ASTM E2526-22 PDF

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 represent potential target organs following systemic administration. 1.2 This test method is part of an in vitro preclinical characterization cascade. 1.3 This test method consists of a protocol utilizing two methods for estimation of cytotoxicity, 3-(4,5dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide (MTT) reduction and lactate dehydrogenase (LDH) release. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM E2526-22 Referenced Document

ASTM F1877 Standard Practice for Characterization of Particles
ASTM F1903 Standard Practice for Testing for Biological Responses to Particles In Vitro
ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods

2022 ASTM E2526-22 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
2008 ASTM E2526-08(2013) Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
2008 ASTM E2526-08 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells