CAN/CSA-Z900.2.1-12

1 Scope 1.1 This Standard addresses issues related to the safety of donated tissues used for third party assisted reproduction. It includes quality system requirements and 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 use 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.