ASTM F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.  
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are 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 or other materials 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 7).  
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, absorptive (for example, sponge-like materials that are capable of absorbing liquid), 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 specimen. Additional procedures that fully remove the extract liquid from the test specimen, 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 test specimen physical structure should be taken into ...
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 reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.  
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 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.  
1.6 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 thi...

General Information

• Status: Published
• Publication Date: 31-Jul-2020
• ICS: 11.100.99 - Other standards related to laboratory medicine
• ICS: 83.080.01 - Plastics in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Refers: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Apr-2016
• Refers: ASTM F748-06(2010) - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Jun-2010
• Refers: ASTM D1239-07 - Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
• Effective Date: 01-Mar-2007
• Refers: ASTM F748-06 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Dec-2006
• Refers: ASTM D1239-98(2006)e1 - Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
• Effective Date: 01-Nov-2006
• Refers: ASTM D543-06 - Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• Effective Date: 01-Apr-2006
• Refers: ASTM D570-98(2005) - Standard Test Method for Water Absorption of Plastics
• Effective Date: 01-Nov-2005
• Refers: ASTM F748-04 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-May-2004
• Refers: ASTM D1239-98 - Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
• Effective Date: 10-Nov-1998
• Refers: ASTM F748-98 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 10-Aug-1998
• Refers: ASTM D570-98 - Standard Test Method for Water Absorption of Plastics
• Effective Date: 10-Jul-1998
• Refers: ASTM D543-95(2001) - Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• Effective Date: 10-Oct-1995
• Refers: ASTM D543-95 - Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• Effective Date: 10-Oct-1995

Overview

ASTM F619-20: Standard Practice for Extraction of Materials Used in Medical Devices establishes guidelines for the extraction and evaluation of plastics and other materials commonly used in medical devices. This extraction process is a critical first step in the biocompatibility assessment, providing the foundation for further biological and chemical testing necessary for regulatory compliance and market approval. By standardizing specimen preparation, extraction conditions, and reporting requirements, ASTM F619-20 ensures reproducibility and comparability among tests conducted by manufacturers, laboratories, and regulatory authorities.

Key Topics

• Extraction Procedures: Specifies the methods for immersing test specimens of medical plastics or device materials in standard extraction vehicles (such as saline or oils) under defined time and temperature settings.
• Extract Liquid: Details on how to obtain and handle the “extract liquid” used for subsequent biological or chemical evaluation.
• Specimen Preparation: Outlines requirements for preparing and sizing test specimens, ensuring the surface area or mass is appropriate for the selected extraction vehicle.
• Reporting Requirements: Sets expectations for comprehensive documentation, including test conditions, material identification, extraction ratios, and any observed changes in test specimens or extracts.
• Limitations: Recognizes that the results depend on the chosen extraction conditions, which may not replicate all end-use applications or device exposures. Users must exercise judgment to ensure relevance.
• Applicability to Material Types: Designed primarily for nonporous, solid plastics, with specific cautions and guideline adjustments for porous or absorbent materials.

Applications

The ASTM F619-20 standard is instrumental throughout the lifecycle of medical device development, manufacturing, and regulatory submission. Its practical uses include:

• Biocompatibility Screening: Provides reliable extract for biological response testing, an essential step in verifying that medical device materials do not cause adverse biological effects.
• Raw Material Evaluation: Supports early-stage selection and assessment of raw materials for suitability in medical device manufacture.
• Process Monitoring: Enables ongoing auditing within manufacturing processes to detect contaminants or unwanted extractables in finished products.
• Quality Assurance: Serves as a reference methodology for academic research, contract laboratories, and manufacturing to maintain high standards of safety and performance.
• Regulatory Compliance: Facilitates submission to regulatory bodies by providing standardized extraction procedures referenced in international regulations and guidelines.
• Material Change Assessment: Assists in evaluating the impact of formulation or supplier changes by comparing extractable profiles.

Related Standards

ASTM F619-20 frequently interacts with and refers to other important standards for testing plastics and materials in medical devices:

• ASTM F748 - Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM D543 - Practices for Evaluating the Resistance of Plastics to Chemical Reagents
• ASTM D570 - Test Method for Water Absorption of Plastics
• ASTM D1239 - Test Method for Resistance of Plastic Films to Extraction by Chemicals
• ASTM E3231 - Guide for Cell Culture Growth Assessment of Single-Use Material
• USP Water for Injection (WFI) - Specification for purity of reagents

For users involved with materials designed for cell-based therapeutics, diagnostics, or biopharmaceutical production, additional guidance is available in ASTM E3231.

---

Keywords: ASTM F619-20, extraction of medical device materials, biocompatibility testing, medical plastics, extractable substances, medical device standards, preclinical evaluation, biological response, quality assurance, regulatory compliance.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F619 − 20
Standard Practice for
Extraction of Materials Used in Medical Devices
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 priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This practice covers methods of extraction of medical
1.7 This international standard was developed in accor-
plastics and may be applicable to other materials. This practice
dance with internationally recognized principles on standard-
identifies a method for obtaining “extract liquid” for use in
ization established in the Decision on Principles for the
determining the biological response in preclinical testing.
Development of International Standards, Guides and Recom-
Further testing of the “extract liquid” is specified in other
mendations issued by the World Trade Organization Technical
ASTM standards. The extract may undergo chemical analysis
Barriers to Trade (TBT) Committee.
as part of the preclinical evaluation of the biological response,
and the material after extraction may also be examined.
2. Referenced Documents
1.2 This practice may be used for, but is not limited to, the
2.1 ASTM Standards:
following areas: partial evaluation of raw materials, auditing
D543 Practices for Evaluating the Resistance of Plastics to
materials within the manufacturing process, and testing final
Chemical Reagents
products.This practice may also be used as a reference method
D570 Test Method for Water Absorption of Plastics
for the measurement of extractables in plastics used in medical
D1239 Test Method for Resistance of Plastic Films to
devices. In general, it is the responsibility of the user of the
Extraction by Chemicals
standard to determine if the methods described in this standard
E3231 Guide for Cell Culture GrowthAssessment of Single-
are appropriate for the materials in their device.
Use Material
1.3 This practice was initially developed for extraction of
F748 PracticeforSelectingGenericBiologicalTestMethods
medical plastics not intended to undergo degradation or ab-
for Materials and Devices
sorption during normal medical device usage. When applied to
2.2 Other Documents:
the extraction of absorbable materials, additional consider-
USP NF 24 or current edition
ations may be necessary in the selection of extraction proce-
dures and fluids.
3. Definitions
1.4 For assessment of compatibility of the Single-use Sys-
3.1 extraction vehicle—a liquid specified for use in testing
temmaterialwiththecellculturemediumorthemanufacturing
the test specimen. Specific extraction vehicles are to be
processes used for cell-based therapeutics, vaccines, cell-based
designated by the ASTM standard that references this practice
diagnostics, or other biopharmaceutical products, the user
(see Section 7 for a list of standard extraction vehicles).
should refer to Guide E3231.
3.2 extract liquid—that liquid which, after extraction of the
1.5 The values stated in SI units are to be regarded as
specimen, is used in tests.
standard. The values given in parentheses are mathematical
conversions to inch-pound units that are provided for informa- 3.3 specimen portion—the unit or units of test specimen
tion only and are not considered standard. placed into the extraction vehicle.
1.6 This standard does not purport to address all of the
3.4 blank—the extraction vehicle not containing the speci-
safety concerns, if any, associated with its use. It is the
men under test which is used for comparison with the extract
responsibility of the user of this standard to establish appro-
liquid.
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contactASTM Customer Service at [e-mail]. ForAnnual Book ofASTM
F04.16 on Biocompatibility Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Aug. 1, 2020. Published September 2020. Originally the ASTM website.
approved in 1979. Last previous edition approved in 2014 as F619 – 14. DOI: Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
10.1520/F0619-20. 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 − 20
material, a suggested protocol is as follows:
4. Summary of Practice
– Determine the volume of extraction vehicle that each 0.1 g or 1.0 cm
4.1 Standard-size specimens of the final product or materi-
of device/material absorbs;
als used in its construction, which may closely simulate the
–then,inperformingtheextraction,addthisadditionalvolumetoeach0.1
g or 1.0 cm in an extraction mixture.
intended device depending upon the use, are immersed in
definedvolumesofselectedliquids(extractionvehicles)forthe
5.5 Test Methods D570 and D1239 and Practices D543 may
time and temperature specified.
be useful in providing supplemental information.
4.2 Achoiceismade,basedontheenduse,oftheextraction
6. Apparatus
vehicles (see Section 7) and one of the combinations of time
and temperature for the test (see Section 12).
6.1 Autoclave (for 121°C extractions), capable of maintain-
ing a temperature of 121 6 2.0°C (249.8 6 3.8°F) for at least
4.3 The resultant test liquids (extract liquids) are kept in
suitable containers as described in 6.3 until used for testing. 1 h and equipped with a display of temperature and pressure.A
slow exhaust cycle is necessary. A rack to hold the extraction
The test liquids shall be stored tightly stoppered at normal
room temperature.Test liquids for biological testing are kept in containers above the water level is also necessary. Loss of fluid
volume should be recorded.
sterile containers. Extraction should be done under aseptic
conditions for use in biological testing, unless otherwise
6.1.1 Sealed, unvented extraction vessels should not be
justified. The test liquids for biological testing should be used removed until the internal temperature and pressure have
within 24 h.
reached ambient conditions and the door can be opened. It is
recommended that the extraction vessels be left undisturbed
5. Significance and Use until any risk of boil-over has passed. When the extraction
vessels are cool to the touch, the lids should be sealed.
5.1 These extraction procedures are the initial part of
several test procedures used in the biocompatibility screening 6.2 Heating Equipment (for other temperature extractions):
of plastics or other materials used in medical devices.
6.2.1 Ovensorincubatorsthatwillmaintaintemperaturesof
37, 50, 70 6 2°C (98, 122, 158 6 3°F).
5.2 The limitations of the results obtained from this practice
6.2.2 Water baths capable of maintaining temperatures de-
should be recognized. The choices of the extraction vehicle,
scribed in 6.2.1. Those with the ability to agitate the extraction
duration of immersion, and temperature of the test are neces-
vessels are preferred.
sarily arbitrary. The specification of these conditions provides
a basis for standardization and serves as a guide to investiga-
6.3 Extraction Containers—Suitable containers that protect
tors wishing to compare the relative resistance of various
the extract liquid from the biological and chemical contamina-
plastics or other materials to extraction vehicles.
tion. They should allow expansion of the liquid, but then be
sealed to prevent evaporation. One suggested container is the
5.3 Correlationoftestresultswiththeactualperformanceor
screw-cap culture test tube of borosilicate glass, unless a larger
serviceability of materials is necessarily dependent upon the
containerisrequiredforthesizeandshapeofthematerialtobe
similarity between the testing and end-use conditions (see
extracted. Screw caps, if used, shall have polytetrafluoroethyl-
12.1.2 and Note 7).
ene liners.
5.4 Caution should be exercised in the understanding and
intent of this practice as follows: 6.4 Balance, accurate to 60.1 mg.
5.4.1 No allowance or distinction is made for variables such
6.4.1 Caution should be exercised when performing weigh-
as end-use application and duration of use. Decisions on
ings in glassware. Depending upon the required accuracy, the
selection of tests to be done should be made based on Practice
relative humidity should be the same for weighings at different
F748.
times.
5.4.2 This practice was originally designed for use with
6.5 Micrometers, capable of measuring dimensions of test
nonporous, solid materials. Its application for other materials,
specimens to 0.025 mm (0.001 in.).
such as those that are porous, absorptive (for example, sponge-
like materials that are capable of absorbing liquid), or
7. Reagents and Materials
resorptive, should be considered with caution. Consideration
7.1 Purity of Reagents—Reagent grade, or better, chemicals
shouldbegiventoalteringthespecifiedmaterial-to-liquidratio
to allow additional liquid to fully hydrate the material and shall be used in all tests. Other grades may be used, provided
it is first ascertained that the reagent is of sufficiently high
additional liquid or other methods to fully submerge the test
specimen. Additional procedures that fully remove the extract purity to permit its use without lessening the accuracy of the
determination.
liquid from the test specimen, such as pressure or physically
squeezing the material, should also be considered as appropri-
ate. Although no definitions are given in this practice for the
following terms, such items as extraction vehicle surface
Reagent Chemicals, American Chemical Society Specifications, American
tension at the specified extraction condition and test specimen
Chemical Society, Washington, DC. For Suggestions on the testing of reagents not
listed by the American Chemical Society, see Annual Standards for Laboratory
physical structure should be taken into account.
Chemicals, BDH Ltd., Poole, Dorset, U.K., and the United States Pharmacopeia
NOTE 1—While there are no standardized methods available at present and National Formulary, U.S. Pharmacopeial Convention, Inc. (USPC), Rockville,
for determining the solvent absorption capacity of an absorptive device or MD.
F619 − 20
7.2 Extraction Vehicles—The following list of standard for full immersion of its component pieces in the extraction
extraction vehicles is intended to simulate the main constitu- vehicle. Under no circumstances shall such cutting be allowed
ents of human body fluids. The extraction vehicles shall be: to reduce the appropriate sample extraction ratio as determined
7.2.1 Sodium Chloride Injection, USP, containing by weight in9.2.1or9.2.2.Ifthespecimencannotbecut,couponsknown
not less than
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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 − 14 F619 − 20
Standard Practice for
Extraction of Medical PlasticsMaterials Used in Medical
Devices
This standard is issued under the fixed designation F619; 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 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 refereereference method for the
measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to
determine if the methods described in this standard are appropriate for the materials in their device.
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 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes
used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to
Guide E3231.
1.5 The values stated in inch-poundSI units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SIinch-pound units that are provided for information only and are not considered standard.
1.6 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
This practice is under the jurisdiction of ASTM 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 March 1, 2014Aug. 1, 2020. Published April 2014September 2020. Originally approved in 1979. Last previous edition approved in 20082014
as F619 – 03 (2008).F619 – 14. DOI: 10.1520/F0619-14. 10.1520/F0619-20.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F619 − 20
2. Referenced Documents
2.1 ASTM Standards:
D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents
D570 Test Method for Water Absorption of Plastics
D1193 Specification for Reagent Water
D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
D1898E3231 Practice for Sampling of PlasticsGuide for Cell Culture Growth Assessment of Single-Use Material (Withdrawn
1998)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
2.2 Other Documents:
USP NF 24 or current edition
3. Definitions
3.1 extraction vehicle—a liquid specified for use in testing the plastic. test specimen. 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 test specimen 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, final product or materials used in its construction, 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.
4.2 A choice 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 suitable containers as described in 6.3 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 containers.
Consideration should be given as to whether the extraction should be done under aseptic conditions.Extraction should be done
under aseptic conditions for use in biological testing, unless otherwise justified. 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 or
other materials used in medical devices.
5.2 The limitations of the results obtained from this practice should be recognized. The choicechoices of the extraction vehicle,
duration of immersion, and temperature of the test isare 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 or other
materials 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 47).
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
F619 − 20
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 absorptive (for example, sponge-like materials that are capable of absorbing liquid), or
resorptive, should be considered with caution. Consideration should be given to altering the specified material to liquid
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.specimen. Additional procedures that fully remove the extract liquid from the test article,specimen, 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
plastictest specimen physical structure should be taken into account.
NOTE 1—While there are no standardized methods available at present for determining the solvent absorption capacity of an absorptive device or material,
a suggested protocol is as follows:
– Determine the volume of extraction vehicle that each 0.1 g or 1.0 cm of device/material absorbs;
– then, in performing the extraction, add this additional volume to each 0.1 g or 1.0 cm in an extraction mixture.
5.5 Test Methods D543, D570, and D1239 and Practices D543 may be useful in providing supplemental information.
6. Apparatus
6.1 Autoclave, Autoclave (for 121°C extractions), capable of maintaining a temperature of 121 6 2.0°C (249.8 6 3.8°F) for at
least 1 h and equipped with a display 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 the 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
boil-over has passed. When the extraction vessels are cool to the touch, the lids should be sealed.
6.2 Heating Equipment: Equipment (for other temperature extractions):
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 Caution should be exercised when performing weighings in glassware. Depending upon the required accuracy, the relative
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.).
F619 − 20
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 is
first ascertained that the reagent is of sufficiently high purity to permit its use without lessening the accuracy of the determination.
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:
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 required, such as polyethylene glycol, DMSO, dimethyl sulfoxide (DMSO), as specified in other
standards. Vehicles should be chosen based on biotolerance, the test protocols to be used, and the ability to extract contaminants
from the material to be tested.
NOTE 2—Depending upon the material under test and the user’s needs, extraction vehicles other than those in 7.2 and 7.3 may be used if the reasons are
justified.
8. Sampling
8.1 The application of this practice may be in various areas. Therefore, although some wel
...