ASTM F2567-06

Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials

SCOPE
1.1 This practice provides a protocol for rapid, in vitro functional screening for classical pathway 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 classical pathway complement activating properties of solid materials intended for use in contact with blood. For this practice, "serum" is synonymous with "complement."
1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum [HS], using 0.1 mL serum per 13100 mm disposable glass test tube. Procedure B describes assaying the exposed serum for significant functional classical pathway complement depletion (decrease in amount of C4) as compared to control serum samples not exposed to the material. The endpoint in Procedure B is lysis of sheep red blood cells (RBC) coated with antibody (hemolysin).
1.4 This practice does not 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 F 748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility. Practice F 1984 provides guidance for testing solid materials for whole complement activation in human serum, but does not discriminate between the classical or alternative pathway of activation. Practice F 2065 provides guidance for testing solid materials for alternative pathway complement activation in serum.
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2006
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Replaced By: ASTM F2567-06(2010) - Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
• Effective Date: 01-Sep-2010

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2567–06
Standard Practice for
Testing for Classical Pathway Complement Activation in
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Serum by Solid Materials
This standard is issued under the fixed designation F2567; 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 2. Referenced Documents
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1.1 This practice provides a protocol for rapid, in vitro 2.1 ASTM Standards:
functionalscreeningforclassicalpathwaycomplementactivat- F748 Practice for Selecting Generic Biological Test Meth-
ing properties of solid materials used in the fabrication of ods for Materials and Devices
medical devices that will contact blood. F1984 Practice for Testing for Whole Complement Activa-
1.2 This practice is intended to evaluate the acute in vitro tion in Serum by Solid Materials
classical pathway complement activating properties of solid F2065 Practice for Testing for Alternative Pathway
materials intended for use in contact with blood. For this Complement Activation in Serum by Solid Materials
practice, “serum” is synonymous with “complement.” 2.2 Other Document:
1.3 This practice consists of two procedural parts. Proce- ISO 10993-4 Biological Evaluation of Medical Devices,
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dureAdescribesexposureofsolidmaterialstoastandardlotof Part 4: Selection of Tests for Interactions with Blood
human serum [HS], using 0.1 mL serum per 133100 mm
3. Terminology
disposable glass test tube. Procedure B describes assaying the
exposed serum for significant functional classical pathway 3.1 Definition of Term Specific to This Standard:
3.1.1 water—distilled, endotoxin-free.
complementdepletion(decreaseinamountofC4)ascompared
to control serum samples not exposed to the material. The 3.2 Abbreviations:
3.2.1 Ab—antibody (hemolysin)
endpointinProcedureBislysisofsheepredbloodcells(RBC)
coated with antibody (hemolysin). 3.2.2 BBS—barbital buffered saline
3.2.3 BBS-G—barbital buffered saline–gelatin
1.4 This practice does not address the use of plasma as a
3.2.4 BBS-GM (Ca Buffer)—barbitalbufferedsaline–gelatin
source of complement.
1.5 This practice is one of several developed for the metals
3.2.5 C8—complement
assessment of the biocompatibility of materials. Practice F748
may provide guidance for the selection of appropriate methods 3.2.6 C4—the fourth component of complement
3.2.7 C4(-)GPS—C4-deficient guinea pig serum [serum
for testing materials for other aspects of biocompatibility.
PracticeF1984providesguidancefortestingsolidmaterialsfor from guinea pigs genetically incapable of producing C4]
3.2.8 EDTA—ethylenediaminetetraacetic acid, disodium
whole complement activation in human serum, but does not
discriminate between the classical or alternative pathway of salt, dihydrate
3.2.9 HAGG—heat aggregated gamma globulin
activation. Practice F2065 provides guidance for testing solid
materials for alternative pathway complement activation in 3.2.10 HS—human serum
3.2.11 I—“ice” control tube with serum but no material,
serum.
1.6 This standard does not purport to address all of the kept on ice
3.2.12 M—tube containing serum plus a test material
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 3.2.13 NM—tube containing serum but no material
3.2.14 RBC—red blood cell(s)
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.16 on Biocompatibility Test Methods. the ASTM website.
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Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved Oct. 1, 2006. Published October 2006. DOI: 10.1520/
F2567-06. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2567–06
4. Summary of Practice 5.4 Assessment of in vitro classical complement activation
as described here provides one method for predicting potential
4.1 This practice is based on a method published by Gaither
4 complement activation by solid medical device materials
et al, 1974 (1).
intended for clinical application in humans when the material
4.2 Solid material specimens are exposed to a standard lot
contacts
...