Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:13
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 13
Character Range: 16230–18482

13  Bioburden testing requirements
 (1) Written specifications for HCT materials and biologicals must include specified microorganisms determined on the basis of a risk assessment.
 (2) Samples must demonstrate that HCT materials are free from contamination with specified microorganisms.
 (3) Samples must demonstrate that biologicals are:
 (a) free from microbial contamination; or
 (b) if, on the basis of a risk assessment, it is not necessary for the biological to be free from microbial contamination—free from contamination with specified microorganisms.
 (4) This section does not apply in relation to:
 (a) human cardiovascular tissue products to which Part 4 applies; and
 (b) human ocular tissue products to which Part 5 applies.
Note 1: Part 4 provides that human cardiovascular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only, and human cardiovascular tissue used in the manufacture of those products, must be free from microbial contamination. However, this section applies in relation to all other human cardiovascular tissue products.
Note 2: 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, this section applies in relation to all other human ocular tissue products.
 (5) Subsection (3) does not apply in relation to:
 (a) human musculoskeletal tissue products to which Part 3 applies; and
 (b) human skin products to which Part 6 applies.
Note 1: Part 3 provides that human musculoskeletal tissue products that are subjected to only minimal manipulation must be free from microbial contamination, and human musculoskeletal tissue used in the manufacture of those products must be free from contamination with specified microorganisms. However, subsection (3) applies in relation to all other human musculoskeletal tissue products.
Note 2: Part 6 provides that human skin products that are subjected to only minimal manipulation and human skin used in the manufacture of those products must be free from contamination with specified microorganisms. However, subsection (3) applies in relation to all other human skin products.