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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of October 15, 2021 No. KR DSM-105

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

According to article 95 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" and subitem 132-1) of Item 16 of the Regulations on the Ministry of Health of the Republic of Kazakhstan approved by the order of the Government of the Republic of Kazakhstan of February 17, 2017 PRIKAZYVAYU:

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

2. Declare invalid the order of the acting minister of health care of the Republic of Kazakhstan of September 8, 2017 No. 684 "About approval of Health regulations "Sanitary and epidemiologic requirements to the laboratories using potentially dangerous chemical and biological substances" (it is registered in the Register of state registration of regulatory legal acts at No. 15990).

3. To provide to committee of sanitary and epidemiologic control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

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

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after sixty calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

 

"Is approved"

Ministry of the industry and infrastructure development of the Republic of Kazakhstan

 

"Is approved"

Ministry of Agriculture of the Republic of Kazakhstan

 

"Is approved"

Ministry of national economy of the Republic of Kazakhstan

 

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of October 15, 2021 No. KR DSM-105

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) are developed according to article 95 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" and subitem 132-1) of Item 16 of the Regulations on the Ministry of Health of the Republic of Kazakhstan approved by the order of the Government of the Republic of Kazakhstan of February 17, 2017 No. 71 and establish sanitary and epidemiologic requirements to the choice of the parcel of land under asset construction, to designing, operation, reconstruction, repair, water supply, water disposal, heat supply, lighting, ventilation, conditioning and to working conditions in microbiological, sanitary and hygienic, radiological laboratories, storage and transportation of materials (microorganisms).

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

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

2) autoclave – the room for work with vessel under high pressure;

3) 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;

4) biological agents or toxins (further – BA 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 – BB);

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) the boxed room (further – boxing) – the isolated room with the platform (preboxing);

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

9) 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;

10) deactivation – removal or decrease in radioactive pollution from any surface or from any circle;

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

12) demercurization – complex of actions for cleaning of mercury in case of its spillage;

13) 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;

14) 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;

15) laboratory – the legal entity or his structural division which is carrying out organoleptic, sanitary and hygienic, microbiological, virologic, parasitological, biochemical, toxicological, radiological researches, dosimetric measurements of physical factors;

16) 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;

17) rearing cage – division of object for content, removal or cultivation of the insects applied to the experimental purposes;

18) infectious material – material which is known or is reasonably supposed that it contains causative agents of infectious diseases;

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

20) 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;

21) flammable substances – flammable substances and combustible liquids which ignite from external source of ignition;

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

23) 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, biological liquids and excrement of organism), probable on content of the listed agents;

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

25) polymerase chain reaction (further – PTsR) – the reaction based on repeated increase in number of copies of fragment of deoxyribonucleic acid (further – DNA) – ribonucleic acid (further – RNA) (amplifications) that allows to find the specific site of genome of the researched microorganism;

26) sanitary and hygienic laboratory – the laboratory conducting sanitary and hygienic, toxicological, chemical researches, measurements of physical factors, other researches and testing;

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

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

29) strain – net culture of microorganism;

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

31) epidemic significant objects – objects, the made products and (or) activities of which in case of violation of requirements of regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population can lead to emergence of food poisonings and (or) infectious, parasitic diseases among the population and (or) do harm to health of the population from physical factors, industrial and radioactive pollution;

32) electrochemiluminescence – the new progressive method of the immune analysis based on the principle of measurement of hemilyuministsention.

Chapter 2. Sanitary and epidemiologic requirements to the choice of the parcel of land under asset construction, to designing, operation, reconstruction, repair of laboratories

3. In case of the choice of the parcel of land under construction of facilities it is not allowed to use the parcels of land:

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

2) stationary unsuccessful on settlement anthrax.

4. The area in case of the choice of the parcel of land under construction of facilities, is determined by requirements of the state standard rates in the field of architecture, town planning and construction according to subitem 23-16) of article 20 of the Law of the Republic of Kazakhstan of July 16, 2001 "About architectural, town-planning and construction activities in the Republic of Kazakhstan" (further – the state standard rates in the field of architecture, town planning and construction).

5. When designing the building of laboratory are located on the independent parcels of land or on the parcel of land of the organization which part they are.

6. When designing operation of laboratories in the independent building is allowed, 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 the treatment-and-prophylactic organizations with separate entrance.

7. When designing objects set and floor area is determined by design assignment according to requirements of the state standard rates in the field of architecture, town planning and construction and according to appendix 1 to these Health regulations.

8. 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.

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

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

11. Window openings, show-windows of the first floor of laboratories have durability equivalent to the following parameters:

1) windows with the regular glazing which is in addition protected by rolling shutters from steel sheet at least 1 mm thick;

2) windows with the regular glazing which is in addition protected by metal lattices (sliding, oar) or blinds of the corresponding durability;

3) windows of special design with the protective glazing steady against single blow bearing 3 blows of the steel sphere weighing 4 kg dumped from height of 9,5 of m and above.

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

13. 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.

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

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

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

17. 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.

18. BBB 2 classes of protection are applied to work with PBA. Rooms where work with PBA is carried out, are equipped with bactericidal irradiators.

19. 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.

20. For the laboratories conducting only research researches with PBA I-IV of groups of pathogenicity in BBB 2 use of false ceilings is allowed.

21. Edges of floor coverings of "infectious" rooms for work from the I-IV groups of pathogenicity are lifted. In the presence of ladders floor has biases.

22. In sanitary and hygienic laboratory floor becomes covered with acidproof material.

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

24. In rooms in which works with flammable 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.

25. In case of reconstruction and repair of laboratories the above-stated requirements are observed.

Chapter 3. Sanitary and epidemiologic requirements to water supply, water disposal, heat supply, lighting, ventilation, conditioning in laboratories

26. Laboratories are provided in good repair drinking and (or) economic and drinking water supply.

27. In the absence of centralized system of water supply use of water from local sources of drinking appointment with the device of internal water supply system and water disposal is allowed.

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

29. 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.

30. In case of placement of laboratories in not channeled and partially channeled area the device of the local sewerage (holes, septic tanks) is provided. Acceptance of sewage is performed in general or the separate underground waterproof reservoirs equipped with covers with hydraulic locks (siphons), located in economic zone of the object territory which cleaning is carried out timely.

31. In the absence of centralized source of heat supply the autonomous boiler room using liquid, solid, gaseous fuel is provided.

32. Natural and artificial lighting of rooms is determined according to the state standard rates in the field of architecture, town planning and construction.

Working rooms are provided with protection of desktops and optics against direct hit of direct sunlight by use of light-protective devices from the material steady against disinfectants.

33. Indoors, where work with luminescent microscope is carried out, the photo to the room, in shower, bathrooms and storage facilities is not provided natural lighting.

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