ASTM F2210 PDF

Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)

ASTM F2210 – Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)

1.1 This guide describes the processing, characterization,production, and quality assurance of cells, tissues, and organs used for TissueEngineered Medical Products (TEMPs). It concerns aspects of processing activitiesfor cells, tissues, and organs to be further processed. These aspects include:(1) cell, tissue, and organ processing (that is,facility, reagents, and procedures for receipt, inspection, and storage; tissueculture components, biological risk factors, and processing area), (2) donors (human and nonhuman) and screening, and (3) cell, tissue, and organ characterization and processing.

1.2 This guide does not apply to any medical productsof human origin regulated by the U.S. Food and Drug Administration (FDA) under21 CFR Parts 16 and 1270 (1)and 21 CFR Parts 207, 807, and 1271 (2).

1.3 This standard does not purport to address all ofthe safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practicesand determine the applicability of regulatory requirements prior to use.