ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of January 26, 2010 No. 29

About approval of the technical regulation about the safety requirements of blood, its products, krovezameshchayushchy solutions and technical means used in transfusion and infusional therapy

According to the Federal Law "About Technical Regulation" Government of the Russian Federation decides:

1. Approve the enclosed technical regulation about the safety requirements of blood, its products, krovezameshchayushchy solutions and technical means used in transfusion and infusional therapy (further - the technical regulation).

The technical regulation becomes effective after 6 months from the date of official publication of this resolution, except for Sections 12 - the 15th appendices N 1 to the technical regulation regarding earlier prepared blood components which become effective after 30 months from the date of entry into force of the technical regulation.

2. To the Ministry of Health and Social Development of the Russian Federation in coordination with the interested federal executive bodies to submit within 6-month term in accordance with the established procedure in the Government of the Russian Federation the draft of the list of the national standards containing rules and methods of researches (testing) and measurements, including the rules of sampling necessary for application and execution of the technical regulation and implementation of assessment of conformity of products to requirements of the technical regulation.

Approved by the order of the Government of the Russian Federation of January 26, 2010, No. 29

The technical regulation about the safety requirements of blood, its products, krovezameshchayushchy solutions and technical means used in transfusion and infusional therapy

I. General provisions

1. This technical regulation establishes:

1) safety requirements of objects of technical regulation;

2) rules of identification of donor blood and its components;

3) rules and forms of assessment of conformity of objects of technical regulation to requirements of this technical regulation;

4) requirements to packaging and marking of donor blood and its components.

2. Treat objects of technical regulation concerning which this technical regulation establishes safety requirements:

1) donor blood and its components;

2) medicines from donor blood;

3) krovezameshchayushchy solutions;

4) the technical means used in transfusion and infusional therapy, in particular products of medical appointment (containers polymeric, systems, devices and devices of single application, including for connection of polymeric highways);

5) processes of procurement, conversion, storage, transportation, utilization, application and safety of donor blood and its components.

3. Requirements of this technical regulation do not extend to the haemo poetic (trunk) cages received from blood, marrow and other tissues of the person and also to the diagnostic medicines received from blood.

4. In case of fulfillment of requirements, established by this technical regulation, the necessary level of safety of life and health of citizens, and also the environment which source of infection can be donor blood and its components in the course of their procurement, conversion, storage, transportation and application is provided.

5. In case of development of technical means, held for use in transfusion and infusional therapy, and also in processes of procurement, storage, transportation, utilization, application and safety of donor blood and its components, the risks assessment of their impact on human body shall be performed.

At the same time the technical solutions providing increase in energy efficiency of these technical means shall be applied.

6. Information on exposure hazard of the technical means specified in Item 5 of this technical regulation on human body shall be available to all citizens who are exposed to manipulations or other contacts with objects of technical regulation of this technical regulation and to be provided by business entities without fail on requests of legal entities and physical persons, and also in case of assessment of conformity.

7. Requirements of this technical regulation are obligatory for execution by all legal entities performing procurement, conversion, storage, transportation, use of donor blood and its components, medicines and krovezameshchayushchy solutions.

8. The concepts used in this technical regulation mean the following:

1) "autologous transfusion" - the procedure of blood transfusion or its components with use of previously received blood or its components, in case of which the donor and the recipient the same person;

2) "аферез" - target release of plasma or cages from donor blood with return to the donor of residual components of blood;

3) "biological full value of donor blood and its components" - set of biological properties of donor blood and its components providing biological functions of blood;

4) "haemo transmissible infections" - the infections connected with infection through donor blood and its products;

5) "finished goods" - the donor blood and its components which underwent everything procedures of conversion and researches and intended for transfusion to the recipient or other use in the medical purposes;

6) "AB0 blood types" - the differentiation of blood on groups based on 4 combinations of erythrocytic antigens A and B, antibodies anti-And yes anti-In in serum of blood of the person;

7) "dose (unit) of blood or its component" - the amount of donor blood or its component containing in one container;

8) "donation" - process of blood extraction of the donor or its components intended for transfusion to the recipient or other use in the medical purposes;

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