S.L. 483.1 Art. 2Interpretation.

In these regulations unless the context otherwise requires:

"the Act" means the Human Blood and Transplants Act;

"allogeneic use" means cells or tissues removed from one person and applied to another; "autologous use" means cells or tissues removed from and applied in the same person; "cells" means individual human cells or a collection of human cells when not bound by any form of connective tissue; "Directive 2004/23/EC" means the Dirctive of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells; "Directive 2006/17/EC" means the Directive of the European Parliament and of the Council of the 8th February 2006 as regards certain technical requirements for the donation, procurement and testing of human tissues and cells as amended by Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells; "direct use" means any procedure where cells are donated and used without any banking; "distribution" means transportation and delivery of tissues or cells intended for human applications; "donation" means donating human tissues or cells intended for human applications;

"donor" means every human source, whether living or deceased, of human cells or tissues;

"human application" means the use of tissues or cells on or in a human recipient and extracorporal applications;

"organ" means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy; "partner donation" means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship;

"preservation" means the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues; "processing" means all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications;

"procurement" means a process by which tissue or cells are made available;

"procurement organisation" means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment; "quality system" means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly; "quarantine" means the status of retrieved tissue or cells, or tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection; "reproductive cells" means all tissues and cells intended to be used for the purpose of assisted reproduction; "serious adverse event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity;

"serious adverse reaction" means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;

"standard operating procedures" (SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product; "storage" means maintaining the product under appropriate controlled conditions until distribution; "tissue" means all constituent parts of the human body formed by cells; "tissue establishment" means a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells; "traceability" means the ability to locate and identify the tissue or cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue or cells, and the ability to identify any recipient at the medical facility or facilities applying the tissue or cells to any recipient< traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues or cells;

"validation" (or "qualification" in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, SOP, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use.