APPENDIX TO THE APPLICATION FOR REGISTRATION OF THE DECLARATION OF CONFORMITY OF PRODUCTS

State registration of the RosTestStandard certification system in the Federal Agency ROSSTANDART registration number ROSS RU.Z1527.04IZhRO

ROSTESTSTANDARD

Certification of products in the RosTestStandard center is carried out for compliance with technical regulations and established State safety and quality standards, we advise who issues, where and how to obtain, issue: a certificate of conformity, declarations of conformity, a certificate of state registration of products and a fire safety certificate. We determine exactly which of the above-mentioned permits is required to be issued according to the list of products subject to mandatory certification in the territory of the Customs Union (EAEU) or declaration of conformity.

STATE CERTIFICATION: 8 (800) 200-87-81 FREE CALL

Instruments and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic equipment, other electromedical equipment and devices for vision examination:

HS codes

9018 - Instruments and devices used in medicine, surgery, dentistry or veterinary medicine, including scintigraphic equipment, other electromedical equipment and instruments for examining vision:

This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (for example, by doctors, surgeons, dentists, veterinary surgeons, midwives) either for the diagnosis, prevention or treatment of disease, or for the operation and etc.
Instruments and devices for anatomical work and for dissection of corpses, dissection, etc. Also included, as are included under certain conditions, are instruments and supplies for dental laboratories (see part (II) below). Appliances of this heading may be made of any material (including precious metals). This heading does not include:

(a) Sterile catgut and other sterile surgical suture material, sterile sheets and sterile sheet swabs (heading 30.06).

(b) Diagnostic or laboratory reagents (heading 3822 00 000 0).

(c) Hygienic and pharmaceutical products of heading 4014.

(d) Laboratory, pharmaceutical or sanitary glassware of heading 7017.

(e) Sanitary fixtures of base metal (especially headings 7324, 7418 and 7615).

(e) Manicure and pedicure sets and instruments (heading 8214).

(g) Wheelchairs for people with limited mobility (heading 8713).

(h) Glasses, sunglasses, etc., corrective, protective and other (heading 9004).

(i) Photographic cameras (heading 90.06), unless they are permanently installed in appliances or fixtures of this heading.

(j) Microscopes, etc. heading 9011 or 9012.

(l) Devices for mechanotherapy, oxygen therapy, ozone therapy, artificial respiration, aerosol therapy, massage, etc. heading 9019.

(l) Orthopedic appliances, artificial body parts and appliances for fractures, including appliances for animals (heading 9021).

(n) X-ray machines, etc. (medical or not) of heading 9022.

(o) Clinical thermometers (heading 9025).

(o) Instruments and apparatus used in laboratories for the analysis of blood, tissue fluids, urine, etc., whether or not the analyzes are for diagnostic purposes (generally heading 9027).

(p) Medical or surgical furniture, including furniture for veterinary use (operating tables, examination tables, hospital beds), dental chairs not containing dental appliances of this heading, etc. (heading 9402).

(c) Disc calculators, used for calculating pulmonary function, body mass indexes, etc., of heading 9017.

On the other hand, this heading covers specialized measuring instruments used exclusively in professional practice, such as cephalometers, calipers for measuring brain lesions, obstetric pelvis meters, etc.

It should also be noted that many of the instruments used in medicine or surgery (human or veterinary) are essentially ordinary hand instruments (for example, hammers, dental hammers, saws, chisels, grooved chisels, forceps, pliers, spatulas, etc.) etc.) or cutlery (scissors, knives, etc.). Such articles are therefore classified in the heading only if they are clearly identifiable as being intended for medical or surgical use by reason of their particular shape, the ease with which they are released for sterilization, the superior quality of workmanship, the nature of their constituent metals or their packaging (often packaged in boxes or boxes containing a set of tools for a specific job: childbirth, autopsy, gynecology, eye or ear surgery, veterinary kits for childbirth, etc.).

The instruments and implements classified here may be equipped with optical devices; they may also use electricity either as a motive force, or for transmission, or as a preventive, therapeutic or diagnostic factor.

This heading also covers instruments and implements using laser or other light or processes using photon beams and ultrasonic instruments and implements.

(I) Instruments and appliances for medicine and surgery,

excluding veterinary

This group of goods includes:

(A) Instruments that can be used under the same name for several purposes, for example:

(1) Needles (for sutures, ligatures, vaccinations, blood tests, hypodermic needles, etc.).

(2) Lancets (for vaccination, bloodletting, etc.).

(3) Trocars (for punctures) (gallbladder, general purpose, etc.).

(4) Surgical knives and scalpels of all types.

(5) Probes (prostate, bladder, urethra, etc.).

(6) Speculums (nasal, mouth, larynx, rectum, vaginal, etc.).

(7) Mirrors and reflectors (for examining the eyes, larynx, ears, etc.).

(8) Scissors, forceps, pliers, chisels, grooved (semicircular) chisels, dental hammers, saws, scrapers, spatulas.

(9) Cannulas, catheters, suction tubes, etc.

(10) Cauteries (thermocauteries, galvanocauters, microcauteries, etc.).

(11) Tweezers; holders for dressings, swabs, sponges or needles (including radium needle holders).

(12) Retractors (labial, jaw, abdominal hooks, tonsil hooks, liver specula, etc.).

(13) Dilators (for the larynx, urethra, esophagus, cervical dilators, etc.).

(14) Wire guides for installation of needle catheters, tissue dilators, endoscopes, etc.

(15) Staples (for seams, etc.).

(16) Syringes (glass, metal, glass and metal, plastic, etc.) of all types, for example, injection, puncture, anesthesia, douching, wound washing, suction (with or without pump), for eyes, ears, throat, uterine, gynecological, etc.

(17) Surgical staplers for placing staples close to the wound.

(B) Special diagnostic instruments and apparatus

These include:

(1) Stethoscopes.

(2) Instruments for measuring respiratory rate (to determine basal metabolic rate).

(3) Sphygmomanometers, tensiometers and oscillometers (for measuring blood pressure).

(4) Spirometers (to determine lung capacity).

(5) Cephalometers.

(6) Pelvimeters

(B) Ophthalmic instruments. They fall into different categories:

(1) Surgical instruments such as corneal trephines, keratomas.

(2) Diagnostic instruments such as ophthalmoscopes; binocular magnifiers with headbands and binocular microscopes, consisting of a microscope, an electric lamp with a slit and a headrest, the whole being mounted on an adjustable support for examining the eyes; tonometers (to check intraocular pressure); eyelid dilators.

(3) Orthopedic and visual acuity apparatus, including amblyoscopes, retinoscopes, skiascopes, strobe meters, keratometers, keratoscopes, trial lens boxes and trial frames (for putting on trial lenses), optometric scales, test charts. However, optometric scales and tables on paper, cardboard or plastic, used for testing color perception, are not included in this heading (heading).

This heading also covers electrically heated eye compresses and electromagnets intended to remove metal particles from the eyes.

(D) Ear instruments, such as oriscopes. However, tuning forks, whether intended for medical use or not, are excluded from this heading (heading 92.09).

(E) Anesthesia devices and instruments (face masks, devices for partial treatment of the face, endotracheal tubes, etc.).

(E) Instruments for treating the nose, throat or tonsil: clamps (for straightening the nasal cartilage); transillumination devices (for sinuses and turbinates); tonsilotomes and surgical instruments for removing tonsils; direct laryngoscopes; brushes for cleaning the larynx, etc.

(G) Pharyngeal, esophageal, gastric and tracheotomy instruments: esophagoscopes, bronchoscopes, devices for aspiration of gastric contents, endotracheal tubes, etc.

(3) Instruments for the urethra and bladder: urethrotomes, bladder stone aspiration devices, prostatectomy and stone crushing instruments.

(I) Artificial kidney machines (dialyzers).

(K) Gynecological and obstetric instruments: vaginal retractors; instruments for hysterectomy; obstetric stethoscopes; specialized optical instruments for examining the genital organs; tweezers; hammer drills; instruments for embryotomy (for dissecting the fetus); cephalothribes and cranioclasts (instruments for crushing the head of a child who died in the uterus); tools for performing internal measurements, etc.

(L) Portable devices for eliminating pneumothorax, blood transfusion devices, artificial leeches. This heading also covers sterile, sealed plastic containers that have been de-aired but contain a small amount of anticoagulant and are fitted with an integral donor tube and phlebotomy needle and are used for the collection, storage and transfusion of human whole blood. However, special bottles for storing blood made of glass are not included here (heading 7010).

(M) Electric rubs for persons suffering from pain in the distal parts of the extremities.

(N) Acupuncture needles: gold, silver, steel.

(O) Endoscopes: gastroscopes, thoracoscopes, peritoneoscopes, bronchoscopic telescopes, cystoscopes, urethroscopes, resectoscopes, etc. However, endoscopes for non-medical purposes are not included here (heading 9013).

(P) Apparatus containing an automatic data processing machine and intended solely for calculating the dose and distribution of therapeutic radiation.

(P) Pressure chambers (also known as decompression chambers). They are used to treat a number of diseases, such as gas gangrene, carbon monoxide poisoning, actinomycosis, anemia from large blood loss, etc.

(C) Lamps specially intended for diagnostic purposes, irradiation, etc. Lamps and pen-shaped lanterns are excluded (heading 8513), as are those not intended for medical purposes (heading 9405).

(II) Dental instruments and devices

In addition to the instruments and apparatus included in this and the preceding heading (such as masks and other dental analgesic apparatus), the principal instruments and apparatus included in this heading are:

(1) Finger guards (whether interconnected or not) and mouth retractors; cheek and lip retractors; spatulas for pressing out the tongue and staples.

(2) Tweezers of all types, elevators, forceps of all types (for removing teeth, straightening protruding teeth, etc.), dental cutters (for cutting, ligating, filling and gouging, etc.), forceps for removing tooth roots .

(3) Nerve processing instruments (nerve extractors and other extractors, nerve hooks, nerve needles, nerve finders, etc.).

(4) Bone cutters and reamers; chisels with grooves and dental hammers for resection of the jaw and maxillary sinus; raspatory; scalpels; special knives and scissors; special tweezers for the dentist; "excavators" and probes.

(5) Special tools for cleaning gums and sockets; instruments for removing tartar; scrapers and chisels for tooth enamel.

(6) Various probes; needles (for abscesses, hypodermic, for sutures, cotton wool, etc.); holders for cotton swabs and swabs on rods; insufflators; dental mirrors.

(7) Tools for setting gold (corks, dental hammers, etc.); instruments for filling (spatula for cement or resin, plugs and dental hammers for amalgam, instruments for introducing amalgam into the tooth cavity, etc.); impression trays.

(8) Dental burs, discs, dental drills and brushes specifically designed for use with a dental drill motor.

This heading also includes instruments used in prosthetic dentistry, both by the practitioner himself and by the dental technician, for example: knives; spatulas and other molding tools; various forceps and tweezers (for securing clamps and crowns, cutting off protrusions, etc.); saws; scissors; dental hammers; expanders; chisels; scrapers; finishing burs; metal forming devices designed to produce metal dental crowns by striking. This heading does not, however, include tools or other articles of general use (furnaces, molds, soldering irons, melting ladles, etc.); they are classified in their respective headings.

This heading also includes the following:

(i) Motors for dental drills with a rotating tool holder located on a separate base designed for mounting on a wall or on equipment described in paragraph (ii) below.

(ii) Complete dental equipment on its base (fixed or mobile device). The main common components are the frame supporting the compressor, transformer, control panel and other electrical apparatus; The devices are often also equipped with the following: a dental drill with a rotating tool holder, a spittoon and a mouth rinser, an electric heater, a hot air insufflator, a spray bottle, a tray with cauterization instruments, diffuse lighting, a shadowless lamp, a fan, a diathermy apparatus, an X-ray apparatus, etc. d.

Some types of this equipment are designed to work with abrasive materials (usually alumina) instead of boron; abrasives are usually applied to the teeth using compressed gas (such as carbon dioxide).

(iii) Spittoons and mouthwashes either on a base, a stand or a swivel. They are usually combined with a source of warm water and a syringe for warm water.

(iv) Dental chairs containing dental equipment and any other dental appliances classified in this heading.

This heading does not, however, include dental chairs which do not contain dental appliances of this heading; These dental chairs fall in heading 94.02, whether or not equipped with such equipment as lights.

This heading excludes certain items of dental equipment mentioned in paragraph (ii) above when presented separately; they are classified under their own respective headings, eg compressors (heading 84.14); X-ray and other apparatus (heading 9022). Heading 9022 also covers X-ray and other apparatus intended for stand-alone or wall mounting in dental offices. A separately presented diathermy apparatus is, however, classified with electromedical apparatus of this heading (see part (IV) below).

It should be noted that dental cements and other dental fillers are classified in heading 30.06; preparations known as "dental wax" or "dental impressions", presented in kits, retail packages or in plates, horseshoes, sticks or similar forms, and other preparations used in dentistry, based on plaster of Paris (calcined gypsum or calcium sulphate) are classified in heading 34.07.

(III) Veterinary instruments and devices

This entry covers a large number of products which, although intended for veterinary use, are similar to those in part (I) or (II) above, for example:

(A) General purpose instruments (eg, needles, lancets, trocars, scalpels, speculums, probes, scissors, forceps, hammers, curettes, retractors, syringes).

(B) Special instruments and devices, such as ophthalmoscopes, eyelid dilators, laryngoscopes, stethoscopes, forceps, embryotomes.

(B) Dental instruments

This item also includes instruments and apparatus intended specifically for veterinary use, for example:

(1) Instruments and devices for the udder, such as teat dilators and puncture probes (for opening the teats of cows); devices for the treatment of postpartum sepsis or mastitis in cows.

(2) Instruments and devices for castration: instruments for crushing the spermatic cord; gluing and clamps for castration (in order to cause atrophy of the gonads in males); vices and castration tongs; ovariotomes, etc.

(3) Instruments and devices for childbirth: specialized obstetric ropes, harnesses, head restraints, forceps and hooks, mechanical devices for calves, etc.

(4) Various instruments: artificial insemination machines; devices for securing the tail; devices for cutting horns; atomizers for the treatment of respiratory, digestive, urinary, genital diseases, etc. organs in animals; special control devices, i.e. to prevent animal movements during operations (mouth openers, fetters, etc.); special syringes for administering drugs and syringes filled with an anesthetic drug or medicine (immune serum, vaccine, etc.) for remote administration to free-roaming animals, for example using a cannon or pistol powered by compressed gas; devices for dispensing pills; special bridles for swallowing doses of drugs; horse hoof crack hooks (for closing cracks in the hoof); endoscopic instruments for determining the sex of chickens, etc.

This heading does not include trichinoscopes (optical instruments for examining pork) (heading 9011), orthopedic devices for animals (heading 9021), operating tables for animals (heading 9402, see relevant explanatory notes).

Tools used by veterinary surgeons and farriers alike are classified in the group (eg, forefoot files; nail or hoof scissors; trimming knives; pliers; tweezers; hammers, etc.); The product group also includes tools for branding cattle (stamps, irons for burning off hoof crusts, etc.) and cutting tools.

(IV) Scintigraphic equipment

These include machines that scan parts of the body and provide an image of an organ or a recording of its functioning. These include devices that include a scintillation counter, the readings of which are converted into continuous signals for the purpose of establishing medical diagnoses (for example, a gamma camera, a scintillation scanner).

(V) Electromedical devices

This heading also includes electromedical apparatus for preventive, therapeutic or diagnostic purposes, excluding X-ray, etc. devices of heading 9022. This set of goods includes:

(1) Electrodiagnostic devices, which include:

(i) Electrocardiographs (devices that, using currents caused by contractions of the heart muscle, record the movements of the heart in the form of electrocardiograms).

(ii) Phonocardiographs (specially designed for recording heart murmurs in the form of phonocardiograms; they can also be used as electrocardiographs).

(iii) Cardioscopes (used in combination with the two previous devices to perform simultaneous observation of cardiograms and phonocardiograms).

(iv) Rheocardiographs (electrical devices for measuring changes in electrical resistance caused by the functioning of the heart).

(v) Electroencephalographs (for brain research).

(vi) Electrosphygmographs (for recording blood pressure and volume).

(vii) Electrotonographs (to record variations in arterial, intravenous or intracardiac pressure).

(viii) Electroretinographs (to measure retinal tension).

(ix) Audiometers and similar apparatus (for testing hearing based on changes in frequency).

(x) Diagnostic equipment combined or operating in conjunction with an automatic data processing system for the purpose of processing and identifying clinical data, etc.

(xi) Ultrasound diagnostic equipment used to examine organs, such as on a tube screen, using ultrasonic waves.

(xii) Instrumentation using nuclear magnetic resonance (NMR) to study the tissues and internal organs of the human body, based on the magnetic properties of the body's atoms, such as hydrogen atoms.

(2) Electrotherapy devices. In addition to being used in diagnostics, these devices are used to treat diseases such as neuritis, neuralgia, hemiplegia, phlebitis, and endocrine anemia. Some of these devices may be combined with the electrosurgical instruments listed in point (6) below.

(3) Ion therapy devices used to administer active drugs (sodium or lithium salicylate, potassium iodide, histamine, etc.) through the skin using an electric current.

(4) Diathermy devices intended for the treatment of certain diseases that require heat (for example, rheumatism, neuralgia, dental diseases). They work by using high-frequency (short-wave, ultrasonic, ultra-short-wave, etc.) currents and use electrodes of various shapes (for example, plates, rings, tubes).

(5) Electroshock treatment devices intended for the treatment of mental or nervous diseases.

(6) Cardiac defibrillators for defibrillation of the heart using electric current.

(7) Electrosurgical devices. They use high frequency electrical currents with a needle, probe, etc. forming one of the electrodes. They can be used to cut tissue (electric cutting) with a lancet (electric lancet) or to coagulate blood (electrocoagulation). Some combination devices can be made to act alternately as electric cutters or electrocoagulators through the use of control pedals.

(8) Devices for actinotherapy. They use radiation lying within, and more often outside, the visible spectrum (infrared, ultraviolet) to treat certain diseases or for diagnostic purposes (special lighting for detecting skin diseases). These machines usually contain lamps, although infrared machines may have heated resistors or heated reflective panels.

(9) Artificial incubators for children. They mainly consist of a transparent plastic compartment, electrical heating equipment, safety and alarm devices and devices for air filtration, oxygen and control devices. In most cases, they are mounted on a cart and have a built-in scale for children.

Housings containing electrodes or other devices intended for use with the apparatus described above are also included.

Parts and Accessories

In accordance with the provisions of Notes 1 and 2 to this chapter (see the general provisions of the Explanatory Notes), parts and accessories for apparatus and accessories of this heading are also classified therein.

Explanations for subheadings:

Subheading 9018 12

This subheading includes electrodiagnostic ultrasound scanning apparatus. This machine sends high-frequency sound waves into the human body through a transducer. The transducer is brought into contact with the human body and periodically emits short ultrasonic pulses and picks up their “echoes”. This echo is a reflected sound signal from organs located inside the human body and its characteristics make it possible to judge the location, size, shape and structure of organ tissue. The description is usually performed by an automatic data processing machine and outputs images of the tissues.

This body scanning technique is used to study the fetuses of pregnant women. It is also good for studying the breasts, heart, liver and gall bladder.

Subheading 9018 13

Magnetic resonance imaging (MRI) is based on the principle of alignment of the nuclei of hydrogen atoms under the influence of an intense magnetic field. If radiofrequency is then applied to these elements, the alignment of the nuclei is shifted. After the radio waves are removed, the nuclei self-align, emitting a weak electrical signal. Since the human body initially contains hydrogen atoms, an image of any part of the body can be generated by return pulses. Since hydrogen is a constituent of water, pulse returns can be used to detect differences between tissues. This makes it possible to obtain images of brain bone and tissue.

Electrodiagnostic magnetic resonance imaging equipment consists of a huge electromagnet, a radio frequency generator and an automatic data processing machine.

Hydrogen was chosen as the element for magnetic resonance reflection due to its abundance in the human body and its known magnetic characteristics. It is also possible to use other elements such as sodium or phosphorus.

Subheading 9018 14

Electrodiagnostic equipment of this subheading is used to obtain a picture of the distribution of gamma rays in the human body. This picture is reproduced using appropriate equipment, such as a scintigraphic scanner and, above all, a gamma radiation camera.

These nuclear scanners require the patient to take a pill or be injected with a radioactive substance (contrast) that is quickly absorbed by the organ being examined. The body is then scanned with a gamma ray counter, which records the amount of radiation emitted by the contrast agent as it enters the organ of interest (such as the brain) to determine where the radioisotope is concentrated.

The visual picture is reproduced by a machine for automatically processing data from the analysis of detected radiation. This painting presents a series of light and dark areas, or contrasting colors, showing where the radioisotope has accumulated in the organ. Such scans provide information about both the structure and performance of the organ being examined.

An example of a scintigraphic apparatus is a tomographic scanner based on positron emission. It combines the principles of nuclear medicine with the imaging technology used by a CT scanner (see Explanatory Note to subheading 9022.12)

Explanations for subheadings

9018 50 100 0

In addition to general-purpose ultrasound diagnostic equipment, this includes special equipment for ultrasound examination of the eyes (for example, to determine the thickness of the cornea and eye lens or the length of the eyeball).

9018 90 850 0

This subheading includes:

1. electric defibrillators to generate electrical impulses that restore normal heart function. Using these devices, equipped with a pulse generator and two defibrillation electrodes, the ECG signal coming from the patient's heart is displayed on the screen or printed by a built-in printer.

2. medical equipment for injecting gases into the human abdominal cavity in order to enable examination of various organs using an endoscope. These instruments, equipped with measuring instruments and displays, are attached to two hoses, the other ends of which are connected to a stopcock and a long needle.

3. medical suction pumps for pumping out secretions, consisting of a pump and a suction device, and used in operating rooms and in ambulances.

4. Contraceptive devices, known as intrauterine devices, consisting of a plastic housing equipped with a copper wire and filled with copper in colloidal form or a hormonal composition.