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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.
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.
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 StandardISO10993-4 Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood
ICS Number Code 11.040.20 (Transfusion, Infusion); 71.100.01 (Products of the chemical industry in general)