ASTM F3206-17 PDF

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.

ASTM F3206-17 Referenced Document

ASTM F2394 Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System*， 2022-10-01 Update
ASTM F2739 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds*， 2019-09-01 Update
ASTM F2809 Standard Terminology Relating to Medical and Surgical Materials and Devices*， 2024-04-20 Update
ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods

2017 ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies