ASTM F813-07
(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
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.
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 and are frequently more sensitive to toxic moieties.
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 be implanted in the human body or placed in contact with tissue, tissue fluids, or blood on a long-term basis. However, care should be taken when testing materials that are resorbable to be sure the method is applicable.
Since cells in this direct contact test method are not protected by an overlying agarose layer, they are more susceptible to potential mechanical damage imparted by the overlying test sample. Investigators wishing to evaluate the cytotoxic response of cells underlying the test sample should consider agarose-based methods similar to Test Method F 895. Alternatively, dependent on sample characteristics, extraction methods such as Practice F 619 may also be considered.
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 F 748.
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 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.
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.
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Standards Content (Sample)
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Designation: F813 − 07
StandardPractice for
Direct Contact Cell Culture Evaluation of Materials for
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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
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1.1 Thispracticecoversareferencemethodofdirectcontact 2.1 ASTM Standards:
cell culture testing which may be used in evaluating the F619Practice for Extraction of Medical Plastics
cytotoxic potential of materials for use in the construction of F748PracticeforSelectingGenericBiologicalTestMethods
medical materials and devices. for Materials and Devices
F895TestMethodforAgarDiffusionCellCultureScreening
1.2 This practice may be used either directly to evaluate
for Cytotoxicity
materialsorasareferenceagainstwhichothercytotoxicitytest
F1027Practice for Assessment of Tissue and Cell Compat-
methods may be compared.
ibility of Orofacial Prosthetic Materials and Devices
1.3 This is one of a series of reference test methods for the
2.2 Other Documents:
assessment of cytotoxic potential, employing different tech-
The American Type Culture Collection (ATCC), Catalogue
3
niques.
of Strains II
4
1.4 Assessment of cytotoxicity is one of several tests USP Negative Control Plastic Reference Standard
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 Since the test sample is not removed at the time of
4. Significance and Use
microscopic evaluation and underlying cells may be affected
bythespecificgravityofthetestsample,thispracticeislimited
4.1 This practice is useful for assessing cytotoxic potential
toevaluationofcellsoutsidetheperimeteroftheoverlyingtest both when evaluating new materials or formulations for
sample.
possible use in medical applications, and as part of a quality
control program for established medical materials and medical
1.7 This standard does not purport to address all of the
devices.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4.2 This practice assumes that assessment of cytotoxicity
priate safety and health practices and determine the applica-
potential provides one method for predicting the potential for
bility of regulatory limitations prior to use.
cytotoxicornecroticreactionstomedicalmaterialsanddevices
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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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.
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Current edition approved Feb. 1, 2007. Published March 2007. Originally American Type Culture Collection, P.O. Box 1549, Manassas, VA 20108.
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approved in 2001. Last previous edition approved in 2001 as F813–01. DOI: U.S. Pharmacopeia, Vol 24, Rand McNally, Taunton, MA, 1994, pp.
10.1520/F0813-07.
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
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F813 − 07
during clinical applications to humans. In general, cell culture 6.1.2 L-glutamine Solution, 29.2 mg/mL of sterile water.
testing methods have shown good correlation with animal 6.1.3 Hanks’ Solution, calcium-and magnesium-free (store
assays and are frequently more sensitive to toxic moieties. at room temperature).
6.1.4 Trypsin,0.1%solutioninHanks’solutionorcalcium-
4.3 This cell culture test method is suitable for adoption in
and magnesium-free, phosphate-buffered saline (store frozen).
specifications and standards for materials for use in the
6.1.5 Water, d
...
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