Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 1
Definitions 1 The following definitions apply in these Regulations. accident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws and that could adversely affect the safety of a transplant recipient or the safety, efficacy or quality of cells, tissues or organs. ( accident ) Act means the Food and Drugs Act . ( Loi ) adverse reaction means an undesirable response in the recipient to transplanted cells, tissues or organs, including the transmission of a disease or disease agent. ( effet indésirable ) banked , with respect to cells and tissues, means processed cells and tissues that have been determined safe for transplantation and that are stored by the source establishment in its inventory and available for distribution or transplantation. ( mise en banque ) cell means the fundamental biological unit of a human organism that is for use in transplantation. ( cellule ) distribute does not include to transplant. ( distribution ) donor means a living or deceased person from whom cells, tissues or organs are retrieved. ( donneur ) donor assessment record includes the donor screening, any available donor testing results, information obtained from the donor’s medical records and a copy of the donor consent. ( dossier de l’évaluation du donneur ) donor identification code means the unique numeric or alphanumeric designation that is assigned by the source establishment to a donor under section 56 and that associates each cell, tissue and organ, or part of one, to that donor. ( code d’identification du donneur ) donor screening means an evaluation based on the donor’s medical and social history and physical examination, the results of any diagnostic procedures performed, and, if applicable, the autopsy. ( évaluation préliminaire du donneur ) donor suitability assessment means an evaluation based on the donor screening and (a) in the case of lymphohematopoietic cells, tissues and organs retrieved from live donors and of tissues retrieved from deceased donors, all donor testing results; and (b) in the case of fresh skin, islet cells and organs retrieved from deceased donors, the donor testing results that are necessary at the time of transplantation. ( évaluation de l’admissibilité du donneur ) donor testing means the laboratory tests and measurements done on a donor or donor specimen to determine all of the following: (a) whether the donor has or ever had a transmissible disease or is or ever was infected with a transmissible disease agent; (b) donor compatibility; and (c) the degree of functionality of the cell, tissue or organ that is to be retrieved. ( examen du donneur ) error means a deviation from the standard operating procedures or applicable laws that could adversely affect the safety of a transplant recipient or the safety, efficacy or quality of cells, tissues or organs. ( manquement ) establishment means a person, a partnership or an unincorporated entity, or a part of any of them, that carries out any of the following activities in respect of cells, tissues or organs: (a) importation; (b) processing; (c) distribution; and (d) transplantation. ( établissement ) exceptional distribution means the distribution under sections 40 to 42 of cells, tissues or organs that have not been processed under these Regulations. ( distribution exceptionnelle ) exterior label means the label that is affixed to the exterior package. ( étiquette extérieure ) exterior package means the outermost package in which a cell, tissue or organ is delivered, transported or shipped. ( emballage extérieur ) general standard means National Standard of Canada CAN/CSA-Z900.1 entitled Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements , as amended from time to time. ( norme générale ) homologous , in respect of a cell, tissue or organ, means that the cell, tissue or organ performs the same basic function after transplantation. ( homologue ) interio