1 Scope 1.1
This Standard addresses issues related to the safety of donated tissues used for assisted reproduction purposes. It includes aspects of safety for the potential and actual donors and recipients, any children born as a result of an assisted reproduction procedure, personnel, and others who may be exposed to or affected by the transplant of reproductive tissues. This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in the donor suitability assessment, retrieval, processing, preservation, packaging, labelling, storage, quarantine, evaluation, recordkeeping,
adverse event reporting, distribution, importation or exportation, and recall of tissues for assisted reproduction. 1.2
This Standard applies to the establishments (or facilities) and individuals specified in Clause 1.2 of CSA Z900.1. 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
The requirements in this Standard apply to reproductive tissues intended for use by third parties (i.e., recipients who are not the donor?s spouse or sexual partner). It is recommended that these requirements be applied to autologous donations whenever feasible, to ensure tissue integrity and function. 1.5
This Standard contains particular requirements for tissues for assisted reproduction and is intended to be used with the CSA Z900.1 general requirements Standard. Where differences exist, the requirements of this Standard apply. 1.6
The safety of all donated tissues used for assisted reproduction in Canada, wherever procured, is the
responsibility of the reproductive tissue processors and designated importers. 1.7
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.