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Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

Standard NumberASTM E2524 - 08(2013)
OrganizationAmerican Society for Testing and Materials
LevelNational
CategoryTest Method
Status
  • JAN 2008Published
  • JAN 2013Reviewed and Confirmed
ABSTRACT
Significance and Use 5.1 This test method is one of a series of tests listed in Practice F748 and ISO 10993-4 to assess the biocompatibility of materials contacting blood in medical applications. 5.2 This test method is similar to Practice F756 but modified to accommodate nanoparticulate materials. 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 F756 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 stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.