1.1 本试验方法包括评估纳米颗粒材料对红细胞完整性的影响。 1.2 该试验方法使用稀释的全血与纳米颗粒材料孵育，并测定受损红细胞释放的血红蛋白。 1.3 此测试方法与实践类似 556英镑 体积减小以适应纳米颗粒材料。 1.4 此测试方法是 体外 临床前表征，对于将在医疗应用中接触血液的纳米颗粒材料来说非常重要。 1.5 以国际单位表示的数值视为标准值。本标准不包括其他计量单位。 1.6 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 5.1 此测试方法是实践中列出的一系列测试之一 F748（表格748） 以及ISO 10993-4，以评估医用接触血液材料的生物相容性。 5.2 此测试方法与实践类似 556英镑 但经过修改以适应纳米颗粒材料。

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.