ASTM F1984-99(2013)
(Practice)Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
SIGNIFICANCE AND USE
5.1 Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. This practice is useful as a simple, inexpensive screening method for determining functional whole complement activation by solid materials in vitro.
5.2 This practice is composed of two parts. In Part A (Section 11), human serum is exposed to a solid material. Complement may be depleted by the classical or alternative pathways. In principle, nonspecific binding of certain complement components also may occur. The alternative pathway can deplete later acting components common to both pathways, that is components other than C1, C4, and C3 (1) .4 In Part B (Section 12), complement activity remaining in the serum after exposure to the test material is assayed by classical pathway-mediated lysis of sensitized RBC.
5.3 Assessment of in vitro whole complement activation, as described here, provides one method for predicting potential complement activation by medical materials intended for clinical application in humans when the material contacts the blood. Other test methods for complement activation are available, including assays for specific complement components and their split products (see X1.3 and X1.4).
5.4 This in vitro test method is suitable for adoption in specifications and standards for screening solid materials for use in the construction of medical devices intended to be implanted in the human body or placed in contact with human blood.
SCOPE
1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood.
1.2 This practice is intended to evaluate the acute in vitro whole complement activating properties of solid materials intended for use in contact with blood. For this practice, the words “serum” and “complement” are used interchangeably (most biological supply houses use these words synonymously in reference to serum used as a source of complement).
1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum, using a 0.1-mL serum/13 x 100-mm disposable test tube. Cellulose acetate powders and fibers are used as examples of test materials. Procedure B describes assaying the exposed serum for significant functional whole complement depletion as compared to control samples.
1.4 This practice does not address function, elaboration, or depletion of individual complement components, nor does it address the use of plasma as a source of complement.
1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F1984 − 99 (Reapproved 2013)
Standard Practice for
Testing for Whole Complement Activation in Serum by Solid
1
Materials
This standard is issued under the fixed designation F1984; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F748PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.1 This practice provides a protocol for rapid, in vitro
2.2 ISO Document:
screening for whole complement activating properties of solid
ISO 10993-4:Biological Evaluation of Medical Devices,
materials used in the fabrication of medical devices that will
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Part 4: Selection of Tests for Interactions with Blood
contact blood.
1.2 This practice is intended to evaluate the acute in vitro
3. Terminology
whole complement activating properties of solid materials
3.1 Abbreviations:
intended for use in contact with blood. For this practice, the
3.1.1 Ab—antibody (hemolysin).
words “serum” and “complement” are used interchangeably
3.1.2 BBS—barbital buffered saline.
(most biological supply houses use these words synonymously
3.1.3 BBS-G—barbital buffered saline—gelatin.
in reference to serum used as a source of complement).
3.1.4 BBS-GM—barbital buffered saline—gelatin metals.
1.3 This practice consists of two procedural parts. Proce-
dureAdescribesexposureofsolidmaterialstoastandardlotof
3.1.5 C'—complement.
human serum, using a 0.1-mL serum/13 x 100-mm disposable
3.1.6 EDTA—ethylenediaminetetraacetic acid, disodium
test tube. Cellulose acetate powders and fibers are used as
salt: dihydrate.
examples of test materials. Procedure B describes assaying the
3.1.7 HS—human serum.
exposed serum for significant functional whole complement
3.1.8 PVDF—polyvinylidene fluoride.
depletion as compared to control samples.
3.1.9 RBC—red blood cell(s).
1.4 This practice does not address function, elaboration, or
depletion of individual complement components, nor does it
4. Summary of Practice
address the use of plasma as a source of complement.
4.1 Solid material specimens are exposed to contact with a
1.5 This practice is one of several developed for the
standard lot of complement under defined conditions (Proce-
assessment of the biocompatibility of materials. Practice F748
dureA).Exposedserumthenistestedforsignificantfunctional
may provide guidance for the selection of appropriate methods
complement depletion compared to controls under identical
for testing materials for other aspects of biocompatibility.
conditions (Procedure B).
1.6 The values stated in SI units are to be regarded as
5. Significance and Use
standard. No other units of measurement are included in this
standard.
5.1 Inappropriate activation of complement by blood-
contacting medical devices may have serious acute or chronic
2. Referenced Documents
effects on the host. This practice is useful as a simple,
2
2.1 ASTM Standards:
inexpensive screening method for determining functional
whole complement activation by solid materials in vitro.
1 5.2 This practice is composed of two parts. In Part A
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
(Section 11), human serum is exposed to a solid material.
F04.16 on Biocompatibility Test Methods.
Complement may be depleted by the classical or alternative
Current edition approved Dec. 1, 2013. Published February 2014. Originally
pathways. In principle, nonspecific binding of certain comple-
approved in 1999. Last previous edition approved in 2008 as F1984–99 (2008).
mentcomponentsalsomayoccur.Thealternativepathwaycan
DOI: 10.1520/F1984-99R13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
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Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
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F1984 − 99 (2013)
deplete later acting components common to both pathways, 6.7 BBS-G-EDTA (to be used in preparing RBC before
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that is components other than C1, C4, and C3 (1). In Part B being washed out), is prepared by adding 10 mLof stock 10X
(Section12),complementactivityremainingintheserumafter EDTA to 90 mL of BBS-G in a volumetric flask.
exposure to the test material is assayed by classical pathway-
7. Preparation of Sh
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