ASTM E2524-08
Historical Standard: ASTM E2524-08 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
SUPERSEDED (see Active link, below)
ASTM E2524
1. Scope
1.1 This test method covers assessing the effect of nanoparticulate materials on the integrity of red blood cells.
1.2 This test method uses diluted whole blood incubated with nanoparticulate material and the hemoglobin released from damaged red blood cells is determined.
1.3 This test method is similar to Practice F 756 with the volumes reduced to accommodate nanoparticulate material.
1.4 This test method is part of the in-vitro preclinical characterization and is important for nanoparticulate material that will contact the blood in medical applications.
1.5 The values given in SI units are to be considered as the 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F756 Practice for Assessment of Hemolytic Properties of Materials
F1877 Practice for Characterization of Particles
F1903 Practice for Testing For Biological Responses to Particles In Vitro
ISO Standard
ISO10993-4 Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.Keywords
hemolysis; nanoparticulate; plasma; whole blood;
ICS Code
ICS Number Code 11.040.20 (Transfusion, Infusion); 71.100.01 (Products of the chemical industry in general)
DOI: 10.1520/E2524-08
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