Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:35
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 35
Character Range: 36055–37043

35  Excised cornea—testing of storage medium etc.
 (1) Where excised cornea is stored in accordance with subparagraph 34(b)(ii), then:
 (a) the storage medium must be tested for microbial contamination using a validated test method prior to transfer of the tissue to a transport medium; and
 (b) subsequent exposure to the transport medium at a temperature validated to maintain tissue quality must not exceed 5 days.
 (2) If testing of the storage medium in accordance with paragraph (1)(a) demonstrates evidence of microbial contamination, then:
 (a) where the excised cornea has not been released for supply—the excised cornea must be rejected for therapeutic use; or
 (b) where the excised cornea has been released for supply—the results of the microbial tests must be reported to the medical practitioner who is responsible for the administration to, or application in the treatment of, the recipient of the product in accordance with the documented procedures of the manufacturer.