ASTM F3206-17
(Guide)Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
SIGNIFICANCE AND USE
4.1 This guide is designed to assist medical device manufacturers as they develop new devices or qualify existing devices (e.g., catheters, needles) for delivering clinical cell therapies. Cytocompatibility considers the impact of the delivery device on the cells passing through the device during the delivery procedure. The biological safety of the device (e.g., the device’s cytotoxicity) should be addressed via other methods, such as ISO 10993-5. It is understood that this guide does not address testing of specific cellular products with specific delivery devices. Such testing may be required by regulatory authorities prior to clinical trial of cellular product or marketing applications. This guide outlines considerations to make the product qualification procedures more likely to succeed and more cost effective.
4.2 The key aspects of assessing device cytocompatibility include selecting a test cell line or cell lines and determining the cell physiology parameters that will be measured to make a determination of cytocompatibility. Acceptance criteria for designating a device as cytocompatible are not detailed here. It will be up to the delivery device end user to determine if the results of a cytocompatibility assessment are sufficient to consider that device cytocompatible. Delivery device lot to lot variability may impact cytocompatibility, therefore validated manufacturing processes should be considered when producing devices for cytocompatibility assessments.
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.
General Information
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Standards Content (Sample)
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.
Designation: F3206 − 17
Standard Guide for
Assessing Medical Device Cytocompatibility with Delivered
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Cellular Therapies
This standard is issued under the fixed designation F3206; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2739 Guide for Quantifying Cell Viability within Bioma-
terial Scaffolds
1.1 This guide outlines the parameters to consider when
F2809 Terminology Relating to Medical and Surgical Mate-
designing in vitro tests to assess the potential impact of a
rials and Devices
delivery device on a cellular product being dispensed. This
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2.2 ISO Standard:
guide does not provide specific protocols, but rather suggests
ISO 10993-5 Biological evaluation of medical devices – Part
what should be considered the minimum characterization
5: Tests for in vitro cytotoxicity
necessary to assess device cytocompatibility. Topics discussed
include selecting an appropriate cell line(s), cell physiology
3. Terminology
parameters to measure, and relevant test procedure variables.
3.1 Definitions:
Only cells suspended in liquid and infused through a device are
3.1.1 cell line, n—a generic term that includes primary,
considered. Cell therapies paired with scaffolds, suspended in
stem, and immortalized cells.
hydrogels, or administered via other methods (e.g., tissue
3.1.2 cytocompatible, adj—referringtothelackofunaccept-
grafting) are not included in the scope of this document. This
document does not address physical characterization of deliv- able impact on a cellular product from interaction with a
medical device used for delivery or interaction with manufac-
ery devices, such as mechanics, composition, or degradation.
turing components. For example, a cytocompatible device does
1.2 This standard does not purport to address all of the
not unacceptably impact the cells passing through it as to
safety concerns, if any, associated with its use. It is the
compromise the potency of the cell therapy product.
responsibility of the user of this standard to establish appro-
3.1.3 immortalized cell, n—a primary cell that has been
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. transformed or otherwise altered to provide an extended
1.3 This international standard was developed in accor- replication capacity beyond that of the originating primary cell.
dance with internationally recognized principles on standard- An immortalized cell may be naturally isolated (e.g., cancer
ization established in the Decision on Principles for the cell) or purposely transformed in the laboratory.
Development of International Standards, Guides and Recom-
3.1.4 primary cell, n—a cell with a finite replication poten-
mendations issued by the World Trade Organization Technical
tial that has not been biologically altered to promote extended
Barriers to Trade (TBT) Committee.
survival. A primary cell may be frozen or freshly isolated but
the passage history must be known and display demonstrable
2. Referenced Documents
senescence.
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2.1 ASTM Standards:
3.1.5 senescence, n—the property attributable to finite cell
F813 Practice for Direct Contact Cell Culture Evaluation of
cultures; namely, their inability to grow beyond a finite number
Materials for Medical Devices
of population doublings. F2809
F2394 Guide for Measuring Securement of Balloon Expand-
3.1.6 stem cells, n—progenitor cells capable of self-
able Vascular Stent Mounted on Delivery System
replication, proliferation, and differentiation. F2809
3.1.7 viable cell, n—a cell capable of sustaining metabolic
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This test method is under the jurisdiction ofASTM Committee F04 on Medical activity that is structurally intact with a functioning cell
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
membrane. F2739
F04.43 on Cells and Tissue Engineered Constructs for TEMPs.
Current edition approved March 1, 2017. Published June 2017. DOI: 10.1520/ 3.2 Definitions of Terms Specific to This Standard:
F3206–17.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from International Organization for Standardization (ISO), ISO
Standards volume information, refer to the standard’s Document Summary page on Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
the ASTM website. Geneva, Switzerland, http://www.iso.org.
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