ASTM F813-20
(Practice)Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
SIGNIFICANCE AND USE
4.1 This practice is useful for assessing cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical materials and medical devices.
4.2 This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays when only chemical toxicities are being considered.
Note 1: The results obtained using this method may not predict in vivo behavior which can be influenced by multiple factors such as those arising from site of application or physical properties that may result from design and fabrication.
4.3 This cell culture test method is suitable for adoption in specifications and standards for materials for use in the construction of medical devices that are intended to have direct contact with tissue, tissue fluids, or blood. However, care should be taken when testing materials that are absorbable, include an eluting or degradable coating, are liquid or gelatinous in nature, are irregularly shaped solid materials, or have a high density or mass, to make sure that the method is applicable. If leachables from the test sample are capable of diffusing through the agar layer, agarose-based methods such as Test Method F895 may be considered as an alternate method, depending on sample characteristics, or in cases where investigators wish to further evaluate the cytotoxic response of cells underlying the test sample.
SCOPE
1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.
1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared.
1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.
1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748.
1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 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: F813 − 20
Standard Practice for
Direct Contact Cell Culture Evaluation of Materials for
1
Medical Devices
ThisstandardisissuedunderthefixeddesignationF813;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 Thispracticecoversareferencemethodofdirectcontact 2.1 ASTM Standards:
cell culture testing which may be used in evaluating the F748PracticeforSelectingGenericBiologicalTestMethods
cytotoxic potential of materials for use in the construction of for Materials and Devices
medical materials and devices. F895TestMethodforAgarDiffusionCellCultureScreening
for Cytotoxicity
1.2 This practice may be used either directly to evaluate
F1027Practice for Assessment of Tissue and Cell Compat-
materialsorasareferenceagainstwhichothercytotoxicitytest
ibility of Orofacial Prosthetic Materials and Devices
methods may be compared.
2.2 Other Documents:
1.3 This is one of a series of reference test methods for the
The American Type Culture Collection (ATCC), Catalogue
assessment of cytotoxic potential, employing different tech-
3
of Strains II
niques.
4
USP Negative Control Plastic Reference Standard
1.4 Assessment of cytotoxicity is one of several tests
employed in determining the biological response to a material, 3. Summary of Practice
as recommended in Practice F748.
3.1 Cell cultures are grown to a confluent monolayer in
1.5 The L-929 cell line was chosen because it has a culture dishes. The growth medium is aspirated and replen-
significant history of use in assays of this type. This is not ishedtoprovidearesting,confluentcelllayer.Testandcontrol
intended to imply that its use is preferred; only that the L-929 specimens are placed in direct contact with the cell layer to
is a well characterized, readily available, established cell line provide an accelerated assessment of the presence or absence
that has demonstrated reproducible results in several laborato- of a cytotoxic effect from a given material or device. See
ries. Practice F1027 for definitions.
1.6 The values stated in SI units are to be regarded as
4. Significance and Use
standard. No other units of measurement are included in this
4.1 This practice is useful for assessing cytotoxic potential
standard.
both when evaluating new materials or formulations for
1.7 This standard does not purport to address all of the
possible use in medical applications, and as part of a quality
safety concerns, if any, associated with its use. It is the
control program for established medical materials and medical
responsibility of the user of this standard to establish appro-
devices.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. 4.2 This practice assumes that assessment of cytotoxicity
1.8 This international standard was developed in accor- potential provides one method for predicting the potential for
cytotoxicornecroticreactionstomedicalmaterialsanddevices
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the during clinical applications to humans. In general, cell culture
testing methods have shown good correlation with animal
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical assays when only chemical toxicities are being considered.
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.16 on Biocompatibility Test Methods. the ASTM website.
3
Current edition approved April 1, 2020. Published June 2020. Originally American Type Culture Collection, P.O. Box 1549, Manassas, VA 20108.
4
approvedin2001.Lastpreviouseditionapprovedin2012asF813–07(2012).DOI: U.S. Pharmacopeia, Vol 24, Rand McNally, Taunton, MA, 1994, pp.
10.1520/F0813-20. 1652–1653. Use latest publication to ensure current cumulative revisions are used.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F813 − 20
NOTE1—Theresultsobtainedusingthismethodmaynotp
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F813 − 07 (Reapproved 2012) F813 − 20
Standard Practice for
Direct Contact Cell Culture Evaluation of Materials for
1
Medical Devices
This standard is issued under the fixed designation F813; 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
1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic
potential of materials for use in the construction of medical materials and devices.
1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods
may be compared.
1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.
1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as
recommended in Practice F748.
1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply
that its use is preferred; only that the L-929 is a well-characterized, well characterized, readily available, established cell line that
has demonstrated reproducible results in several laboratories.
1.6 Since the test sample is not removed at the time of microscopic evaluation and underlying cells may be affected by the
specific gravity of the test sample, this practice is limited to evaluation of cells outside the perimeter of the overlying test sample.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.8 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F1027 Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
2.2 Other Documents:
3
The American Type Culture Collection (ATCC), Catalogue of Strains II
4
USP Negative Control Plastic Reference Standard
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Oct. 1, 2012April 1, 2020. Published November 2012June 2020. Originally approved in 2001. Last previous edition approved in 20072012 as
F813 – 07.F813 – 07(2012). DOI: 10.1520/F0813-07R12.10.1520/F0813-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
American Type Culture Collection, P.O. Box 1549, Manassas, VA 20108.
4
U.S. Pharmacopeia, Vol 24, Rand McNally, Taunton, MA, 1994, pp. 1652–1653. Use latest publication to ensure current cumulative revisions are used.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F813 − 20
3. Summary of Practice
3.1 Cell cultures are grown to a confluent monolayer in culture dishes. The growth medium is aspirated and replenished to
provide a resting, confluent cell layer. Test and control specimens are placed in direct contact with the cell layer to provide an
accelerated assessment of the presence or absence of a cytotoxic effect from a given material or device. See Practice F1027 for
definitions.
4. Significance and Use
4.1 This prac
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