Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:27
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 27
Character Range: 29614–30460

27  Tissue not subjected to a bioburden reduction process
 (1) Human cardiovascular tissue that is not subjected to a bioburden reduction process must be collected, subjected to any processing prior to packaging, sampled for bioburden testing, packaged in an operating theatre, transported to a manufacturing site, and cryopreserved.
 (2) The cryopreservation of human cardiovascular tissue mentioned in subsection (1) must commence:
 (a) in the case of a deceased donor—within 48 hours of asystole; or
 (b) in the case of a living donor—within 48 hours of collection.
 (3) Human cardiovascular tissue that is sampled in accordance with subsection (1) must be tested for bioburden and, following that testing, must:
 (a) demonstrate no microbial contamination; or
 (b) be rejected for therapeutic use if microbial contamination is demonstrated.