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Title: Section 52-5.1 - Definitions

Effective Date


Section 52-5.1 Definitions.

For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Batchmeans a specific quantity of tissue that is intended to have uniform characteristics and quality within specific limits, and is produced according to the same processing protocol and during the same processing cycle.

(b) Musculoskeletal tissue donormeans a human being, living or dead, who is the source of musculoskeletal tissue, including autogeneic tissue, for transplantation. (c) Critical work areameans an area where sterile tissue containers or aseptically retrieved tissue are exposed to the environment.

(d) Critical surfacemeans a surface which comes into contact with aseptically retrieved tissue, sterile tissue containers or sterile container covers.

(f) Controlled work areameans an area where unsterilized tissue, in-process materials and tissue containers are handled.


VOLUME A-1 (Title 10)