ASTM E2524-08(2013)
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

Standard No.
ASTM E2524-08(2013)
Release Date
2008
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM E2524-22
Latest
ASTM E2524-22
Scope

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.

TABLE 1 Calibration Standards

Level

Nominal Conc.,
mg/mL

Preparation Procedure

Cal 1

0.8

2 mL of stock solution

Cal 2

0.4

1 mL of Cal1 + 1 mL of CMH reagent

Cal 3

0.2

1 mL of Cal2 + 1 mL of CMH reagent

Cal 4

0.1

1 mL of Cal3 + 1 mL of CMH reagent

Cal 5

0.05

1 mL of Cal4 + 1 mL of CMH reagent

Cal 6

0.025

1 mL of Cal5 + 1 mL of CMH reagent


TABLE 2 Quality Controls

Level

ASTM E2524-08(2013) Referenced Document

  • ASTM F1877 Standard Practice for Characterization of Particles
  • ASTM F1903 Standard Practice for Testing for Biological Responses to Particles In Vitro
  • ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
  • ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
  • ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1

ASTM E2524-08(2013) history

  • 2022 ASTM E2524-22 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
  • 2008 ASTM E2524-08(2013) Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
  • 2008 ASTM E2524-08 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles


Copyright ©2024 All Rights Reserved