1.1 本试验方法提供了一种定量分析生理溶液（等渗，pH 7.2±0.2）中纳米颗粒材料对粒细胞-巨噬细胞集落形成单位（CFU-GM）影响的方案。 1.2 CFU-GM反映了分化为粒细胞和巨噬细胞的活骨髓细胞的数量。CFU-GM计数的减少表明受试物质对骨髓的毒性，通常用于鉴定具有骨髓抑制特性的药物产品，这是一种免疫抑制。 1.3 本试验方法使用小鼠骨髓造血干细胞，这些细胞增殖和分化形成离散的细胞簇或集落，并进行计数。 1.4 本试验方法是 体外 用于医疗应用中全身给药的纳米颗粒材料的临床前表征级联。 1.5 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户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 造血来源的干细胞具有多潜能，可能对纳米颗粒材料的刺激作用特别敏感。 5.2 颗粒对巨噬细胞反应的影响有着广泛的历史，可以通过实践进行评估 F1903 .本文所述的测试方法将评估对干细胞的影响，干细胞可能是巨噬细胞系的祖细胞。

1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution (isotonic, pH 7.2 ± 0.2) on granulocyte-macrophage colony-forming units (CFU-GM). 1.2 CFU-GM reflects the number of viable bone marrow cells which differentiate into granulocytes and macrophages. A decrease in CFU-GM count is indicative of a test substance’s toxicity to bone marrow and is commonly used for the identification of drug products with myelosuppressive properties, a form of immunosuppression. 1.3 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted. 1.4 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration 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 Stem cells of hematopoietic origin are pluripotential and may be particularly sensitive to the effects of stimulation by nanoparticulate materials. 5.2 The effect of particles on macrophage responses has an extensive history and can be assessed by Practice F1903 . The test method described here will assess the effect on stem cells which can be progenitor cells to the macrophage line.