Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:5
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 5
Character Range: 8670–10084

5  Standards
 (1) The matters specified in Part 2 constitute a standard for all biologicals.
 (2) The matters specified in Part 3 constitute a standard for human musculoskeletal tissue products that are subjected to only minimal manipulation.
 (3) The matters specified in Part 4 constitute a standard for human cardiovascular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only.
 (4) The matters specified in Part 5 constitute a standard for human ocular tissue products that are subjected to only minimal manipulation and are manufactured for allogeneic use only.
 (5) The matters specified in Part 6 constitute a standard for human skin products that are subjected to only minimal manipulation.
 (6) The matters specified in Part 7 constitute a standard for human amnion products that are subjected to only minimal manipulation.
Note 1: Part 2 constitutes a general standard that applies to all biologicals, whether or not the biological is also subject to a standard specified in Part 3, 4, 5, 6 or 7.
Note 2: Parts 3 to 7 constitute specific standards that apply to certain human musculoskeletal tissue products, human cardiovascular tissue products, human ocular tissue products, human skin products, and human amnion products, respectively.
Example: Human musculoskeletal tissue products to which Part 3 applies must comply with both Parts 2 and 3.