ASTM F619-79(1997)e1

Standard Practice for Extraction of Medical Plastics

SCOPE
1.1 This practice covers methods for extraction of medical plastics in liquids that simulate body fluids in their action on the plastics. This practice identifies two methods of extraction: one used for obtaining "extract liquid" to be analyzed by chemical and physical tests; and the other obtaining "extract liquid" for use in determining the biological response of animals. Further testing of the "extract liquid" is specified in other ASTM standards. The plastic 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 problems, 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-Dec-1997
• 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

• Replaced By: ASTM F619-02 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 10-Apr-2002
• 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-Dec-1997
• Referred By: ASTM F451-21 - Standard Specification for Acrylic Bone Cement
• Effective Date: 10-Dec-1997
• Referred By: ASTM F749-20 - Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
• Effective Date: 10-Dec-1997
• 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-Dec-1997
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Dec-1997
• 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-Dec-1997
• Referred By: ASTM F750-20 - Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
• Effective Date: 10-Dec-1997
• Referred By: ASTM F3127-22 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• Effective Date: 10-Dec-1997
• Referred By: ASTM F2148-18 - Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
• Effective Date: 10-Dec-1997
• Referred By: ASTM F719-20e1 - Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
• Effective Date: 10-Dec-1997
• Referred By: ASTM F2147-01(2016) - Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
• Effective Date: 10-Dec-1997
• 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: 10-Dec-1997
• Referred By: ASTM F756-17 - Standard Practice for Assessment of Hemolytic Properties of Materials
• Effective Date: 10-Dec-1997
• Referred By: ASTM F3089-23 - Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
• Effective Date: 10-Dec-1997

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 619 – 79 (Reapproved 1997) An American National Standard
Standard Practice for
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.
e NOTE—Keywords were added editorially in May 1998.
1. Scope tioning and Testing Materials
1.1 This practice covers methods for extraction of medical
3. Terminology Definitions
plastics in liquids that simulate body fluids in their action on
3.1 extraction vehicle—a liquid specified for use in testing
the plastics. This practice identifies two methods of extraction:
the plastic. Specific extraction vehicles are to be designated by
one used for obtaining“ extract liquid” to be analyzed by
the ASTM standard that references this practice (see Section 7
chemical and physical tests; and the other obtaining “extract
for a list of standard extraction vehicles).
liquid” for use in determining the biological response of
3.2 extract liquid— that liquid which is tested for biological
animals. Further testing of the “extract liquid” is specified in
and chemical/physical response; the end result of this practice.
other ASTM standards. The plastic after extraction may also be
3.3 specimen portion— the unit or units of plastic placed
examined.
into the extraction vehicle.
1.2 This practice may be used for, but is not limited to the
3.4 blank—the extraction vehicle not containing the speci-
following areas: partial evaluation of raw materials, auditing
men under test which is used for comparison with the extract
materials within the manufacturing process, and testing final
liquid.
products. This practice may also be used as a referee method
for the measurement of extractables in plastics used in medical
4. Summary of Practice
devices.
4.1 Standard-size specimens of the plastic, which may
1.3 The values stated in SI units are to be regarded as the
closely simulate the intended device depending upon the use,
standard.
are immersed in definite volumes of selected liquids (extraction
1.4 This standard does not purport to address all of the
vehicles) for the time and temperature specified.
safety concerns, if any, associated with its use. It is the
4.2 A choice is made, based on the end use, of the extraction
responsibility of the user of this standard to establish appro-
vehicles (see Section 7) and one of the combinations of time
priate safety and health practices and determine the applica-
and temperature for the test (see Section 12).
bility of regulatory limitations prior to use.
4.3 The resultant test liquids (extract liquids) are kept in
2. Referenced Documents glass containers until used for testing. Test liquids for biologi-
cal testing are kept in sterile glass containers. The test liquids
2.1 ASTM Standards:
for biological testing should be used within 24 h.
D 543 Test Method for Resistance of Plastics to Chemical
Reagents
5. Significance and Use
D 570 Test Method for Water Absorption of Plastics
5.1 These extraction procedures are the initial part of
D 618 Practice for Conditioning Plastics and Electrical
2 several test procedures used in the biocompatibility screening
Insulating Materials for Testing
of plastics used in medical devices.
D 1193 Specification for Reagent Water
5.2 The limitations of the results obtained from this practice
D 1239 Test Method for Resistance of Plastic Films to
should be recognized. The choice of extraction vehicle, dura-
Extraction by Chemicals
4 tion of immersion, and temperature of the test is necessarily
D 1898 Practice for Sampling of Plastics
arbitrary. The specification of these conditions provides a basis
E 171 Specification for Standard Atmospheres for Condi-
for standardization and serves as a guide to investigators
wishing to compare the relative resistance of various plastics to
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
extraction vehicles.
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
5.3 Correlation of test results with the actual performance or
F04.16 on Biocompatibility.
Current edition approved May 31, 1979. Published August 1979. Originally serviceability of plastics is necessarily dependent upon the
published as F 619 – 79.
Annual Book of ASTM Standards, Vol 08.01.
Annual Book of ASTM Standards, Vol 11.01.
4 5
Annual Book of ASTM Standards, Vol 08.02. Annual Book of ASTM Standards, Vol 15.09.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 619
similarity between the testing and end-use conditions (see all reagents shall conform to the specifications of the Commit-
12.1.2 and Note 7). tee on Analytical Reagents of the American Chemical Society,
5.4 Caution should be exercised in the understanding and where such specifications are available. Other grades may be
intent of this practice as follows: used, provided it is first ascertained that the reagent is of
5.4.1 No allowance or distinction is made for variables such sufficiently high purity to permit its use without lessening the
as end-use application, for example, short-term versus long- accuracy of the determination.
term application or implantation. 7.2 Purity of Water— Unless otherwise indicated, refer-
5.4.2 No allowance is made to distinguish between a non- ences to water shall be understood to mean reagent water
porous versus a porous plastic. Although no definitions are conforming to Specification D 1193, Type II.
given in this practice for the following terms, such items as 7.3 Extraction Vehicles—The following list of standard
extraction vehicle surface tension at the specified extraction extraction vehicles is intended to simulate the main constitu-
condition and plastic specimen physical structure should be ents of human body fluids. Aqueous solutions shall be made
taken into account. with distilled water. The extraction vehicles shall be:
5.5 Test Methods D 543, D 570, and D 1239 may be useful 7.3.1 Sodium Chloride Injection, USP, containing by weight
in providing supplemental information. not less than 0.85 % and not more than 0.95 % sodium
chloride.
6. Apparatus
7.3.2 Vegetable Oil:
6.1 Autoclave, capable of maintaining a temperature of 121
7.3.2.1 Sesame Oil, USP.
6 2.0°C (249.8 6 3.8°F), and equipped with a thermometer,
7.3.2.2 Cottonseed Oil, USP.
pressure gage, vent cock, and a rack to hold the extraction
NOTE 1—To preclude the use of vegetable oil of poor or deteriorated
containers above the water level.
quality, the following additional negative reactivity test, beyond the
6.1.1 The autoclave preferably should have a water cooling
respective description in the USP, may be performed.
system that will allow for the cooling of the extraction
Select three healthy, thin-skinned albino rabbits, not previously used for
any test, whose fur can be clipped closely and whose skin is free of
containers to about, but not less than, 22°C (71.6°F) immedi-
mechanical irritation or trauma. On the day of the test, clip the fur from
ately following the heating cycle.
the dorsal surface. Divide the test area into a grid of suitably identified
6.1.2 Autoclaves not equipped with a water cooling system
individual injection sites. Inject 0.2 ml intracutaneously at each of ten sites
may be used. However, sealed, unvented, extraction vessels
on each animal. In handling the animals, avoid touching the injection sites
should not be removed from such an autoclave until internal
during observation periods. Examine the injected sites 24, 48, and 72 h
temperature and pressure have reached ambient conditions.
after the injection. No site should show an edema or erythema over an area
Such vessels, when hot, represent an extreme explosion hazard
greater than 5 mm (0.197 in.) in diameter. Qualify a vegetable oil batch
and store under adequate conditions until use. Ideal storage conditions
capable of causing serious injury or even death.
may be under a nitrogen blanket in complete darkness. The primary
6.2 Balance, accurate to 60.1 mg.
objective is to prevent oxidative type reactions.
6.2.1 Caution should be exercised when performing weigh-
ings in glassware. Depending upon the required accuracy, the 7.3.3 Water for Injection, USP.
relative humidity should be the same for weighings at different 7.3.4 Other extraction vehicles, as required.
times.
NOTE 2—Depending upon the medical plastic under test and the user’s
6.3 Extraction Containers—Suitable glass containers that
needs, extraction vehicles other than those in 7.3 may be used. An
protect the extract liquid from biological and chemical con-
example is pseudoextracellular fluid (PECF).
tamination or evaporation. One suggested container is the
8. Sampling
screw-cap culture test tube of borosilicate glass, unless a larger
container is required for the size and shape for the material to 8.1 The application of this practice may be in various areas.
be extracted. Screw caps, if used, shall have a rubber liner,
Therefore, although some well-known quality sampling meth-
whose exposed surface shall be completely covered with ods may be used, a statistician should be consulted to ensure a
polytetrafluorethylene film 0.05 to 0.075 mm (0.002 to 0.003
statistically valid sampling plan.
in.) in thickness. 8.2 Practice D 1898 may also be consulted.
6.4 Heating Equipment:
9. Test Specimen
6.4.1 Oven, forced air-circulation type that will maintain
temperatures of 50 to 70 6 2°C (122 to 158 6 3.6°F).
9.1 This practice is designed primarily for application to
6.4.2 Water Bath, capable of maintaining temperatures of 50
plastics in the condition in which they are used. The plastic
to 70 6 2°C (122 to 158 6 3.6°F).
should be exposed to all conditions and substances as during a
6.5 Micrometers, capable of measuring dimensions of test
production run, such as washing, packaging, and sterilization.
specimens to 0.025 mm (0.001 in.).
6.6 Room, or enclosed space capable of being maintained at
the Standard Laboratory Atmosphere, as prescribed in Practice
“Reagent Chemicals, American Chemical Society Specifications,” Am. Chemi-
D 618 (see 11.3). cal Soc., Washington, D.C. For suggestions on the
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