Licensing procedure
Article 12 of Federal Law No. 99-FZ of May 4, 2011, which defines the general licensing rules in Russia, establishes that all types of medical activities are classified as licensed. A specific list of areas of dentistry in the license is given in an additional regulatory document - Government Decree No. 291 of April 16, 2012. It includes the following areas of work activity of a doctor in dentistry:
- hygienic;
- general;
- children's;
- area of general practice;
- orthopedic;
- preventive;
- therapeutic;
- surgical
Each of these areas requires a separate license. To obtain it, the applicant will have to study the list for a dental office license, which describes the necessary equipment. The issuance of such documents is carried out by Roszdravnadzor and relevant departments of regional executive authorities.
To obtain a license, the applicant provides the regulatory agency with a package of documents confirming that he meets the established standards and has purchased the necessary equipment in quantities not less than the established one. Based on the results of consideration of the application, a decision is made to grant a license or refuse to issue it. If the decision is positive, the validity period of such a document is not limited in accordance with Part 4 of Article 9 of 99-FZ.
Required documents
To obtain a license to operate a dental clinic, the applicant will need to draw up an application according to the established template. It is given in the appendix to Roszdravnadzor Order No. 3166 dated May 5, 2014. You will need to attach a list of documents to it that will confirm that you have fulfilled the current requirements for licensing orthodontists or other dentists and are ready to start working. The list of such documents includes:
- notarized copies of the company’s constituent documentation;
- copies of documents confirming the legal right to use premises suitable for the provision of services and having an area not less than the established one - for example, a certificate of ownership or a lease agreement;
- copies of documents indicating that the applicant has the legal right to use medical equipment and equipment in an amount not less than necessary to perform work in the chosen field of dentistry;
- information on the compliance of the existing premises with sanitary and epidemiological safety standards;
- copies of registration certificates for the equipment used;
- copies of diplomas, certificates and certificates confirming that the head of the organization and its doctors have the required level of education, qualifications and work experience in the relevant profile that is not less than established - for example, this is a physiotherapy room for licensing a dental organization or a functional diagnostics room;
- copies of diplomas or certificates of staff members who will be involved in the maintenance of medical equipment, or a copy of the agreement with the organization that will provide such maintenance;
- a copy of the receipt confirming payment of the state fee for the provision of the service for issuing a license;
- a list of documents provided as part of the package.
List of required equipment
One of the important licensing conditions that the applicant must meet is the equipment of dentistry for licensing, that is, the availability of medical equipment in an amount no less than necessary to provide quality services. This issue is regulated by a separate legal act - order of the Ministry of Health dated December 7, 2011 N 1496n. Appendix No. 11 to this order provides the current standards for equipping different types of dental offices for licensing. This section of the document contains standards for:
- general practice offices as part of a dental clinic;
- therapeutic, surgical, orthopedic dentistry offices as part of a specialized clinic;
- a dental laboratory operating as part of a specialized clinic;
- an orthodontic, physiotherapeutic, x-ray room as part of a dental clinic, as well as a functional diagnostics room and a mobile unit;
- centralized sterilization unit as part of the clinic.
The required dental equipment for a license given in the document is differentiated for organizations in which doctors provide inpatient and outpatient care to patients.
ATTEK center services
The ATTEK Center has been providing support for licensing applications for dental clinics and offices for many years. This is one of the core areas of our activity, which is handled by highly professional employees. They thoroughly know the standards of current legislation and regulatory authorities in this area, and in addition, they regularly monitor current legislation for changes. We offer you a full range of work that allows you to quickly obtain a dental license.
Equipment standard for a general practice department (office) of a dental clinic Standard equipment for a general practice department (office) at a dental clinic
Appendix No. 11 to the Procedure for providing medical care to the adult population for dental diseases, approved. by order of the Ministry of Health and Social Development of the Russian Federation dated December 7, 2011 No. 1496n.
Name of medical equipment, instruments, soft equipment, medical products, etc. | Required quantity, pcs. | |
1 | Autoclave (steam sterilizer), in the absence of a central sterilization unit | at least 1 per department (office) |
2 | Water distiller (medical), in the absence of a central sterilization unit | at least 1 per department (office) |
3 | Autoclave for handpieces (tabletop steam sterilizer)* | at least 1 per office |
4 | Amalgam mixer* | at least 1 per office |
5 | An air-abrasive device for removing dental plaque in the absence of a universal working place for a dentist (hereinafter referred to as MRU) and a dental unit (hereinafter referred to as US) | at least 1 per doctor’s workplace |
6 | Apparatus for disinfection of impressions, dental products and instruments* | at least 1 per office |
7 | Apparatus for diagnosing pulp vitality (electroodontometer) | at least 1 per office |
8 | Device for making individual mouth guards* | at least 1 per department (office) |
9 | Apparatus for determining the depth of the root canal (apex locator) | at least 1 per office |
10 | Device for phonophoresis (medicinal electrophoresis)* in the absence of a physiotherapy room | at least 1 per office |
11 | Ultrasonic dental plaque removal device (scaler) if not available in MRU and US | at least 1 per doctor’s workplace |
12 | Articulator (dental) with facebow* | at least 1 per office |
13 | Surgical aspirator (suction device), if not available in MRU and US | at least 1 per doctor’s workplace |
14 | Bixes (sterilization box for storing sterile instruments and material) | as needed*** |
15 | Dental drill* | at least 1 per office |
16 | Portable dental drill* | at least 1 per department (office) |
17 | Vibrating table (dental, dental)* | at least 1 per office |
18 | Gypsum sedimentation tanks (sludge trap) | at least 1 per sink |
19 | Dental burner (alcohol, gas, piezo) | at least 1 per office |
20 | Dental diathermocoagulator if not available in MRU and US | at least 1 per doctor’s workplace |
21 | Additional accessories (retraction cords and rings, matrix systems, wedges, occlusion registration materials) | at least 1 name of each position per office |
22 | Assorted hemostatic clamps | at least 5 titles per office |
23 | Assorted eye probes for probing the duct of the salivary glands | at least 3 titles per office |
24 | Dental instruments (small): - burs, - polishers, - finishers, - shaped heads, - separation discs and wheels, - cutters, - root instruments | on demand |
25 | Incubator for microbiological tests (CO2 incubator for growing cell and tissue cultures)* | at least 1 per department (if there is a separate room, taking into account the requirements of SanPiN) |
26 | Disposable products: - syringes and injection needles, - assorted scalpels, - masks, examination, diagnostic, surgical gloves, paper chest napkins for patients, - hand towels in a container, - sanitary napkins, medical underwear for medical personnel, - dressings, - saliva ejectors, - impression trays, - plastic glasses | on demand*** |
27 | Dental injector, for carpule anesthesia | at least 3 per doctor’s workplace |
28 | Universal dental injector, dosing, for carpule anesthesia* | at least 1 per office |
29 | Chambers for storing sterile instruments (in the absence of a packaging system) | at least 1 per office |
30 | Dental compressor (oil-free), if not available in MRU and US | on demand, taking into account the calculated power |
31 | Dental crown remover | at least 1 per doctor’s workplace |
32 | Corsage straight | at least 3 per office |
33 | Dental rubber dam* | on demand |
34 | Dental chair, if not available in MRU and US | at least 1 for two doctor positions during two-shift work |
35 | Surgical hooks, serrated, different sizes | at least 5 per office |
36 | Lamp (irradiator) bactericidal for premises | on demand*** |
37 | Dental lamp for photo polymerization (light removal) in the absence of MRU and US | at least 1 per doctor’s workplace |
38 | Dental impression trays (for orthopedic work)* | at least 10 per 1 doctor position |
39 | Surgical spoons (bone), different sizes | at least 3 per 1 doctor position |
40 | Binocular magnifying glass for doctors | at least 1 per office |
41 | Packaging machine (apparatus for pre-sterilization packaging of instruments) in the absence of a central sterilization unit* | at least 1 per department |
42 | Working place (set of equipment) for a dentist: Dental unit (DS), including a dentist’s unit (drill), a dental chair, a dental hydraulic unit, a dental operating lamp (these parts can be attached to a single supporting frame, or attached mutually, or separately to load-bearing structures (wall, furniture) or a universal working place for a dentist* (MRU), including a US equipped with a turbine, micromotor, diathermocoagulator, ultrasonic scaler, vacuum cleaner, negatoscope | at least 1 set for two medical positions with a two-shift working day |
43 | Micrometer (dental) | at least 1 per doctor’s workplace |
44 | Dental micromotor with or without optics (if not available in MRU and US) | at least 1 per doctor’s workplace |
45 | A set of devices, instruments, medicines, teaching materials and documents for providing emergency medical care for life-threatening conditions (a first aid kit for providing emergency care for general somatic complications in dental offices) | at least 1 per office |
46 | Set (tools, brushes, discs, pastes) for grinding and polishing fillings and dentures | at least 1 set for 1 doctor position |
47 | Set of instruments for examining the mouth (basic): - medical dental tray, - dental mirror, - angular dental probe, - dental tweezers, - dental excavators, - wide double-sided trowel, - trowel-filler, - dental spatula | on demand*** |
48 | An assortment of tools for removing dental plaque: - excavators - hooks for removing tartar | at least 2 per doctor’s workplace |
49 | Tracheotomy instrument set | at least 1 per clinic (department) |
50 | Set of tools, needles and suture material | at least 2 types |
51 | A set of medications for individual prevention of parenteral infections (anti-AIDS first aid kit) | at least 1 per office |
52 | Set of reagents for control (indicators) of disinfection and sterilization | on demand*** |
53 | Microbiological kits (reagents, reagents for bacteriological research) for testing acid-forming microflora when using an incubator for microbiological tests* | at least 1 set for 10 visits |
54 | Straight dental mechanical handpiece for micromotor if MRU and US are not included in the kit | at least 2 per doctor’s workplace |
55 | Dental mechanical angular handpiece for micromotor if MRU and US are not included in the kit | at least 2 per doctor’s workplace |
56 | Dental turbine handpiece without fiber optics in the absence of MRU and US in the kit, and installation without fiber optics | at least 2 per doctor’s workplace |
57 | Dental turbine handpiece with fiber optics* if MRU and US are not included in the kit, and installed with fiber optics | at least 2 per doctor’s workplace |
58 | Dental endodontic handpiece* reducing mechanical angular for micromotor in the absence of MRU and US included in the kit | at least 1 per office |
59 | Dental gear handpiece* with fiber optics, increasing mechanical angular for micromotor, for turbine bur when MRU and US are not included in the kit | at least 1 per 1 doctor position |
60 | X-ray viewer if MRU and US are not included in the kit | at least 1 per office |
61 | Dental knife for plaster | at least 1 per doctor’s workplace |
62 | Assorted scissors | at least 3 per doctor’s workplace |
63 | Dental crown scissors | at least 1 per doctor’s workplace |
64 | Dental knife-spatula | at least 1 per doctor’s workplace |
65 | Occluder | at least 1 per 1 doctor position |
66 | Dust suction device (dental vacuum cleaner) if MRU and US are not included in the kit | at least 1 per doctor’s workplace |
67 | Saliva suction device (dental saliva ejector) if MRU and US are not included in the kit | at least 1 per doctor’s workplace |
68 | Impression materials (dental impression materials) of different groups | at least 3 titles per office |
69 | Ultrasonic cleaner (device for ultrasonic cleaning and disinfection of instruments and products) | at least 1 per office |
70 | Protective glasses (from light radiation) for the doctor, patient and assistant | at least 1 set per doctor’s workplace |
71 | Dental parallelometer* | at least 1 per office |
72 | Anatomical tweezers of different sizes | at least 2 per doctor’s workplace |
73 | Device and means for cleaning and lubricating tips in the absence of an autoclave for tips | at least 1 per office |
74 | Device (installation) for disposal of syringes and needles* in the absence of centralized disposal | on demand*** |
75 | Consumable dental materials and medications: - medicinal, - filling, - cushioning materials, - adhesive materials, - materials for sealing dentin, - materials for temporary filling and temporary fixation of fixed dentures, - for permanent fixation of fixed dentures, - anesthetics, - antiseptics drugs, - for the treatment of hypersensitivity, - for fluoride prophylaxis | at least 2 names of each type of material per cabinet |
76 | Radiovisiograph or dental x-ray, in the absence of an x-ray room or a contract for radiology diagnostics | at least 1 set per clinic (department)*** |
77 | Dental raspatory | at least 2 per doctor’s workplace |
78 | Dental retractors (gingival) | at least 2 per doctor’s workplace |
79 | Dental lamp without MRU and US included in the kit | 1 per doctor’s workplace |
80 | Individual air conditioning and humidification system in medical rooms** | in accordance with SanPiN |
81 | Scalpels (holders) and disposable blades in assortment | at least 2 per doctor’s workplace |
82 | Personal protective equipment against ionizing radiation in the presence of a radiation source | in accordance with SanPiN |
83 | Means and containers for disinfecting instruments | in accordance with SanPiN |
84 | Glasperlene dental sterilizer for small instruments* | at least 1 per doctor’s workplace |
85 | Dry air sterilizer in the absence of a central sterilization unit and an autoclave | at least 1 per office |
86 | Plaster dental table with a working surface made of stainless steel or plastic with a hole for removing plaster waste | at least 1 per office*, at least 1 per department |
87 | Doctor's desk | at least 1 per doctor’s workplace |
88 | Dental table | at least 1 per doctor’s workplace |
89 | Chair for a medical assistant if MRU and US are not included in the set | at least 1 per assistant’s workplace |
90 | Chair for a dentist if MRU and US are not included in the kit | at least 1 per doctor’s workplace |
91 | Medical cabinet for storing consumables | at least 1 per office |
92 | Medical cabinet for medicines | at least 1 per office |
93 | Wardrobe for medical clothes and linen | on demand*** |
94 | Dental spatula for mixing impression materials | at least 1 per doctor’s workplace |
95 | Dental modeling spatula for wax | at least 1 per doctor’s workplace |
96 | Dental spatula for mixing plaster | at least 1 per doctor’s workplace |
97 | Dental forceps for removing teeth and tooth roots on the upper and lower jaws in an assortment | at least 15 per doctor’s workplace |
98 | Dental crampon forceps | at least 1 per workplace |
99 | Protective shields (against mechanical eye damage) for doctors and assistants | at least 2 per doctor’s workplace |
100 | Dental elevators for removing tooth roots on the upper and lower jaws in an assortment | at least 5 per doctor’s workplace |
101 | Diagnostic kits for conducting tests to identify neoplasms (screening) and monitoring the treatment of neoplasms* | at least 1 per office |
102 | Depophoresis kit* | 1 per office |
* Positions that are mandatory for equipment only when using (declaring) technology that involves the use of these devices, tools, and medications. ** Offices and premises are equipped in which it is not possible to meet sanitary and hygienic requirements with the existing stationary ventilation and air conditioning systems. *** In accordance with sanitary and epidemiological rules and regulations.
Documentation
Order of the Ministry of Health and Social Development of the Russian Federation No. 1496n dated December 7, 2011 Appendix No. 11 Standard for equipment of the department (office) of general practice of a dental clinic
Equipment for dental organizations: regulatory framework
So, the list of main regulatory documents that regulate the standards for equipping a general dentistry office for licensing and other types of dental organizations includes:
- Federal Law of November 21, 2011 No. 323-FZ, dedicated to issues of protecting the health of citizens;
- Sanitary and epidemiological requirements for medical organizations SanPiN 2.1.3.2630-10, approved by Resolution of the Chief State Sanitary Doctor of May 18, 2010 No. 58;
- Decree of the Government of the Russian Federation of April 16, 2012 No. 291, establishing the procedure for licensing medical activities;
- current Order of the Ministry of Health dated December 7, 2011 No. 1496n, which defines the rules for the provision of dental care to adult citizens by doctors;
- Order of the Ministry of Health of November 13, 2012 No. 910n, establishing the rules for the provision of dental care to children by doctors;
- new Order of the Ministry of Health dated July 31, 2021 No. 786n, introducing an updated procedure for the provision of dental services to the adult population by doctors.
New rules for equipping dentistry from 2021
From January 1, 2021, a new list of dental office equipment for licensing, approved by Order of the Ministry of Health No. 786n, will come into force in Russia. The procedure for its operation is determined by an additional regulatory document - Order of the Ministry of Health dated June 9, 2021 No. 560n, which also comes into force on January 1, 2021.
The new equipment rules involve the following changes to the current procedure:
- In addition to the required number of doctors, each dental office must install its own dental X-ray machine with a digital image receiver. This technique will require the hiring of specialized personnel, including radiologists, and consequently, the permitted organizational and legal forms of organizations that are allowed to engage in this type of work activity will also change. Individual entrepreneurs are prohibited from working with such installations: they will have to re-register as an LLC;
- operating LLCs, whose list of working equipment for licensing a dental office previously included only a visiograph, will be required to purchase a panoramic X-ray machine. This means they will need a larger room, since each installation will require at least 4 square meters of additional space.
The operation of additional working equipment must be carried out in accordance with SanPiN 2.6.1.1192-03, approved by Resolution of the Chief State Sanitary Doctor of February 18, 2003 No. 8: they regulate the rules of work for doctors in X-ray rooms. In addition, when making changes to the standard list of equipment for equipping a dental laboratory for licensing, all organizations will need to re-issue documents for the equipment, which, of course, will require additional time and financial costs.
Regulatory documents for dentists
Order of the Ministry of Health of Russia dated February 2, 2021 No. 41n “On the specifics of certification by medical workers and pharmaceutical workers to obtain a qualification category in 2021”
Decree of the Government of the Russian Federation of June 17, 2020 No. 868
“On the invalidation of certain acts and certain provisions of certain acts of the Government of the Russian Federation and on the repeal of certain acts of federal executive authorities containing mandatory requirements, compliance with which is assessed during control measures in the implementation of state control of the quality and safety of medical activities” view
Memo on the actions of medical workers directly working with patients confirmed to have a new coronavirus infection (COVID-19) and patients suspected of COVID-19 view
Order of the Ministry of Health of the Russian Federation dated July 31, 2020 No. 786n “On approval of the Procedure for providing medical care to the adult population for dental diseases” (comes into force on January 1, 2021) view
Order of the Ministry of Health of the Russian Federation dated April 30, 2020 No. 394-N “Features of certification for medical workers and pharmaceutical workers to obtain a qualification category”
Letter of the Ministry of Health of the Russian Federation dated April 24, 2020 No. 16-7/I/2-5471 on the application of Order of the Ministry of Health of Russia dated April 14, 2020 No. 327n “On the specifics of admission of individuals to carry out medical activities and (or) pharmaceutical activities without a specialist certificate or certificate of completion of specialist accreditation and (or) in specialties not covered by the specialist certificate or specialist accreditation certificate" view
Order of the Ministry of Health of Russia dated April 14, 2020 No. 327n “On the peculiarities of admission of individuals to carry out medical activities and (or) pharmaceutical activities without a specialist certificate or certificate of completion of specialist accreditation and (or) in specialties not covered by a specialist certificate or certificate of specialist accreditation" view
Infographic “Temporary guidelines for the prevention, diagnosis and treatment of the new coronavirus infection COVID-19” view
Order of the Ministry of Health of the Russian Federation dated June 14, 2021 No. 422n “On approval of the Procedure for providing medical care in the field of maxillofacial surgery” download
Order of the Ministry of Health of the Russian Federation dated December 21, 2021 No. 898n “On amendments to the order of the Ministry of Health of Russia dated December 22, 2017 No. 1043n “On approval of the terms and stages of accreditation of specialists, as well as categories of persons with medical, pharmaceutical or other education and specialists subject to accreditation»» download
Order of the Ministry of Health of the Russian Federation dated December 22, 2021 No. 1043n “On approval of the terms and stages of accreditation of specialists, as well as categories of persons with medical, pharmaceutical or other education and specialists subject to accreditation”
Order of the Ministry of Health of the Russian Federation dated October 13, 2021 No. 804n “On approval of the range of medical services” download
Order of the Ministry of Health of the Russian Federation dated October 13, 2021 No. 805 “On amendments to the annex to the order of the Ministry of Health of the Russian Federation dated December 30, 2014 No. 959 “On the list of chief freelance specialists of the Ministry of Health of the Russian Federation in the federal districts of the Russian Federation”
Order of the Ministry of Health of the Russian Federation dated June 29, 2021 No. 425n “On approval of the procedure for familiarizing the patient or his legal representative with medical documentation reflecting the patient’s health status”
Order of the Ministry of Health of the Russian Federation dated June 2, 2021 N 334n (as amended on December 20, 2016) “On approval of the Regulations on the accreditation of specialists”
Order of the Ministry of Labor and Social Protection of the Russian Federation dated May 10, 2016 No. 227n “On approval of the professional standard “Dentist””
Order of the Ministry of Health of the Russian Federation dated March 14, 2016 No. 127n “On approval of the terms and stages of accreditation of specialists, as well as categories of persons with medical, pharmaceutical or other education and specialists subject to accreditation” has become invalid
Order of the Ministry of Health of the Russian Federation dated December 19, 2021 No. 973n “On approval of standard industry standards of time for performing work related to one patient’s visit to a cardiologist, endocrinologist, or dental therapist” download
Order of the Ministry of Health of the Russian Federation dated April 23, 2013 No. 240n “On the procedure and timing of certification for medical workers and pharmaceutical workers to obtain a qualification category” download
Order of the Ministry of Health of Russia dated November 13, 2012 No. 910n (as amended on September 28, 2021) “On approval of the procedure for providing medical care to children with dental diseases” download
Orders of the Ministry of Health of the Republic of Bashkortostan:
Order of the Ministry of Health of the Republic of Bashkortostan dated September 28, 2021 No. 1476-A “On the prevention of HIV infection in the performance of professional duties”
Order of the Ministry of Health of the Republic of Belarus dated April 8, 2021 No. 483-D “On the certification commission of the Ministry of Health of the Republic of Bashkortostan for assigning qualification categories to medical and pharmaceutical employees." Attachments to the order.
Order of the Ministry of Health of the Republic of Bashkortostan dated January 28, 2021 No. 91-D “On approval of the personnel of the main freelance specialists of the Ministry of Health of the Republic of Bashkortostan” Order Personnel
Order of the Ministry of Health of the Republic of Belarus dated January 25, 2021 No. 70 “ON THE TEMPORARY PROCEDURE FOR PASSING CERTIFICATION FOR MEDICAL AND PHARMACEUTICAL WORKERS TO OBTAIN A QUALIFICATION CATEGORY”
Order of the Ministry of Health of the Republic of Belarus dated April 23, 2020 No. 375-A “On amendments to the order of the Ministry of Health of the Republic of Belarus dated April 2, 2020 No. 273-A “On the provision of emergency dental care to patients undergoing treatment in hospitals, in self-isolation at home (contact with patients with COVID-19, with an established diagnosis of a new coronavirus infection COVID-19) in the Republic of Bashkortostan"
Order of the Ministry of Health of the Republic of Belarus dated April 9, 2020 No. 660-D “On temporary measures to organize certification and assign qualification categories to medical and pharmaceutical workers in pursuance of Decree of the Government of the Russian Federation dated April 3, 2020 No. 440 “On the extension of permits and other features regarding licensing activities in 2021""
Order of the Ministry of Health of the Republic of Belarus dated 04/02/2020 No. 273-A “On the provision of emergency dental care to patients undergoing treatment in hospitals, in self-isolation at home (contacts of patients with COVID-19, with an established diagnosis of a new coronavirus infection COVID-19) in Republic of Bashkortostan" Order of the Ministry of Health of the Republic of Bashkortostan dated December 26, 2021 No. 2331-D "On improving the organization of medical care for the adult population in the field of oncology in medical organizations of the Republic of Bashkortostan"
Order of the Ministry of Health of the Republic of Bashkortostan dated October 25, 2021 No. 1899-D “On the routing of the child population in the Republic of Bashkortostan, including disabled children and children with limited mobility, when providing medical care in the field of pediatric dentistry”
Order of the Ministry of Health of the Republic of Bashkortostan dated March 14, 2021 No. 478-D “On the main freelance specialists of the Ministry of Health of the Republic of Bashkortostan” download
Order of the Ministry of Health of the Republic of Belarus dated March 29, 2017 No. 692-D “On the Councils of the Ministry of Health of the Republic of Bashkortostan” download
Order of the Ministry of Health of the Republic of Bashkortostan dated July 1, 2021 No. 2021 “On the organization of medical care for the adult population for dental diseases in medical organizations of the Republic of Bashkortostan” download
Order of the Ministry of Health of the Republic of Bashkortostan dated September 27, 2021 No. 2834-D “On the organization of medical care for the adult population in the profile of “maxillofacial surgery” in medical organizations of the Republic of Bashkortostan” download
Order of the Ministry of Health of the Republic of Bashkortostan dated April 20, 2012 No. 1071 “On improving measures for the prevention and early diagnosis of oral cancer”
Order of the Autonomous Institution of the Republican Dental Clinic dated May 8, 2021 No. 182-d “On the temporary procedure for organizing the work of the Autonomous Institution of the Republican Dental Clinic in order to implement measures to prevent and reduce the risks of the spread of the new coronavirus infection (COVID-19)” download
Requirements for dental equipment
One of the key standards that a dental organization must satisfy in order to obtain a license to conduct its activities is compliance with established standards for equipping it with equipment and tools. The current list of drugs and equipment for organizing a dental office is contained in Resolution No. 1496n. It contains lists of required items, the number of which is calculated depending on various factors, including:
- number of doctors' jobs;
- the number of divisions operating in the organization;
- the required number of types of equipment per organization;
- number of patient visits;
- number of doctor positions;
- number of assistant jobs;
- number of shells;
- other criteria.
Some types of positions are acquired by the organization at its own discretion if necessary - but not less than the minimum values.
General requirements
According to Resolution No. 1496n, the preparation of a list of equipment for dental offices for licensing must be carried out in accordance with the type of organization and the profile of its working activities. The appendices to this regulatory document separately formulate standards for the following types of dental institutions.
Type of organization | Units within its composition that are subject to equipment requirements |
Dental clinic | Department or office of therapeutic dentistry |
Department or office of surgical dentistry | |
Department or office of orthopedic dentistry | |
Dental laboratory | |
Orthodontic department or office | |
Physiotherapeutic department or office | |
X-ray department or office | |
Functional diagnostics room | |
Centralized sterilization department or unit | |
Mobile dental office | |
General medical facility providing dental care on an outpatient basis | Department of therapeutic dentistry |
Department of Surgical Dentistry | |
Department of Orthopedic Dentistry | |
Dental laboratory | |
Orthodontic department | |
X-ray department | |
Dental office in educational organizations, recruiting stations and enterprises | |
Hospital | Maxillofacial and Dental Surgery Department |
Operating room of the surgical maxillofacial and dental department | |
Profile division of the surgical maxillofacial and dental department |
Standards for different types of organizations
For specialized departments of dental clinics, the list of equipment for licensing a dental office most often contains 100 or more items. For auxiliary units it is somewhat shorter, but also requires a fairly serious approach to equipping everything necessary.
Equipment standard for the radiology department of the clinic
N | Name | Quantity, pcs. |
1. | Dental x-ray diagnostic device | 1 per office |
2. | Dental chair | 1 per dental device |
3. | Computed tomograph* | 1 per department |
4. | Disposable products: | of necessity*** |
— masks | ||
— examination gloves, diagnostic | ||
- paper chest napkins for patients | ||
- hand towels in a container | ||
— sanitary napkins | ||
- dressings | ||
5. | Lamp (irradiator) bactericidal for premises | of necessity*** |
6. | Mobile bactericidal lamp (irradiator) for indoors* | of necessity*** |
7. | Dental film developing machine | 1 per office |
8. | Wall-mounted X-ray viewer | 1 per doctor’s workplace |
9. | Assorted scissors | 3 per office |
10. | Orthopantomograph with teleradiographic attachment* | at least 1 per department (office) |
11. | Dental radiovisiograph included | 1 per department (office) |
12. | Individual air conditioning and humidification system in medical rooms** | of necessity*** |
13. | Personal protective equipment for X-ray examinations (set) | of necessity*** |
14. | Means and containers for disinfecting instruments | of necessity*** |
15. | Doctor's desk | 1 per doctor’s workplace |
16. | X-ray technician's table | 1 per doctor’s workplace |
17. | Doctor's chair | 1 per doctor’s workplace |
18. | Medical chair | 1 per doctor’s workplace |
19. | Cabinet for storing chemical reagents and materials | at least 1 per office |
20. | Medicine cabinet | at least 1 per office |
21. | Drying cabinet for X-ray films | at least 1 per department (office) |
22. | Wardrobe for medical clothes and linen | of necessity |
*Items that are required to be equipped only when using (declaring) a technology that involves the use of these devices, tools, and medications. **Offices and rooms are equipped in which it is not possible to meet sanitary and hygienic requirements with the existing stationary ventilation and air conditioning systems. ***In accordance with sanitary and epidemiological rules and regulations.
Standard for equipping a functional diagnostics unit in dentistry for a specialized clinic
N | Name | Quantity, pcs. |
1. | Axiograph* | at least 1 |
2. | Dental articulator with facebow* | at least 1 |
3. | Electroodontic diagnostic apparatus * (odontosensimeter, odontometer) | at least 1 |
4. | Disposable products: | on demand*** |
- syringes and needles for injections | ||
— masks | ||
— examination gloves, diagnostic | ||
- paper chest napkins for patients | ||
- hand towels in a container | ||
— sanitary napkins | ||
- dressings | ||
— saliva ejectors | ||
- plastic glasses | ||
5. | Chambers for storing sterile instruments (in the absence of a packaging system) | at least 1 per office |
6. | Kinesiograph* | 1 |
7. | Dental chair if not available in US | 1 per dental device |
8. | Lamp (irradiator) bactericidal for premises | on demand*** |
9. | Mobile bactericidal lamp for indoors* | on demand*** |
10. | Dentist's working place: Dental unit (US), including a dentist's unit (drill), a special chair, a dental hydraulic unit, and a dental operating lamp. These parts can be mounted on a single supporting frame or attached mutually or separately to supporting structures (walls, furniture) | 1 for 2 medical positions with a two-shift working day |
11. | Myotonometer* (gnatodynamometer) | at least 1 |
12. | Myostim* (electroneurostimulator, neuromyostimulator, peripheral nerve stimulator) | at least 1 |
13. | Oral examination kit (basic): | on demand*** |
- medical dental tray, | ||
- dental mirror, | ||
- angular probe, | ||
- dental tweezers, | ||
— dental excavators, | ||
— wide double-sided ironing board, | ||
- dental spatula | ||
14. | Periotest* (device for determining the mobility of teeth, crowns and implants) | at least 1 |
15. | Reopolarograph* | at least 1 |
16. | Lamp without MRU and US included in the kit | 1 per doctor’s workplace |
17. | Doctor's desk | 1 per doctor’s workplace |
18. | Dental table | 1 per doctor’s workplace |
19. | Medical chair | 1 per doctor’s workplace |
20. | Doctor's chair | 1 |
21. | T-scan for assessing dentition occlusion* (device for determining central occlusion) | 1 |
22. | Medical cabinet for storing consumables and instruments | at least 1 per office |
23. | Medical cabinet for medicines | at least 1 per office |
24. | Wardrobe for medical clothes and linen | on demand*** |
25. | Electromyograph for contact studies* | at least 1 |
*Items that are required to be equipped only when using (declaring) a technology that involves the use of these devices, tools, and medications. **Offices and rooms are equipped in which it is not possible to meet sanitary and hygienic requirements with the existing stationary ventilation and air conditioning systems. ***In accordance with sanitary and epidemiological rules and regulations.
Standard equipment for a general dental office
Appendix No. 3 to the Procedure for providing medical care to the adult population for dental diseases, approved by order of the Ministry of Health and Social Development of the Russian Federation dated July 31, 2021 N 786n
STANDARD OF EQUIPMENT FOR A DENTAL CLINIC
Standard equipment for a general dentistry office
N p/p | Code of type of nomenclature classification of medical devices <1> | Name of the type of medical device in accordance with the nomenclature classification of medical devices | Name of equipment (equipment) | Required quantity, pcs. |
1. | 119630 | Dental unit | Work place (set of equipment) for a dentist: Dental unit (US), including a dentist's unit (drill), a dental chair, a dental hydraulic unit, a dental operating lamp (these parts can be attached to a single supporting frame, or attached mutually or separately to load-bearing structures (wall, furniture)) or A universal working place for a dentist (MRU), including a US equipped with a turbine, micromotor, diathermocoagulator, ultrasonic scaler, vacuum cleaner, negatoscope | at least 1 |
2.<2> | 122760 | Gas formaldehyde sterilizer | Sterilizer for instruments, in the absence of a centralized sterilization department | 1 |
125800 | Microwave sterilizer for unpackaged products | |||
330780 | Steam sterilizer | |||
125810 | Steam sterilizer for unpackaged products | |||
150480 | Ozone/hydrogen peroxide sterilizer | |||
173090 | Dry heat sterilizer | |||
183670 | Chemical liquid sterilizer | |||
188040 | Sterilizer-boiler | |||
211070 | Ethylene oxide sterilizer | |||
211110 | Ethylene oxide/steam sterilizer | |||
215790 | Plasma sterilizer | |||
237470 | Gas sterilizer based on hydrogen peroxide | |||
253700 | Steam sterilizer | |||
291960 | Electrolytic sterilizer | |||
330770 | Bactericidal sterilization chamber | |||
3.<4> | 119850 | External defibrillator with manual control | Automatic external defibrillator | 1 per department |
126500 | External automatic defibrillator for professional use, powered by rechargeable battery | |||
262440 | External semi-automatic defibrillator for professional use, powered by a non-rechargeable battery | |||
4. | 185950 | Distillation water purification system | Water distiller (medical), in the absence of a central sterilization unit | 1 |
5. | 121300 | Dental pulp condition analysis system | Apparatus for diagnosing pulp vitality (electroodontometer) | 1 per department (office) |
6. | 127410 | Ultrasonic system for cleaning root canals/removing dental plaque | Ultrasonic dental plaque removal device (scaler) if not available in MRU and US | at least 1 per doctor’s workplace |
7.<2><5> | 209330 | Dental X-ray intraoral system, mobile, digital | Dental X-ray machine with a digital image receiver (radiovisiograph) (in the absence of an X-ray room or an agreement with a medical organization that has a license for radiology work (services)) | at least 1 set (per department/office) |
191300 | Dental x-ray intraoral stationary system, digital | |||
191230 | Dental x-ray extraoral stationary system, digital | |||
173230 | Dental X-ray portable intraoral system, digital | |||
8.<2> | 269850 | Container for chemical disinfection system for medical instruments | Containers for disinfecting instruments | at least 1 |
185890 | Container for sterilization | |||
127550 | Ultrasonic bath for cleaning and disinfecting instruments | |||
9.<2> | 257280 | Container for collecting sharps and cutting medical waste | Container for collecting household and medical waste | at least 2 |
336200 | Package for collection, storage and transportation of medical waste | |||
123680 | Container for biological waste | |||
10. | 257280 | Container for collecting sharps and cutting medical waste | Container for disposal of syringes, needles and other disposable instruments | at least 1 |
11. | 118770 | Syringe for dental anesthesia, reusable | Dental injector, for carpule anesthesia | at least 3 per doctor’s workplace |
12. | 113870 | Air compressor for medical products | Dental compressor (oil-free), in the absence of MRU and US or a centralized compressed air supply system | taking into account the calculated power |
13. | 121250 | Dental/surgical polymerization lamp | Dental lamp for photopolymerization (light curing) in the absence of MRU and US | 1 |
14.<2> | 131980 | Ultraviolet bactericidal lamp | Germicidal irradiator/air purifier/device for disinfection and (or) air filtration and (or) disinfection of surfaces | 1 |
209360 | Mobile laminar flow installation | |||
152690 | High-efficiency filtering air purifier, mobile | |||
152700 | High-efficiency filtering air purifier, stationary | |||
292620 | Electrostatic deposition air purifier, mobile | |||
15. | 282070 | Dental drill motor with remote control | Dental micromotor with or without optics (if MRU and US are not included in the kit) | at least 2 |
16.<2> | 119690 | Dental drill handpiece | Dental mechanical angular handpiece for micromotor if MRU and US are not included in the kit | at least 2 per workplace |
256310 | Handpiece of a combined dental drill with mains power | |||
282060 | Dental drill handpiece, with remote control | |||
17. | 216740 | Dental drill handpiece, pneumatic | Dental turbine handpiece without fiber optics if MRU and US are not included in the kit and installed without fiber optics | at least 2 per workplace |
18.<2> | 238570 | Medical X-ray viewer, with power supply | X-ray viewer if MRU and US are not included in the kit | 1 per department |
238840 | Medical X-ray viewer, without electrical control | |||
19.<2> | 146180 | LED dental lamp, mains powered | Dental lamp without MRU and US included in the kit | 1 per doctor’s workplace |
151730 | Dental reflected light lamp | |||
20. | 270010 | Surgical instrument table | Dental table | 1 |
21. | 121630 | Dentist stool | Dentist's chair if MRU and US are not included in the set | 1 |
22.<4> | 279970 | First aid kit containing medicines | Layout of emergency prevention of parenteral infections for primary health care, emergency medical care, specialized medical care and palliative care <3> | 1 per office |
23.<2> | 119180 | Cabinet for dental instruments | Medical cabinet for storing consumables | 1 |
260470 | General purpose rack | |||
139690 | Medicine storage cabinet | |||
270000 | Medical cabinet for instruments | |||
24. | 170630 | Tooth extraction forceps | Dental forceps for removing teeth and tooth roots on the upper and lower jaws in an assortment | at least 15 per doctor’s workplace |
25.<5> | 215850 | Pharmaceutical refrigerator | Refrigerator for storing medicines | 1 per medical organization |
26. | 103830 | Root elevator | Dental elevators for removing tooth roots on the upper and lower jaws in an assortment | at least 5 per doctor’s workplace |
<1> Part 2 of Article 38 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724).
<2> One of the following items must be present.
<3> Clause 5.2.12 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collected Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2021, N 9, Art. 1268 ).
<4> Recognized as invalid according to the order of the Ministry of Health of the Russian Federation dated February 18, 2021 No. 109n “On introducing changes to the Procedure for providing medical care to the adult population for dental diseases, approved by order of the Ministry of Health of the Russian Federation dated July 31, 2020 No. 786n.”
<5> Updated in accordance with the order of the Ministry of Health of the Russian Federation dated February 18, 2021 No. 109n “On amendments to the Procedure for providing medical care to the adult population for dental diseases, approved by order of the Ministry of Health of the Russian Federation dated July 31, 2021 No. 786n.”