Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:15
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 15
Character Range: 18649–20140

15  Collection from deceased donors
 (1) HCT materials must be collected from a deceased donor as soon as possible after asystole, and collection must be completed:
 (a) if the body has been refrigerated below 10°C within 12 hours of asystole—not later than 24 hours after asystole; or
 (b) if paragraph (a) does not apply—not later than 15 hours after asystole.
 (2) This section does not apply in relation to:
 (a) human musculoskeletal tissue products to which Part 3 applies; and
 (b) human ocular tissue products to which Part 5 applies; and
 (c) human amnion products to which Part 7 applies.
Note 1: Part 3 provides requirements in relation to the collection of human musculoskeletal tissue used in the manufacture of human musculoskeletal tissue products that are subjected to only minimal manipulation. However, this section applies in relation to all other human musculoskeletal tissue products.
Note 2: Part 5 provides requirements in relation to the collection of human ocular tissue used in the manufacture of 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.
Note 3: Part 7 provides requirements in relation to the collection of human amnion used in the manufacture of human amnion products that are subjected to only minimal manipulation. However, this section applies in relation to all other human amnion products.