ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of September 13, 2010 No. 932

About approval of the technical regulation "Requirements to Safety of Blood and Its Components Used in Haemo Transfusion Therapy" and modification of the order of the Government of the Republic of Kazakhstan of December 29, 2009 No. 2243

According to the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed technical regulation "Requirements to Safety of Blood and Its Components Used in Haemo Transfusion Therapy".

2. Bring in the order of the Government of the Republic of Kazakhstan of December 29, 2009 No. 2243 "About approval of the Plan for development of technical regulations" the following change:

in the Plan for development of technical regulations approved by the resolution:

in the column 20, the word of "products" to replace 2 lines, sequence number with the word of "components".

3. This resolution becomes effective after six months from the date of the first official publication.

Approved by the order of the Government of the Republic of Kazakhstan of September 13, 2010, No. 932

Technical regulation "Requirements to Safety of Blood and Its Components Used in Haemo Transfusion Therapy"

1. Scope

1. This technical regulation "Requirements to Safety of Blood and Its Components Used in Haemo Transfusion Therapy" (further - the Technical regulation) is developed according to requirements of the Law of the Republic of Kazakhstan "About technical regulation".

2. This Technical regulation establishes requirements to safety of blood and its components used in haemo transfusion therapy taking into account risk degree for health of the population.

3. Objects of technical regulation concerning which this Technical regulation establishes safety requirements are the donor blood of the person entering the Single commodity nomenclature of foreign economic activity of custom union (The ETN foreign trade activities code of TS 3002 10 950) and its components used when performing transfusion therapy.

2. Terms and determinations

4. In this Technical regulation the following main terms and determinations are used:

1) apirogennost - absence in object of technical regulation of the substances causing undesirable temperature reaction in the person;

2) asepsis - package of measures for prevention of hit of potential causative agents of infectious diseases on object of technical regulation, surface, fabric, in bodies and the patient's cavities;

3) aferez - removal from the circulating blood of separate components of blood and their procurement with use of special separators of blood cells;

4) haemo transfusion therapy - method of treatment in case of which donor components and medicines of blood are used;

5) AB0 blood types - various combinations of anti-genes of erythrocytes (agtlyutinogen) and antibodies in relation to them (agglutinins) which are in blood plasma (combination of certain anti-genes on surface of erythrocytes and certain antibodies in blood serum;

6) cross pollution - pollution of materials or products other materials or products;

7) the donor - the physical person who showed voluntary willingness to perform giving (donation) blood and its components for the medical purposes;

8) contamination - pollution of initial raw materials, materials, semi-product or ready-made product foreign impurity;

9) blood type - the term covering all genetically inherited factors which manage to be revealed in the blood of the person which are not changing during life;

10) blood components - the blood components allocated in the form of plasma and uniform elements (blood cells and acellular circles), having directed therapeutic properties;

11) whole blood (donor) - the blood taken from the donor with use of sterile and apirogenny anticoagulant and container. Generally whole blood is intended for preparation of components of blood;

12) blood medicines - the medicines received in case of conversion of components (plasma) of blood;

13) leykofiltration - removal of leukocytes from blood and its components by means of special leykotsitarny filters;

14) pathogenic biological agents - the microorganisms capable in case of hit (introduction) in human body to cause infectious condition (clinically expressed disease or carriage);

15) plasma - the liquid component of blood exempted from its uniform elements;

16) plasma exchange - the procedure of donation of blood providing procurement of plasma from the donor with the return transfusion to it blood cells;

17) determination the Rhesus factor - accessories - consists in identification in blood of people of availability or lack of anti-genes of erythrocytes of system Rhesus factor (D, With, E). All groups which contain anti-gene of Rho (D) it is conditionally considered to be Rhesus factor positive (Rh+), all groups which are not containing anti-gene of Rho (D) - Rhesus factor negative (Rh-);

18) the recipient - the patient to whom transfusion of donor blood or its components is made;

19) transfusion infections - the infectious diseases which are transmitted to the recipient in case of transfusion of donor blood and its components. The most significant - HIV, parenteral hepatitises, syphilis, Cytomegaloviral and herpetic infections;

20) tsitaferez - the procedure of aferez intended for receipt of cellular components of blood, such as erythrocytes, leukocytes or platelets (method of receipt of cellular components of blood from one donor with use of automatic separators of blood).

3. Dangerous factors (risks) arising when using objects of technical regulation

5. The blood and its components used in haemo transfusion therapy have risks of damnification to health and human life and processes which include the following risks:

1) the infectious diseases caused by availability of pathogenic biological agents;

2) the complications connected with bacterial infection of blood and its components;

3) pyrogene reactions;

4) the immunological reactions connected with incompatibility of blood of the donor and recipient;

5) the complications connected with abuse of regulations of procurement, conversion, storage, transportation and use of donor blood and its components.

6. Processes in case of which there are above-stated risks are processes of fence, conversion (production) of storage, use, transportation.

7. Decrease in above-mentioned exposure hazards on human body of blood, its components used in haemo transfusion therapy to minimum and their prevention shall be performed:

1) in case of new product development and technology of its production which include the following stages:

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