Sec. 52-5.10. Required records of tissue acquisition, testing, processing and storage

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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.

                    
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