ASTM F619-14
Standard Practice for Extraction of Medical Plastics

Standard No.

ASTM F619-14

Release Date

2014

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F619-20

Latest

ASTM F619-20

Scope

5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices.

5.2 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.

5.3 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).

5.4 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 F748.

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.

5.5 Test Methods D543, D570, and D1239 may be useful in providing supplemental information.

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 1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.

1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are prov......

ASTM F619-14 Referenced Document

• ASTM D1193 Standard Specification for Reagent Water
• ASTM D1239 Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
• ASTM D1898 
• ASTM D543 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• ASTM D570 Standard Test Method for Water Absorption of Plastics
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ASTM F619-14 history

• 2020 ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
• 2014 ASTM F619-14 Standard Practice for Extraction of Medical Plastics
• 2003 ASTM F619-03(2008) Standard Practice for Extraction of Medical Plastics
• 2003 ASTM F619-03 Standard Practice for Extraction of Medical Plastics
• 2002 ASTM F619-02 Standard Practice for Extraction of Medical Plastics
• 1979 ASTM F619-79(1997)e1 Standard Practice for Extraction of Medical Plastics