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The document ceased to be valid since  December 27, 2017 according to Item 2 of the Order of the Minister of Health of the Republic of Kazakhstan of September 8, 2017 No. 684

I.O.'S ORDER OF THE MINISTER OF NATIONAL ECONOMY OF THE REPUBLIC OF KAZAKHSTAN

of April 15, 2015 No. 338

About approval of Health regulations "Sanitary and epidemiologic requirements to the laboratories using potentially dangerous chemical and biological substances"

According to Item 6 of article 144 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed Health regulations "Sanitary and epidemiologic requirements to the laboratories using potentially dangerous chemical and biological substances".

2. To provide to committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan in the procedure established by the legislation:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days after state registration of this order its direction on official publication in periodic printing editions and in information system of law of Ad_let;

3) placement of this order on official Internet resource of the Ministry of national economy of the Republic of Kazakhstan.

3. To impose control of execution of this order on the supervising vice-minister of national economy of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Acting minister of national economy of the Republic of Kazakhstan

M. Kusainov

It is approved

Minister of health and social development of the Republic of Kazakhstan

April 15, 2015

 

____________ T. Duysenova

Approved by the Order of the Minister of national economy of the Republic of Kazakhstan of April 15, 2015 No. 338

Health regulations "Sanitary and epidemiologic requirements to the laboratories using potentially dangerous chemical and biological substances"

Chapter 1. General provisions

1. These Health regulations "Sanitary and epidemiologic requirements to the laboratories using potentially dangerous chemical and biological substances" (further - Health regulations) establish sanitary and epidemiologic requirements to the laboratories which are carrying out organoleptic, toxicological, sanitary and chemical, microbiological, bacteriological, virologic, parasitological, molecular and biological (polymerase chain reaction), immunobiological (the immunofermental analysis and other serological researches) laboratory researches, measurements of noise, vibration, electromagnetic fields and physical factors, the radiation researches including radiometry and dosimetry (further - laboratory) which non-compliance creates threat of life or to health of the person, and also origin and spread of diseases.

2. Health regulations also establish sanitary and epidemiologic requirements to:

1) to the choice of the parcel of land under building(s) construction, to designing, construction, reconstruction of laboratory and commissioning;

2) to content, operation and working conditions in laboratories;

3) to ensuring radiation, chemical, microbiological, virologic, toxicological, parasitological safety (including in case of accident elimination);

4) to storage and transportation of materials (microorganisms);

5) to water supply, water disposal, lighting and ventilation.

3. Observance of requirements of Health regulations extends to physical persons and legal entities irrespective of patterns of ownership.

4. In Health regulations the following terms and determinations are used:

1) emergency (further - accident) - the situation which arose in laboratory during the work with biological material, creating real or potential possibility of allocation of the pathogenic biological agent in air of production zone, the environment or infection of personnel;

2) bacteriological laboratory - the laboratory making researches on allocation of bacteria of biological material and objects of the environment, to determination of anti-genes and antibodies;

3) check-point (further - the check point) - the special room intended for providing the omission of people and the permitted type of vehicles;

4) biological agents or toxins - the microorganisms and difficult connections of the proteinaceous nature of bacterial, vegetable or animal origin capable in case of hit or contact with human bodies or animals, and also with plants to cause their diseases or death;

5) biological safety - system of the medicobiological, organizational and technical actions directed to protection of the working personnel, the population and the environment from impact of biological agents (further - BA);

6) boxing of biological safety (further - BBB) - the design used for physical isolation (deduction and controlled removal from the working area) microorganisms for the purpose of prevention of possibility of infection of personnel and contamination of air of the working area and the environment;

7) biological protection (further - bioprotection) - ensuring protection, control and accounting of BA and toxins for the purpose of prevention of their loss, theft, misuse, diversion, unauthorized access or deliberate unauthorized leakage;

8) the boxed room (further - boxing) - the isolated room with the platform (predboksnik);

9) vivarium - division of the organization where the different types of laboratory animals used for experiments contain;

10) virologic laboratory - the laboratory making researches on allocation of viruses of biological material and objects of the environment, to determination of anti-genes and antibodies;

11) deactivation - removal or decrease in radioactive pollution from any surface or from any circle;

12) dezara - the ultra-violet bactericidal irradiator, is applied to disinfection of air in rooms;

13) demercurization - complex of actions for cleaning of mercury in case of its spillage;

14) DNA - deoxyribonucleic acid;

15) diagnostic testings - the researches of objects of the biotic and abiotic nature conducted for the purpose of detection and identification of the activator, its anti-gene or antibodies to it;

16) AIDS - acquired immunodeficiency syndrome;

17) infectious zone - the room or group of premises of laboratory where manipulations with pathogenic biological agents or the pathogenic biological agent, probable on contamination, with material and their storage are performed;

18) laboratory - the organization or its structural division which is carrying out organoleptic, toxicological, sanitary and chemical, bacteriological, virologic, parasitological, molecular and biological, immunobiological laboratory researches, measurements of noise, vibration, electromagnetic fields and physical factors, the radiation researches including radiometry and dosimetry;

19) infectious material - substances which are known or is reasonably supposed that they contain causative agents of infectious diseases;

20) the immunofermental analysis (further - IFA) - the method of different determination of biological molecules based on interaction of anti-gene with antibody with use of fermental tag;

21) rearing cage - division of the organization for content, removal or cultivation of the insects applied to the experimental purposes;

22) microbiological laboratory - the laboratory which is carrying out researches on identification of microorganisms in biological material and objects of the environment;

23) microbiological researches include bacteriological, virologic, parasitological, molecular and biological, immunobiological researches;

24) microorganisms are difficult connections of the proteinaceous nature of bacterium, viruses, mycoplasmas, rikketsiya, hlamidiya and mushrooms which under certain conditions and in certain concentration can exert impact on health of the person;

25) flammable substances - flammable substances and combustible liquids which ignite from external source of ignition;

26) technical reinforcement of object (room) - set of engineering protection of structural elements of buildings, rooms, their perimeters, special technical means of protection (system of the security, disturbing alarm system; access control systems; video control and video security systems of television observation; detectors of detection of radioactive, chemical and other toxic agents; detectors of detection of weapon, explosive substances and devices) and systems of the fire alarm, including systems of automatic detection and suppression of the fires;

27) the pathogenic biological agent (further - PBA) - microorganisms, pathogenic for the person (bacteria, viruses, rikketsiya, hlamidiya, protozoa, mushrooms, mycoplasmas, endo-and ektoparazita), the gene engineering modified microorganisms, poisons biological and phytogenesis (toxins), helminths, and also material (including blood, other biological liquids and excrement of organism), probable on content of the listed agents;

28) parasitological laboratory - the laboratory which is carrying out researches on identification of helminths and the simplest in biological material and objects of the environment;

29) perimeter - the border of the protected territory (zone) equipped with the protecting building constructions (barriers) and check-points;

30) polymerase chain reaction (further - PTsR) - the reaction based on repeated increase in number of copies of fragment of DNK-RNK (amplification) that allows to find the specific site of genome of the researched microorganism;

31) radiological laboratory - the laboratory which is conducting radiation control, radiological researches on determination of content of radionuclides in various objects, and also taking radiation, radiometric, spectrometer monitorings;

32) RNA - ribonucleic acid;

33) pilot studies - all work types with use of microorganisms, helminths, toxins and poisons of biological origin;

34) risk assessment - evidence-based assessment of probability of penetration and distribution of BA and the potential social, medicobiological, phyto-veterinary, ecological and economic consequences connected with it;

35) net zone - the room or group of premises of laboratory where manipulations with BA are not carried out;

36) toxic and strong agents - the chemical compounds causing pathological changes in case of their hit in organism in small doses and concentration;

37) temporary laboratories (epidemiological groups, expeditions) - the laboratories functioning periodically are organized in case of epidemic flashes;

38) conditional and infectious zone - the room or group of rooms within infectious zone;

39) strain - net culture of microorganism;

Epidemiologically significant objects - objects, the made products and (or) activities of which in case of violation of requirements of the legislation of the Republic of Kazakhstan in the sphere of sanitary and epidemiologic wellbeing of the population can lead 40) to emergence of food poisonings and the outbreaks of infectious diseases among the population.

Chapter 2. Sanitary and epidemiologic requirements to the choice of the parcel of land under building(s) construction, to designing, construction, reconstruction and commissioning of laboratories

5. It is not allowed to design and perform construction on the parcels of land under condition:

1) its uses in the past under cattle mortuaries and places of burial of toxic waste;

2) stays on the parcel of land, the settlement, stationary unsuccessful on anthrax.

6. Buildings of laboratories are located on the independent parcels of land or on the parcel of land of the organization which part it is.

7. Requirements to placement of laboratory:

It is allowed to place laboratories in the independent building, it is built-in - the attached production rooms with separate entrance, on certain floors of factory buildings, the profile organizations in the presence of separate entrance, kliniko-diagnostic laboratories - in treatment-and-prophylactic with separate entrance.

8. The laboratories which are carrying out microbiological researches III-IV of groups of pathogenicity are placed at distance at least 30 meters (further - m) from residential and public buildings.

9. The territory, buildings of laboratories conform to requirements of the legislation of the Republic of Kazakhstan in the sphere of architectural, town-planning and construction activities and to have set of rooms and areas according to appendix 1 to Health regulations.

10. The laboratories which are carrying out microbiological researches have at least two entrances: with sanitary propusknik for employees and for delivery of material to research. Receipt of material for research through transfer window is allowed.

11. Capital barriers for stationary laboratories in which work with PBA I-II of groups of pathogenicity or material probable on contamination of PBA I-II of groups of pathogenicity is carried out are under construction according to standard projects.

12. In external barrier availability of not locked doors, gate, gates, and also breaches and other damages is not allowed.

13. It is forbidden to adjoin barrier extensions, except the buildings which are part of its perimeter, at the same time windows of the first floors of the buildings coming to the unprotected territory are equipped with metal lattices.

14. On perimeter of barrier of the territory lighting is established.

15. In case of placement of laboratory on the first floor at windows of all rooms metal lattices are established.

16. Temporary laboratories are placed in the adapted buildings, rooms in case of observance of safety requirements, providing with enough water, the electric power, channeling.

17. For barrier it is allowed to use regular fences (wooden, metal, trellised, mesh).

18. Laboratories have available working rooms and other rooms, according to production capacity and the nomenclature of the carried-out researches. Premises of laboratory are used for the direct designated purpose. The works which are not connected with accomplishment of service duties are not carried out.

19. Premises of laboratories have constructive architectural and planning execution and equipment by the technical security systems in total providing protection against penetration.

20. On the objects occupied with carrying out experimental, diagnostic and production works, and also storage of PBA I-II of groups of pathogenicity sets access control.

21. Internal finishing of rooms is carried out according to their functional purpose.

The surface of floor, walls, ceiling in laboratory rooms smooth, without cracks, easily processed, steady against action washing and disinfectants, are not allowed slippery floors.

22. Edges of floor coverings of "infectious" rooms for work from the I-IV groups of pathogenicity are lifted, and closed up aflush with walls. In the presence of ladders floor has biases. In rooms of infectious zone the device of false ceilings is not allowed.

23. In sanitary and chemical laboratory floor becomes covered with acidproof material.

24. In radiological laboratory floor, ceiling and walls become covered with the slabosorbiruyushchy materials resistant to detergents.

25. In rooms in which works with fire are carried out - and explosive substances, two exits are provided.

Desktops become covered with anticorrosive, fireproof material, for work with acids and alkalis - with the device of sides.

26. Works with toxic agents are carried out in certain rooms (rooms) or in separate fume cupboard.

27. Windows and doors of boxes and other rooms are closed tightly. Window leaves are protected by grid from insects. Doors in boxing and preboxing have the surveyed windows.

28. All boxes have preboxing where sinks for washing of hands are established (washstands), in case of absence use of skin anti-septic tanks, mirror and reservoirs with disinfecting solutions is allowed.

29. The layout of premises of microbiological laboratories excludes recross of pure and infectious currents. On entrance door the name of laboratory and the international sign "Biological Danger" is designated. On doors of rooms plates with indication of their appointment are hung out.

30. The registry and the room for acceptance of tests is placed in case of entrance to laboratory. In the presence for intake of material separate toilets for personnel and the examined persons are provided in laboratories of Item.

31. Width of the main passes to workplaces or between two rows of the equipment constitutes at least 1,5 of m taking into account speakers of designs.

32. In case of fire, refrigerators (thermostats, safes) in which PBA I-II of groups of pathogenicity are stored are not taken out.

33. BBB 2 classes of protection are applied to work with PBA. Rooms where work with PBA is carried out, are equipped with bactericidal irradiators taking into account operating time of each irradiator with mark in the magazine.

34. The devices, the equipment and measuring instruments used in work of laboratory undergo certification and checking in the presence of technical data sheet and the work instruction on operation taking into account safety requirements.

35. Repair of the laboratory equipment and engineering systems of safety of divisions is performed by technical services and specialists according to business necessity.

Chapter 3. Sanitary and epidemiologic requirements to water supply, channeling, lighting and ventilation in laboratory

36. The laboratory is connected to centralized systems of cold and hot water supply, channeling, electric utility service, heating.

37. In case of absence in the settlement of centralized water supply system and channeling, autonomous water supply systems and channelings are installed.

38. In laboratory sinks for washing of hands of personnel and sink or bathtub for washing of ware and stock with eyeliner of cold and hot water via mixers are equipped. Washing of hands is performed by supply of liquid soap from dispensor and drying of hands is made by one-time paper towels.

39. The laboratory is equipped with supply and exhaust ventilation with artificial motivation and separate (autonomous) ventilating devices for air suction from fume cupboards, for laboratory of district level ventilation with mechanical motivation is allowed.

40. Content of explosive and poisonous gases, vapors and dust in air of working rooms does not exceed maximum permissible concentration.

41. Fume cupboards in which works with the substances allocating harmful and combustible vapors and gases are conducted are equipped with the upper and lower suctions and sides preventing running off of liquid on floor.

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