ASTM-E2524 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

ASTM-E2524 - 2022 EDITION - CURRENT
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Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 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.

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.

Keywords

hemolysis; nanoparticulate; plasma; whole blood;

To find similar documents by ASTM Volume:

14.02 (General Test Methods; Forensic Psychophysiology; Forensic Sciences; Terminology; Conformity Assessment; Statistical Methods; Nanotechnology; Forensic Engineering; Manufacture of Pharmaceutical Products)

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

71.100.01 (Products of the chemical industry in general)

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Document Number

ASTM-E2524-22

Revision Level

2022 EDITION

Status

Current

Modification Type

Reinstated

Publication Date

Oct. 4, 2022

Document Type

Test Method

Page Count

6 pages

Committee Number

E56.03