Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:30
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 30
Character Range: 31989–33382

30  Storage and transportation

     Human cardiovascular tissue
 (1) Immediately following collection and prior to processing in accordance with either section 27 or 28, human cardiovascular tissue must be:
 (a) stored as follows:
 (i) at a temperature between 0°C to 10°C; or
 (ii) as otherwise validated by the manufacturer to prevent microbial proliferation and to ensure the quality, safety and efficacy of the human cardiovascular tissue product manufactured using the tissue; and
 (b) transported in a manner that ensures the relevant storage conditions specified in paragraph (a) are maintained during transportation.

     Human cardiovascular tissue products
 (2) Human cardiovascular tissue products that are cryopreserved must be stored as follows:
 (a) at or below minus 100°C for not more than 5 years after collection of the human cardiovascular tissue; or
 (b) 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.
 (3) Human cardiovascular tissue products that are cryopreserved must be transported in a manner that ensures the relevant storage conditions specified in subsection (2) are maintained during transportation.

Part 5—Standard for human ocular tissue products