scope:

This Standard addresses issues related to the safety of human cells of lymphohematopoietic origin used for transplantation purposes. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who may be exposed to or affected by the transplant of lymphohematopoietic cells.

This Standard applies to establishments (or facilities) performing transplantation of lymphohematopoietic cells, and establishments (or facilities) and individuals involved in the donor suitability assessment, collection, processing, preservation, packaging, labelling, storage, quarantine, evaluation, recordkeeping, adverse event reporting, distribution, importation or exportation, and recall of lymphohematopoietic cells intended for transplantation, including

a) clinical transplant programs;

b) collection facilities for lymphohematopoietic cells; and

c) processing facilities for lymphohematopoietic cells.

Note: The establishments (or facilities) listed in Items a) to c) may exist in the same geographical location or be physically separated and/or independently operated.

This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.

This Standard does not address the collection, processing, or administration of erythrocytes, mature granulocytes, platelets, plasma, or plasma-derived products intended for transfusion support.

This Standard contains particular requirements for lymphohematopoietic cells for transplantation and is intended to be used with the CSA Z900.1 general requirements Standard. Where differences exist, the requirements of this Standard apply.

In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements.