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  • ASTM
    F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
    Edition: 2017
    $144.00
    Unlimited Users per year

Description of ASTM-F3206 2017

ASTM F3206-17

Active Standard: Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies




ASTM F3206

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.


Keywords

catheter; cell compatibility; cell therapy; cytocompatibility; medical device; stem cells;


ICS Code

ICS Number Code 11.100.01 (Laboratory medicine in general)


DOI: 10.1520/F3206-17



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