Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 1
 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 ) interior label means the label that is affixed to the interior package. ( étiquette intérieure ) interior package means the innermost package of a cell, tissue or organ that has a non-sterile exterior. ( emballage intérieur ) lymphohematopoietic standard means National Standard of Canada CAN/CSA-Z900.2.5 entitled Lymphohematopoietic Cells for Transplantation , as amended from time to time. ( norme sur les cellules lymphohématopoïétiques ) medical director , in respect of an establishment, means a physician or dentist who is licensed under the laws of the jurisdiction in which the establishment is situated to provide health care or dental care and who is responsible for the application of the standard operating procedures and for all medical or dental procedures carried out there, as the case may be. ( directeur médical ) minimally manipulated means (a) in respect of a structural tissue, that the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement; and (b) in respect of cells and nonstructural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility. ( manipulation minimale ) ocular standard means National Standard of Canada CAN/CSA-Z900.2.4 entitled Ocular Tissues for Transplantation , as amended from time to time. ( norme sur les tissus oculaires ) organ means a perfusable human organ for use in transplantation, whether whole or in parts, and whose specific function is intended to return after revascularization and reperfusion. It includes any adjunct vessels that are retrieved with the organ for use in organ transplantation. ( organe ) organ standard means National Standard of Canada CAN/CSA-Z900.2.3 entitled Perfusable Organs for Transplantation , as amended from time to time. ( norme sur les organes ) package insert means the document that is prepared by the source establishment to accompany a cell, tissue or organ. ( encart informatif ) processing , in respect of cells, tissues and organs, means any of the following activities: (a) donor screening; (b) donor testing; (c) donor suitability assessment; (d) retrieval, except for organs and islet cells; (e) testing and measurements performed on the cells, tissues or organs after they are retrieved; (f) preparation for use in transplantation, except for organs; (g) preservation; (h) quarantine; (i) banking; and (j) packaging and labelling. ( traitement ) quality assurance system means the co-ordinated activities of an establishment that relate to the safety of cells, tissues and organs. It includes (a) the standard operating procedures; (b) records to demonstrate that the standard operating procedures have been implemented; and (c) audit processes to verify that the standard operating procedures are being implemented. ( système d’assurance de la qualité ) scientific director , in respect of an establishment, means an individual who is responsible for the application of the standard operating procedures and for all technical procedures carried out there. ( directeur scientifique ) serious adverse reaction means an adverse reaction that results in any of the following consequences for the recipient: (a) their in-patient hospitalization or its prolongation; (b) persistent or significant disability or incapacity; (c) medical, dental or surgical intervention to preclude a persistent or significant disability or incapacity; (d) a life-threatening condition; and (e) death. ( effet indésirable grave ) source establishment means (a) subject to paragraph (b), in the case of an organ from a deceased donor, the relevant organ donation organization; (b) in the case of adjunct vessels that are retrieved with an organ and not used immediately in the organ tra