1.1 本指南描述了推荐的急性 体外试验 药物涂层球囊（DCB）涂层的表征方法。这些方法包括:涂层完整性、涂层厚度、药物涂层均匀性和释放的颗粒。具体而言，本指南详细介绍了: 1.1.1 通过检查涂层气球表面来表征完整性。 1.1.2 涂层厚度测量。 1.1.3 纵向和周向药物涂层均匀性（球囊表面药物分布的均匀性）的定量。 1.1.4 在模拟使用测试（插入、跟踪、部署、缩回和撤回）期间，定量不同尺寸范围内释放的颗粒数量，以及颗粒的化学和结晶度特征。 1.2 本文件不涉及: 1.2.1 药物涂层气球（DCBs）的机械测试。 1.2.2 DCBs的原料药评估（如含量测定、有关物质、剂量单位均匀性）。 1.2.3 生产发布和稳定性测试，尽管某些部分可能全部或部分适用。 1.2.4 标准分析测试（如药物含量、药物相关物质、药物剂量均匀性）。 1.3 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== 5.1 本文所述的方法允许 体外试验 DCB药物包衣属性的表征，以及临床前和临床安全性和有效性数据，确定了具有表征包衣属性的DCB是安全有效的。活性药物成分的不均匀分布、设备上的涂层异常和颗粒释放可能会影响临床安全性和治疗效益。 药物涂层的可变性可能会导致药物可用性不足或过高，以及设备性能不一致。 5.2 个体表征测试可能没有直接的临床相关性，尽管基于实验室的表征结果可以与其他数据相结合，以提供对影响临床安全性和有效性的特征的见解。台架测试在可重复和受控的条件下进行，提供有关药物涂层完整性、厚度、均匀性、颗粒脱落、颗粒特性和颗粒结晶度的信息。 5.3 药物包衣的分布特征是包衣的完整性、厚度和均匀性。颗粒物计数可以提供制造可重复性的度量，并可以提供以下指示 体内 如果模拟使用颗粒物和 体内 颗粒物被证明是相似的，或者颗粒物测试结果与 体内 安全。颗粒的化学特性和结晶度可能进一步说明与颗粒持久性、溶解性或其他特征相关的动力学，这些特征可能与 体内 安全。进行此测试和收集数据进一步允许对设备进行潜在的比较（例如，证明这些涂层属性的临床前和临床设备之间的等效性）。 5.4 本指南中描述的方法仅用于表征目的，不适用于药物涂层球囊导管的生产释放测试。然而，某些内容可能适用于生成发布数据。 此处提供的一般指南可用于产品开发过程各个阶段的产品控制。

1.1 This guide describes recommended acute in vitro characterization methods for drug-coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. Specifically, this guide details: 1.1.1 Characterization of integrity by inspection of the coated balloon surface. 1.1.2 Measurement of coating thickness. 1.1.3 Quantitation of drug coating uniformity (uniformity of drug distribution over the balloon surface) longitudinally and circumferentially. 1.1.4 Quantitation of the number of particulates released, in various size ranges, during simulated use testing (insertion, tracking, deployment, retraction, and withdrawal) along with chemical and crystallinity characterization of particulates. 1.2 This document does not address: 1.2.1 Mechanical testing of drug-coated balloons (DCBs). 1.2.2 Drug substance evaluation (e.g., assay, related substances, uniformity of dosage units) of DCBs. 1.2.3 Production release and stability testing, although some sections may be applicable in whole or in part. 1.2.4 Standard analytical testing (e.g., drug content, drug related substances, drug uniformity of dosage). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 The methods described herein allow for in vitro characterization of DCB drug coating attributes that, along with pre-clinical and clinical safety and effectiveness data, establish that the DCBs, with the characterized coating attributes, are safe and effective. Clinical safety and therapeutic benefit may be affected by nonuniform distribution of the active pharmaceutical ingredient, coating anomalies on the device, and particulate release. Variability in drug coating may result in insufficient or excessive drug availability and inconsistent device performance. 5.2 Individual characterization tests may not have direct clinical relevance, although bench-based characterization results can be combined with other data to provide insight to characteristics that influence clinical safety and effectiveness. Bench testing is performed under repeatable and controlled conditions, providing information about drug coating integrity, thickness, uniformity, particulate shedding, particulate identity, and particulate crystallinity. 5.3 Distribution of the drug coating is characterized by coating integrity, thickness, and uniformity. Particulate counts can provide a measure of manufacturing repeatability, and may provide an indication of in vivo safety if simulated use particulates and in vivo particulates are shown to be similar, or if particulate testing results are correlated to in vivo safety. Chemical identity of particulates and crystallinity may further advise the kinetics related to the potential for particulate persistence, dissolution, or other characteristics which may relate to in vivo safety. Conducting this testing and gathering the data further allows for the potential comparison of devices (e.g., demonstrating equivalence between pre-clinical and clinical devices for these coating attributes). 5.4 The methods described in this guide are for characterization purposes and are not intended for production release testing of drug-coated balloon catheters. However, some content may be applicable to generating release data. The general guidelines presented here may be used for product control at various stages of the product development process.