Scope
1.1
This Standard addresses issues related to the safety of human tissues 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 tissues.
1.2
This Standard applies to establishments (or facilities) and individuals involved in the donor suitability assessment, retrieval, processing, preservation, packaging, labelling, storage, quarantine, evaluation, recordkeeping, adverse event reporting, distribution, importation or exportation, and recall of human tissues intended for transplantation, including
a) tissue banks;
b) tissue processing facilities;
c) cell culture laboratories;
d) transplant programs and facilities (hospital and clinic);
e) tissue retrieval organizations; and
f) other tissue-dispensing services.
1.3
This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.
1.4
This Standard contains particular requirements for tissues 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.
1.5
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.
