ASTM F619-20
(Practice)Standard Practice for Extraction of Materials Used in Medical Devices
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...
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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
1
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
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-
3
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 service@astm.org. 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.
3
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 1
...
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
1
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.
1
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
1
---------------------- Page: 1 ----------------------
F619 − 20
2. Referenced Documents
2
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:
3
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 b
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