ASTM F3206 PDF

1.1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to assess device cytocompatibility. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure, and relevant test procedure variables. Only cells suspended in liquid and infused through a device are considered. Cell therapies paired with scaffolds, suspended in hydrogels, or administered via other methods (e.g., tissue grafting) are not included in the scope of this document. This document does not address physical characterization of delivery devices, such as mechanics, composition, or degradation.