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  • ASTM
    E2524-08(2013) Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
    Edition: 2013
    $93.60
    Unlimited Users per year

Description of ASTM-E2524 2013

ASTM E2524 - 08(2013)

Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

Active Standard ASTM E2524 | Developed by Subcommittee: E56.03

Book of Standards Volume: 14.02




ASTM E2524

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.

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

Nominal Conc.,
mg/mL

Preparation Procedure

QC 1

0.625

1.5 mL of stock solution + 0.42 mL of CMH reagent

QC 2

0.125

200 ?L of QC1 + 800 ?L of CMH reagent

QC 3

0.0625

100 ?L of QC1 + 900 ?L of CMH reagent


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.


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

ASTM International is a member of CrossRef.

ASTM E2524

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ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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