1.1 本指南为选择合适的器械尺寸和确定合适的样本尺寸（即样本数量）提供了指导，用于血管内器械的设计验证测试。提出了一种方法来确定应选择哪些器件尺寸进行测试，以充分验证器件设计是否符合每个设计输入要求（即测试特性）。此外，提出并讨论了不同的统计方法，以帮助指导开发人员确定和证明验证设计输入需求的样本量。用于确定器件尺寸选择和样本尺寸选择的替代方法可用于设计验证。 1.2 本指南适用于物理设计验证测试。 本指南涉及体外试验；体内/动物研究不在本指南范围内。本指南不直接涉及设计验证；然而，提出的方法可能适用于体外设计验证测试。未提供与计算模拟（例如灵敏度分析和容差分析）相关的采样指南。未提供使用模型（如实验设计）进行设计验证测试的指南。本指南不涉及跨多个制造批次的采样，因为这通常作为过程验证来完成。应特别考虑某些测试，如疲劳（见实践 E739 )和保质期测试（见第节 8. ). 1.3 对于设计验证装置尺寸和样本尺寸选择时应考虑的血管内装置，可能存在监管指南。 1.4 单位- 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.5 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。 1.6 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====== 4.1 本指南旨在为选择合适的器械尺寸和确定合适的样本尺寸提供指导，以用于血管内器械的设计验证。每个设计输入要求的设备尺寸和样本尺寸应在测试前确定。选择用于验证测试的设备尺寸应确定整个设备矩阵能够达到设计输入要求。如果未对所有设备尺寸进行测试，则应提供理由。 4.2 用于分析数据的样本量证明和统计程序应基于可靠的科学原则，并应适合得出合理的结论。 样本量不足可能导致错误结论的发生率高于预期。 4.3 第节提供了关于确定设备尺寸选择和适当样本大小的方法的指导 5. 和 6. .

1.1 This guide provides guidance for selecting an appropriate device size(s) and determining an appropriate sample size(s) (that is, number of samples) for design verification testing of endovascular devices. A methodology is presented to determine which device size(s) should be selected for testing to verify the device design adequately for each design input requirement (that is, test characteristic). Additionally, different statistical approaches are presented and discussed to help guide the developer to determine and justify sample size(s) for the design input requirement being verified. Alternate methodologies for determining device size selection and sample size selection may be acceptable for design verification. 1.2 This guide applies to physical design verification testing. This guide addresses in-vitro testing; in-vivo/animal studies are outside the scope of this guide. This guide does not directly address design validation; however, the methodologies presented may be applicable to in-vitro design validation testing. Guidance for sampling related to computational simulation (for example, sensitivity analysis and tolerance analysis) is not provided. Guidance for using models, such as design of experiments (DOE), for design verification testing is not provided. This guide does not address sampling across multiple manufacturing lots as this is typically done as process validation. Special considerations are to be given to certain tests such as fatigue (see Practice E739 ) and shelf-life testing (see Section 8 ). 1.3 Regulatory guidance may exist for endovascular devices that should be considered for design verification device size and sample size selection. 1.4 Units— The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.5 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. 1.6 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 ====== 4.1 The purpose of this guide is to provide guidance for selecting appropriate device size(s) and determining appropriate sample size(s) for design verification of endovascular devices. The device size(s) and sample size(s) for each design input requirement should be determined before testing. The device size(s) selected for verification testing should establish that the entire device matrix is able to achieve the design input requirements. If testing is not performed on all device sizes, justification should be provided. 4.2 The sample size justification and statistical procedures used to analyze the data should be based on sound scientific principles and should be suitable for reaching a justifiable conclusion. Insufficient sample size may lead to erroneous conclusions more often than desired. 4.3 Guidance regarding methodologies for determining device size selection and appropriate sample size is provided in Sections 5 and 6 .