Clarification on the procedure for obtaining a license for the use of portable X-ray devices in veterinary medicine
Federal Law of 4 May 2011 , the number 99-FZ "On licensing of certain activities" is set , that the activities in the field of ionizing radiation sources (generation) (except in the case, If these sources are used in medical practice); subject to compulsory licensing. (Chapter 2, Article 12, paragraph 39)
ca.. By generating ionizing radiation sources include all X-ray machines.
Resolution of the Government of 2 April 2012 g. N 278 LICENSING OF ACTIVITIES IN THE FIELD OF USE OF RADIATION SOURCES (GENERATION) (Except in the case, If these sources are used in medical ACTIVITY) Unknown , that the licensing of the use of ionizing radiation sources (generation) (except in the case, If these sources are used in medical practice) implements Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Further – licensing authority). In accordance with the Regulations on the Federal Service for Supervision of Consumer Rights Protection and Human Welfare, approved by the Russian Federation Government 30.06.2004 g. № 322, RF Government Resolution 19.06.2012 № 612 "On amendments to some acts of the Government of the Russian Federation in connection with the change in the organization of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being", The Federal Service for Supervision of Consumer Rights Protection and Human Welfare issues licenses to operate, involving the use of infectious agents, and activity in the use of ionizing radiation sources.
Central office of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare is responsible for licensing activities: – activities in the field of ionizing radiation sources (except in the case, If these sources are used in medical practice):design, engineering, production of ionizing radiation sources and means of radiation protection, Operation of charged particle accelerators.
Territorial bodies of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare is responsible for licensing activities: – in the use of ionizing radiation sources (except in the case, If these sources are used in medical practice)-the following types of work: placement, exploitation, Maintenance, storage (medical X-ray machines, including dental (Diagnostic and therapeutic; portable and stationary); X-ray flaw (stationary and portable); devices for X-ray diffraction and X-ray analysis; X-ray equipment maintenance and process control (Thickness Gauges, densitometers, urovnomerov et al.); instruments for inspecting baggage and goods, neutron generators); disposal of ionizing radiation sources; Radiation protection operation.
ca.. zoobusiness companies received a reply from the Union of Rospotrebnadzor on licensing activities in the field of ionizing radiation sources in veterinary medicine. Deputy Head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor) I.V. Bragin reports, that in conformity with the Law № 99-FZ "On licensing of certain activities" is licensed activities in the field of ionizing radiation sources (except in the case, If these sources are used in medical practice). In accordance with the law "On veterinary» Veterinary activities - is an area of scientific knowledge and practice, to prevent animal diseases and their treatment, release of adequate and safe in respect of veterinary livestock products and the protection of the population against diseases, common to man and animals. For the reason that, that the veterinary activity is the work with the animals and does not provide services in relation to man, accordingly may not apply to works and services in the framework of medical practice. Rospotrebnadzor reported, that legal entities and individual entrepreneurs, carrying out veterinary activities, during which exploit the source of ionizing radiation, You must have a license for this type of activity, indicating the types of work (operation and storage source). To obtain a license the license applicants should contact the Office of Rospotrebnadzor place of business.
REQUIRED DOCUMENTS
1. Application for license (original, 1 PC.) Application for a license with the indication (name, organizational and legal form, of the legal entity (including location geographically separate units and facilities, used for the implementation of the licensed activity), licensed activity, that the license applicant intends to carry out, state registration number of records on the establishment of a legal entity and document data, confirming that the payment of the legal entity in the Unified State Register of Legal Entities, taxpayer identification number, and the document data about the production of the license applicant at the Tax Authority) for a legal entity. .
ca.. When filling out the application , In case if you do not have a separate room for the operation of the portable X-ray machine (X-ray room), After specifying the location of the legal entity must specify the location in the room where you plan to use the X-ray machine ( dressing room, operating or in the field).
2. constituent documents (notarized copy, 1 PC.) Copies of documents, not notarized, presented with the presentation of the original.
3. Documents, confirming that the workers licensing requirements and conditions (certified copy, 1 PC.) Copy of training set sample at least 1 every five years for radiation safety in the amount of not less than 72 hours. A copy of the document confirming the existence of higher or secondary special education.
4. The list of radiation sources, that the license applicant intends to use, including copies of legal documents on radiation sources and sanitary-epidemiological conclusions on radiation sources and work with them (certified copy, 1 PC.).
Detailed list of the documents available on the website of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare link: https://rospotrebnadzor.ru/gosserv/for/11/category/91/100/
In accordance with the Decree of the Government of 2 April 2012 g. N 278 Claim 8. When, If the application for granting a license executed in violation of the, specified in Paragraph 1 this article, and (or) documents, specified in part 3 this article, presented not in full, within three working days from the date of receipt of the application for a license the licensing authority gives the applicant the license notice of the need to address within thirty days of violations and (or) submission of documents, are missing, or sends a notification by registered mail with return receipt requested.
If a representative of the licensing authority requires, the license applicant, X-ray room, it shall notify, in writing, their demands and provide a normative document by which it imposes a requirement.
Currently, the primary standard document is SanPin 2.6.1.1192-03 “Hygiene requirements for the design and operation of X-ray rooms, devices and conduct radiological examinations” (approved. Chief state sanitary doctor of the Russian Federation 14 February 2003 city).
When using the mobile and portable devices outside the X-ray room (the wards, operating) provides for the following events:
– finding people at certain distances and for a time, designed for this type of X-ray machines and specified in the instructions for their operation;
– Improvement selection for permanent or temporary storage of X-ray machines;
– radiation direction towards, where there is the smallest number of people;
– removing people at the greatest possible distance from the X-ray machine;
– limit time people stay near the X-ray machine;
– the use of mobile means of radiation protection;
– the use of staff and patients of personal protective equipment.
CONCLUSION
To use the portable X-ray machines must be:
1) Ensure that the conditions p. 7.24 SanPin 2.6.1.1192-03 “Hygiene requirements for the design and operation of X-ray rooms, devices and conduct radiological examinations” (approved. Chief state sanitary doctor of the Russian Federation 14 February 2003 city).
2) Have a staff organization (legal entity or individual entrepreneur) specialists having certificates of advanced training on cycle “Radiation safety of staff and patients during X-ray examinations”.
3) License to use ionizing radiation sources (generation).
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