GSO ASTM F3206:2022
Gulf Standard
Current Edition
·
Approved on
12 May 2022
·
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
GSO ASTM F3206:2022 Files
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GSO ASTM F3206:2022 Scope
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.
1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
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