- (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.
In addition to the recordkeeping requirements of Subpart 52-2 of this Part, each musculoskeletal tissue bank shall maintain tissue records which include: