Title: Section 52-5.10 - Required records of tissue acquisition, testing, processing and storage

Effective Date

11/01/2000

52-5.10 Required records of tissue acquisition, testing, processing and storage. In addition to the recordkeeping requirements of Subpart 52-2 of this Part, each musculoskeletal tissue bank shall maintain tissue records which include:

(a) spark testing for vacuum in the case of freeze-dried tissue; and

(b) if the tissue is sterilized by ethylene oxide, amount of ethylene oxide, ethylene glycol and ethylene chlorhydrin residue for each type of musculoskeletal tissue within a batch.

Volume

VOLUME A-1 (Title 10)

up