ASTM F619-03

Standard Practice for Extraction of Medical Plastics

SIGNIFICANCE AND USE
These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices.
The limitations of the results obtained from this practice should be recognized. The choice of extraction vehicle, duration of immersion, and temperature of the test is necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics to extraction vehicles.
Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 4).
Caution should be exercised in the understanding and intent of this practice as follows:
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F 748.
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, or absorptive, or resorptive, should be considered with caution. Consideration should be given to altering the specified material to liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test article. Additional procedures that fully remove the extract liquid from the test article, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and plastic specimen physical structure should be taken into account.
Test Methods D 543, D 570, and D 1239 may be useful in providing supplemental information.
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining "extract liquid" for use in determining the biological response in preclinical testing. Further testing of the "extract liquid" is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 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: 31-Oct-2003
• ICS: 11.120.01 - Pharmaceutics in general
• ICS: 83.080.01 - Plastics in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Replaces: ASTM F619-02 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 01-Nov-2003
• Replaced By: ASTM F619-03(2008) - Standard Practice for Extraction of Medical Plastics
• Effective Date: 01-Aug-2008
• Referred By: ASTM F2212-20 - Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• Effective Date: 01-Nov-2003
• Referred By: ASTM F3089-23 - Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
• Effective Date: 01-Nov-2003
• Referred By: ASTM F1904-23 - Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>
• Effective Date: 01-Nov-2003
• Referred By: ASTM F756-17 - Standard Practice for Assessment of Hemolytic Properties of Materials
• Effective Date: 01-Nov-2003
• Referred By: ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
• Effective Date: 01-Nov-2003
• 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: 01-Nov-2003
• Referred By: ASTM F750-20 - Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
• Effective Date: 01-Nov-2003
• 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: 01-Nov-2003
• Referred By: ASTM F3321-19 - Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• Effective Date: 01-Nov-2003
• Referred By: ASTM F720-17 - Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2148-18 - Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
• Effective Date: 01-Nov-2003
• Referred By: ASTM F648-21 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Nov-2003
• 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: 01-Nov-2003

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:F619–03
Standard Practice for
1
Extraction of Medical Plastics
This standard is issued under the fixed designation F 619; 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.
1. Scope F 748 Practice for Selecting Generic Biological Test Meth-
ods for Materials and Devices
1.1 This practice covers methods of extraction of medical
2.2 Other Documents:
plastics and may be applicable to other materials. This practice
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USP NF 24 or current edition
identifies a method for obtaining “extract liquid” for use in
determining the biological response in preclinical testing.
3. Terminology Definitions
Further testing of the “extract liquid” is specified in other
3.1 extraction vehicle—a liquid specified for use in testing
ASTM standards. The extract may undergo chemical analysis
the plastic. Specific extraction vehicles are to be designated by
as part of the preclinical evaluation of the biological response,
theASTM standard that references this practice (see Section 7
and the material after extraction may also be examined.
for a list of standard extraction vehicles).
1.2 This practice may be used for, but is not limited to the
3.2 extract liquid—that liquid which, after extraction of the
following areas: partial evaluation of raw materials, auditing
specimen, is used in tests.
materials within the manufacturing process, and testing final
3.3 specimen portion—the unit or units of plastic placed
products. This practice may also be used as a referee method
into the extraction vehicle.
for the measurement of extractables in plastics used in medical
3.4 blank—the extraction vehicle not containing the speci-
devices.
men under test which is used for comparison with the extract
1.3 The values stated in SI units are to be regarded as the
liquid.
standard.
1.4 This standard does not purport to address all of the
4. Summary of Practice
safety concerns, if any, associated with its use. It is the
4.1 Standard-size specimens of the plastic, which may
responsibility of the user of this standard to establish appro-
closely simulate the intended device depending upon the use,
priate safety and health practices and determine the applica-
areimmersedindefinedvolumesofselectedliquids(extraction
bility of regulatory limitations prior to use.
vehicles) for the time and temperature specified.
2. Referenced Documents 4.2 Achoiceismade,basedontheenduse,oftheextraction
2 vehicles (see Section 7) and one of the combinations of time
2.1 ASTM Standards:
and temperature for the test (see Section 12).
D 543 Practices for Evaluating the Resistance of Plastics to
4.3 The resultant test liquids (extract liquids) are kept in
Chemical Reagents
glass containers until used for testing. The test liquids shall be
D 570 Test Method for Water Absorption of Plastics
stored tightly stoppered at normal room temperature. Test
D 1193 Specification for Reagent Water
liquidsforbiologicaltestingarekeptinsterileglasscontainers.
D 1239 Test Method for Resistance of Plastic Films to
Consideration should be given as to whether the extraction
Extraction by Chemicals
3 should be done under aseptic conditions. The test liquids for
D 1898 Practice for Sampling of Plastics
biological testing should be used within 24 h.
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5. Significance and Use
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
5.1 These extraction procedures are the initial part of
F04.16 on Biocompatibility Test Methods.
several test procedures used in the biocompatibility screening
Current edition approved Nov. 1, 2003. Published December 2003. Originally
approved in 1979. Last previous edition approved in 2002 as F 619 – 02. of plastics used in medical devices.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contactASTM Customer Service at [e-mail]. ForAnnual Book ofASTM
Standards volume information, refer to the standard’s Document Summary page on
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the ASTM website. Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
3
Withdrawn. MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F619–03
5.2 The limitations of the results obtained from this practice containerisrequiredforthesizeandshapeofthematerialtobe
should be recognized. The choice of extraction vehicle, dura- extracted. Screw caps, if used, shall have polytetrafluoroethyl-
tion of immersion, and temperature of the test is necessarily ene liners.
arbitrary.The sp
...