of January 6, 2017 No. 2
About approval of Sanitary standards and the rules "Safety Requirements when Implementing Works with Opportunistic Microorganisms and Pathogenic Biological Agents, to the Organization and Carrying Out Their Accounting, Storage, Transfer and Transportation"
Based on Article 13 and part seven of article 16-1 of the Law of the Republic of Belarus of January 7, 2012 "About sanitary and epidemiologic wellbeing of the population", paragraph two of subitem 8.32 of Item 8 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:
1. Approve the enclosed Sanitary standards and the rules "Safety Requirements when Implementing Works with Opportunistic Microorganisms and Pathogenic Biological Agents, to the Organization and Carrying Out Their Accounting, Storage, Transfer and Transportation".
2. This resolution becomes effective in fifteen working days after its signing.
First Deputy Minister
Approved by the Resolution of the Ministry of Health of the Republic of Belarus of January 6, 2017 No. 2
1. These Sanitary standards and rules establish requirements when implementing works with opportunistic microorganisms (further, unless otherwise specified, - UPM) and pathogenic biological agents (further, unless otherwise specified, - PBA), to the organization and carrying out their accounting, storage, transfer and transportation.
2. For the purposes of these Sanitary standards and rules the main terms and their determinations in the values established by the Law of the Republic of Belarus of January 7, 2012 "About sanitary and epidemiologic wellbeing of the population" are used (The national register of legal acts of the Republic of Belarus, 2012, No. 8, 2/1892), and also the following terms and their determinations:
emergency - emergency situation in case of which the real or potential possibility of allocation of UPM and PBA in air of production zone, the environment and infections of workers and the population is created;
the attenuirovanny strain - strain of certain species of microorganism which it is spontaneous or as a result of selection lost virulence, but kept immunogenicity;
biological safety - system of the organizational, medicobiological and technical actions and funds allocated for protection of workers, the population and the environment from impact of UPM and PBA;
biological danger - potential danger of adverse effect of UPM and PBA per capita and the environment;
boxing of biological safety (further - the box of BB) - design or the device with directed (laminar) flow of air used for physical isolation (deduction and controlled removal from the working area) UPM and PBA for the purpose of prevention of possibility of infection of workers, objects of research and contamination of air of the working area and the environment;
the box room (further - boxing) - the room consisting of boxing and preboxing and intended for creation of aseptic conditions when carrying out researches or prevention of microbic pollution of the external environment;
diagnostic testings - the researches of biological material conducted for the purpose of detection and identification of the activator, its anti-gene, antibodies to it and (or) genetic material;
"infectious" zone - the room or group of premises of laboratory where manipulations with objects of research, UPM and PBA and their storage are performed;
kontaminirovanny material - the material containing UPM and PBA;
most isolated laboratory - the laboratory of the highest level of biological safety intended for carrying out diagnostic, production and experimental works with PBA of the third and fourth risk groups constituting high danger to employees of laboratory and the population;
material, suspicious on contamination of UPM and PBA, - any material which may contain UPM and PBA and to constitute potential danger of infection of the person and the environment;
sanitary and microbiological researches - researches on detection of UPM and PBA in water, air, the soil, foodstuff, food raw materials, sterns and objects of the habitat of the person;
"net" zone - the room or group of premises of laboratory where works with UPM and PBA and their storage are not carried out;
strain - net culture of certain species of microorganism at which morphological and physiological features are studied.
3. These Sanitary standards and rules are obligatory for observance by legal entities, the individual entrepreneurs who are carrying out works with UPM and PBA, and also for the project, construction and other organizations dealing with issues of the choice of the parcels of land, designing of again under construction and reconstructed laboratories in which works with UPM and PBA are carried out.
4. Work with UPM and PBA is performed by legal entities (individual entrepreneurs) having the permission issued according to the procedure, established by the legislation of the Republic of Belarus (further, unless otherwise specified, - the organizations).
5. The state sanitary inspection behind respect for these Sanitary standards and rules is performed according to the procedure, established by the legislation of the Republic of Belarus.
6. Perpetrators bear responsibility according to legal acts of the Republic of Belarus for violation of these Sanitary standards and rules.
7. The laboratories which are carrying out works with UPM and PBA (further, unless otherwise specified, - laboratories), shall be placed in the certain building, in is built-in - the attached rooms, on certain floors of the building or the isolated building blocks. On entrance door of laboratory there shall be locking device, call for challenge of workers and the name of laboratory.
8. On entrance door of the laboratory which is carrying out works with PBA second, third and fourth of risk groups the sign "Biological Danger" according to appendix 2 to the Instruction about safety requirements to the closed systems when implementing works of the second, third and fourth risk levels of the genetically engineered activities approved by the resolution of the Ministry of Health of the Republic of Belarus of August 25, 2006 No. 65 "About some safety issues of genetically engineered activities" shall be placed (The national register of legal acts of the Republic of Belarus, 2006, No. 151, 8/14992).
9. The laboratory shall be provided with water supply system, the sewerage, the electric power, heating, telephone communication. On case of failure or carrying out preventive repair of hot water supply backup water-heating devices shall be provided.
10. Again under construction and reconstructed laboratories shall be equipped with autonomous (reserve) source of power supply.
11. Laboratories shall have at least two entrances. Availability of one entrance for the laboratories which are carrying out only diagnostic or only sanitary and microbiological researches with UPM and PBA of the first and second risk groups is allowed.
12. Premises of laboratory divide into "net" and "infectious" zones. The layout of premises of laboratories shall exclude hit of infectious material in "net" zone.
13. In "net" zone of laboratories the following rooms shall be located:
clothes for clothes with separate storage of personal and working clothes;
rooms for carrying out preparatory work (washing, the room for preparation and pouring of nutrient mediums, preparatorsky and others);
the room for sterilization of nutrient mediums and laboratory glassware (further - sterilizing);
the room for work with documents and literature;
the room for rest and meal;
head's office structural division;
storage and utility rooms.
14. In "infectious" zone of laboratories the following rooms shall be located:
sanitary propusknik for laboratories during the work with PBA of the third and fourth risk groups;
the room for acceptance, registration and storage of material (tests);
the rooms for diagnostic testings equipped with boxes and (or) boxes of BB with allocation of certain rooms or accurately designated zones for each group of activators;
the rooms for sanitary and microbiological researches equipped with boxes and (or) boxes of BB with allocation of certain rooms or accurately designated zones for each group of sanitary and microbiological researches;
rooms for carrying out parasitological and (or) zooentomological works;
rooms for the molecular and biological researches including conducted by method of polymerase chain reaction (further - PTsR-researches);
the room for disinfecting (further - autoclave);
rooms for work with the infected animals.
15. In case of absence in the laboratories working with UPM and PBA of the first and second risk groups, necessary set of rooms on condition of separation of operating mode on time and observance of flows of materials transaction it is allowed:
combine "net" and "infectious" autoclave in one room;
use for pouring of nutrient mediums boxes for sanitary and bacteriological researches (only for the existing production and sanitary and microbiological laboratories);
combine carrying out sanitary and parasitological and kliniko-parasitological researches in one working room with separation of engineering procedures on time.
16. Under the organization of several laboratories by general for them can be:
autoclave for disinfecting of UPM and PBA of the first and second risk groups;
rooms for preparation of nutrient mediums and other auxiliary rooms.
17. The registry and the room for acceptance of tests is placed in case of entrance to laboratory.
18. On doors of rooms plates with indication of their appointment are hung out.
19. In the presence for intake of material separate toilets for workers and the examined persons are provided in laboratories of Item.
20. Rooms of "infectious" zone shall be equipped with bactericidal irradiators. When calculating duration of radiation it is necessary to consider recommendations of the manufacturer, but it shall be at least 30 minutes. The quantity of sources of bactericidal radiation is calculated according to room amount. The time management of work of irradiators is kept in any form.
21. The device of entrances to the building and premises of laboratory shall provide possibility of movement of the laboratory equipment, furniture, stock.
22. Internal finishing of rooms shall be executed according to their functional purpose. The surface of floor, walls, ceiling in rooms of "infectious" zone of laboratory, rooms for carrying out preliminary works shall be smooth, without cracks, steady against repeated effect of detergents and means of disinfection, availability of false ceilings is not allowed.
23. All working premises of laboratory, the room for rest and meal, sanitary propusknik, toilets shall be equipped with sinks for washing of hands of workers with batchers for liquid soap and solutions of anti-septic tanks. In rooms of "infectious" zone of laboratory where carry out works with PBA of the third and fourth risk groups, installation of the water supply system which is not protected by technical means from suction and the return current of water is not allowed.
24. Premises of laboratories shall have constructive architectural and planning execution and equipment by the technical security systems providing physical protection against unauthorized penetration of strangers.
25. Systems of heating, ventilation (conditioning) of air shall provide the normalized parameters of microclimate and the air circle of rooms in which work with UPM and PBA, according to the legislation of the Republic of Belarus is carried out.
26. Heating devices shall have the smooth surface steady against impact of the washing and disinfecting solutions.
In case of the device of barriers of heating devices the open entry for the current operation and cleaning shall be provided.
Places of input of engineering communications shall be hermetic.
27. Buildings of laboratories shall be equipped with systems of supply and exhaust ventilation with mechanical or natural motivation.
28. Regardless of availability of systems of forced ventilation in rooms of "net" zone the possibility of natural airing shall be provided.
Window blocks and apertures shall contain in good repair and to be equipped with protection devices from penetration of insects.
Premises of laboratories with the engineering procedure which is followed by allocation in air of hazardous substances shall be equipped with fume cupboards.
29. The laboratory shall have the independent system of ventilation isolated from other ventilating systems. Ventilating systems of the laboratories which are carrying out works with PBA of the third and fourth risk groups are equipped with devices of disinfecting of air and (or) filters of thin cleaning. Under the organization of works with PBA of the third and fourth risk groups it is necessary to exclude movement of air masses from "infectious" zone in "net" zone.
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