently in accordance with the codes of the Classifier.
Director of a law firm
"Unico-94"
M.I.MILUSHIN
10.2001
AT the assortment of pharmacies must necessarily contain goods for sanitary and hygienic purposes and items for patient care, since in case of serious illnesses, after surgical interventions, for non-walking patients and in other cases, they are necessary to ensure human life. They belong to medical products, in the range of which are hygiene and dressings, medical clothing and more.
Medical devices (MD)- these are medical products made of glass, polymer, rubber, textile and other materials, reagent kits 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 of the Russian Federation No. 444 dated 13.12. 2001 "On the validity period of registration certificates for medical products and medical equipment").
This group of products occupies about 20% of the total market of medical devices, which underlines its importance for the medical industry. At present, only a fifth (20%) of this type of production is domestic.
Order of the Ministry of Health and Medical Industry No. 161 dated June 9, 1995 regulates the assortment list of medical products, items for patient care, prevention, sanitation and hygiene, which should be in pharmacies.
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 - Compression paper - Eye trays - Ankles - Heating pads - Sponges - Hemostatic tourniquets - Injection needles - Stomach bags and collection bags - Catheters - Lined oilcloth, comp-Ressnaya, polyvinyl chloride, medical Rings for children's teeth " Uterine rings - Crutches for adults, children, adolescents and tips for them - Circles for lining - Esmarch's mugs (irrigator) - Eye blades - Breast pumps - Urine bags - Knee pads - Finger pads | - Medical scissors - Disposable diapers - Hygienic bags (pads) for women, tampons - Medical gloves - Eye pipettes - Spittoons - Drinkers - Oxygen pillows - Hygienic rubber belts - Ice bubbles - Respirators, medical masks - Baby nipples - Douches - Protective equipment ( caps, condoms, intrauterine devices) - Cups for taking medicines - Bedpans - Suspensories - Medical thermometers - Canes - Medical tubes - Medical stockings, half-stockings (knee socks) - Medical syringes |
Separate goods (catheters, scissors, thermometers, syringes, etc.) are discussed in other topics. This topic deals with groups of other products.
According to their functional purpose, sanitary, hygiene and patient care products can be systematized into groups shown in Fig. ten.
Rice. 10. Classification of sanitary and hygiene products, patient care items according to their functional purpose.
For patient care to take medication, mainly liquid, water, cups, drinking bowls, eye pipettes, etc.
To perform certain medical procedures blood suction cups, Esmarch's mugs, hemostatic tourniquets, gloves, syringes, thermometers, etc.
In the case of bed rest, the patient needs sanitary and hygiene products for the toilet: bedpans, urinals, colostomy bags, oilcloth.
Individual products are intended for personal hygiene of patients, in particular, bandages, catheters, uterine rings, spittoons, suspensories, etc.
At the same time, the assortment also includes sanitary and hygiene products that are needed healthy people, children, women, including and pregnant women, for example, first-aid kits, children's dental rings, breast pumps, fingertips, nipples, women's packages, masks, medical respirators, etc.
In recent years, groups or series of products have appeared on the Russian pharmaceutical market, designed to solve certain problems of healthy or sick people. For example: 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 discharge channels-grooves that regulate the flow of air into the bottle;
- physiological pacifiers "drop" have a teardrop shape;
- physiological bottles consist of a cap-glass, a nipple of a physiological, hygienic plug, a bottle, a valve that prevents the occurrence of colic in children, and a removable bottom;
- adjustable breast pump Designed for expressing breast milk in lactating women.
Product series tena- for the care of patients with urinary incontinence, includes adult diapers, absorbent sheets. The use of these tools simplifies patient care and provides the patient with a feeling of comfort.
Types of domestically produced goods: SCA Haijin Products (Russia):
Gaskets-dipers "Lady" for women have an anatomical shape, suitable for use both at night and during the day, invisible under clothing; normal, extra, super types are produced, in packs of 7-12 pcs.
"Slip" pads are available in 2 sizes: M - medium, L - large, 10 pcs. packaged;
Gaskets "Comfort" are produced complete with fixing shorts;
Pads-sheets "Bad", size 60x60 or 60x90, 20-30 pcs. packaged.
A certain group of goods is made up of personal hygiene products for women on the days of the menstrual cycle and for every day. These include pads, tampons, bags that perform one function - the absorption (absorption) of body secretions and ensuring the comfort of women.
Hygienic intravaginal products for use on "critical" days - tampons Tampax are made from specially bleached cotton fiber, viscose or a mixture thereof, have a return cord. 3 types are produced: mini, normal and super-super plus; in a package of 8 pcs.
They are compact and allow a woman to lead an active lifestyle. Researchers of 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 an unexpected deterioration in health occurs when using tampons (fever, vomiting, diarrhea, muscle pain, dizziness, etc.), then you should immediately consult a doctor, because. the cause may be toxins produced by staphylococcus aureus. These health changes are called toxic shock syndrome. No cases of TSS have been registered in Russia yet. The use of tampons in the postpartum period, especially during surgical interventions, is undesirable and is possible only after consulting a doctor. Produced by affiliates of Procter & Gamble (USA).
Procter & Gamble (USA) also produces a series of hygiene products for women, in particular:
Allways ultra- hygiene products for use on "critical" days, and 4 types are produced depending on the characteristics of the course of these days in women: 1) light - the length of the gasket is 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-weave top layer, consisting of the smallest three-dimensional funnel-shaped pores. It lets moisture into the gasket and prevents it from escaping to the surface under pressure. The pads have elongated elastic "wings" for secure fixation to the linen. 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 the company's branches in Germany, Hungary, Turkey.
A range of pads for daily use Oldeyz. They have a softer surface, provide odor control, create a comfortable environment for the female body, and prevent skin irritation and diaper rash.
Gaskets are available oldyz black black color, Oldeys black tanga- black color, Oldeys tanga- regular color, with a shape changed for underwear, Oldeys luj- big, normal- medium, pitches- small size, in packs of 16-22 pieces, 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. Various sizes are available to suit different discharge volumes. Requires a change every 3-6 hours. Tampons OBI. 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 fries 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, the shape follows the lines of the body, securely fixed on the underwear. In packs of 16 to 30 pieces, may be black,
Various types are available: Care free, Care free black, Care free flexiform(breathable), Care free fresh(with fresh scent) Care free ultra(for use on critical days), etc. Produced by Johnson and Johnson (Italy).
The composition of the rubber compound:
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 crosslinked with the help of sulfur at the site of double bonds. This process can only take place under certain conditions:
1)using sulfur three types: ground sulfur, precipitated sulfur and "sulfur color"
2)using metal oxides and some synthetic resins
3) using nuclear irradiation of raw rubber compound
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 degradation. Externally manifested as brittleness, brittleness, cracks, hardness. These processes are manifested under the influence of oxygen, heating, irradiation. Substances that protect against thermal and oxide aging are divided into:
1) physical action: wax, paraffin, ozocerite, ceresin. These substances, sweating out, form a protective film on the surface, i.e. protect the product from aging.
2) chemical action: phenols, amines, aromatic hydrocarbons. These substances are very active and react with oxygen in the air first of all.
7.special substances:
7.1 anti-fatigue - p-phenyldiamine
7.2.antiozonants - antilux, santaflux and flexozone
7.3 Phenols protect against light aging.
Types of rubber:
1. Styrene-butadiene rubber - the most common type in the 19th century. Currently the cheapest. It is unstable to temperature influences, therefore it quickly fails.
2. Polychloropropylene rubber is resistant to light, ozone, oils. It is used for textile products of non-woven production.
3.Polyisoprene rubber - serves 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.
Similar information.
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 diseases, monitoring the state 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 devices can be recognized as interchangeable if they are comparable in terms of functionality, quality and technical characteristics and are capable of replacing each other.
2. Medical devices 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, efficacy and safety of medical devices, their state registration, production, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, conformity assessment, state control, storage, transportation, sale, 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. The manufacturer (manufacturer) of a medical device develops technical and (or) operational documentation, in accordance with which the production, manufacture, storage, transportation, installation, adjustment, use, operation, including maintenance, as well as repair, disposal or destruction of medical equipment are carried out. products. Requirements for the content of the 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 accordance with the procedure established by the Government of the Russian Federation and the federal executive body authorized by it is permitted.
5. Medical devices that are manufactured to individual orders of patients, which are subject to special requirements for the appointment of medical professionals and are intended solely for personal use by a particular patient, as well as medical devices intended for use on the territory of the international medical cluster or on the territories of innovative scientific and technological centers are not subject to state registration. These medical devices 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 previous edition)
6. The procedure for importing medical devices into the territory of the Russian Federation for the purpose 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 within the framework 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, efficiency and safety of medical devices, as well as tests in order to approve the type of measuring instruments (in relation to medical devices 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 the effectiveness and safety of medical devices, National tax in accordance with the legislation of the Russian Federation on taxes and fees.
10. In accordance with the procedure 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 previous edition)
11. The following information shall be entered into the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices:
(see text in previous edition)
1) name of the medical device;
2) the date of state registration of the medical device 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 product;
5) class of potential risk of using a medical device;
7) name and location of the organization - the applicant of the medical device;
8) name and location of the organization - manufacturer (manufacturer) of a medical device or surname, name and (if any) patronymic, place of residence of an individual entrepreneur - manufacturer (manufacturer) of a medical device;
(see text in previous edition)
9) address of the place of production or manufacture of the medical product;
10) information about interchangeable medical devices.
12. Counterfeit medical device - a medical device accompanied by false information about its characteristics and (or) manufacturer (manufacturer).
13. Poor-quality medical device - a medical device that does not meet the requirements of the regulatory, technical and (or) operational documentation of the manufacturer (manufacturer) or, in its absence, the requirements of other regulatory documentation.