NORMATIVE DOCUMENTS

The Statute of FSUE "RIHTOP" at FMBA, Russia. The Federal Medical and Biological Agency, Decree No 5 of 23 January 2006 have approved this document.

The Certificate of accreditation (No. CA 13.151 of 11 June 2011) has been issued by the Russian Federal Agency on surveillance in the area of consumer rights protection and human welfare, and by State System of Sanitary and Epidemiological Control. This document grants the right to the RIHTOP for the development of normative and methodic documents relating to hygienic standards (HS), methodic instructions (MI), sanitary rules (SR), sanitary standards (SS), guidelines (G), sanitary rules and norms (SanRuN), and methodic instructions on control procedures (MIC).

The Commission on problems of pre-clinical and clinical investigations of medicines at the Federal Agency on surveillance in health and social development field (Roszdravnadzor) has included the Federal State Unitary Enterprise - Research Institute of Hygiene, Toxicology and Occupational Pathology - in the list of organizations and facilities engaged in the implementation of pre-clinical investigations of medicines. As of 27 January 2011, No. 04Н-34/11 Roszdravnadzor's letter had been issued.

Federal Medical and Biological Agency (FMBA Russia) issued a certificate of accreditation № 77.777.000.000015.1010 on 29/10/2010, certifying that the FSUE "RIHTOP" may be called as an expert organization for an survey of territories, buildings, structures, facilities, equipment, vehicles and transported goods used for activities; can carry out sampling of products, objects of ecological and work environment and their studying, testing, examination and investigations aimed at establishing a causal link of identified violations of the mandatory requirements to factors of injury.

The Administration of the Federal Security Service of Russia for the Volgograd Region issued a license 0023516 to work with information classified as state secret. Identification Number 1044-LZ 05.12.2012.

The Department of Implementation of Conventional Liabilities of the Ministry of Industry and Trade of the Russian Federation issued a license No 10236-UKh-PU dd. March 5, 2009 to perform works on and render services for chemical weapon storage, transportation, and disposal.

On March 30, 2011, FSUE RIHTOP FMBA Russia was issued a License No. FS-34-01-001485 (Series FS-1, No. 0119240) by the Federal Service on Surveillance in Healthcare and Social Development for the right to perform medical activities in the following areas: before-doctor medical care; outpatient and polyclinic medical care including specialized medical support of clinical laboratory diagnostics, occupational pathology, expert proficiency evaluation, and expert evaluation of occupational causation of diseases.

Accreditation Certificate of Testing Laboratory (Facility) # ROSS RU.0001.518718 was awarded to FSUE “RIHTOP” FMBA, Russia by Federal Agency on Technical Regulating and Metrology on October 28, 2011. The Certificate proves that Laboratory Facility FSUE “RIHTOP” FMBA Russia is certified for its technical expertise and independence to perform works during tests according to the area of certification:

  • on the objects of environmental industrial control for adherence to sanitary rules (water – organoleptic indicators, general sanitary parameters, acute, subacute and chronic toxicity, sanitary-hygienic parameters; soil – migration, translocation, and general sanitary indicators; production and consumer waste - migration indicator, acute, subacute and chronic toxicity, hazard of waste, impact on plants and animals, impact on biological activity);
  • on the factors of industrial environment and working process (microclimate, noise, light environment, difficulty, intensity);
  • on the objects of qualitative analysis (water – assessment by basic signs of harmfulness, atmospheric air – assessment of sanitary-hygienic parameters, soil – assessment by the basic indicators of harmfulness, waste – determination of hazard class basing on toxicity degree, industrial environment – assessment of the factors by degree of harmfulness and hazard);
  • on sampling from the objects of analytical control (air of working zone, atmospheric air, soil, water, production waste).

Federal Accreditation Service of Ministry of Economic Development of the Russian Federation (Rosakkreditatsiya) have accredited Chemistry Department of FSUE “RIHTOP” of FMBA Russia in Integrated National Accreditation System with issuing of Accreditation certificate of testing laboratory № ROSS RU.0001.518981 (РОСС RU.0001.518981) for testing in accordance with approved area of accreditation:

  • Objects subjected to social-hygienic monitoring (soil – lewisite, mustard, sarin; water – lewisite, mustard, Vx, soman, sarin);
  • Factors of industrial (working) zone (air of working zone – Vx, soman, sarin; wipe-samples from skin covering – lewisite, mustard, Vx, soman, sarin, arsenic; wipe-samples from technological equipment surfaces – lewisite, mustard, Vx; wipe-samples from surfaces of personal protective equipment – soman, Vx);
  • Objects of industrial ecological control for adherence to sanitary rules, objects of R&D works (water – aluminum, beryllium, cadmium, cuprum, arsenic, nickel, nitrate-ions, nitrite-ions, lead, sulfate-ions, phosphate ions, fluoride-ions, chloride-ions, chrome; soil – arsenic; ash from incinerators of chemical weapons destruction facilities – mustard, lewisite, soman, sarin, arsenic; waste of metal structures after roasting – mustard, lewisite, soman, sarin, arsenic; biomaterials – barium, beryllium, vanadium, cadmium, cobalt, lithium, manganese, cuprum, nickel, mercury, lead, selenium, argentum, strontium, thallium, titanium, chrome, zink.
  • Effective term - up to April 27, 2017.

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