ASTM E2526-08
Historical Standard: ASTM E2526-08 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
SUPERSEDED (see Active link, below)
ASTM E2526
1. Scope
1.1 This test method provides a methodology to assess the cytotoxicity of suspensions of nanoparticulate materials in porcine proximal tubule cells (LLC-PK1) and human hepatocarcinoma cells (Hep G2) which represents potential target organs following systemic administration
1.2 This test method is part of the in vitro preclinical characterization cascade.
1.3 This test method consists of a protocol utilizing two methods for estimation of cytotoxicity, 3-(4,5-Dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide (MTT) reduction and lactate dehydrogenase (LDH) release.
1.4 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
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F1877 Practice for Characterization of Particles
F1903 Practice for Testing For Biological Responses to Particles In Vitro
ISO Standard
ISO10993-5 Biological Evaluation of Medical Devices: Part 5 Tests for in vitro Cytotoxicity Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.Keywords
cytotoxicity; hepatocytes; kidney cells; nanoparticles;
ICS Code
ICS Number Code 07.100.10 (Medical microbiology)
DOI: 10.1520/E2526-08
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