ASTM F619-02

Standard Practice for Extraction of Medical Plastics

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: 09-Apr-2002
• 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 F619-79(1997)e1 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F619-03 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 01-Nov-2003
• Referred By: ASTM F3127-22 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• Effective Date: 10-Apr-2002
• Referred By: ASTM F648-21 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 10-Apr-2002
• 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-Apr-2002
• 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: 10-Apr-2002
• 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-Apr-2002
• Referred By: ASTM F750-20 - Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
• Effective Date: 10-Apr-2002
• Referred By: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 10-Apr-2002
• Referred By: ASTM F720-17 - Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
• Effective Date: 10-Apr-2002
• Referred By: ASTM F749-20 - Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
• Effective Date: 10-Apr-2002
• 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-Apr-2002
• Referred By: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Apr-2002
• Referred By: ASTM F3089-23 - Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
• Effective Date: 10-Apr-2002

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 619 – 02
Standard Practice for
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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.
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1. Scope USP NF 24 or current edition
1.1 This practice covers methods of extraction of medical
3. Terminology Definitions
plastics and may be applicable to other materials. This practice
3.1 extraction vehicle—a liquid specified for use in testing
identifies a method for obtaining “extract liquid” for use in
the plastic. Specific extraction vehicles are to be designated by
determining the biological response in preclinical testing.
the ASTM standard that references this practice (see Section 7
Further testing of the “extract liquid” is specified in other
for a list of standard extraction vehicles).
ASTM standards. The extract may undergo chemical analysis
3.2 extract liquid—that liquid which, after extraction of the
as part of the preclinical evaluation of the biological response,
specimen, is used in tests.
and the material after extraction may also be examined.
3.3 specimen portion—the unit or units of plastic placed
1.2 This practice may be used for, but is not limited to the
into the extraction vehicle.
following areas: partial evaluation of raw materials, auditing
3.4 blank—the extraction vehicle not containing the speci-
materials within the manufacturing process, and testing final
men under test which is used for comparison with the extract
products. This practice may also be used as a referee method
liquid.
for the measurement of extractables in plastics used in medical
devices.
4. Summary of Practice
1.3 The values stated in SI units are to be regarded as the
4.1 Standard-size specimens of the plastic, which may
standard.
closely simulate the intended device depending upon the use,
1.4 This standard does not purport to address all of the
are immersed in defined volumes of selected liquids (extraction
safety concerns, if any, associated with its use. It is the
vehicles) for the time and temperature specified.
responsibility of the user of this standard to establish appro-
4.2 A choice is made, based on the end use, of the extraction
priate safety and health practices and determine the applica-
vehicles (see Section 7) and one of the combinations of time
bility of regulatory limitations prior to use.
and temperature for the test (see Section 12).
2. Referenced Documents 4.3 The resultant test liquids (extract liquids) are kept in
glass containers until used for testing. The test liquids shall be
2.1 ASTM Standards:
stored tightly stoppered at normal room temperature. Test
D 543 Practices for Evaluating the Resistance of Plastics to
2 liquids for biological testing are kept in sterile glass containers.
Chemical Reagents
2
Consideration should be given as to whether the extraction
D 570 Test Method for Water Absorption of Plastics
3 should be done under aseptic conditions. The test liquids for
D 1193 Specification for Reagent Water
biological testing should be used within 24 h.
D 1239 Test Method for Resistance of Plastic Films to
2
Extraction by Chemicals
5. Significance and Use
2
D 1898 Practice for Sampling of Plastics
5.1 These extraction procedures are the initial part of
F 748 Practice for Selecting Generic Biological Test Meth-
4 several test procedures used in the biocompatibility screening
ods for Materials and Devices
of plastics used in medical devices.
2.2 Other Documents:
5.2 The limitations of the results obtained from this practice
should be recognized. The choice of extraction vehicle, dura-
tion of immersion, and temperature of the test is necessarily
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arbitrary. The specification of these conditions provides a basis
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
for standardization and serves as a guide to investigators
F04.16on Biocompatibility Test Methods.
wishing to compare the relative resistance of various plastics to
Current edition approved Apr. 10, 2002. Published June 2002. Originally
e1
extraction vehicles.
published as F 619 – 79. Last previous edition F 619 – 79 (1997) .
2
Annual Book of ASTM Standards, Vol 08.01.
3
Annual Book of ASTM Standards, Vol 11.01.
5
4 Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
Annual Book of ASTM Standards, Vol 13.01.
MD 20852.
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