10 CRR-NY 52-5.1NY-CRR
10 CRR-NY 52-5.1
10 CRR-NY 52-5.1
52-5.1 Definitions.
For the purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:
(a) Batch means 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 donor means a human being, living or dead, who is the source of musculoskeletal tissue, including autogeneic tissue, for transplantation.
(c) Critical work area means an area where sterile tissue containers or aseptically retrieved tissue are exposed to the environment.
(d) Critical surface means a surface which comes into contact with aseptically retrieved tissue, sterile tissue containers or sterile container covers.
(e) Controlled work area means an area where unsterilized tissue, in-process materials and tissue containers are handled.
10 CRR-NY 52-5.1
Current through May 31, 2021
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IMPORTANT NOTE REGARDING CONTENT CURRENCY: JULY 31, 2023, is the date of the most recently produced official NYCRR supplement covering this rule section. For later updates to this section, if any, please: consult editions of the NYS Register published after this date; or contact the NYS Department of State Division of Admisnistrative Rules at [email protected]. See Help for additional information on the currency of this unofficial version of the NYS Rules.