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 potential and actual donors and recipients, any children born as a result of an assisted reproduction procedure, personnel, and others who might 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 processing, evaluation, recordkeeping, adverse event reporting, distribution, importation or exportation, and recall of tissues for assisted reproduction. Annex A is intended to provide guidance regarding reimbursements.
