LAW OF THE REPUBLIC OF BELARUS

of November 30, 2010 No. 197-Z

About donorship of blood and its components

Accepted by the House of Representatives on November 11, 2010

Approved by Council of the Republic on November 17, 2010

Chapter 1. General provisions

Article 1. The main terms used in this Law and their determinations

For the purposes of this Law the following main terms and their determinations are used:

autodonorstvo - the complex of actions including medical examination of the patient, blood extraction and (or) its components (further - blood, its components) at the patient in connection with the forthcoming carrying out concerning its difficult medical intervention which can be followed by blood loss, laboratory research, conversion, labeling, quality control, storage and transportation of blood, its components of the patient for the purpose of the subsequent transfusion to their this patient;

safety of blood, its components - set of properties and characteristics in case of which blood, its components do not pose hazard to life and health of the patient;

the auxiliary medical technologies applied in donorship of blood, its components (further - auxiliary medical technologies), - introduction in organism of the blood donor, its components (further - the donor) immunobiological medicines or erythrocytes (further - immunization of the donor), use of other medical technologies approved according to the procedure, established by the legislation;

mobile team on procurement of blood, its components (further - mobile team) - the structural division of the organization of service of blood performing procurement of blood, its components out of the organization of service of blood;

donation of blood, its components (further if other is not established, - donation) - complex of medical interventions on blood extraction, its components at the donor;

the donor - the patient who had medical examination and taking blood test, its components including the patient to whom auxiliary medical technologies are applied;

donor function - passing by the donor of medical examination, application concerning the donor of auxiliary medical technologies and (or) donation;

donorship of blood, its components (further - donorship) - complex of the actions aimed at providing and direct implementation of procurement of blood, its components;

unit (dose) of component of blood - blood component amount which can be, as a rule, made by conversion of one unit (dose) of blood;

unit (dose) of blood - 450 milliliters plus-minus of 10 percent of whole blood without amount of the preserving solution;

procurement of blood, its components - the complex of actions including medical examination of the donor, application concerning the donor of auxiliary medical technologies, donation, laboratory research, conversion, labeling and quality control of blood, its components;

karantinization - storage of components of blood with prohibition of their use on purpose throughout the period of time established by the legislation for the purpose of decrease in risk of transfer of pathogenic biological agents;

quality of blood, its components - compliance of blood, its components to the requirements established by acts of the legislation;

blood components - the blood components (leukocytes, plasma, platelets, erythrocytes) taken from the patient or made by conversion of blood of the patient and intended for medical application, industrial production of medicines productions of products of medical appointment, use in the scientific purposes and (or) educational process;

contract manufacturing of medicines from blood, its components (contractual fractionation) - industrial production of medicines based on the contract for contract manufacturing according to which the domestic manufacturer of medicines on the processing equipment belonging to it on the property right, economic maintaining, operational management or other legal cause makes medicines from blood, its components provided by the legal entity - the customer of production of such medicines, with the subsequent transfer of the made medicines to this legal entity - to the customer;

blood - the whole blood taken from the patient intended for medical application, conversion for the purpose of production of components of blood and also for industrial production of medicines, production of products of medical appointment, use in the scientific purposes and (or) educational process;

blood isoimmune - the blood containing specific proteinaceous structures against antigens of fabrics or cells of human body (isoimmune antibodies) of natural origin or developed by immunization of the donor;

blood immune - the blood containing specific proteinaceous structures against antigens of biological agents (immune antibodies) of natural origin or developed by immunization of the donor;

medical application of blood, its components - use by health workers of blood, its components in case of delivery of health care;

mobile complex for procurement of blood, its components (further - mobile complex) - the vehicle which is specially intended for procurement of blood, its components out of the organization of service of blood;

Proper practice of subjects of the address of blood, its components (further - Proper practice) - the regulatory legal act approved by the Ministry of Health and establishing requirements for the organization of the address of blood, its components;

adverse effect of blood transfusion, its components - transfusion reaction, posttransfusion complication;

depletion of blood, its components leukocytes (further - depletion by leukocytes) - conversion of blood, its components for the purpose of decrease in residual quantity of leukocytes in unit (dose) of blood, unit (dose) of component of blood;

radiation by ionizing radiation - conversion of blood, its components for the purpose of the prevention of origin at the recipient transfuzionno the caused disease "transplant against the owner";

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