GOVERNMENT OF THE REPUBLIC OF ARMENIA
DECISION
No 108-N of 12 February 2015
ON APPROVING THE GENERAL REQUIREMENTS TO THE SYSTEM OF LABORATORY BIOSAFETY, BIOSECURITY, CHEMICAL AND RADIATION SAFETY
Based on point 9 of part 1 of Article 6 of the Law of the Republic of Armenia “On public healthcare”, the Government of the Republic of Armenia hereby decides:
(Preamble edited by No 1505-N of 26 September 2024)
1. To approve the general requirements to the system of laboratory biosafety, biosecurity, chemical and radiation safety, according to the Annex.
2. To assign the Minister of Healthcare of the Republic of Armenia to develop and approve within one year following the entry into force of this Decision:
(1) model manuals on laboratory biosafety, biosecurity and chemical and radiation safety and standard procedures for actions;
(2) sanitary standards entitled as “Requirements for operation of biological, chemical and radiation laboratories”;
(3) methodical instructions entitled as “Requirements for first-aid supplies in laboratories dealing with biological, chemical and radiation agents and the list of first-aid supplies and instruction on their use”;
(4) methodical guidance entitled as “Requirements for storage and use of chemical substances in chemical and biological laboratories”.
3. To assign the Minister of Healthcare of the Republic of Armenia, the Minister of Agriculture of the Republic of Armenia, the Minister of Territorial Administration and Emergency Situations of the Republic of Armenia, the Minister of Defence of the Republic of Armenia and the Head of the State Service for Food Safety of the Ministry of Agriculture of the Republic of Armenia to develop — within a period of six months after entry into force of this Decision — and to approve upon joint order the methodical guidance entitled as “Requirements for suitability of personal and collective protective equipment used in chemical and biological laboratories” for the organisations carrying out laboratory works, the management powers whereof are reserved, respectively, to the Ministry of Healthcare of the Republic of Armenia or the Ministry of Agriculture of the Republic of Armenia, or the Ministry of Territorial Administration and Emergency Situations of the Republic of Armenia, or the Ministry of Defence of the Republic of Armenia, or the State Service for Food Safety of the Ministry of Agriculture of the Republic of Armenia.
4. This Decision shall enter into force on the tenth day following the date of its official promulgation.
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Prime Minister of the Republic of Armenia |
H. Abrahamyan |
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17 February 2015 Yerevan |
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Annex to Decision of the Government of the Republic of Armenia No 108-N of 12 February 2015 |
GENERAL REQUIREMENTS TO THE SYSTEM OF LABORATORY BIOSAFETY, BIOSECURITY, CHEMICAL AND RADIATION SAFETY
I. GENERAL PROVISIONS
1. This legal act shall regulate the relations pertaining to biosafety, biosecurity, chemical and radiation safety of organisations carrying out laboratory works (hereinafter referred to as “the organisation”) and operating under the subordination of the Ministry of Healthcare of the Republic of Armenia, Ministry of Agriculture of the Republic of Armenia, Ministry of Territorial Administration and Emergency Situations of the Republic of Armenia, Ministry of Defence of the Republic of Armenia, State Service for Food Safety of the Ministry of Agriculture of the Republic of Armenia.
2. These requirements may be set forth for private laboratories under relevant civil-law contracts.
3. The following main concepts shall be used in this legal act:
(1) system for ensuring biosafety, biosecurity, chemical and radiation safety — a comprehensive set of system operations and procedures used to ensure biosafety, biosecurity, chemical and radiation safety in laboratories dealing with biological, chemical and radiation factors;
(2) laboratory biosafety — a set of containment principles, technologies and practices that are implemented to prevent accidental exposure to biological pathogens and toxic substances, or their inadvertent release;
(3) laboratory biosecurity — a set for protection, control and record-registration of biological agents and toxins to prevent loss, theft, misuse, diversion, unauthorised access or unauthorised intentional release, thus protecting the employees of the organisation, the public and the environment;
(4) laboratory chemical safety — a set of processes and practices that is implemented to ensure the safe handling of chemical substances, excludes chemical poisoning among laboratory workers, technological emergencies and inadvertent release of chemical substances into the environment;
(4) laboratory radiation safety — ensuring radiation safety requirements while working with iozining radiation sources in laboratory settings;
(6) biosafety officer — laboratory specialist with higher education who possesses work experience in laboratory biosafety, has participated in biosafety and biosecurity courses and co-ordinates biosafety and biosecurity processes of a certain organisation;
(7) chemical safety officer — laboratory specialist with higher chemical education and qualification, skills and abilities in the field of laboratory activities who co-ordinates the chemical safety processes of the organisation engaged in certain chemical laboratory activities;
(8) radiation safety officer — laboratory specialist with relevant education and qualification, skills and abilities in the field of laboratory activities, who co-ordinates the radiation safety processess of the organisation engaged in certain radiation laboratory activities;
(9) biological agent — any microorganism, including genetically modified, cell culture and endoparasite, that may cause infection to humans, animals or plants.
4. In organisations all processes shall be documented in the form of manuals and standard procedures for actions approved by the director of the given organisation, by ensuring that all employees have access thereto.
5. Organisations shall introduce response plans for accidents, incidents and unforeseen situations and plans for the use of personal protective equipment approved by the director of the organisation concerned, based on biosafety level of the organisation, as well as given the directions of activities and criteria set by the World Health Organisation.
6. A staff position for biosafety, or biosecurity, or chemical or radiation safety officer shall be designated in each organisation, as of the direction of activities.
7. The director of each organisation shall approve and review, once every five years, the ongoing development programmes related to issues of biosafety, or biosecurity, or chemical or radiation safety, respectively, of employees of the given organisation.
8. Each organisation shall carry out assessment of dangers, threats and risks. It shall be carried out by the laboratory specialists of the organisation, under the direction of biosafety, chemical or radiation safety officers, by using relevant assessment tools approved by the director of the organisation concerned.
9. Based on the results of assessment of dangers, threats and risks, the director of the organisation concerned shall adopt measures to counter and reduce them, shall select appropriate protective measures and shall develop standard procedures which aim to enhance work safety.
10. In each organisation the director shall establish a classified (biosafety) commission which co-ordinates processes in the field of biosafety. Depending on the capacity of the organisation (an organisation included in the reference or laboratory network) or significance of its activities, individual commissions for chemical and radiation safety may also be established, or chemical and radiation safety issues may be co-ordinated by the biosafety commission with the involvement of relevant specialists.
11. The employees of the organisation shall undergo medical examination, according to the requirements of the Decisions of the Government of the Republic of Armenia No 347-N of 27 March 2003 and No 1089-N of 15 July 2004.
12. The gas supply, power supply, ventilation, water supply, sewerage systems must have smooth operation.
13. Possible evacuation plans must be posted in a visible place within the organisation.
14. The first-aid kit shall be placed in a visible and accessible place within the organisation, and shall be approved by the head of the state authorised body in the sector of healthcare.
15. The biosafety, chemical and radiation safety officers shall, according to the schedule established by the director of the organisation concerned, provide to the employees of the organisation dealing with biological, chemical and radiation factors, training on biosafety, biosecurity, chemical, radiation, fire safety rules, safety rules when working with electric appliances, and shall conduct testing of the knowledge acquired.
16. The organisation must be equipped with fire safety, first-aid and personal protective equipment, as of their area of use.
17. The personnel of the organisation must have knowledge of fire safety rules, fire protection measures and technical safety rules, principles of first aid, use of individual protective equipment. Fire extinguishers shall be placed in a visible place within the organisation, and laboratory personnel shall receive appropriate training on the use of fire extinguishers.
18. The authorised body of the field of healthcare of the Republic of Armenia shall approve the requirements to the activities on biosafety, biosecurity, chemical and radiation safety, based on which the director of each organisation shall approve the requirements to the activities of biosafety and biosecurity, chemical and radiation safety officer of the given organisation that are outlined in the job description of the position thereof or are defined in separate acts.
II. DESCRIPTION SPECIFICS OF THE SYSTEM OF LABORATORY BIOSAFETY, BIOSECURITY, SYSTEM OF CHEMICAL SAFETY AND RADIATION SAFETY
19. The director of each organisation dealing with biological factor shall approve the following:
(1) the laboratory biosafety and biosecurity plan incorporating all processes implemented to ensure biosafety and biosecurity within the given organisation;
(2) the laboratory biosafety and biosecurity manuals — the manual entitled as “Capacities of the biosafety specialist” (based on the requirements of CWA 16335:2011 standard), biological risk assessment standards (based on the requirements of CWA15793 standard);
(3) the infection control plan of the organisation incorporating also the medical surveillance issues of the personnel dealing with pathogenic biological agents (compulsory medical examination, immunoprophylaxis, special medical examination of the personnel using respirator masks, according to the respiratory protection plan);
(4) the biological waste management procedure;
(5) the biorisk assessment tools and templates (developed based on the model biorisk assessment tools and templates provided by the reference laboratory)
(6) the requirements to the work of the biosafety and biosecurity, chemical and radiation safety officer of the organisation;
(7) ongoing professional development programmes for the personnel of the organisation on matters of biosafety, biosecurity, chemical and radiation safety.
20. Each organisation shall use protective equipment to prevent the spread of the infection, including biosafety cabinets, automatic single-use drip equipment and other laboratory equipment, personal protective equipment, for the operation and maintenance whereof standard procedures for actions are adopted.
21. For the purpose of record-registration and storage of samples or pathogenic cultures with long-term or short-term storage within the organisation, the director of the organisation concerned shall approve the standard procedures for actions, according to which these processes are implemented.
22. The director of the organisation shall approve the insect and rodent control programmes. Disinsection and deratisation activities shall be carried out on a contractual basis as prescribed by the legislation of the Republic of Armenia.
23. The organisation engaged in chemical laboratory activities shall be located in a building with at least 2nd class fire resistance, based on fire-hazardous nature and flammability of the materials used, according to the Construction Standards “Fire Safety of Buildings and Premises” approved by the state authorised body in the field of urban development of the Republic of Armenia.
24. Laboratory workstations and equipment shall be marked with job-specific labels and the international biosafety symbol.
25. The director of each organisation dealing with a chemical factor shall approve the following:
(1) the laboratory chemical safety programme incorporating all processes implemented to ensure chemical safety in the laboratory concerned;
(2) the manual on laboratory chemical safety;
(3) the chemical risk assessment standards;
(4) the laboratory chemical contamination control programme;
(5) the chemical waste management procedure;
(6) templates, designed for the given laboratory, for chemical risk assessment in the chemical laboratory that are developed based on model chemical risk assessment tools.
26. The organisation engaged in chemical laboratory activities must have a reserve supply of neutralizing agents for chemical reagents.
27. After work the employees, including the duty officer and safety officer, shall be obliged to inspect the condition of the workstations.
28. At the end of the working day the safety officer of the organisation shall, along with the duty officer, lock up the organisation, activate the alarm system and put the building of the organisation under security based on the contract with the Security Department of the Police of the Republic of Armenia adjunct to the Government of the Republic of Armenia.
29. Employees of the organisation dealing with radioactive materials shall, once a year, undergo medical examination as prescribed by the Radiation Safety Rules approved by the Decision of the Government of the Republic of Armenia No 1489-N of 18 August 2006.
30. The organisation designed to handle radioactive materials shall be located in a separate building or in a section or on the floor separated from other premises of the general-purpose building.
31. The organisation shall ensure the physical protection of existing radioisotope sources and temporarily stored radioactive waste; the radioisotope sources shall be stored in metal cabinets with a secure lock, and the sections where these cabinets and radioactive waste containers are located shall be locked, sealed, and equipped with reliable video surveillance and alarm systems.
32. The organisation shall keep records of existing radioisotope sources and temporarily stored radioactive waste as prescribed by the legislation of the Republic of Armenia.
33. The power supply panels of the organisation, as well as its control facilities for water supply, heat supply, gas supply and other general systems shall be located outside the working sections.
34. All sections of the organisation shall be equipped with the exhaust ventilation system and air-filtering equipment to prevent the release of radioactive materials into the external environment.
35. The furniture, equipment, devices and tools within the organisation shall be attached to the sections wherein they are mainly used. They shall be appropriately labelled and may be transferred to other sections only if they undergo radiometric monitoring and the existing label is replaced.
36. The organisation shall constantly maintain an emergency reserve of deactivating materials.
37. The personnel of the organisation shall have knowledge of the radiation safety rules.
38. The director of each organisation dealing with a radiation factor shall approve the following:
(1) the laboratory radiation safety programme incorporating all processes implemented for radiation safety within the organisation concerned;
(2) the radioactive waste management procedure;
(3) templates, designed for the given organisation, for radiation risk assessment in the organisation that are developed based on model radiation risk assessment tools;
(4) the procedure for examining the laboratory personnel for radioactive contamination after dealing with radioactive materials;.
(5) requirements to the personal protective equipment of the personnel of the organisation dealing with radiation factors and those to their use;
(6) radiation safety instructions (developed by the radiation safety officer of the organisation in accordance with the Radiation Safety Rules approved by the Decision of the Government of the Republic of Armenia No 1489-N of 18 August 2006 and agreed with the Chairperson of the State Nuclear Safety Regulatory Committee adjunct to the Government of the Republic of Armenia).
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Minister-Chief of Staff of the Government of the Republic of Armenia |
D. Harutyunyan |
Published on a joint site 09.07.2025.
| Փոփոխող ակտ | Համապատասխան ինկորպորացիան |
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| Փոփոխող ակտ | Համապատասխան ինկորպորացիան |
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