Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:41
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 41
Character Range: 38589–39314

41  Bioburden testing
 (1) Human skin sampled in accordance with subsection 40(1) must be tested for bioburden and, following that testing, must:
 (a) demonstrate no microbial contamination with specified microorganisms; or
 (b) be rejected for therapeutic use if microbial contamination with specified microorganisms is demonstrated.
 (2) If bioburden testing in accordance with subsection (1) demonstrates microbial contamination with microorganisms other than specified microorganisms, then the results of the testing must be reported by the manufacturer of the human skin product to the medical practitioner who is responsible for the administration to, or application in the treatment of, the recipient of the product.