Section 2: Health safety rules

The provisions of this sub-section apply to any removal of organs, tissues or cells and any collection of products carried out with a view to their use or that of their derivatives for therapeutic purposes for others, including in the context of biomedical research within the meaning of Article L. 1121-1. The provisions of this sub-section also apply in the case of incorporation of these elements or products, in particular…

I – Prior to any removal or collection of elements and products of the human body for therapeutic purposes from a living or deceased person, doctors and, in the situation referred to in IV, midwives ensure the identity of the potential donor and compliance with the health safety rules in force. II – The doctors and, where appropriate, the midwives will screen potential donors. The aim of this selection is…

The clinical selection of donors referred to in article R. 1211-13 is supplemented for any removal or collection of elements and products of the human body for therapeutic purposes by medical biology analyses intended to diagnose certain transmissible infectious diseases. In the event of a positive diagnosis, the grafting or use of human body products for therapeutic purposes is prohibited. The list of infectious diseases mentioned in the previous paragraph…

When elements of the human body used on French territory are imported from a State in which one or more of the medical biology analyses mentioned in article R. 1211-14 are not performed, they are accompanied by a biological sample enabling these analyses to be performed in France prior to any therapeutic use. The infectious disease(s) likely to be the subject of this procedure are set by an order of…

The analyses provided for in article R. 1211-14 are supplemented, depending on the nature of the samples envisaged, by other medical biology analyses designed to diagnose transmissible infectious diseases, the results of which, even if they reveal a risk of transmission or if they are not yet known at the time of the transplant, do not prohibit the transplant. The list of infectious diseases and the conditions under which the…

An order of the Minister for Health sets out : 1° The nature of and conditions for carrying out medical biology tests to detect infection markers; 2° Where technically possible, the nature and conditions for carrying out medical biology analyses to detect infectivity markers; 3° The nature of the analysis consisting of searching for the virus genome; 4° The procedures for using the results of the analyses defined in this…

One or more samples of the biological product used to carry out the medical biology analyses provided for in articles R. 1211-14 to R. 1211-16 are kept under conditions set by order of the Minister for Health.

I.-In order to be used for therapeutic purposes, any element or product of the human body removed or collected must be accompanied by information relating in particular to the clinical and biological selection of donors, labelling and traceability of the element or product, the content of which is specified by order of the Minister for Health. II – The user doctor or dental surgeon is obliged to take note of…

I. – The purpose of traceability of elements and products of the human body is to establish the link between the donor and the recipient, from the time of removal to the time of therapeutic use or destruction, and vice versa. This traceability is established : 1° By information, the nature and content of which are laid down by order of the Minister for Health; 2° And, as far as…

When the nature of the element or product of the human body removed or collected and the uses envisaged for it allow this without impairing the effectiveness of these uses, treatments, in particular physical or chemical treatments, to eliminate or inactivate infectious agents that reduce the risks of transmission are carried out.