A self-contained area to handle medical waste

DO YOU WANT TO ORGANIZE MEDICAL WASTE TREATMENT IN ACCORDANCE WITH ALL THE NORMS, BUT YOU DON'T HAVE ANY CORRESPONDING PREMISE?

We offer a fully equipped complex, which price corresponds to the price of low-performance equipment from the competitors!

Autonomous premise for medical waste treatment was made in accordance with the requirements of SanPin 2.1.7.2790-2010.

  • It provides separation of contaminated and clean flows.
  • It is equipped with supply and exhaust ventilation, fire alarm, power supply, lighting, heating, plumbing, ultraviolet bactericidal lamps.
  • It is made of high-quality and strong materials, resistant to disinfection treatment: full-metal frame with sandwich panels, thickness of 100 mm, flooring made of galvanized steel.
  • Cost of installation of the disinfector-destructor SAMot-01 is included in the cost of the complex.

You will get high-grade, comfortable, heat-insulated equipped autonomous premises at minimum cost - in fact you only need to find a free site on the territory and make connection to electricity and water supply networks.

Requirements for premises for SAMot-01 complexes

Requirements to premises for installation of CAMot-01 correspond to:

Requirements SanPiN 2.1.7.2790-10 "Sanitary and epidemiological requirements for medical waste management" (hereinafter - SanPin A);

Requirements SanPiN 2.1.3.2630-10 "Sanitary and epidemiological requirements for organizations engaged in medical activities" (hereinafter referred to as SanPiN B);

Design features of SAMot-01, described in the operating manual (hereinafter referred to as "OM").

Requirements for a premise for Class B and C medical waste management

Requirements

Substantiation

Status

Is a division of the company

Paragraph 10.1. SanPiN A

Functions performed

Collection, accumulation, machine disinfection/waste processing, Class B and C waste disposal

Paragraph 10.1. SanPiN A

Location

The site is located in specially equipped premises of the medical organization or on an independent territory

The site cannot be located in medical establishments (except for disinfection facilities in the laboratories that work with pathogens of 1-4 pathogenicity groups).

The site can be located both in a stand-alone building in an economic zone with access roads, as well as in a building, including in basements with autonomous exhaust ventilation

Paragraph 10.1. SanPiN A

Paragraph 10.2 SanPiN А

chapter I, item 7.3 SanPiN B

Utilities

Sewerage, water supply, electricity, heating and autonomous ventilation

Paragraph 10.2 SanPiN А

Premises

It is necessary to provide the technological process flow and an opportunity of observation of the principle of separation into "clean" and "contaminated".

For newly constructed and reconstructed buildings:

Receipt and temporary storage (accumulation) of non-contaminated wastes

Workroom for waste disinfection

Temporary storage of treated wastes (premises will be provided if there is no condition of storage in the territory)

Washing and disinfection of containers

Premise for temporary storage of containers, racks, bogies

Warehouse of consumables

Sanitary facilities (dressing room, shower room, bathroom, storage for cleaning equipment)

Staff room with a workplace

If the volume of waste to be treated is up to 200 liters per day, below is a minimum set of premises in two zones:

"Contaminated" zone, which includes a room for receipt and temporary storage of medical wastes, waste treatment facility equipped with disinfection/ waste processing facilities for Class B and C wastes, a washing and disinfection room. If you have small volumes you can store the incoming wastes and disinfect them in the same room.

"Clean" zone, which includes storage facilities for disinfected/detoxified waste, washed and disinfected means for waste moving (it is possible to store them in one room), warehouse of supplies, staff room, bathroom, shower room.

Paragraph 10.2 SanPiN А

Paragraph 3.3. chapter 1 SanPiN B

Appendix 1,

Paragraph 10.3.1 SanPiN А

Requirements for the room for installation of SAMot-01 (working place for disinfection of wastes)

Requirements

Substantiation

Dimensions of the premises

Height - not less than 2,6 m

Area of the premises is not less than 12 m2 (for newly constructed and reconstructed buildings)

Width of installation openings:

SAMot-01/100, SAMot-01/150 - not less than 95 cm.

SAMot-01/200 - not less than 105 cm;

SAMot-01/250 - not less than 140 cm.

The area occupied by SAMot-01 installation subject to compliance with paragraph 10.9 SanPin A: "the distance from the walls to the equipment should be not less than 0,6 m, and from the service area - at least 1 m, minimum dimensions of the passages - not less than 0,6 m":

SAMot-01/100 – 6.25 m2

SAMot-01/150 – 6.25 m2

SAMot-01/200 – 6.5 m2

SAMot-01/250 – 8.8 m2

Paragraph 10.3. SanPiN A

Paragraph 3.1. chapter 1 SanPiN B

Appendix 1 SanPiN А

Appendix 1 SanPin B (line number 113, section "Diagnostic laboratories")

Overall dimensions of the complex

(Table 1 of the OM)

Paragraph 10.9 SanPiN А

Overall dimensions of the complex

(Table 1 of the OM)

Electric power supply

SAMot-01/100, SAMot-01/150:

220 V, 50 Hz through the automatic circuit-breaker at least 25 A, with mandatory grounding (recommended cable: 3x2.5); It can be connected via a socket that can withstand a load of up to 5 kW. Peak power consumption - up to 5 kW.

SAMot-01/200

380 V, 50 Hz through the automatic circuit-breaker at least 40 A, with mandatory grounding (recommended cable: 5х4). Peak power consumption - up to 12 kW

SAMot-01/250

380 V, 50 Hz through the automatic circuit-breaker at least 63 A, with mandatory grounding (recommended cable: 5х6). Peak power consumption - up to 17 kW

paragraph 2.3.6, Table 1 OM

Ventilation

Autonomous intake and extract ventilation system with mechanical activation. Should prevent any flow of air masses from the "contaminated" zones to "clean" zones.

Air exchange rate: 5-10 (preferably - with an opportunity of mechanical adjustment of the ratio from 5 up to 10, so that the operator could adjust the intensity depending on a season); In premises larger than 28 m2 we recommend installation of local sensors (for more details see the ventilation file)

Paragraph 10.6 SanPiN А

appendix 3 SanPiN B

Recommended by the manufacturer

Microclimate

Temperature: 18-25˚С

Humidity: no more than 75%

Paragraph 10.7 SanPiN А

Water supply and sewerage

Watering tap, floor traps (trays), wash hand basin

There is no need to connect SAMot to water supply, sewerage, water treatment systems.

Paragraph 10.8 SanPiN А

Information provided by the manufacturer

Illumination

Combined or artificial illumination, which meets hygienic requirements for illumination of residential and public buildings

Artificial illumination level is not less than 200 lux

Fixtures must have closed diffusers.

Clean the fixtures at least 2 times a year

Paragraph 10.5 SanPiN А

chapter I p. 7.2. c), 7.8 SanPiN B

Additional equipment

Bactericidal lamps or other air disinfection devices

Paragraph 10.9 SanPiN А

Surfaces

Wall, floor and ceiling surface should be smooth, resistant to moisture, detergents and disinfectants (for the full height of the walls). Floors should be covered with moisture resistant material that does not slip and is resistant to mechanical influence.

External and internal surface of furniture and equipment must be smooth, made of materials resistant to moisture, detergents and disinfectants.

The places where the sinks are to be installed, should be finished with ceramic tiles or other moisture-resistant materials at a height of 1.6 m from the floor and at a width of at least 20 cm on each side.

It is allowed to use suspension, stretched, boarded and other types of ceilings, which ensure smoothness of the surface and an opportunity of carrying out their wet cleaning and disinfection

Paragraph 10.4 SanPiN А

Paragraph 4.2-4.3, 4.5 chapter 1 SanPiN B

Paragraph 4.6. chapter 1 SanPiN B

Paragraph 4.7. chapter 1 SanPiN B

Extract from SanPiN 2.1.7.2790-10 regarding requirements for the premises of the process site for medical waste processing

X. Requirements for organization of a process site for processing of Class B and C medical wastes

10.1. The class B and C waste processing site is a subdivision of the organization that is engaged in medical and/or pharmaceutical activities or an independent specialized organization (hereinafter - site). The site is located in specially equipped premises of the medical organization or on an independent territory and collects, accumulates, disinfects/processes, recycles Class B and C wastes. The site cannot be located in medical establishments (except for disinfection facilities in the laboratories that work with pathogens of 1-4 pathogenicity groups). Structure and minimum areas of the premises of the site are shown in Appendix 1 to the present sanitary regulations.

10.2. General requirements for the site.

The site can be located in a separate building in a service zone with access roads, as well as in the main building, including in basements with autonomous exhaust ventilation (except for systems for destruction of wastes by burning, pyrolysis). Distance from residential and public buildings to the site and the system for destruction of wastes by burning, pyrolysis will be determined in accordance with the requirements of the legislation.

The site must be provided with sewerage, water supply, electricity, heating and autonomous ventilation. Space-planning and constructive solutions of the premises of the site must provide a route for the technological process and an opportunity of observation of the principle of separation into "clean" and "contaminated" zones.

On the territory of the site there will be facilities for reception, treatment (disinfection or processing), temporary storage (accumulation) of wastes, washing and disinfection of racks, carts, containers and other equipment used for moving the wastes.

10.3. Requirements to the premises of the site.

The premises of the site are conditionally divided into zones:

- "contaminated", which includes premises for reception and temporary storage of incoming medical wastes, waste treatment room equipped with facilities for disinfection/processing of classes B and C waste, washing and disinfection room. In case of small volumes, temporary storage of incoming waste and their disinfection can be made in one premise. When storing class B and C wastes for more than 24 hours, refrigerating equipment is necessary.

"Clean" zone, which includes storage facilities for disinfected/detoxified waste, washed and disinfected means for waste moving (it is possible to store them in one room temporarily), warehouse of supplies, staff room, bathroom, shower room.

The height of the premises should meet the dimensions of the installed equipment, but not less than 2.6 m.

10.4. Wall, floor and ceiling surface should be smooth, resistant to moisture, detergent, and extinguishing agents. Floors should be covered with moisture resistant material that does not slip and is resistant to mechanical influence.

External and internal surface of furniture and equipment must be smooth, made of materials resistant to moisture, detergents and disinfectants.

10.5. Illumination requirements.

In all premises it is necessary to provide combined or artificial illumination in accordance with hygienic requirements for natural, artificial and combined illumination of residential and public buildings. In production rooms the level of artificial light should be not less than 200 lux.

The fixtures must be equipped with covered diffusers. Clean the fixtures at least 2 times a year.

10.6. Requirements for air exchange.

Air exchange in the premises of the site should provide conformity with the microclimate limits, compliance with hygienic standards for the occupational exposure and meet the requirements set out in Appendix 2 to this sanitary regulations.

The ventilation system should prevent any flow of air masses from "contaminated" areas (rooms) to "clean" ones.

The site premises should be equipped with autonomous intake and extract ventilation system with mechanical activation. The air exchange system will be specified in the process specification. The air exchange rate for the exhaust and the need for installation of the local suction devices will be determined according to the calculation, depending on the type, quantity and power of the technological equipment.

"Contaminated" zone premises should be equipped with exhaust ventilation with mechanical activation without organized intake.

10.7. Requirements to microclimate of the premises.

The air temperature in the production premises should be within 18-25°C, relative humidity not higher than 75%.

10.8 Requirements to water supply and sewerage.

Main production premises (for receipt and temporary storage of waste, disinfection, washing and processing of equipment and tools) should be equipped with a watering tap, floor traps (trays). The disinfection/processing room should be equipped with a wash hand basin.

10.9. Requirements to the site equipment.

The equipment should be located in such a way as to provide unimpeded access to all the equipment. Distance from the walls to the equipment must be not less than 0.6 m, and from the service area - not less than 1.0 m. Minimum dimensions of the passages must be at least 0.6 m.

Premises for temporary storage of wastes should be equipped with scales.

Temporary storage and waste disinfection/ processing facilities should be equipped with bactericidal lamps or other air disinfection devices.

10.10. Hygienic requirements to maintenance of premises, equipment and implements.

All the premises, equipment and implements must be kept clean. The routine cleaning should be wet cleaning at least once a day using detergents and disinfectants. Overall cleaning should be carried out at least once a month. It is necessary to clean walls, furniture, technological equipment, floor. Wipe the equipment with a rag, moistened with a disinfecting solution, remove visible dirt from the walls, then wash the floor.

Cleaning equipment, separate for "clean" and "contaminated" zones, must have a clear marking with indication of the types of cleaning operations, it should be used only as intended and stored separately in the storerooms or lockers of the main production premises.

Appendix 1
to SanPiN 2.1.7.2790-10
STRUCTURE AND MINIMUM AREA OF WASTE MANAGEMENT PREMISES FOR CLASS B AND C WASTES <*>

Item No.

Premise name

Minimal area, sq. m.

1.

Receipt and temporary storage (accumulation) of non-contaminated wastes

6

2.

Workroom for waste disinfection

depending on overall dimensions of the equipment, but not less than 12

3.

Temporary storage of treated wastes (premises will be provided if there is no condition of storage in the territory)

depending on capacity of the site, but not less than 6

4.

Washing and disinfection of containers, racks, carts

4

5.

Premise for temporary storage of containers, racks, carts

8

6.

Warehouse of consumables

4

7.

Sanitary facilities (dressing room, shower room, bathroom, storage of cleaning equipment)

6

8.

Staff room with a workplace

8

--------------------------------

Notes

<*> For newly built and reconstructed buildings.

<**> If the volume of waste to be treated is up to 200 liters a day, it is allowed to have minimum set of premises in two zones in accordance with paragraph 10.3.1.

Appendix 2
to SanPiN 2.1.7.2790-10
CALCULATED TEMPERATURES, AIR EXCHANGE RATIOS FOR THE PREMISES OF THE SITE FOR CLASS B AND C MEDICAL WASTE PROCESSING

N
Item number

Description
of the premises

Interior
temperature, °C

Air exchange
ratio

Air exchange
ratio for exhaust ventilation
and natural
air exchange

intake

exhaust

1

2

3

4

5

6

1.

Receipt and temporary storage (accumulation) of non-contaminated wastes - receipt of non-contaminated wastes

16

-

1,5

2

2.

Workroom for waste disinfection

18-20

for calculation for removal of heat- and moisture excess <*>

for calculation heat- and moisture excess <*>

not allowed

3.

Temporary storage of treated waste

16

-

2

not allowed

4.

Washing and disinfection of containers, racks, carts

18

3

4

not allowed

5.

Premise for temporary storage of containers, racks, carts

18

-

1

1

6.

Warehouse of consumables

16

1

1

1

7.

Sanitary facilities (dressing room, shower room, bathroom, storage for cleaning equipment)

23

intake from the corridor

75 m3/h per 1 d.c.

2

8.

Staff room with a workplace

20

1

1

1

--------------------------------

Note

<*> Depending on technology and type of equipment.

Extract from SanPiN 2.1.3.2630-10 regarding requirements that can be attributed to the premises of the technological site of medical waste treatment

Chapter I General requirements for organizations engaged in medical activity

Requirements for buildings, structures, premises

3.1. Architectural, planning and structural solutions for buildings and premises for medical activities should provide optimal conditions for carrying out of therapeutic and diagnostic process, compliance with the sanitary and epidemiological regime and work of the medical staff. Hight of the premises should be not less than 2.6 m.

3.3. Structure, layout and equipment of the premises should provide routes for technological processes and prevent them from crossing when there are routes with varying degrees of epidemiological hazard.

3.6. Structure, composition, functional purpose and area of premises should be determined by the capacity and activities of the organization, taking into account the requirements of the valid regulatory documents stated in the design task. Minimum areas of the premises should be taken in accordance with Appendices 1 and 2 to the present sanitary rules. In order to create optimal conditions for the medical-diagnostic process, comfort stay of the patient and to ensure safety of medical personnel, areas of individual rooms can be increased. Areas of the premises not indicated in the table will be taken from the design task and will depend on dimensions and arrangement of the equipment, the number of persons in the room with observance of the sequence of technological processes and standard distances thus providing rational arrangement of equipment and unimpeded movement of the personnel and patients.

3.9. To protect against the blinding effect of sunlight and overheating, windows oriented to the southern rumbles of the horizon will be equipped with sunscreens (visors, blinds).

3.19. Intermediate floors, partitions, joints between them and openings for engineering communications and wires should be rodent-proof.

Requirements for interior decoration of the premises

4.2. Surface of walls, floors and ceilings should be smooth, without any defects, easily accessible for wet cleaning and resistant to detergents and disinfectants. When using panels they should also provide a smooth surface.

4.3. The floor covering should be attached to the basis. Joints of walls and floors should have be rounded, the joints should be tight. When using linoleum coatings, the edges of linoleum near the walls can be placed under skirting boards or taken up to the walls. Seams of adjacent sheets of linoleum should be soldered.

4.5. Finish of the wet premises (shower rooms, bath rooms, etc.) and "contaminated" premises (premises for disassembly and storage of dirty laundry, temporary storage of waste and others) must be moisture resistance for the entire height of the room. Flooring should be made of waterproof materials.

4.6. In the places where sinks and other sanitary appliances are installed, as well as in the places with equipment which operation is accompanied with possible moistening of walls and partitions, it is necessary to provide finishing with ceramic tiles or other moisture-resistant materials up to a height of 1.6 m from the floor and width at least 20 cm from the equipment and appliances on both sides.

4.7. It is allowed to use suspension, stretched, boarded and other types of ceilings, which ensure smoothness of the surface and an opportunity of carrying out their wet cleaning and disinfection.

Requirements to water supply and sewerage

5.1. All newly constructed, reconstructed and active medical institutions should be equipped with a water pipe, sewage system, centralized hot water supply. The quality of water for household and drinking purposes must comply with the requirements of sanitary regulations.

If you have a source of water supply water consumption by medical institution is only possible if the source has a sanitary-epidemiological conclusion.

5.2. Cleaning and disinfection of wastewater from prevention and treatment facilities should be made by municipal or other sewage treatment facilities, which provide effective cleaning and disinfection of sewage. If there are no municipal or other treatment facilities, waste water from prevention and treatment facility should undergo complete biological cleaning and disinfection using local facilities.

5.4. For newly constructed and reconstructed prevention and treatment facilities in case of failure or preventive maintenance of the hot water supply system, centralized reserve hot water supply should be provided. The existing institutions should have water heating devices as a backup source.

5.8. In the offices where instrument are being treated, it is necessary to provide a separate washbasin or two-cavity sink (washbasin).

Requirements to heating, ventilation, microclimate and indoor air

6.1. Heating, ventilation and air conditioning systems should provide normalized parameters for microclimate and air environment of the premises where the medical activities are carried out.

6.2. Heating appliances should have a smooth surface, which eliminates dust adsorption and should be resistant to cleaning and disinfection solutions. Place them on the outside walls, under the windows. The heating devices should not be placed on the inner walls in the wards.

When installing the barriers for heating appliances, it is necessary to provide an unimpeded access for operation and cleaning.

6.3. Central heating systems of the prevention and treatment facilities use a heating medium - water, which temperature in heating appliances is 70-85°C. Use of other liquids and solutions in the heating systems is not allowed.

6.4. Buildings of prevention and treatment facilities should be equipped with exhaust ventilation systems with mechanical and/or natural activation.

6.5. The systems of mechanical intake and exhaust ventilation must be certified. Operation (maintenance) of the mechanical intake and exhaust ventilation and air conditioning should be carried out by a responsible person of the organization or by another specialized organization. Once a year, it is necessary to check the effectiveness of the work, to carry out routine repairs (if necessary) as well as cleaning and disinfection of the mechanical supply and exhaust ventilation systems.

6.7. When operating the ventilation systems it is necessary to meet regulatory requirements for noise and vibration levels.

6.8. Classes of purity, acceptable levels of bacterial air pollution, permissible temperature and the recommended air exchange ratio in the premises of medical organizations will be stated in Appendix 3.

Maximum permissible concentrations of harmful chemicals in the air of industrial premises are stated in Appendix 4.

6.9. Design and operation of ventilation systems should prevent from any flow of air masses from "contaminated" premises to "clean" premises.

6.10. Air exchange rate is determined on the basis of calculation of the specified purity, temperature and relative humidity of the air.

Temperature and organization of air exchange in the premises will correspond to the values stated in Appendix 3.

6.13. In all the premises the air will be supplied to the upper zone. The air will be removed from the upper zone.

6.22. The outside air will be taken for ventilation and air conditioning systems from a clean zone at a height of at least 2 m from the ground surface. Outside air, supplied by air-handling units, should be cleaned with coarse and fine filters.

6.23. Exhaust air will be emitted 0.7 m above the roof. It is allowed to blow air to the facade of the building after cleaning it with appropriate filters.

6.28. In order to maintain a comfortable temperature in the doctors' offices, wards, administrative and auxiliary rooms, it is possible to use split systems under condition of cleaning and disinfection of the filters and heat exchanger chamber in accordance with the manufacturer's recommendations, but at least once every 3 months. It is also possible to use radiant heat panels for this purpose (cooling).

6.29. Exhaust ventilation with mechanical activation without organized intake will be provided from the premises: Shower rooms, sanitary units, premises for dirty laundry, temporary storage of waste and storages for disinfectants, reagents and other substances with strong smell.

6.33. In order to accommodate the equipment of ventilation systems it is necessary to provide special rooms, separate for supply and exhaust systems. Duct ventilation equipment can be placed over a board ceiling in corridors and in rooms without permanent stay of people.

6.34. Air intake ventilation and air conditioning ducts should have internal non-absorbing surface, which prevent small particles of materials or protective coatings from being taken to the rooms.

6.35. The air ducts of the ventilation (air-conditioning) systems after the high-efficiency filters (H11-H14) will be made of stainless steel or other materials with a smooth, corrosion-resistant, non-dusting surface.

6.36. Air ducts, air-venting and air-intake grilles, ventilation chambers, ventilation units and other devices must be kept clean, should have no mechanical damages, traces of corrosion, breach of tightness. Ventilation chambers should be used only for their intended purpose. Cleaning of the premises of the ventilation chambers should be carried out at least once a month, and air inlets - at least once every six months. Maintenance, cleaning and disinfection of ventilation systems should be carried out at least once a year. Elimination of current faults, defects should be carried out without any delay.

6.38. Supply and exhaust grilles should be located at the maximum distance from each other within one room.

6.39. Airways of attics and basements should be protected against rodents, birds and synanthropic insects.

6.41. Administration of the prevention and treatment facility should monitor microclimate and microbial contamination parameters of the air environment at least once every 6 months and air contamination with chemicals at least once a year.

6.42. Air recirculation in a single room is allowed only if you install high efficiency filter (H11-H14) with an addition of external air in accordance with the calculation in order to ensure regulatory parameters of the microclimate and air purity.

6.43. In the presence of centralized air-conditioning and humidification systems for the purpose of prevention of hospital-associated legionellosis, it is necessary to carry out microbiological monitoring of these systems for legionella twice a year. Sampling should be performed in accordance with the current requirements*(1). Low capacity air-conditioning systems without any air humidification and split-system control are not subject to legionella monitoring.

Requirements for natural and artificial illumination

7.2. The following premises can be illuminated without any natural light or with second light illumination with observance of standardized microclimate and air exchange rate parameters:
c) premises of auxiliary services (dispatch offices, loading rooms, archives, storerooms and storehouses of all kinds, thermostatic, preparation room, central linen rooms, facilities for preparation of disinfection solutions, washing rooms, dining rooms, including for patients, premises for kitchens, laundries, central sterilization, disinfection offices, premises for corpse storage and dressing, mourning hall, medical waste treatment facilities, sanitary passages, sanitary rooms, clyster rooms);

7.3. The premises listed in subparagraphs "a" - "c" of paragraph 7.2. can be placed in a basement

7.5. In the medical organizations, the level of natural and artificial illumination must comply with sanitary norms and rules (Appendix 5).

7.7. Artificial illumination (general and local), the light source, the type of lamp will be accepted in accordance with the applicable standards.

7.8. Fixtures for general illumination of the premises, placed on ceilings, should be equipped with continuous (closed) diffusers.

7.12. In order to ensure standard parameters of artificial illumination, the workplaces for the personnel shall be equipped with local lighting fixtures.

Requirements for implements and technological equipment

8.3. Workplaces of the personnel should be made in compliance with ergonomic requirements.

8.5. Each department should be equipped with small mechanization facilities (wheelbarrows, wheelchairs, drug, laundry, food, waste carts) of the required amount depending on the bed capacity and the department profile.

8.7. Surface of the seats (chairs, benches, banquettes, etc.) for patients and staff should be made of materials with low thermal conductivity.

8.8 Medical, diagnostic and auxiliary facilities, except for administrative, medical should be equipped with medical furniture. External and internal surface of medical furniture should be smooth and made of materials resistant to detergents and disinfectants.

8.9.2. Medical equipment and medical products used for medical and pharmaceutical activities must undergo sanitary-epidemiological and hygienic assessment in order to confirm their compliance with current legislation in the field of sanitary and epidemiological welfare of people * (3) (Appendix 6).

!!! Appendix 6 only states: Disinfection-sterilization, washing equipment, equipment for sanitary processing, based on ultraviolet radiation, ultrasound, microwave;

8.9.3. Tests for sanitary, epidemiological and hygienic assessment of medical equipment and medical products will be carried out in accordance with the established procedure.

8.9.4. Actual values of the monitored parameters of medical equipment and medical products are stated in Appendix 7.

8.9.5. The actual values of the monitored parameters received during the testing and hygienic assessment of medical equipment and medical products should not exceed the permitted values specified in Appendix 7.

In cases when the levels of physical factors generated by medical equipment products, exceeding the allowable values specified in Annex 7 of the document (average and high risk products), such medical equipment should only be used in professional use conditions and their assessment should be conducted in compliance with the limit values (LV) of physical factors set for occupational exposure with obligatory determination of complex personal protection measures providing safe operation of the medical equipment.

8.9.6. Concentrations of harmful chemicals, disinfectants and sterilizing agents, biological factors released into the air during the operation of medical devices, should not exceed the maximum permissible concentrations (MPCs) and safe reference levels of exposure (SRL) established for atmospheric air.

Appendix 1
to SanPiN 2.1.3.2630-10
Minimal area of premises

Item No.

Premise name

Area (m2)

3.5. Diagnostic laboratories

113

Autoclave room for disinfection

12

4. Auxiliary, office and household premises common to all structural units

166

Storage room for cleaning items and disinfectant solutions

4

167

Premises for temporary storage of medical wastes

4

168

Sanitary room (temporary storage of dirty laundry, medical waste, place for washing bed-pans)

8

Appendix 3
to SanPiN 2.1.3.2630-10
Clean room grade, recommended air exchange, permissible settlement temperature (approved by the decree of the Chief State Sanitary Doctor of the Russian Federation of May 8, 2010 N 58)

Premise name

Clean room grade

Sanitary and microbiological parameters

Permissible air temperature (calculated)

Recommended air exchange for 1 hour, not less than *

Exhaust ratio for natural air exchange

total number of microorganisms per 1 m3 of air (CFU/m3)

intake

exhaust

before work

after work

Premises of disinfection chambers:

Receipt/loading

unloading "clean" parts

Г

Not rated

Not rated

16

From a "clean" premise

5

5

Through the "contaminated" parts

Not allowed

* Ratio in "inflow" column is indicated for outdoor air. The design air exchange should provide compliance with the air environment requirements specified in this table.

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