Commonwealth Consolidated Regulations

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Definitions relating to goods comprising etc. human cells and tissues

  (1)   This regulation applies to goods that comprise, contain, or are derived from human cells or tissues.

  (2)   The human cells or tissues are the original cells or tissues .

  (3)   The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.

  (4)   Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient ), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.

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