Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:24
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 24
Character Range: 27872–28851

24  Storage and transportation
  Human musculoskeletal tissue products must be:
 (a) stored as follows:
 (i) at minus 20°C to minus 40°C for not more than 6 months after the collection of the human musculoskeletal tissue; or
 (ii) frozen or cryopreserved at less than minus 40°C for not more than 5 years after the collection of the human musculoskeletal tissue; or
 (iii) if the products are freeze‑dried—at room temperature for not more than 5 years after the collection of the human musculoskeletal tissue; or
 (iv) in accordance with conditions that are validated on the basis of validated data or documented evidence from relevant scientific literature, including justified time and temperature specifications, to ensure the quality, safety and efficacy of the products; and
 (b) transported in a manner that ensures the relevant storage conditions specified in paragraph (a) are maintained during transportation.

Part 4—Standard for human cardiovascular tissue products