Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:12
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 12
Character Range: 15506–16230

12  Samples for bioburden testing
 (1) Samples must be taken for bioburden testing.
 (2) Samples must be:
 (a) taken using a validated sampling technique; and
 (b) tested using a validated test method.
Note: Subsections (1) and (2) apply in relation to all biologicals, other than human ocular tissue products to which Part 5 applies.
 (3) This section does not apply in relation to human ocular tissue products to which Part 5 applies.
Note: Part 5 specifies bioburden testing requirements in relation to human ocular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only. However, subsections (1) and (2) apply in relation to all other human ocular tissue products.