ASTM F3206-2017 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies《传递细胞疗法的医疗器械细胞相容性标准评定指南》.pdf
《ASTM F3206-2017 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies《传递细胞疗法的医疗器械细胞相容性标准评定指南》.pdf》由会员分享,可在线阅读,更多相关《ASTM F3206-2017 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies《传递细胞疗法的医疗器械细胞相容性标准评定指南》.pdf(4页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F3206 17Standard Guide forAssessing Medical Device Cytocompatibility with DeliveredCellular Therapies1This standard is issued under the fixed designation F3206; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year
2、of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide outlines the parameters to consider whendesigning in vitro tests to assess the potential impact of adeli
3、very device on a cellular product being dispensed. Thisguide does not provide specific protocols, but rather suggestswhat should be considered the minimum characterizationnecessary to assess device cytocompatibility. Topics discussedinclude selecting an appropriate cell line(s), cell physiologyparam
4、eters to measure, and relevant test procedure variables.Only cells suspended in liquid and infused through a device areconsidered. Cell therapies paired with scaffolds, suspended inhydrogels, or administered via other methods (e.g., tissuegrafting) are not included in the scope of this document. Thi
5、sdocument does not address physical characterization of deliv-ery devices, such as mechanics, composition, or degradation.1.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-
6、priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of Inter
7、national Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF2394 Guide for Measuring Securement of
8、 Balloon Expand-able Vascular Stent Mounted on Delivery SystemF2739 Guide for Quantifying Cell Viability within Bioma-terial ScaffoldsF2809 Terminology Relating to Medical and Surgical Mate-rials and Devices2.2 ISO Standard:3ISO 10993-5 Biological evaluation of medical devices Part5: Tests for in vi
9、tro cytotoxicity3. Terminology3.1 Definitions:3.1.1 cell line, na generic term that includes primary,stem, and immortalized cells.3.1.2 cytocompatible, adjreferring to the lack of unaccept-able impact on a cellular product from interaction with amedical device used for delivery or interaction with m
10、anufac-turing components. For example, a cytocompatible device doesnot unacceptably impact the cells passing through it as tocompromise the potency of the cell therapy product.3.1.3 immortalized cell, na primary cell that has beentransformed or otherwise altered to provide an extendedreplication cap
11、acity beyond that of the originating primary cell.An immortalized cell may be naturally isolated (e.g., cancercell) or purposely transformed in the laboratory.3.1.4 primary cell, na cell with a finite replication poten-tial that has not been biologically altered to promote extendedsurvival. A primar
12、y cell may be frozen or freshly isolated butthe passage history must be known and display demonstrablesenescence.3.1.5 senescence, nthe property attributable to finite cellcultures; namely, their inability to grow beyond a finite numberof population doublings. F28093.1.6 stem cells, nprogenitor cell
13、s capable of self-replication, proliferation, and differentiation. F28093.1.7 viable cell, na cell capable of sustaining metabolicactivity that is structurally intact with a functioning cellmembrane. F27393.2 Definitions of Terms Specific to This Standard:1This test method is under the jurisdiction
14、of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.43 on Cells and Tissue Engineered Constructs for TEMPs.Current edition approved March 1, 2017. Published June 2017. DOI: 10.1520/F320617.2For referenced ASTM standards, visit the AS
15、TM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Ch
16、emin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on sta
17、ndardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.2.1 ancillary equipment, nequipment to be paired withthe delivery device (e.g., fitti
18、ngs, syringes, etc.) to facilitate invitro testing through which the cells will pass but are not partof the delivery device as used in the clinic.3.2.2 delivery device, na medical device designed todeliver therapeutic cells into the body.4. Significance and Use4.1 This guide is designed to assist me
19、dical device manu-facturers as they develop new devices or qualify existingdevices (e.g., catheters, needles) for delivering clinical celltherapies. Cytocompatibility considers the impact of the deliv-ery device on the cells passing through the device during thedelivery procedure. The biological saf
20、ety of the device (e.g.,the devices cytotoxicity) should be addressed via othermethods, such as ISO 10993-5. It is understood that this guidedoes not address testing of specific cellular products withspecific delivery devices. Such testing may be required byregulatory authorities prior to clinical t
21、rial of cellular productor marketing applications. This guide outlines considerationsto make the product qualification procedures more likely tosucceed and more cost effective.4.2 The key aspects of assessing device cytocompatibilityinclude selecting a test cell line or cell lines and determiningthe
22、 cell physiology parameters that will be measured to makea determination of cytocompatibility. Acceptance criteria fordesignating a device as cytocompatible are not detailed here. Itwill be up to the delivery device end user to determine if theresults of a cytocompatibility assessment are sufficient
23、 toconsider that device cytocompatible. Delivery device lot to lotvariability may impact cytocompatibility, therefore validatedmanufacturing processes should be considered when producingdevices for cytocompatibility assessments.5. Cell Selection5.1 The cellular response to delivery device contact wi
24、llcomprise the readout for the cytocompatibility characteriza-tions considered in this guide. Given this, selection of the testcell line to be used is critical. Selecting a cell line thatrepresents the intended use of the delivery device isencouraged, but not required. A single cell line or a panel
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