1.1 本试验方法解决了在水悬浮液中使用分批模式（离线）动态光散射（DLS）测定纳米颗粒尺寸（等效球体流体动力学直径），并建立了适用于许多商业DLS仪器的一般程序。本测试方法规定了最佳实践，包括样品制备、性能验证、数据分析和解释以及结果报告。该文件包括分析员的其他一般信息，例如特定介质的建议设置、潜在干扰和方法限制。讨论了使用DLS数据进行监管提交的具体问题。 1.2 原则上，本试验方法中描述的程序和实践可适用于在典型实验时间范围内表现出布朗运动且运动稳定的任何粒子。实际上，这包括直径高达约1000 nm的颗粒，受试验方法中所述限制。 1.3 本试验方法不提供所有可能材料和应用的试样制备程序，也不涉及取样前的合成或处理。试样（悬浮液）制备程序应为各种材料和条件提供可接受的结果。分析员必须验证其特定应用的适当性。 1.4 该测试方法适用于实现相关光谱的DLS仪器。使用基于频率分析的仪器的分析员仍然可以找到与测量过程的许多方面相关的有用信息，包括适用性限制和最佳实践。在线（流动模式）分布式账本系统测量在此不作专门处理，可能存在与批处理模式操作相关的其他限制或问题。 1.5 单位- 以国际单位制表示的数值应视为标准值。在适当情况下，c。 g、 除国际单位制外，还提供了美国单位。 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 粒径是制造或工程纳米颗粒的一个关键特性，用于广泛的应用。为了评估产品的安全性、有效性、性能、质量、公共健康影响或监管状态，在使用条件下或制造过程中正确测量和统一报告尺寸和相关参数对供应商、分析师、监管机构和其他利益相关者至关重要。 5.2 本试验方法主要用于分析尺寸在1 nm至100 nm之间的水悬浮液中的纳米颗粒，但可适用于扩散胶体颗粒，即使其尺寸在纳米尺度范围（高达1000 nm）之外。 5.3 有关分布式账本系统测量（包括操作方面）的更详细指导，请参阅 附录X2 本试验方法。 注1: 用户也可参考指南 E2490 这为DLS在纳米材料中的应用提供了广泛的指导。指导 E2490 实施本试验方法不需要。

1.1 This test method addresses the determination of nanoparticle size (equivalent sphere hydrodynamic diameter) using batch-mode (off-line) dynamic light scattering (DLS) in aqueous suspensions and establishes general procedures that are applicable to many commercial DLS instruments. This test method specifies best practices, including sample preparation, performance verification, data analysis and interpretation, and reporting of results. The document includes additional general information for the analyst, such as recommended settings for specific media, potential interferences, and method limitations. Issues specific to the use of DLS data for regulatory submissions are addressed. 1.2 The procedures and practices described in this test method, in principle, may be applied to any particles that exhibit Brownian motion and are kinetically stable during the course of a typical experimental time frame. In practice, this includes particles up to about 1000 nm in diameter, subject to limitations as described in the test method. 1.3 This test method does not provide test specimen preparation procedures for all possible materials and applications, nor does it address synthesis or processing prior to sampling. The test specimen (suspension) preparation procedures should provide acceptable results for a wide range of materials and conditions. The analyst must validate the appropriateness for their particular application. 1.4 This test method is applicable to DLS instruments that implement correlation spectroscopy. Analysts using instruments based on frequency analysis may still find useful information relevant to many aspects of the measurement process, including limits of applicability and best practices. On-line (flow-mode) DLS measurements are not treated here specifically and may have additional limitations or issues relative to batch-mode operation. 1.5 Units— The values stated in SI units are to be regarded as standard. Where appropriate, c.g.s. units are given in addition to SI. 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 Particle size is a key property of manufactured or engineered nanoparticles used in a wide range of applications. For purposes relevant to evaluations of safety, effectiveness, performance, quality, public health impact, or regulatory status of products, the correct measurement and uniform reporting of size and related parameters under use conditions, or during the manufacturing process, are critical to suppliers, analysts, regulators and other stakeholders. 5.2 This test method is intended principally for the analysis of nanoparticles in aqueous suspension with dimensions between about 1 nm and 100 nm, but may be applied to diffusive colloidal particles even if their dimensions fall outside the nanoscale range (up to 1000 nm). 5.3 For more detailed guidance on DLS measurements, including operational aspects, refer to Appendix X2 of this test method. Note 1: The user is also referred to Guide E2490 , which provides broad guidance for the application of DLS to nanomaterials. Guide E2490 is not required for the implementation of this test method.