ASTM F813-01

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

SCOPE
1.1 This practice describes 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 method 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 an established cell line, well-characterized and readily available, that has demonstrated reproducible results in several laboratories.  
1.6 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.

General Information

• Status: Historical
• Publication Date: 09-Oct-2001
• ICS: 07.100.10 - Medical microbiology
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Replaces: ASTM F813-83(1996)e1 - Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• Effective Date: 10-Oct-2001
• Replaced By: ASTM F813-07 - Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• Effective Date: 01-Feb-2007
• Referred By: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 10-Oct-2001
• Referred By: ASTM F451-21 - Standard Specification for Acrylic Bone Cement
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2565-21 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• Effective Date: 10-Oct-2001
• Referred By: ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 10-Oct-2001
• Referred By: ASTM F3206-17 - Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• Effective Date: 10-Oct-2001
• Referred By: ASTM E2526-22 - Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2695-12(2020) - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2347-15 - Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2064-17 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• Effective Date: 10-Oct-2001
• Referred By: ASTM F648-21 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2103-18 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
• Effective Date: 10-Oct-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F813–01
Standard Practice for
Direct Contact Cell Culture Evaluation of Materials for
1
Medical Devices
This standard is issued under the fixed designation F 813; 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 (e) indicates an editorial change since the last revision or reapproval.
4
1. Scope USP Negative Control Plastic Reference Standard
1.1 Thispracticecoversareferencemethodofdirectcontact
3. Summary of Practice
cell culture testing which may be used in evaluating the
3.1 Cell cultures are grown to a confluent monolayer in
cytotoxic potential of materials for use in the construction of
culture dishes. The growth medium is aspirated and replen-
medical materials and devices.
ished to provide a resting, confluent cell layer. Test and control
1.2 This method may be used either directly to evaluate
specimens are placed in direct contact with the cell layer to
materials or as a reference against which other cytotoxicity test
provide an accelerated assessment of the presence or absence
methods may be compared.
of a cytotoxic effect from a given material or device. See
1.3 This is one of a series of reference test methods for the
Practice F 1027 for definitions.
assessment of cytotoxic potential, employing different tech-
niques.
4. Significance and Use
1.4 Assessment of cytotoxicity is one of several tests
4.1 This practice is useful for assessing cytotoxic potential
employed in determining the biological response to a material,
both when evaluating new materials or formulations for
as recommended in Practice F 748.
possible use in medical applications, and as part of a quality
1.5 The L-929 cell line was chosen because it has a
control program for established medical materials and medical
significant history of use in assays of this type. This is not
devices.
intended to imply that its use is preferred; only that the L-929
4.2 This practice assumes that assessment of cytotoxicity
is an established cell line, well-characterized and readily
potential provides one method for predicting the potential for
available, that has demonstrated reproducible results in several
cytotoxicornecroticreactionstomedicalmaterialsanddevices
laboratories.
during clinical applications to humans. In general, cell culture
1.6 This standard does not purport to address all of the
testing methods have shown good correlation with animal
safety concerns, if any, associated with its use. It is the
assays and are frequently more sensitive to toxic moieties.
responsibility of the user of this standard to establish appro-
4.3 This cell culture test method is suitable for adoption in
priate safety and health practices and determine the applica-
specifications and standards for materials for use in the
bility of regulatory limitations prior to use.
construction of medical devices that are intended to be im-
planted in the human body or placed in contact with tissue,
2. Referenced Documents
tissue fluids, or blood on a long-term basis. However, care
2.1 ASTM Standards:
shouldbetakenwhentestingmaterialsthatareresorbabletobe
F 748 Practice for Selecting Generic Biological Test Meth-
2 sure the method is applicable.
ods for Materials and Devices
F 1027 Practice forAssessment of Tissue and Cell Compat-
5. Apparatus
2
ibility of Orofacial Prosthetic Materials and Devices
5.1 The following apparatus shall be used:
2.2 Other Documents:
5.2 Incubator, to maintain 37 62°Cand4to6%CO with
2
The American Type Culture Collection (ATCC), Catalogue
3 greater than 90 % relative humidity.
of Strains II
5.3 Tissue Culture Grade Culture Dishes,thataresterileand
35 mm in diameter by 10 mm deep.
NOTE 1—Plastic dishes are recommended because they provide a flat
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
surface that contributes to the formation of a uniform cell monolayer.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved October 10, 2001. Published January 2002.
2
Annual Book of ASTM Standards, Vol 13.01.
3 4
American Type Culture Collection, 12031 Parklawn Drive, Rockville, MD U.S. Pharmacopeia, Vol 24, Rand McNally, Taunton, MA, 1994, pp.
10852. 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
5.4 Disposable, Sterile, Centrifuge Tubes. 8.2.1 Use aqueous phenol (0.45 6 0.05 % by volume) as a
5.5 Inverted Optical Microscope, with magnifications of positive control for a diffuse reaction of cellu
...