ASTM F619-03(2008)
(Practice)Standard Practice for Extraction of Medical Plastics
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:
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.
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 inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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.
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Designation: F619 − 03(Reapproved 2008)
Standard Practice for
Extraction of Medical Plastics
ThisstandardisissuedunderthefixeddesignationF619;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D1898 Practice for Sampling of Plastics (Withdrawn 1998)
F748 PracticeforSelectingGenericBiologicalTestMethods
1.1 This practice covers methods of extraction of medical
for Materials and Devices
plastics and may be applicable to other materials. This practice
2.2 Other Documents:
identifies a method for obtaining “extract liquid” for use in
USP NF 24 or current edition
determining the biological response in preclinical testing.
Further testing of the “extract liquid” is specified in other
3. Definitions
ASTM standards. The extract may undergo chemical analysis
3.1 extraction vehicle—a liquid specified for use in testing
as part of the preclinical evaluation of the biological response,
the plastic. Specific extraction vehicles are to be designated by
and the material after extraction may also be examined.
theASTM standard that references this practice (see Section 7
1.2 This practice may be used for, but is not limited to the
for a list of standard extraction vehicles).
following areas: partial evaluation of raw materials, auditing
3.2 extract liquid—that liquid which, after extraction of the
materials within the manufacturing process, and testing final
specimen, is used in tests.
products. This practice may also be used as a referee method
3.3 specimen portion—theunitorunitsofplasticplacedinto
for the measurement of extractables in plastics used in medical
the extraction vehicle.
devices.
3.4 blank—the extraction vehicle not containing the speci-
1.3 The values stated in inch-pound units are to be regarded
men under test which is used for comparison with the extract
as standard. The values given in parentheses are mathematical
liquid.
conversions to SI units that are provided for information only
and are not considered standard.
4. Summary of Practice
1.4 This standard does not purport to address all of the
4.1 Standard-size specimens of the plastic, which may
safety concerns, if any, associated with its use. It is the
closely simulate the intended device depending upon the use,
responsibility of the user of this standard to establish appro-
areimmersedindefinedvolumesofselectedliquids(extraction
priate safety and health practices and determine the applica-
vehicles) for the time and temperature specified.
bility of regulatory limitations prior to use.
4.2 Achoiceismade,basedontheenduse,oftheextraction
vehicles (see Section 7) and one of the combinations of time
2. Referenced Documents
and temperature for the test (see Section 12).
2.1 ASTM Standards:
4.3 The resultant test liquids (extract liquids) are kept in
D543 Practices for Evaluating the Resistance of Plastics to
glass containers until used for testing. The test liquids shall be
Chemical Reagents
stored tightly stoppered at normal room temperature. Test
D570 Test Method for Water Absorption of Plastics
liquidsforbiologicaltestingarekeptinsterileglasscontainers.
D1193 Specification for Reagent Water
Consideration should be given as to whether the extraction
D1239 Test Method for Resistance of Plastic Films to
should be done under aseptic conditions. The test liquids for
Extraction by Chemicals
biological testing should be used within 24 h.
5. Significance and Use
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
5.1 These extraction procedures are the initial part of
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
several test procedures used in the biocompatibility screening
Current edition approved Aug. 1, 2008. Published August 2008. Originally
of plastics used in medical devices.
approved in 1979. Last previous edition approved in 2003 as F619 – 03. DOI:
10.1520/F0619-03R08.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contactASTM Customer Service at service@astm.org. ForAnnual Book ofASTM www.astm.org.
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F619 − 03 (2008)
5.2 The limitations of the results obtained from this practice screw-cap culture test tube of borosilicate glass, unless a larger
should be recognized. The choice of extraction vehicle, dura- containerisrequiredforthesizeandshapeofthematerialtobe
tion of immersion, and temperature of the test is necessarily extracted. Screw caps, if used, shall have polytetrafluoroethyl-
arbitrary.The specification of these conditions provides a basis ene liners.
for standardization and serves as a guide to investigators
6.4 Balance, accurate to 60.1 mg.
wishingtocomparetherelativeresistanceofvariousplasticsto
6.4.1 Caution should be exercised when performing weigh-
extraction vehicles.
ings in glassware. Depending upon the required accuracy, the
5.3 Correlationoftestresultswiththeactualperformanceor relative humidity should be the same for weighings at different
serviceability of materials is necessarily dependent upon the times.
similarity between the testing and end-use conditions (see
6.5 Micrometers, capable of measuring dimensions of test
12.1.2 and Note 4).
specimens to 0.025 mm (0.001 in.).
5.4 Caution should be exercised in the understanding and
7. Reagents and Materials
intent of this practice as follows:
5.4.1 No allowance or distinction is made for variables such
7.1 Purity of Reagents—Reagent grade, or better, chemicals
as end-use application and duration of use. Decisions on
shall be used in all tests. Other grades may be used, provided
selection of tests to be done should be made based on Practice
it is first ascertained that the reagent is of sufficiently high
F748.
purity to permit its use without lessening the accuracy of the
5.4.2 This practice was originally designed for use with
determination.
nonporous, solid materials. Its application for other materials,
7.2 Extraction Vehicles—The following list of standard
such as those that are porous, or absorptive, or resorptive,
extraction vehicles is intended to simulate the main constitu-
should be considered with caution. Consideration should be
ents of human body fluids. The extraction vehicles shall be:
given to altering the specified material to liquid ratio to allow
7.2.1 Sodium Chloride Injection, USP, containing by weight
additional liquid to fully hydrate the material and additional
not less than 0.85 % and not more than 0.95 % sodium
liquid or other methods to fully submerge the test article.
chloride.
Additional procedures that fully remove the extract liquid from
7.2.1.1 Other aqueous solutions shall be made with USP
the test article, such as pressure or physically squeezing the
WFI (water for injection).
material,shouldalsobeconsideredasappropriate.Althoughno
7.2.2 Vegetable Oil:
definitions are given in this practice for the following terms,
7.2.2.1 Sesame Oil, USP.
such items as extraction vehicle surface tension at the specified
7.2.2.2 Cottonseed Oil, USP.
extraction condition and plastic specimen physical structure
7.3 Other extraction vehicles as required, such as polyeth-
should be taken into account.
ylene glycol, DMSO, as specified in other standards. Vehicles
5.5 Test Methods D543, D570, and D1239 may be useful in
shouldbechosenbasedonbiotolerance,thetestprotocolstobe
providing supplemental information.
used, and the ability to extract contaminants from the material
to be tested.
6. Apparatus
NOTE 1—Depending upon the material under test and the user’s needs,
6.1 Autoclave, capable of maintaining a temperature of 121
extraction vehicles other than those in 7.2 and 7.3 may be used if the
6 2.0°C (249.8 6 3.8°F) for at least 1 h and equipped with a
reasons are justified.
display of temperature and pressure. A slow exhaust cycle is
necessary. A rack to hold the extraction containers above the
8. Sampling
water level is also necessary. Loss of fluid volume should be
8.1 The application of this practice may be in various areas.
recorded.
Therefore, although some well-known quality sampling meth-
6.1.1 Sealed, unvented extraction vessels should not be
ods may be used, a statistician might be consulted to ensure a
removed until internal temperature and pressure have reached
statistically valid sampling plan.
ambient conditions and the door can be opened. It is recom-
8.2 Practice D1898 may also be consulted.
mended that the extraction vessels be left undisturbed until any
risk of boil over has passed. When the extraction vessels are
9. Test Specimen
cool to the touch, the lids should be sealed.
9.1 This practice is designed primarily for application to
6.2 Heating Equipment:
materials in the condition in which they are used. The material
6.2.1 Ovensorincubatorsthatwillmaintaintemperaturesof
should be exposed to all conditions and substances as during a
37, 50, 70 6 2°C (98, 122, 158 6 3°F).
production run, such as washing, packaging, and sterilization.
6.2.2 Water baths capable of maintaining temperatures de-
scribed in 6.2.1. Those with the ability to agitate the extraction
vessels ar
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F619–02 Designation: F 619 – 03 (Reapproved 2008)
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 (´) indicates an editorial change since the last revision or reapproval.
1. 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 Thispracticemaybeusedfor,butisnotlimitedtothefollowingareas:partialevaluationofrawmaterials,auditingmaterials
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.
1.3The values stated in SI units are to be regarded as the standard.
1.3 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 provided for information only and are not considered 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.
2. Referenced Documents
2.1 ASTM Standards:
D 543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents
D 570 Test Method for Water Absorption of Plastics
D 1193 Specification for Reagent Water
D 1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
2 3
D 1898Practice for Sampling of Plastics Practice for Sampling of Plastics
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
2.2 Other Documents:
USP NF 24 or current edition
3. Terminology Definitions
3.1 extraction vehicle—a liquid specified for use in testing the plastic. Specific extraction vehicles are to be designated by the
ASTM standard that references this practice (see Section 7 for a list of standard extraction vehicles).
3.2 extract liquid— that liquid which, after extraction of the specimen, is used in tests.
3.3 specimen portion— the unit or units of plastic placed into the extraction vehicle.
3.4 blank—the extraction vehicle not containing the specimen under test which is used for comparison with the extract liquid.
4. Summary of Practice
4.1 Standard-size specimens of the plastic, which may closely simulate the intended device depending upon the use, are
immersed in defined volumes of selected liquids (extraction vehicles) for the time and temperature specified.
This practice is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Apr. 10, 2002.Aug. 1, 2008. Published June 2002.August 2008. Originally published as F619–79.approved in 1979. Last previous edition
´1
F619–79 (1997) .approved in 2003 as F 619 – 03.
Annual Book of ASTM Standards, Vol 08.01.
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.ForAnnualBookofASTMStandards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Withdrawn.
Annual Book of ASTM Standards, Vol 13.01.
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 619 – 03 (2008)
4.2 Achoice is made, based on the end use, of the extraction vehicles (see Section 7) and one of the combinations of time and
temperature for the test (see Section 12).
4.3 The resultant test liquids (extract liquids) are kept in glass containers until used for testing. The test liquids shall be stored
tightly stoppered at normal room temperature. Test liquids for biological testing are kept in sterile glass containers. Consideration
should be given as to whether the extraction should be done under aseptic conditions. The test liquids for biological testing should
be used within 24 h.
5. Significance and Use
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 F 748.
5.4.2No allowance is made to distinguish between nonporous or porous materials or 5.4.2 This practice was originally designed
for use with nonporous, solid materials. Its application for other materials, such as those that are absorptiveporous, or
resorbable.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 D 543, D 570, and D 1239 may be useful in providing supplemental information.
6. Apparatus
6.1 Autoclave,capableofmaintainingatemperatureof121 62.0°C(249.8 63.8°F)foratleast1handequippedwithadisplay
of temperature and pressure. A slow exhaust cycle is necessary. A rack to hold the extraction containers above the water level is
also necessary. Loss of fluid volume should be recorded.
6.1.1 Sealed, unvented extraction vessels should not be removed until internal temperature and pressure have reached ambient
conditions and the door can be opened. It is recommended that the extraction vessels be left undisturbed until any risk of boil over
has passed. When the extraction vessels are cool to the touch, the lids should be sealed.
6.2 Heating Equipment:
6.2.1 Ovens or incubators that will maintain temperatures of 37, 50, 70 6 2°C (98, 122, 158 6 3°F).
6.2.2 Water baths capable of maintaining temperatures described in 6.2.1.Those with the ability to agitate the extraction vessels
are preferred.
6.3 Extraction Containers—Suitable containers that protect the extract liquid from the biological and chemical contamination.
They should allow expansion of the liquid, but then be sealed to prevent evaporation. One suggested container is the screw-cap
culture test tube of borosilicate glass, unless a larger container is required for the size and shape of the material to be extracted.
Screw caps, if used, shall have polytetrafluoroethylene liners.
6.4 Balance, accurate to 60.1 mg.
6.4.1 Cautionshouldbeexercisedwhenperformingweighingsinglassware.Dependingupontherequiredaccuracy,therelative
humidity should be the same for weighings at different times.
6.5 Micrometers, capable of measuring dimensions of test specimens to 0.025 mm (0.001 in.).
7. Reagents and Materials
7.1 Purity of Reagents—Reagent grade, or better, chemicals shall be used in all tests. Other grades may be used, provided it
isfirstascertainedthatthereagentisofsufficientlyhighpuritytopermititsusewithoutlesseningtheaccuracyofthedetermination.
7.2 Extraction Vehicles—The following list of standard extraction vehicles is intended to simulate the main constituents of
human body fluids. The extraction vehicles shall be:
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852.
Reagent Chemicals, American Chemical Society Specifications, American Chemical Society, Washington, DC. For Suggestions on the testing of reagents not listed by
the American Chemical Society, see Annual Standards for Laboratory Chemicals, BDH Ltd., Poole, Dorset, U.K., and the United States Pharmacopeia and National
Formulary, U.S. Pharmacopeial Convention, Inc. (USPC), Rockville, MD.
F 619 – 03 (2008)
7.2.1 Sodium Chloride Injection, USP, containing by weight not less than 0.85 % and not more than 0.95 % sodium chloride.
7.2.1.1 Other aqueous solutions shall be made with USP WFI (water for injection).
7.2.2 Vegetable Oil:
7.2.2.1 Sesame Oil, USP.
7.2.2.2 Cottonseed Oil, USP.
7.3 Other extraction vehicles as
...
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