ASTM-F2567 2010

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F2567-06(2010) Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials

Published By	Publication Date	Number of Pages
ASTM	2010	10

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Categories: 11.100.20 - Biological evaluation of medical devices, ASTM

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Description

ASTM F2567-06-Reapproved2010

Withdrawn Standard: Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)

ASTM F2567

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 13×100 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 F748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility. Practice F1984 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 F2065 provides guidance for testing solid materials for alternative pathway complement activation in serum.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 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.

Keywords

biocompatibility; blood compatibility; classical pathway; complement testing; materials; medical devices; Blood materials/applications; Medical devices/equipment; Serum; Biocompatibility

ICS Code

ICS Number Code 11.100.20 (Biological evaluation of medical devices)

DOI: 10.1520/F2567-06R10

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Summary of Practice Significance and Use Preparation of Buffers
3	Preparation of Sheep RBC Absorption of Serum (Complement) Determination of Optimal Hemolysin Concentration
4	Titration of Human Complement and C4(-)GPS to Determine Optimal Dilutions Procedure A—Exposure of Material to Human Serum
5	FIG. 1 FIG. 2
6	Procedure B—Assay of Human Serum Exposed to Material in Procedure A, for its Ability to Reconstitute C4 Classical Pathway Complement Activity of C4(-)GPS FIG. 3
7	Necessary Controls Report Section and Data Analysis FIG. 4
8	Keywords FIG. 5
9	X1. RATIONALE X1.1 X1.2 X1.3 FIG. 6
10	X1.4 X1.5 REFERENCES

Additional information

Standard Title	F2567-06(2010) Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials
Published Code	ASTM
Publication Date	2010
Pages Count	10
ICS Codes	11.100.20 - Biological evaluation of medical devices