Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:34
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 34
Character Range: 35039–36055

34  Storage and transportation
  Human ocular tissue products must be stored as follows:
 (a) in the case of an eye globe—in a moist chamber system at 0°C to 10°C for not more than 48 hours after collection of the eye globe; or
 (b) in the case of excised cornea—either:
 (i) in a corneal storage medium at 0°C to 10°C for not more than 14 days after collection of the cornea; or
 (ii) in a storage medium at 28°C to 37°C for not more than 30 days after collection of the cornea; or
 (iii) in a cryopreservation medium between minus 75°C to minus 196°C for not more than 2 years after the collection of the cornea; or
 (c) in the case of sclera—maintained in at least 75% v/v ethanol solution for not more than 1 year after collection of the sclera; or
 (d) 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.